Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Lead Agency: SHORT TITLE Reference Number; Title of Reg/Agency Action Tribal Consultation Policy Treasury (no reference number) Tribal Consultation Policy Agency release date; due date Agency’s Summary of Action for comments Released: This notice announces an interim policy outlining the guiding principles for all 12/3/2014 Department of Treasury (Treasury) bureaus and offices engaging with tribal Governments on matters with tribal implications. Treasury will update the Due date: policy periodically and refine it as needed to reflect ongoing engagement and 4/2/2015 collaboration with tribal partners. http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28383.pdf Notes: 12/3/2014: Coordinate response with NCAI. 1/21/2015: Elliott to check in with NCAI. IRS may be invited to Feb MMPC meeting. 2/4/2015: Richard to discuss Treasury – IRS relationship with Christie Jacobs with regard to the consultation policy and will circulate existing Treasury / IRS consultation policy, if any. 3/12/2015: Elliott to draft one page comment (in conjunction with NCAI efforts) 4/1/2015: Draft comment is embedded below. Draft NIHB Comments on Tribal Treasury Consultation Pol Survey Report Form for CLIA CMS-1557 Released: 3/6/2015 1. Type of Information Collection Request: Extension of a currently approved collection; Title: Survey Report Form for Clinical Laboratory Improvement 3/6/2015: Paperwork Amendments (CLIA) and Supporting Regulations; Use: Surveyors use the form Reduction Act notice. No PRA Request for Comment Due date: to report their findings during a CLIA survey. For each type of survey comments recommended. 4/6/2015 conducted (i.e., initial certification, recertification, validation, complaint, http://www.gpo.gov/fdsys/pkg/FR-2015-03addition/deletion of specialty/subspecialty, transfusion fatality investigation, 06/pdf/2015-05165.pdf or revisit inspections) the form incorporates the requirements specified in the CLIA regulations. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 1 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Transcatheter Mitral Valve Repair National Coverage Decision CMS-10531 PRA Request for Comment Released: 3/6/2015 Due date: 4/6/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0306/pdf/2015-05165.pdf 2. Type of Information Collection Request: New collection; Title: Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The CMS National Coverage Determination (NCD) titled, “Transcatheter Mitral Valve Repair (TMVR),” requires this data collection. Medicare covers the TMVR device only when specific conditions are met, including that the heart team and hospital submit data in a prospective, national, audited registry. The data includes patient-, practitioner-, and facility-level variables that predict outcomes such as all-cause mortality and quality of life. 3/6/2015: Paperwork Reduction Act notice. No comments recommended. The Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TMVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TMVR technologies for the treatment of mitral regurgitation (MR). The data also will include the variables on the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, functioning, and quality of life. The KCCQ allows the derivation of an overall summary score from the physical function, symptoms (frequency and severity), social function, and quality of life domains. Employer Notification of Objection to Covering Contraceptive Services CMS-10535 PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0306/pdf/2015-05165.pdf Roster key: Released: 3/6/2015 Due date: 4/6/2015 The data collected and analyzed in the TVT Registry will help determine if TMVR is reasonable and necessary (e.g., improves health outcomes) for Medicare beneficiaries under Section 1862(a)(1)(A) of the Social Security Act. Furthermore, data from the Registry will assist the medical device industry and the FDA in surveillance of the quality, safety, and efficacy of new medical devices to treat mitral regurgitation. For purposes of the TMVR NCD, the TVT Registry has contracted with the Data Analytic Centers to conduct the analyses. In addition, CMS will make data available for research purposes under the terms of a data use agreement that only provides de-identified datasets. 3. Type of Information Collection Request: Revision of a currently approved collection; Title: Employer Notification to HHS of its Objection to Providing Coverage for Contraceptive Services; Use: The proposed rules titled “Coverage of Certain Preventive Services Under the Affordable Care Act” (79 FR 51118) would continue to require each closely-held, for-profit corporation seeking treatment as an eligible organization to provide notification that it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive 3/6/2015: Paperwork Reduction Act notice. No comments recommended. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 2 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 services. Issuers and third party administrators providing payments for contraceptive services for participants and beneficiaries in plans of eligible organizations would have to meet the notice requirements as set forth in the 2013 final regulations. Medicaid Eligibility Changes Under ACA CMS-10410 Released: 2/6/2015 PRA Request for Comment Due date: 4/7/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf Income and Eligibility Verification System Reporting CMS-R-74 PRA Request for Comment Released: 2/6/2015 Due date: 4/7/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf Hospital and Hospital Health Care Complex Cost Report CMS-2552-10 Released: 2/6/2015 Due date: Roster key: The interim final regulations titled “Coverage of Certain Preventive Services Under the Affordable Care Act” (79 FR 51092) continue to allow eligible organizations that have religious objections to providing contraceptive coverage to notify an issuer or third party administrator using EBSA Form 700, as set forth in the July 2013 final regulations. In addition, the interim final regulations permit an alternative process under which an eligible organization could notify the HHS Secretary that it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive services. 1. Type of Information Collection Request: Extension of a currently approved collection; Title: Medicaid Program; Eligibility Changes Under the Affordable Care Act of 2010; Use: The eligibility systems are essential to the goal of increasing coverage in insurance affordability programs while reducing administrative burden on states and consumers. The electronic transmission and automation of data transfers serve as key elements in managing the expected insurance affordability program caseload that started in 2014. 2. Type of Information Collection Request: Extension of a currently approved collection; Title: Income and Eligibility Verification System Reporting and Supporting Regulations; Use: A state Medicaid agency that currently obtains and uses information from certain sources, or with more frequency than specified, could continue to do so to the extent that the verifications prove useful and not redundant. An agency that has found it effective to verify all wage or benefit information with another agency or with the recipient can continue these practices if it chooses. In addition, the agency can implement an approved targeting plan under 42 CFR 435.953. Agency experience should guide its decision whether to exceed these regulatory requirements on income and eligibility verification. While states can target resources when verifying income of course, agencies remain accountable for their accuracy in eligibility determinations. 3. Type of Information Collection Request: Revision of a currently approved collection; Title: Hospital and Hospital Health Care Complex Cost Report; Use: Providers of services participating in the Medicare program must, under sections 1815(a) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g), 2/6/2015: Extension of a currently approved Paperwork Reduction Act notice. No comments recommended. 2/6/2015: Extension of a currently approved Paperwork Reduction Act notice. No comments recommended. 2/6/2015: Paperwork Reduction Act notice. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 3 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 PRA Request for Comment 4/7/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. CMS seeks OMB review and approval of this revision to form CMS-2552-10, Hospital and Hospital Health Care Complex Cost Report. Hospitals participating in the Medicare program file these cost reports annually to determine the reasonable costs incurred to provide medical services to patients. The revisions made to the hospital cost report comport with the statutory requirement for hospice payment reform in § 3132 of ACA and the statutory requirement establishing a prospective payment system for Federally Qualified Health Centers in § 10501(i)(3)(A) of ACA. Medicare Enrollment Application: Reassignment of Benefits CMS-855R PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0206/pdf/2015-02414.pdf Released: 2/6/2015 Due date: 4/7/2015 4. Type of Information Collection Request: Revision of a currently approved collection; Title: Medicare Enrollment Application: Reassignment of Medicare Benefits ; Use: The CMS-855R enrollment application allows physicians and non-physician practitioners to reassign their Medicare benefits to a group practice and to gather information from the individual that tells CMS who he/she is, where he/she renders services, and information necessary to establish correct claims payment. CMS periodically evaluates and revises the CMS-855R enrollment application to simplify and clarify the information collection without jeopardizing its need to collect specific information. The proposed changes incorporate changes related to hospice care and a PPS system for FQHCs. This PRA notice may be of interest to some Indian health care providers. 2/6/2015: Paperwork Reduction Act notice. Minor changes to an already approved collection. No comments recommended. CMS has made very few minor revisions to the CMS-855R (Reassignment of Benefits) Medicare enrollment application (OMB 0938-1179). CMS has revised two sections within the form to maintain sync with online and paper forms. The previously approved CMS-855R section 2 collected information regarding the individual practitioner reassigning benefits and section 3 collected information regarding the organization/group receiving the reassigned benefits. CMS has reversed these two sections but has not revised information or data collection within these sections. With the exception of this section reversal and adding the word “optional” to sections 4 and 5 (primary practice location and contact person information), CMS has made no other revisions. These revisions offer no new data collection in this revision package. The addition of the optional choice in sections 4 and 5 could potentially reduce the burden to providers who choose not to complete either or both optional sections. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 4 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Rural Health Care Services Outreach Program Measures HRSA (OMB 0906-xxxx) PRA Request for Comment Released: 3/9/2015 Due date: 4/8/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0309/pdf/2015-05414.pdf Type of Information Collection Request: New collection; Title: Rural Health Care Services Outreach Program Measures; Use: The Rural Health Care Services Outreach (Outreach) Program--authorized by Section 330A(e) of the Public Health Service Act (PHS Act), as amended--seeks to “promote rural health care services outreach by expanding the delivery of health care services to include new and enhanced services in rural areas.” The goals for the Outreach Program include the following: (1) Expand the delivery of health care services to include new and enhanced services exclusively in rural communities; (2) deliver health care services through a strong consortium in which every consortium member organization actively participates and engages in the planning and delivery of services; (3) utilize and/or adapt an evidence-based or promising practice model(s) in the delivery of health care services; and (4) improve population health and demonstrate health outcomes and sustainability. 3/10/2015: Paperwork Reduction Act notice. No comments recommended. For this program, HRSA draft performance measures to provide data to the program and to enable the agency to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 1993. These measures cover the principal topic areas of interest to the HRSA Office of Rural Health Policy, including: (a) Access to care; (b) population demographics; (c) staffing; (d) consortium/network; (e) sustainability; and (f) project specific domains. HRSA will use several measures for the Outreach Program. All measures will speak to ORHP progress toward meeting the goals set. HRSA received no comments in response to the 60-day notice published in the December 22, 2014, Federal Register (79 FR 76334). Distributions from an HSA, Archer MSA or Medical Advantage MSA Form 1099-SA PRA Request for Comment Released: 2/10/2015 Due date: 4/13/2015 Type of Information Collection Request: Extension of a currently approved collection; Title: Distributions from an HSA, Archer MSA, or Medical Advantage MSA; Use: Individuals use this form to report distributions from a medical savings account as required by Internal Revenue Code section 220(h). IRS has made no changes to this form. Released: 2/11/2015 Type of Information Collection Request: Extension of a currently approved collection; Title: Initial Plan Data Collection to Support Qualified Health Plan 2/10/2015: Paperwork Reduction Act notice. No comments recommended. http://www.gpo.gov/fdsys/pkg/FR-2015-0210/pdf/2015-02639.pdf Data Collection to Support QHP Certification and Other Exchange Operations Roster key: 2/11/2015: Paperwork Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 5 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 CMS-10433 PRA Request for Comment Due date: 4/13/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0211/pdf/2015-02852.pdf Rural Health Network Development Program HRSA (OMB 0906-xxxx) PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05733.pdf Released: 3/13/2015 Due date: 4/13/2015 (QHP) Certification and Other Financial Management and Exchange Operations; Use: As required by CMS-9989-F, Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange Establishment Rule), each Exchange must assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). In addition to data collection for the certification of QHPs, the reinsurance and risk adjustment programs outlined by tACA, detailed in 45 CFR part 153, as established by CMS-9975-F, Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk Corridors, and Risk Adjustment (77 FR 17220), have general information reporting requirements that apply to issuers, group health plans, third party administrators, and plan offerings outside of the Exchanges. Subsequent regulations for these programs including the final HHS Notice of Benefit and Payment Parameters for 2014 and the Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014, and the final HHS Notice of Benefit and Payment Parameters for 2015 provide further reporting requirements. Type of Information Collection Request: New collection; Title: Rural Health Network Development Program; Use: Under the Rural Health Network Development Program--authorized under Section 330A(f) of the Public Health Service Act (PHS Act), as amended--the HRSA Office of Rural Health Policy (ORHP) supports grants for eligible entities to promote, through planning and implementation, the development of integrated health care networks that have combined the functions of the entities participating in the networks to: (i) Achieve efficiencies; (ii) expand access to, coordinate, and improve the quality of essential health care services; and (iii) strengthen the rural health care system as a whole. Reduction Act notice extending a previously approved collection. There may be issues pertaining to gathering data from QHPs on contract offerings to Indian health care providers, but such comments are likely better directed to the underlying regulations rather than the associated PRA notice. As such, no comments recommended. 3/13/2015: Paperwork Reduction Act notice. No comments recommended. For this program, HRSA drafted performance measures to provide data to the program and to enable the agency to provide aggregate program data. These measures cover the principal topic areas of interest to ORHP, including: (a) Network infrastructure; (b) network collaboration; (c) sustainability; and (d) network assessment. HRSA will use several measures for this program. HRSA received no comments in response to the 60-day notice published in the December 22, 2014, Federal Register (79 FR 76334). Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 6 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Medical Expenditure Panel Survey-Insurance Component AHRQ (OMB 0935-0110) PRA Request for Comment Released: 2/18/2015 Due date: 4/20/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0218/pdf/2015-02905.pdf Type of Information Collection Request: Revision of a currently approved collection; Title: Medical Expenditure Panel Survey--Insurance Component; Use: Employer-sponsored health insurance serves as the source of coverage for 78 million current and former workers, plus many of their family members. The Medical Expenditure Panel Survey--Insurance Component (MEPS-IC) measures on an annual basis the extent, cost, and coverage of employer-sponsored health insurance. AHRQ produces these statistics at the National, State, and sub-State (metropolitan area) level for private industry, as well as for State and Local governments. All of the supporting documents for the current MEPS-IC are available on the OMB Web site at http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=2013100935-001. 2/20/2015: Paperwork Reduction Act notice. No comments recommended. To ensure that the MEPS-IC can capture important changes in the employersponsored health insurance market due to the implementation of ACA, AHRQ will field a longitudinal survey in 2015 to include a sample of 5,000 small private sector employers that responded to the 2014 MEPS-IC. The OMB clearance approved on November 21, 2013, included the 2014 longitudinal survey, a survey of 3,000 respondents to the 2013 MEPS-IC, but did not include the 2015 longitudinal survey because AHRQ had not finalized the sample size. This information collection request includes no other changes. Receipt of Non-VA Care and Selection of Provider for Veterans Choice Program VA (OMB 2900-0823) PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf Roster key: Released: 2/19/2015 Due date: 4/20/2015 1. Type of Information Collection Request: Extension of a currently approved collection; Title: Election to Receive Authorized Non-VA Care and Selection of Provider for the Veterans Choice Program; Use: Section 17.1515 requires eligible veterans to notify VA whether the veteran elects to receive authorized non-VA care through the Veterans Choice Program, get placed on an electronic waiting list, or get scheduled for an appointment with a VA health care provider. Section 17.1515(b)(1) also allows eligible veterans to specify a particular non-VA entity or health care provider, if that entity or provider meets certain requirements. 2/20/2015: Paperwork Reduction Act notice. Uncertain about applicability to veterans who are HIS beneficiaries. It may be worthwhile to review this document in regard to decisions by IHS beneficiaries who are veterans to elect to receive care at I/T/U facilities. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 7 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Health Care Plan Information for Veterans Choice Program VA (OMB 2900-0823) PRA Request for Comment Released: 2/19/2015 Due date: 4/20/2015 2. Type of Information Collection Request: Extension of a currently approved collection; Title: Health Care Plan Information for the Veterans Choice Program; Use: Section 17.1510(d) requires eligible veterans to submit to VA information about their health care plan to participate in the Veterans Choice Program. http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf Submission of Medical Record Information Under Veterans Choice Program VA (OMB 2900-0823) PRA Request for Comment Released: 2/19/2015 Due date: 4/20/2015 3. Type of Information Collection Request: Extension of a currently approved collection; Title: Submission of Medical Record Information under the Veterans Choice Program; Use: Participating eligible entities and providers must submit a copy of any medical record related to hospital care or medical services furnished under the Veterans Choice Program to an eligible veteran. http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf Submission of Information on Credentials by Eligible Entities or Providers VA (OMB 2900-0823) PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0219/pdf/2015-03354.pdf Roster key: Released: 2/19/2015 Due date: 4/20/2015 4. Type of Information Collection Request: Extension of a currently approved collection; Title: Submission of Information on Credentials and Licenses by Eligible Entities or Providers; Use: Section 17.1530 requires eligible entities and providers to submit verification that the entity or provider maintains at least the same or similar credentials and licenses as those required of VA health care providers, as determined by the VA Secretary. 2/20/2015: Paperwork Reduction Act notice. Uncertain about applicability to veterans who are IHS beneficiaries (as compared to exiswting MOAs in effect). It may be worthwhile to review this document in regard to decisions by IHS beneficiaries who are veterans to elect to receive care at I/T/U facilities. 2/20/2015: Paperwork Reduction Act notice. Uncertain about applicability to veterans who are IHS beneficiaries (as compared to existing MOAs in effect). It may be worthwhile to review this document in regard to decisions by IHS beneficiaries who are veterans to elect to receive care at I/T/U facilities. 2/20/2015: Paperwork Reduction Act notice. Uncertain about applicability to veterans who are IHS beneficiaries (as compared to MOAs that are currently in place). It Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 8 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 may be worthwhile to review this document in regard to decisions by IHS beneficiaries who are veterans to elect to receive care at I/T/U facilities. Rural Access to Emergency Devices Grant Program HRSA (OMB 0915-xxxx) PRA Request for Comment Released: 2/20/2015 Due date: 4/21/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0220/pdf/2015-03525.pdf Survey of Retail Prices CMS-10241 Released: 3/25/2015 PRA Request for Comment Due date: 4/24/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf Roster key: Type of Information Collection Request: New collection; Title: Rural Access to Emergency Devices Grant Program; Use: This program, authorized by the Public Health Improvement Act title IV--Cardiac Arrest Survival Act of 2000, subtitle B-Rural Access to Emergency Devices, section 413 and the Consolidated and Further Continuing Appropriations Act, seeks to: (1) Purchase automated external defibrillators (AEDs) approved, or cleared for marketing, by FDA; (2) provide defibrillator and basic life support training in automated external defibrillator usage through the American Heart Association, the American Red Cross, or other nationally recognized training courses; and (3) place the AEDs in rural communities with local organizations. For this program, HRSA drafted performance measures to provide data useful to the program and to enable the agency to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 1993. These measures cover the principal topic areas of interest to the HRSA Office of Rural Health Policy, including: (a) The number of counties served by the program; (b) the number of AEDs purchased and placed and the locations of the placements; (c) the number of training sessions and the number of individuals trained; (d) the number of times an AED is used and the outcome; and (e) the number of lay persons and first responders who administer CPR or use an AED on an individual. 1. Type of Information Collection Request: Revision of a currently approved collection; Title: Survey of Retail Prices: Payment and Utilization Rates and Performance Rankings; Use: Survey of Retail Prices: Payment and Utilization Rates, and Performance Rankings; Use: This study has two parts. Part I focuses on the retail community pharmacy consumer prices. It also includes reporting by the states of payment and utilization rates for the 50 most widely prescribed drugs and comparing state drug payment rates with the national retail survey prices. Part II focuses on the retail community pharmacy ingredient costs. This segment surveys the average acquisition costs of all covered outpatient drugs purchased by retail community pharmacies, with prices updated on at least a monthly basis. Subsequent to the publication of the 60-day notice in the December 19, 2014, Federal 2/20/2015: Paperwork Reduction Act notice. No comments recommended. 3/26/2015: Paperwork Reduction Act notice. No comments recommended. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 9 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Administrative Requirements for DRA Section 6071 CMS-10249 PRA Request for Comment Released: 3/25/2015 Due date: 4/24/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf Outcome and Assessment Information Set-OASIS-C1/ICD-10 CMS-10545 PRA Request for Comment Released: 3/25/2015 Due date: 4/24/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0325/pdf/2015-06884.pdf Appointment of Representative CMS-1696 Released: 2/27/2015 PRA Request for Comment Due date: Roster key: Register (79 FR 75816), CMS has reduced the burden by removing requirements for Part I pending funding decisions. CMS has made no changes to Part II. 2. Type of Information Collection Request: Extension of a currently approved collection; Title: Administrative Requirements for Section 6071 of the Deficit Reduction Act; Use: State Operational Protocols should provide enough information such that: The CMS Project Officer and other federal officials can use it to understand the operation of the demonstration and/or prepare for potential site visits without needing additional information; the State Project Director can use it as the manual for program implementation; and external stakeholders can use it to understand the operation of the demonstration. CMS uses the financial information collection in its financial statements and shares it with the auditors who validate the financial position of the agency. The national evaluation contractor uses the Money Follows the Person Rebalancing Demonstration (MFP) Finders File, MFP Program Participation Data File, and MFP Services File to assess program outcomes, while CMS uses the information to monitor program implementation. The national evaluation contractor uses MFP Quality of Life data to assess program outcomes. The evaluation determines how participant quality of life changes after transitioning to the community. The national evaluation contractor and CMS use the semi-annual progress report to monitor program implementation at the grantee level. 3. Type of Information Collection Request: New collection; Title: Outcome and Assessment Information Set (OASIS) OASIS-C1/ICD-10; Use: Home health agencies (HHAs) must collect the outcome and assessment information data set (OASIS) to participate in the Medicare program. CMS requests a new OMB control number for the proposed revised OASIS item set, referred to hereafter as OASIS-C1/ICD-10. OMB on October 7, 2014, approved the current version of the OASIS-C1/ICD-9 data set (OMB 0938-0760), which will remain in use until the implementation of the ICD-10 coding system, currently scheduled for October 1, 2015. Subsequent to the publication of the 60-day notice in the January 9, 2015, Federal Register (80 FR 1419), CMS has made a minor typographical correction to the data set. 1. Type of Information Collection Request: Extension of a currently approved collection; Title: Appointment of Representative; Use: Beneficiaries, providers and suppliers, and any party seeking to appoint a representative to assist them with their initial determinations and filing appeals complete the 3/26/2015: Paperwork Reduction Act notice. No comments recommended. 3/26/2015: Paperwork Reduction Act notice. No comments recommended. 2/27/2015: Paperwork Reduction Act notice of existing collection without Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 10 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-04115.pdf Medicare Fee-for-Service Prepayment Medical Review CMS-10417 PRA Request for Comment 4/28/2015 Appointment of Representative form. This extension request proposes nonsubstantive changes to the form. Released: 2/27/2015 2. Type of Information Collection Request: Extension of a currently approved collection; Title: Medicare Fee-for-Service Prepayment Medical Review; Use: Medicare contractors request the information required under this collection to determine proper payment or suspicion of fraud. Medicare contractors request the information from providers or suppliers submitting claims for payment from the Medicare program when data analysis indicates aberrant billing patterns or other information that might present a vulnerability to the Medicare program. Due date: 4/28/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-04115.pdf Collection of Qualitative Feedback on Agency Service Delivery IHS-2015-0002 PRA Request for Comment Released: 2/27/2015 Due date: 4/28/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0302/pdf/2015-04112.pdf Verification of Clinic Data--Rural Health Clinic Form CMS-29 PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf Roster key: Released: 3/30/2015 Due date: 4/29/2015 Type of Information Collection Request: Extension of a currently approved collection; Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys; Use: The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the commitment of the Administration to improving service delivery. Qualitative feedback provides useful insights on perceptions and opinions but, unlike statistical surveys that yield quantitative results, is not generalizable to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences, and expectations; provide an early warning of issues with service; or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between IHS and its customers and stakeholders. It also will allow feedback to contribute directly to the improvement of program management. 1. Type of Information Collection Request: Extension of a currently approved collection; Title: Verification of Clinic Data--Rural Health Clinic Form and Supporting Regulations; Use: This form serves as an application completed by suppliers of Rural Health Clinic (RHC) services requesting participation in the Medicare program. This form initiates the process of obtaining a decision as to whether applicants meet the conditions for certification as a supplier of RHC services. It also promotes data reduction or introduction to and retrieval from the Automated Survey Process Environment (ASPEN) and related survey and certification databases by the CMS Regional Offices. change. No comments recommended. 2/27/2015: Paperwork Reduction Act notice of existing collection without change. No comments recommended. 3/3/2015: Paperwork Reduction Act notice of existing collection without change. No comments recommended. 3/30/2015: Paperwork Reduction Act notice of existing collection without change. No comments recommended. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 11 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Site Investigation for Independent Diagnostic Testing Facilities CMS-10221 PRA Request for Comment Released: 3/30/2015 Due date: 4/29/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf Site Investigation for Suppliers of DMEPOS CMS-R-263 Released: 3/30/2015 PRA Request for Comment Due date: 4/29/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07219.pdf New System of Records Notice (Restricted Dataset Requesters) HHS (no reference number) Privacy Act of 1974; System of Records Notice Roster key: Released: 4/1/2015 Due date: 30 days (approx. 5/1/2015) 2. 2. Type of Information Collection Request: Extension of a currently approved collection; Title: Site Investigation for Independent Diagnostic Testing Facilities (IDTFs); Use: CMS enrolls Independent Diagnostic Testing Facilities (IDTFs) into the Medicare program via a uniform application, CMS-855B. Implementation of enhanced procedures for verifying the enrollment information has improved the enrollment process, as well as identified and prevented fraudulent IDTFs from entering the Medicare program. This process requires verification of compliance with IDTF performance standards. The site investigation form for IDTFs provides a standardized, uniform tool to gather information from an IDTF to inform CMS whether it meets certain standards required of an IDTF (as found in 42 CFR 410.33(g)) and where it practices or renders its services. The site investigation form also has aided in verifying compliance with the required performance standards found in 42 CFR 410.33(g). CMS has made no revisions to this form since the last submission for OMB approval. 3. Type of Information Collection Request: Extension of a currently approved collection; Title: Site Investigation for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Use: CMS enrolls suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) into the Medicare program via a uniform application, CMS-855S. Implementation of enhanced procedures for verifying the enrollment information has improved the enrollment process, as well as identified and prevented fraudulent DMEPOS suppliers from entering the Medicare program. This process requires verification of compliance with supplier standards. The site investigation form provides a standardized, uniform tool to gather information from a DMEPOS supplier to inform CMS whether it meets certain qualifications required of a DMEPOS supplier (as found in 42 CFR 424.57(c)) and where it practices or renders its services. The site investigation form also has aided in verifying compliance with the required supplier standards found in 42 CFR 424.57(c). CMS has made no revisions to this form since the last submission for OMB approval. In accordance with the requirements of the Privacy Act of 1974, as amended, HHS has established a new department-wide system of records, “Records about Restricted Dataset Requesters,” System Number 09-90-1401, to cover records about individuals within and outside HHS who request restricted datasets and software products from HHS (e.g., for health-related scientific research and study purposes), when HHS maintains the requester records in a system from which an individual requester retrieves them directly (by name 3/30/2015: Paperwork Reduction Act notice of existing collection without change. No comments recommended. 3/30/2015: Paperwork Reduction Act notice of existing collection without change. No comments recommended. 4/1/2015: Paperwork Reduction Act notice. No comments recommended. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 12 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0401/pdf/2015-07444.pdf State Annual Long-Term Care Ombudsman Report and Instructions HHS (OMB 0985-0005) PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0304/pdf/2015-04470.pdf Released: 3/4/2015 Due date: 5/4/2015 or other personal identifier). HHS has deleted the System of Records Notice (SORN) previously published at 78 FR 32654 for “Online Application Ordering for Products from the Healthcare Cost and Utilization Project (HCUP),” System Number 09-35-0003, and replaced it with this new department-wide SORN. Type of Information Collection Request: Extension of a currently approved collection; Title: State Annual Long-Term Care Ombudsman Report and Instructions; Use: States provide the following data and narrative information in the report: Numbers and descriptions of cases filed and complaints made on behalf of long-term care facility residents to the statewide ombudsman program; Major issues identified impacting on the quality of care and life of long-term care facility residents; Statewide program operations; and Ombudsman activities in addition to complaint investigation. 3/5/2015: Paperwork Reduction Act notice. No comments recommended. The data collected on complaints filed with Ombudsman programs and narrative on long-term care issues provide information to CMS and others on patterns of concerns and major long-term care issues affecting residents of long-term care facilities. Both the complaint and program data collected assist the states and local Ombudsman programs in planning strategies and activities, providing training and technical assistance, and developing performance measures. The report and instructions are available at http://www.aoa.acl.gov/AoA_Programs/Elder_Rights/Ombudsman/NORS.asp x. Agent/Broker Data Collection in FederallyReleased: Type of Information Collection Request: Extension of a currently approved Facilitated Exchanges 3/6/2015 collection; Title: Agent/Broker Data Collection in Federally-Facilitated Health 3/6/2015: Paperwork CMS-10464 Insurance Exchanges; Use: CMS collects personally identifiable information Reduction Act notice. Due date: from agents/brokers to register them with the Federally-Facilitated PRA Request for Comment 5/5/2015 Marketplace (FFM) and permit them to assist individuals and employers in No comments enrolling in the FFM. CMS uses this collection of information to ensure recommended. http://www.gpo.gov/fdsys/pkg/FR-2015-03agents/brokers possess the basic knowledge required to enroll individuals 06/pdf/2015-05166.pdf and Small Business Health Options Program (SHOP) employers/employees through the Marketplaces. Agents/brokers will use CMS or third-party systems to enter identifying information and register with the FFM. As a component of registration, agents/brokers must complete online training courses through a CMS or third-party Learning Management System (LMS). Upon completion of their applications and training requirements, Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 13 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 SHOP Effective Date and Termination Notice Requirements CMS-10555 PRA Request for Comment Released: 3/9/2015 Due date: 5/8/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0309/pdf/2015-05420.pdf National Implementation of the Hospital CAHPS Survey CMS-10102 PRA Request for Comment Released: 3/13/2015 Due date: 5/12/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05796.pdf Excise Tax on High Cost EmployerSponsored Health Coverage Notice 2015-16 Section 4980I--Excise Tax on High Cost Employer-Sponsored Health Coverage http://www.irs.gov/pub/irs-drop/n-1516.pdf Released: 2/23/2015 Due date: 5/15/2015 agents/brokers must attest to their agreement to adhere to FFM standards and requirements through a CMS or third-party LMS. Type of Information Collection Request: New collection; Title: Small Business Health Options Program (SHOP) Effective Date and Termination Notice Requirements; Use: CMS requires that, for plan years beginning on or after January 1, 2017, the Small Business Health Options Program (SHOP) must ensure that a qualified health plan (QHP) issuer notifies qualified employees, enrollees, and new enrollees in a QHP through the SHOP of the effective date of coverage. As required by the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameter for 2016 (CMS-9944-F), published on February 27, 2015, if any enrollee has his or her coverage terminated through the SHOP due to non-payment of premiums or a loss of eligibility to participate in the SHOP, the SHOP must notify the enrollee or the qualified employer of the termination of such coverage. In the termination of coverage, the SHOP must include the termination date and reason for termination to the enrollee or qualified employer. Type of Information Collection Request: Extension of a currently approved collection; Title: National Implementation of the Hospital CAHPS Survey; Use: Since 2006, the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey--also known as the CAHPS Hospital Survey or Hospital CAHPS, a standardized survey instrument and data collection methodology--has measured patient perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for collecting and public reporting information that enables valid comparisons across all hospitals to support consumer choice. This notice seeks to initiate and inform the process of developing regulatory guidance regarding the excise tax on high cost employer-sponsored health coverage under § 4980I of the Internal Revenue Code (Code). Section 4980I, added to the Code by ACA, applies to taxable years beginning after December 31, 2017. Under this provision, if the aggregate cost of “applicable employersponsored coverage” (referred to in this notice as applicable coverage) provided to an employee exceeds a statutory dollar limit, which is revised annually, the excess is subject to a 40% excise tax. This notice describes potential approaches with regard to a number of issues under § 4980I, which IRS might incorporate in future proposed regulations, and invites comments on these potential approaches. The issues addressed in this notice primarily relate to (1) the definition of applicable coverage, (2) the Roster key: 3/10/2015: Paperwork Reduction Act notice. No comments recommended. 2/25/2015: There may be Tribal-specific comments warranted on the application of the “Cadillac tax”. In order to determine what comments might be appropriate, it would be useful to gain an understanding of the extent to which plans offered by Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 14 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 determination of the cost of applicable coverage, and (3) the application of the annual statutory dollar limit to the cost of applicable coverage. The Department of the Treasury (Treasury) and IRS invite comments on the issues addressed in this notice and on any other issues under § 4980I. Treasury and IRS anticipate issuing another notice, before the publication of proposed regulations under § 4980I, describing and inviting comments on potential approaches to a number of issues not addressed in this notice, including procedural issues relating to the calculation and assessment of the excise tax. After considering the comments on both notices, Treasury and IRS anticipate publishing proposed regulations under § 4980I. The proposed regulations will provide further opportunity for comment, including an opportunity to comment on the issues addressed in the preceding notices. 2015-03-17 Summary of IRS Notice 2015-16.pdf Proposed Project Behavioral Health Information Technologies Survey SAMHSA (no reference number) PRA Request for Comment http://www.gpo.gov/fdsys/pkg/FR-2015-0317/pdf/2015-06038.pdf Released: 3/17/2015 Due date: 5/18/2015 Type of Information Collection Request: New collection; Title: Proposed Project Behavioral Health Information Technologies Survey; Use: The SAMHSA Center for Substance Abuse Treatment (CSAT) and Center for Behavioral Health Statistics and Quality (CBHSQ) propose a survey to assess health information technology (HIT) adoption among SAMHSA grantees. As part of its Strategic Initiative to advance the use of HIT to support integrated behavioral health care, SAMHSA has worked to develop a survey instrument that will examine the status of and plans for HIT adoption by behavioral health service providers implementing SAMHSA grant programs. This project seeks to acquire baseline data necessary to inform the Strategic Initiative. The survey of SAMHSA grantees regarding their access to and use of HIT will provide valuable information that will inform the behavioral HIT literature. tribal employers are projected to be subject to this tax. 3/12/2015: Sam to share an analysis/summary of the regulation. Efforts underway to determine the extent to which tribal employers have insurance coverage that may approach the threshold levels to be subject to the excise tax. 3/17/2015: A summary of this notice is embedded to the left. 3/17/2015: Paperwork Reduction Act notice. No comments recommended. This data collection will allow SAMHSA to identify the current status of HIT adoption and use among a diverse group of grantees. Data from the survey will allow SAMHSA to enhance the HIT-related programmatic activities among its grantees by providing data on how HIT facilitates the implementation of different types of SAMHSA grants, thereby fostering the appropriate adoption of HIT within SAMSHA-funded programs. The survey will collect data once, providing a snapshot view of the current state of HIT adoption. The proposed participant pool includes SAMHSA Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 15 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Branded Prescription Drug Fee REG-112805-10 (OMB 1545-2209) Released: 3/17/2015 PRA Request for Comment Due date: 5/18/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0317/pdf/2015-06073.pdf Hospital National Provider Survey CMS-10550 Released: 3/20/2015 PRA Request for Comment Due date: 5/19/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06408.pdf grantee program leadership who volunteer to provide the assistance needed to ensure a high rate of response. Awardees from nine different SAMHSA programs drawn from CMHS, CSAT, and CSAP comprise the pool of survey participants. The survey will use a Web-based tool with embedded skip logic for respondents to avoid questions not applicable to them. Type of Information Collection Request: Extension of a currently approved collection; Title: Branded Prescription Drug Fee; Use: Section 9008 of ACA imposes an annual fee on manufacturers and importers of branded prescription drugs that have gross receipts of over $5 million from the sales of these drugs to certain government programs (covered entity/covered entities). Section 51.7T(b) of IRS temporary regulations provide that the agency will send each covered entity notification of its preliminary fee calculation by May 15 of the fee year. If a covered entity chooses to dispute the preliminary fee calculation, the covered entity must follow the procedures for submitting an error report established in §51.8T. IRS will use the data voluntarily supplied by a covered entity that disputes its preliminary fee calculation to verify the accuracy of the data and the calculation used to determine the fee. 1. Type of Information Collection Request: New collection; Title: Hospital National Provider Survey; Use: Section 3104 of ACA requires that the Secretary of HHS conduct an assessment of the quality and efficiency impact of the use of endorsed measures in specific Medicare quality reporting and incentive programs. ACA further specifies that the initial assessment must occur no later than March 1, 2012, and once every 3 years thereafter. CMS developed and tested this planned data collection as part of the 2015 Impact Report and will conduct data collection for reporting in the 2018 Impact Report. 3/17/2015: Paperwork Reduction Act notice. No comments recommended. 3/20/2015: Paperwork Reduction Act notice. No comments recommended. This data collection, which involves hospital quality leaders, includes: (1) A semi-structured qualitative interview and (2) a standardized survey. CMS will analyze the data from the qualitative interviews and standardized surveys to provide it with information on the quality and efficiency impact of measures that it uses to assess care in the hospital inpatient and outpatient settings. The surveys seek to understand whether the use of performance measures has led to changes in provider behavior and where undesired effects have occurred as a result of implementing quality and efficiency measures. The survey also will help identify characteristics associated with high performance, which, if understood, could assist in leveraging improvements in care among lower performing hospitals. The survey seeks to assess the Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 16 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Nursing Home National Provider Survey CMS-10551 Released: 3/20/2015 PRA Request for Comment Due date: 5/19/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06408.pdf Health Insurance Providers Fee REG-143416-14 Released: 2/26/2015 Health Insurance Providers Fee Due date: 5/27/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0226/pdf/2015-03945.pdf Medicare and Medicaid EHR Incentive Program--Stage 3 CMS-3310-P Released: 3/20/2015 Published: Roster key: impacts of the measures that CMS uses in the context of public reporting (pay-for-reporting) and value-based purchasing programs. 2. Type of Information Collection Request: New collection; Title: Nursing Home National Provider Survey; Use: Section 3104 of ACA requires that the Secretary of HHS conduct an assessment of the quality and efficiency impact of the use of endorsed measures in specific Medicare quality reporting and incentive programs. ACA further specifies that the initial assessment must occur no later than March 1, 2012, and once every 3 years thereafter. CMS developed and tested this planned data collection as part of the 2015 Impact Report and will conduct data collection for reporting in the 2018 Impact Report. This data collection, which involves nursing home quality leaders, includes: (1) A semi-structured qualitative interview and (2) a standardized survey. CMS will analyze the data from the qualitative interviews and standardized surveys to provide it with information on the quality and efficiency impact of measures that it uses to assess care in nursing homes delivering skilled nursing care. The surveys seek to understand whether the use of performance measures has led to changes in provider behavior (both at the nursing home-level and at the frontline of care) and whether undesired effects have occurred as a result of implementing quality and efficiency measures. The survey also will help identify characteristics associated with high performance, which, if understood, could assist in leveraging improvements in care among lower performing nursing homes. The survey seeks to assess the impacts of the measures that CMS uses in the context of public reporting (pay-for-reporting) and quality improvement. This document contains proposed regulations that provide rules for the definition of a covered entity for purposes of the fee imposed by section 9010 of ACA. Elsewhere in this issue of the Federal Register, IRS has issued temporary regulations (TD 9711). The text of those temporary regulations also serves as the text of these proposed regulations. The proposed regulations clarify certain terms in section 9010. The proposed regulations affect individuals engaged in the business of providing health insurance for U.S. health risks. This Stage 3 proposed rule would specify the meaningful use criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments 3/20/2015: Paperwork Reduction Act notice. No comments recommended. 3/18/2015: Under review. 1/21/2015: NIHB technical experts will be asked if they have suggested comments. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 17 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-06685.pdf 2015 Edition Health IT Certification Criteria, et al. HHS ONC (RIN 0991-AB93) 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-06612.pdf Information Collection for Machine Readable Data for FFM QHPs CMS-10558 PRA Request for Comment 3/30/2015 Due date: 5/29/2015 Released: 3/20/2015 Published: 3/30/2015 Due date: 5/29/2015 Released: 3/30/2015 Due date: 5/29/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07089.pdf Cooperative Agreement to Support Navigators in Exchanges CMS-10463 Released: 3/30/2015 Due date: Roster key: under Medicare for Stage 3 of the EHR Incentive Programs. It would continue to encourage electronic submission of clinical quality measure (CQM) data for all providers where feasible in 2017, propose to require the electronic submission of CQMs where feasible in 2018, and establish requirements to transition the program to a single stage for meaningful use. Finally, this Stage 3 proposed rule would change the EHR reporting period so that all providers would report under a full calendar year timeline with a limited exception under the Medicaid EHR Incentive Program for providers demonstrating meaningful use for the first time. These changes together support broader CMS efforts to increase simplicity and flexibility in the program while driving interoperability and a focus on patient outcomes in the meaningful use program. This notice of proposed rulemaking introduces a new edition of certification criteria (the 2015 Edition health IT certification criteria or “2015 Edition”), proposes a new 2015 Edition Base Electronic Health Record (EHR) definition, and proposes to modify the HHS ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition also would establish the capabilities and specify the related standards and implementation specifications that Certified EHR Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when these programs require the use of such edition. 1. Type of Information Collection Request: New collection; Title: Information Collection for Machine Readable Data for Provider Network and Prescription Formulary Content for FFM QHPs; Use: For plan years beginning on or after January 1, 2016, qualified health plan (QHP) issuers must make available provider and formulary data in a machine-readable format. As required by the final rule titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016” (CMS-9944-F) and published in the February 27, 2015, Federal Register (80 FR 10750), QHP issuers in the Federally-Facilitated Marketplaces (FFMs) must publish information regarding their formulary drug lists and provider directories on their Web site in an HHS-specified format at times determined by HHS. 2. Type of Information Collection Request: Revision of a currently approved collection; Title: Cooperative Agreement to Support Navigators in FederallyFacilitated and State Partnership Exchanges; Use: Section 1311(i) of ACA requires Exchanges to establish a Navigator grant program as part of their 3/30/2015: Paperwork Reduction Act notice. No comments recommended. 3/30/2015: Paperwork Reduction Act notice. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 18 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 PRA Request for Comment 5/29/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07089.pdf Negotiation Cooperative Agreement HHS-2015-IHS-TSGN-0001 Released: 2/18/2015 Office of Tribal Self-Governance; Negotiation Cooperative Agreement Due date: 6/3/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0218/pdf/2015-03235.pdf Planning Cooperative Agreement Applications HHS-2015-IHS-TSGP-0001 Planning Cooperative Agreement Applications: Tribal Self-Governance Program http://www.gpo.gov/fdsys/pkg/FR-2015-0220/pdf/2015-03206.pdf Roster key: Released: 2/20/2015 Due date: 6/3/2015 function to provide consumers with assistance when needed. Navigators will assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within Exchanges, as well as other required duties. Section 1311(i) requires that an Exchange operating as of January 1, 2014, must establish a Navigator Program under which it awards grants to eligible individuals or entities that satisfy the requirements of Exchange Navigators. In States with a Federally-Facilitated Marketplace (FFM) or State Partnership Marketplace (SPM), CMS will award these grants. Navigator awardees must provide weekly, monthly, quarterly, and annual progress reports to CMS on the activities performed during the grant period and any sub-awardees receiving funds. The IHS Office of Tribal Self-Governance (OTSG) seeks limited competition Negotiation Cooperative Agreement applications for the Tribal SelfGovernance Program (TSGP). This program, authorized under Title V of the Indian Self-Determination and Education Assistance Act (ISDEAA), provides Tribes with resources to help defray costs related to preparing for and conducting TSGP negotiations. TSGP negotiations require careful planning and preparation by both tribal and federal parties, including the sharing of precise, up-to-date information. The design of the negotiations process: (1) Enables a Tribe to set its own priorities when assuming responsibility for IHS PSFAs, (2) observes the government-to-government relationship between the United States and each Tribe, and (3) involves the active participation of both tribal and IHS representatives, including the OTSG. Because each tribal situation is unique, a successful transition by a Tribe into the TSGP, or an expansion of its current program, requires focused discussions between the federal and tribal negotiation teams about the specific health care concerns and plans of the Tribe. The IHS Office of Tribal Self-Governance (OTSG) seeks limited competition Planning Cooperative Agreement applications for the Tribal Self-Governance Program (TSGP). This program, authorized under Title V of the Indian SelfDetermination and Education Assistance Act (ISDEAA), provides resources to Tribes interested in entering TSGP and to existing Self-Governance Tribes interested in assuming new or expanded Programs, Services, Functions and Activities (PSFAs). Title V of ISDEAA requires a Tribe or tribal organization to complete a planning phase to the satisfaction of the Tribe. The planning phase must include legal and budgetary research and internal tribal government planning and organization preparation relating to the administration of health care programs. No comments recommended. CFDA number: 93.444 Key dates: --Application Deadline: 6/3/2015 --Review: 6/10/2015 --Earliest Anticipated Start: 7/1/2015 --Signed Tribal Resolutions Due: 6/10/2015 CFDA number: 93.444 Key dates: --Application Deadline: 6/3/2015 --Review: 6/10/2015 --Earliest Anticipated Start: 7/1/2015 --Signed Tribal Resolutions Due: 6/10/2015 Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 19 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Tribal Management Grant Program HHS-2015-IHS-TMD-0001 Released: 3/19/2015 Office of Direct Service and Contracting Tribes; Tribal Management Grant Program Due date: 6/3/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0319/pdf/2015-06353.pdf Revisions to the Table for Calculating the Premium Tax Credit, et al. Rev. Proc. 2014-37 Revisions to the Table for Calculating the Health Insurance Premium Tax Credit, Updates to the Percentage for Determining Qualification for Minimum Essential Coverage, and Cross-Reference to the Percentage for Determining Qualification for Shared Responsibility Payment Exemption http://www.irs.gov/pub/irs-drop/rp-1437.pdf Released: 7/24/2014 Due date: None IHS seeks competitive grant applications for the Tribal Management Grant (TMG) program, authorized under 25 U.S.C. 450h(b)(2) and 25 U.S.C. 450h(e) of the Indian Health Self-Determination and Education Assistance Act (ISDEAA), as amended. The TMG program, a competitive grant program, helps federally-recognized Indian Tribes and Tribal organizations (T/TOs) to assume all or part of existing IHS programs, functions, services, and activities (PFSA) and further develop and improve their health management capability. The TMG Program provides competitive grants to T/TOs to establish goals and performance measures for current health programs; assess current management capacity to determine the appropriateness of new components; analyze programs to determine the practicality of T/TO management; and develop infrastructure systems to manage or organize PFSA. This revenue procedure provides indexing adjustments for certain provisions under sections 36B and 5000A of the Internal Revenue Code. In particular, it updates the Applicable Percentage Table in § 36B(b)(3)(A)(i). This table is used to calculate the premium tax credit for an individual for taxable years beginning after calendar year 2014. This revenue procedure also updates the required contribution percentage in § 36B(c)(2)(C)(i)(II), which is used to determine whether an individual qualifies for affordable employer-sponsored minimum essential coverage under § 36B for plan years beginning after calendar year 2014. Additionally, this revenue procedure cross-references the required contribution percentage under § 5000A(e)(1)(A) for plan years beginning after calendar year 2014, as determined under guidance issued by HHS. This percentage is used to determine whether an individual qualifies for an exemption from the individual shared responsibility payment because of a lack of affordable minimum essential coverage. CFDA number: 93.228 Key dates: --Application Deadline: 6/3/2015 --Review: 6/22-26/2015 --Earliest Anticipated Start: 9/1/2015 --Signed Tribal Resolutions Due: 6/19/2015 --Proof of Non-Profit Status Due: 6/3/2015 7/30/2014: No comment requested. Associated with IRS REG104579-113 and TD-9863. 8/1: See analysis to the left. Analysis: For 2015 and subsequent years, adjustments to-1. The percentages will be updated by the ratio of premium growth in the preceding calendar year to income growth in the preceding calendar year. 2. Premium growth is measured by per enrollee spending for employer-sponsored health insurance in the preceding year to per enrollee spending in the calendar year two years prior. 3. Income growth is measured by GDP per capita for the preceding calendar year to the GDP per capita for the calendar year two years Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 20 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 4. 5. 6. prior. Adjustments are rounded to hundredth of a percentage point. The adjusted percentages are applicable to tax years and plan years after 2014. The adjustment to each of the applicable percentages for 2015 approximates .0063 (or .63%, or two-thirds of one percent); the effect of this adjustment is an increase in the percentages ranging from .01 percentage points (from 2.00% to 2.01%) to .05 percentage points (from 8.00% to 8.05%) to .06 percentage points (from 9.50% to 9.56%). Applicable percentage table 1. Required contribution of household income used in calculating amount of premium tax credit. 2. In 2014, the applicable percentage table ranges from 2.0% to 9.5% of household income. 3. For 2015, IRS estimates the adjusted applicable percentage table will range from 2.01% to 9.56%. Required contribution percentage 1. This measure is used to determine if someone is eligible for affordable employer-sponsored health insurance. 2. In 2014, the “required contribution percentage” is 9.5%. 3. For 2015, IRS estimates the adjusted “required contribution percentage” to be 9.56%. Medicaid DSH Payments: Uninsured Definition CMS-2315-F Medicaid Program; Disproportionate Share Roster key: Released: 12/3/2014 Due date: None Affordability percentage 1. This measure is used to determine if someone is eligible for an exemption due to health insurance options not being “affordable.” 2. In 2014, the “affordability percentage” was defined as spending more than 8% of household income. 3. For 2015, IRS estimates the adjusted “affordability percentage” to be 8.05%. [NOTE: CMS-9944-P identifies some of the applicable percentages for 2016.] This final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under the Social Security Act (the Act). Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or “have no health insurance (or other 1/5/2015: See analysis to the left comparing tribal recommendations and the final rule issued by CMS. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 21 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Hospital Payments--Uninsured Definition http://www.gpo.gov/fdsys/pkg/FR-2014-1203/pdf/2014-28424.pdf source of third party coverage) for the services furnished during the year.” This rule provides that, in auditing DSH payments, CMS will apply the quoted test on a service-specific basis; the calculation of uncompensated care for purposes of the hospital-specific DSH limit will include the cost of each service furnished to an individual by that hospital for which the individual had no health insurance or other source of third party coverage. Analysis: NIHB submitted comments on the proposed version of this rule on February 17, 2012. A summary of the recommendations from NIHB, as well as the responses from CMS in this final rule, appears below. 1. Tribal Consultation: CMS did not engage in tribal consultation on the proposed rule as required; CMS should engage in consultation with AI/ANs prior to issuing the final rule. 2/4/2015: Doneg will check with Carl Harper to see the understanding of the impact. Invite CMS to TTAG to discuss this if it is a problem. 3/12/2015: Requests are pending with IHS on whether IHS is currently receiving Medicaid DSH payments. Response: Not accepted. According to CMS, “We solicited input on the proposed rule from IHS, Tribal, and urban programs on March 16, 2012, during an All Tribes’ Call. The purpose of the call was to solicit input regarding how implementation or changes to regulatory provisions would affect American Indians and Alaska Native beneficiaries and the operation of the Indian health program delivery system.” [79 FR 71690] 2. Treatment of IHS and Tribal Hospitals: When IHS and tribal hospitals render services to IHS-eligible individuals, compensation for these services is assumed, despite the acknowledged inadequacy of available IHS funding, and these hospitals cannot include the cost of delivering these services to otherwise uninsured individuals in their calculation of uncompensated care, meaning that the proposed rule would effectively exclude them from participation in the Medicaid DSH program; CMS should address this issue in the final rule, possibly by extending to IHS and tribal hospitals the regulatory protections under the Medicaid DSH program for facilities that receive funding from a State or local government. Response: Not accepted. CMS stated, “The determining factor in deciding whether an American Indian or Alaska Native has health insurance for an inpatient or outpatient hospital service is if the providing entity is an IHS facility or tribal health program. In the case of Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 22 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 contract services, the coverage of the services is specifically authorized via a purchase order or equivalent document because individuals in these circumstances are considered to have a source of third party payment. The cost of services and any revenues received would be excluded from the DSH calculation. Individuals obtaining inpatient or outpatient hospital services from a non-IHS or tribal facility without a purchase order (or other authorization) would be considered uninsured for these services. The costs of these services and revenues received could be included in the DSH limit calculation.” [79 FR 71689] In addition, CMS stated, “An American Indian or Alaska Native would be considered to have no health insurance when he or she obtains services without a purchase order or equivalent authorization to pay for them. If contract providers have provided needed services that were not pursuant to a purchase order, the American Indian or Alaska Native would be considered uninsured (absent private coverage) and the costs and any revenues associated with these services could be included in the limit.” [79 FR 71689-90] CMS also noted that the recommendation to treat IHS and tribal hospitals similarly to “a State or unit of local government within a State” falls outside the scope of the rule. [79 FR 71690] 3. Use of HIPAA Definition of Creditable Coverage: The proposed rule uses the HIPAA definition of creditable coverage; CMS should not use this definition, which is neither required nor, in the case of services rendered to IHS-eligible individuals, warranted, as it results in considering IHPs rendering services to IHS-eligible persons as fully compensated for these services without regard to the level of available IHS funding. Response: Accepted in part. CMS stated, “In this final rule, we are defining “individuals who have no health insurance (or other source of third party coverage) for the services furnished during the year” for purposes of calculating the hospital-specific DSH limit on a servicespecific basis, rather than on an individual basis, and thus do not make reference to the regulatory definition of creditable coverage. The definition instead requires a determination of whether, for each specific service furnished during the year, the individual has third party coverage.” [79 FR 71690] Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 23 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Additional Requirements for Charitable Hospitals TD 9708 Additional Requirements for Charitable Hospitals; Community Health Needs Assessments for Charitable Hospitals; Requirement of a Section 4959 Excise Tax Return and Time for Filing the Return http://www.gpo.gov/fdsys/pkg/FR-2014-1231/pdf/2014-30525.pdf Released: 12/31/2014 Due date: None This document contains final regulations that provide guidance regarding the requirements for charitable hospital organizations added by ACA. These final regulations will affect charitable hospital organizations. These final regulations provide guidance on the requirements described in section 501(r), the entities that must meet these requirements, and the reporting obligations relating to these requirements under section 6033. In addition, the final regulations provide guidance on the consequences described in sections 501(r)(1), 501(r)(2)(B), and 4959 for failing to satisfy the section 501(r) requirements. 1/7/2015: See analysis to the left comparing the tribal recommendation and the final rule issued by IRS. Analysis: This rule finalizes REG-130266-11, issued on June 26, 2012, and REG-10649912, issued on April 5, 2013. ANTHC submitted comments on REG-130266-11 on September 24, 2012. A summary of the recommendation from ANTHC, as well as the response from IRS in this final rule, appears below. Hospitals Operated by Tribes: The proposed rule should expressly clarify that hospitals operated by tribes or tribal organizations, even as part of a 501(c)(3) organization, are exempt from its application to avoid ambiguity on this issue. Based on its definitions of “hospital facility” and “hospital organization,” the rule applies solely to entities recognized or seeking to be recognized as tax exempt under 26 U.S.C. § 501(c)(3) that operate a facility required by a state to be licensed, registered, or similarly recognized as a hospital. No states have asserted their authority to require a license of a tribal hospital facility, and the Indian Self-Determination and Education Assistance Act of 1975 and subsequent amendments, as well as the Indian Health Care Improvement Act, pre-empt any state authority in this area. Response: Not addressed this rule; accepted in other rule. IRS accepted this recommendation previously. In the preamble to REG106499-12, IRS clarified that, “pending any future guidance regarding other categories of hospital organizations or facilities, a tribal facility that is not required by a state to be licensed, registered, or similarly recognized as a hospital is not a ‘hospital facility’ for purposes of section 501(r), and a section Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 24 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Annual Update of the HHS Poverty Guidelines HHS (no reference number) Annual Update of the HHS Poverty Guidelines Released: 1/22/2015 Due date: None http://www.gpo.gov/fdsys/pkg/FR-2015-0122/pdf/2015-01120.pdf 501(c)(3) organization will not be considered a ‘hospital organization’ solely as a result of operating such a tribal facility.” [78 FR 20525] This notice provides an update of the HHS poverty guidelines to account for the increase in prices as measured by the Consumer Price Index for the last calendar year. A table comparing the 2015 HHS poverty guidelines with the 2014 guidelines is embedded below. HHS Poverty Guidelines 2014-2015 Table.docx TSGAC Handout attached. TSGAC Revised- 2015 FPL Handout - Medicaid and Marketplace 2015-01-23a.pdf Penalty Relief Related to Advance Payments of the Premium Tax Credit Notice 2015-9 Released: 1/26/2015 1/22/2015: No response required/requested. These poverty level figures will be used for Medicaid eligibility determinations for the remainder of 2015 and until revised FPL guidelines are issued in 2016. (The Marketplace will continue to use the 2014 FPL guidelines for 2015 QHP enrollment.) Handout on use of 2015 FPL linked to the left. This notice provides limited relief for taxpayers who have a balance due on their 2014 income tax return as a result of reconciling advance payments of 1/31/2015: No comments the premium tax credit against the premium tax credit allowed on the tax requested or Due date: return. Specifically, this notice provides relief from the penalty under § recommended. Penalty Relief Related to Advance Payments None 6651(a)(2) of the Internal Revenue Code for late payment of a balance due of the Premium Tax Credit for 2014 and the penalty under § 6654(a) for underpayment of estimated tax. To qualify for the relief, taxpayers must meet certain requirements described in http://www.irs.gov/pub/irs-drop/n-15this notice. This relief applies only for the 2014 taxable year. 09.pdf The § 6651(a)(2) penalty is not imposed if the taxpayer shows that the failure was due to reasonable cause and not willful neglect. the Service will abate the § 6651(a)(2) penalty for taxable year 2014 for taxpayers who (i) are otherwise current with their filing and payment obligations; (ii) have a balance due for the 2014 taxable year due to excess advance payments of the premium tax credit; and (iii) report the amount of excess advance credit payments on their 2014 tax return timely filed, including extensions the Service will waive the § 6654 penalty for taxable year 2014 for an underpayment of estimated tax for taxpayers who have an underpayment attributable to excess advance credit payments if the taxpayers (i) are otherwise current with their filing and payment obligations; and (ii) report the amount of the excess advance credit Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 25 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 payments on a 2014 tax return timely filed, including extensions Taxpayers should be aware that this Notice does not extend the time to file a return. Additionally, § 6601 imposes interest on amounts of tax not paid by the due date, determined without regard to an extension of time for payment. Taxpayers will be required to pay interest on the balance due from the original deadline to pay, which is generally April 15, 2015, even if they qualify for penalty relief under this Notice. Taxpayers who file their returns after April 15, 2015 must fully pay the underlying liability by April 15, 2016 to be eligible for relief under this Notice. Interest will accrue until the underlying liability is fully paid. To request a waiver of the § 6654(a) penalty as provided in this Notice, taxpayers should check box A in Part II of Form 2210, complete page 1 of the form, and include the form with their return, along with the statement: “Received excess advance payment of the premium tax credit.” Special Protections for AI/ANs CMS (no reference number) Released: 1/27/2015 Health Insurance Marketplace Protections for American Indians and Alaska Natives Due date: None http://www.cms.gov/Outreach-andEducation/American-Indian-AlaskaNative/AIAN/Downloads/AIANsSpecialProtections-Fact-Sheet.pdf AI/AN Trust Income and MAGI CMS (no reference number) Released: 1/27/2015 American Indian and Alaska Native Trust Income and MAGI Due date: None Roster key: This relief does not apply to any underpayment of the individual shared responsibility payment resulting from the application of § 5000A because such underpayments are not subject to either the § 6651(a)(2) penalty or the § 6654(a) penalty. This fact sheet explains the protections for AI/ANs in the Marketplace, Medicaid, and CHIP. This fact sheet addresses special enrollment periods, zero and limited cost-sharing plans, Medicaid and CHIP protections, and Indian-specific exemptions. 1/26/2015: Handout prepared and released by CMS on Indian-specific benefits and protections under the ACA and Medicaid. No response requested. This fact sheet describes Modified Adjusted Gross Income (MAGI) and what that means for AI/AN Trust Income. This fact sheet includes frequently asked questions and answers and a list of specific types of AI/AN exempt income. 1/26/2015: Handout prepared and released by CMS on Indian-specific income provisions under the ACA, Medicaid and federal Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 26 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 http://www.cms.gov/Outreach-andEducation/American-Indian-AlaskaNative/AIAN/Downloads/AIAN-TrustIncome-and-MAGI-FactSheet.pdf FAQ About Excepted Benefits CCIIO (no reference number) Released : 2/13/2015 FAQs About Affordable Care Act Implementation: Excepted Benefits Due date: None http://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/SupplmentalFAQ_2-13-15-final.pdf law. No response requested This guidance, prepared jointly by HHS and the Departments of Labor and the Treasury (collectively, the Departments), answers an additional Frequently Asked Question (FAQ) regarding implementation of ACA, specifically addressing the issue of excepted benefits. The Departments have become aware of health insurance issuers selling supplemental products that provide a single benefit. At least one issuer has characterized this type of coverage as an excepted benefit. These issuers claim that the products meet the criteria for supplemental coverage to qualify as an excepted benefit outlined in guidance and seek to fill the gaps of primary coverage in the sense that they provide a benefit not covered under the primary group health plan. This guidance answers the question of whether health insurance coverage that supplements group health coverage by providing additional categories of benefits qualifies as supplemental excepted benefits. According to this guidance: 2/20/2015: No comments requested or recommended. “It depends. The Departments’ prior guidance provided an enforcement safe harbor for supplemental insurance products that are specifically designed to fill gaps in primary coverage, such as coinsurance or deductibles. In determining whether insurance coverage sold as a supplement to group health coverage can be considered ‘similar supplemental coverage’ and an excepted benefit, the Departments will continue to apply the applicable regulations and the four criteria indicated in the guidance discussed above. In addition, the Departments intend to propose regulations clarifying the circumstances under which supplemental insurance products that do not fill in cost-sharing under the primary plan are considered to be specifically designed to fill gaps in primary coverage. Specifically, the Departments intend to propose that coverage of additional categories of coverage would be considered to be designed to ‘fill in the gaps’ of the primary coverage only if the benefits covered by the supplemental insurance product are not an essential health benefit (EHB) in the State where it is being marketed. If any benefit in the coverage is an EHB in the State where it is marketed, the insurance coverage would not be an excepted benefit under our intended proposed regulations, and would have to comply with the applicable provisions of title XXVII of PHS Act, part 7 of ERISA, and chapter 100 the Code. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 27 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 We note that this standard applies to coverage that purports to qualify as an excepted benefit as ‘similar supplemental coverage provided to coverage under a group health plan’ under PHS Act section 2791(c)(4), ERISA section 733(c)(4), and Code section 9832(c)(4). This standard does not apply to other circumstances where the coverage may qualify as another category of excepted benefits, such as limited excepted benefits under section 2791(c)(2), ERISA section 733(c)(2), and Code section 9832(c)(2). Application of Code § 4980D to Certain Health Coverage Arrangements Notice 2015-17 Guidance on the Application of Code § 4980D to Certain Types of Health Coverage Reimbursement Arrangements http://www.irs.gov/pub/irs-drop/n-1517.pdf Roster key: Released : 2/17/2015 Due date: None Pending publication and finalization of the above proposed regulations, the Departments will not initiate an enforcement action if an issuer of group or individual health insurance coverage fails to comply with the provisions of the PHS Act, ERISA, and the Code, as amended by the Affordable Care Act, with respect to health insurance coverage that (1) provides coverage of additional categories of benefits that are not EHB in the applicable State (as opposed to filling in cost-sharing gaps under the primary plan); (2) complies with the applicable regulatory requirements and meets all of the criteria in the existing guidance on ‘similar supplemental coverage’; and (3) has been filed and approved with the State (as may be required under State law). As noted above, for purpose of the second criterion of the existing guidance, coverage would be considered designed to ‘fill gaps in primary coverage’ even if it does not include coverage of cost-sharing under the group health plan, only if the benefits are not covered by the group health plan and are not EHBs in the State. The Departments encourage States that have primary enforcement authority over the provisions of the PHS Act, as amended by the Affordable Care Act, to utilize the same enforcement discretion under such circumstances.” This notice reiterates the conclusion in previous guidance addressing employer payment plans, including Notice 2013-54, that employer payment plans are group health plans that will fail to comply with the market reforms that apply to group health plans under ACA. For this purpose, an employer payment plan as described in Notice 2013-54 refers to a group health plan under which an employer reimburses an employee for some or all of the premium expenses incurred for an individual health insurance policy or directly pays a premium for an individual health insurance policy covering the employee, such as arrangements described in Revenue Ruling 61-146. This notice also provides transition relief from the assessment of excise tax under Internal Revenue Code (Code) § 4980D for failure to satisfy market reforms in certain circumstances. The transition relief applies to employer health care arrangements that constitute (1) employer payment plans, as described in REVIEW. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 28 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Notice 2013-54, if the plan is sponsored by an employer that is not an Applicable Large Employer (ALE) under Code § 4980H(c)(2) and §§54.4980H1(a)(4) and -2; (2) S corporation health care arrangements for 2-percent shareholder-employees; (3) Medicare premium reimbursement arrangements; and (4) TRICARE-related health reimbursement arrangements (HRAs). This notice also provides additional guidance on the tax treatment of employer payment plans. This notice supplements and clarifies the guidance provided in Notice 2013-54 and other guidance in response to comments and questions from taxpayers and stakeholder groups about certain aspects of that guidance. 2016 Letter to Issuers in FFMs CCIIO (no reference number) Released: 2/20/2015 Final 2016 Letter to Issuers in the FederallyFacilitated Marketplaces Due date: None http://www.cms.gov/CCIIO/Resources/Regul ations-andGuidance/Downloads/2016_Letter_to_Issue rs_2_20_2015.pdf This final 2016 Letter to Issuers in the Federally-Facilitated Marketplaces (Letter) provides issuers seeking to offer qualified health plans (QHPs), including stand-alone dental plans (SADPs), in the Federally-Facilitated Marketplaces (FFMs) or the Federally-Facilitated Small Business Health Options Programs (FF-SHOPs) with operational and technical guidance to help them successfully participate in those Marketplaces in 2016. Unless otherwise specified, references to the FFMs include the FF-SHOPs. 2/25/2015: See analysis of final rule (as compared to tribal recommendations) to the left. Throughout this Letter, CMS identifies the areas in which States performing plan management functions in the FFMs have flexibility to follow an approach different from that articulated in this guidance. CMS notes that the policies articulated in this Letter apply to the certification process for plan years beginning in 2016. Previously published rules concerning market-wide and QHP certification standards, eligibility and enrollment procedures, and other Marketplacerelated topics appear in 45 CFR Subtitle A, Subchapter B. Additional requirements appear in a final rule titled, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016” (2016 Payment Notice Final Rule), CMS-9944-F, released on February 20, 2015. CMS expects issuers to consult all applicable regulations, in conjunction with the final version of this Letter, to ensure full compliance with the requirements of ACA. Throughout the plan year, QHPs might have to correct deficiencies identified in CMS post-certification activities, as a result of the investigation of consumer complaints or oversight by State regulators or by CMS, or in response to an industry-standard internal compliance and risk management program. QHP issuers in the FFMs also might have other requirements for plan years beginning in 2016, as indicated in future Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 29 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 rulemaking. Analysis: TTAG submitted comments on the draft version of this letter on January 12, 2015. A summary of the recommendations from TTAG, as well as the responses from CMS in this final letter, appears below. 1. Application of Requirements Related to Indian Health Providers (IHPs): The requirements in the 2016 Issuer Letter apply solely to issuers when offering qualified health plans (QHPs) through the Federally-Facilitated Marketplace (FFM); CMS should extend these requirements to issuers when offering QHPs in State-Based Marketplaces. Response: Not accepted. 2. Special Enrollment Period for Tax Season CMS (no reference number) Released: 2/20/2015 CMS Announces Special Enrollment Period for Tax Season Due date: None http://www.cms.gov/Newsroom/MediaRele aseDatabase/Press-releases/2015-Pressreleases-items/2015-02-20.html Roster key: Requirement for Issuers to Offer Contracts to IHPs: The draft 2016 Issuer Letter does not retain a provision in the 2015 Issuer Letter (page 20) requiring issuers--in cases in which they fail to 30 percent essential community provider (ECP) guideline--to attest in a narrative justification to having made good faith contract offers to all IHPs in a QHP service area and instead states on page 26, “If an issuer’s application does not satisfy the 30 percent ECP standard as well as the requirement to offer contracts in good faith to all available Indian health providers in the service area,” the issuer must provide a narrative justification (emphasis added); CMS should delete the italicized phrase, as it would allow an issuer to offer a QHP through the FFM without having made good faith contract offers to all available IHPs. Response: Not accepted. CMS finalized this statement as proposed. This press release announces a special enrollment period (SEP) for individuals who did not have health coverage in 2014 and face the fee or “shared responsibility payment” when they file their 2014 taxes in states using the Federally-Facilitated Marketplace (FFM). This SEP period will allow these individuals who were unaware or did not understand the implications of this new requirement to enroll in 2015 health insurance coverage through the FFM from March 15 to April 30. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 30 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Basic Health Program Federal Funding Methodology for PY 2016 CMS-2391-FN Basic Health Program; Federal Funding Methodology for Program Year 2016 http://www.gpo.gov/fdsys/pkg/FR-2015-0224/pdf/2015-03662.pdf Released: 2/20/2015 Published: 2/24/2015 REVIEW. Due date: None Corrected Form 1095-As CMS (no reference number) Released: 2/20/2015 What Consumers Need to Know about Corrected Form 1095-As Due date: None http://blog.cms.gov/2015/02/20/whatconsumers-need-to-know-about-correctedform-1095-as/ This document provides the methodology and data sources necessary to determine federal payment amounts made in program year 2016 to states that elect to establish a Basic Health Program under ACA to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through the Affordable Insurance Exchanges. This blog post provides information for the 20 percent of tax filers who had Federally-Facilitated Marketplace coverage in 2014, used tax credits to lower their premium costs, and received a Form 1095-A with incorrect information. According to this post, these 800,000 individuals (< 1 percent of total tax filers) will receive an updated Form 1095-A because the original version they received listed an incorrect benchmark plan premium amount. This post recommends that Marketplace consumers concerned about the status of their Form 1095-A should take the following actions: 1. 2. 3. FYI. No action needed. Determine whether they are affected by logging in to their account at HealthCare.gov; If they received a form with incorrect information, wait to file their tax return until they receive a corrected form; and If they need to file their tax return immediately, use the online tool or call the Marketplace Call Center at 1-800-318-2596 to determine the correct amount of the second-lowest-cost silver plan that applied to their household in 2014. More information on this issue, as well as a link to the online tool, is available at https://www.healthcare.gov/blog/is-your-form-1095a-correct/. An FAQ document for assisters about this issue is available at https://marketplace.cms.gov/technical-assistance-resources/slc-silverplan.pdf. Press coverage of this blog post is available at http://www.manatt.com/health-reform-weekly-highlights-2-24-15.aspx. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 31 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Modifications to the Multi-State Plan Program for Exchanges OPM (RIN 3206-AN12) Patient Protection and Affordable Care Act; Establishment of the Multi-State Plan Program for the Affordable Insurance Exchanges Released: 2/24/2015 Due date: None http://www.gpo.gov/fdsys/pkg/FR-2015-0224/pdf/2015-03421.pdf Health Insurance Providers Fee TD 9711 Released: 2/26/2015 Health Insurance Providers Fee Due date: None http://www.gpo.gov/fdsys/pkg/FR-2015-0226/pdf/2015-03944.pdf HHS Notice of Benefit and Payment Parameters for 2016 CMS-9944-F Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016 Roster key: Released: 2/20/2015 Published: 2/27/2015 Due date: None This final rule implements modifications to the Multi-State Plan (MSP) Program based on the experience of the program to date. OPM established the MSP Program pursuant to ACA. This final rule clarifies the approach used to enforce the applicable standards of ACA with respect to health insurance issuers that contract with OPM to offer MSP options; amends MSP standards related to coverage area, benefits, and certain contracting provisions under section 1334 of ACA; and makes non-substantive technical changes. NOTE: Tribal organizations made 16 recommendations on the OPM rule that initially established the Multi-State Plan Program (MSPP). In a final rule issued on March 11, 2013, OPM accepted only one of these recommendations in full but either accepted in part or acknowledged by other means most of the others; the rule did not address four of the recommendations. In the Q1 FY 2015 NIHB evaluation report, a comparison of the proposed version to this latest final rule with the unaccepted recommendations previously categorized as having “potential for future actions” indicated that OPM had not addressed any of these recommendations. The proposed rule also included no Indian-specific provisions. A prior analysis of the proposed rule recommended that tribal organizations consider commenting on a proposal to delete the requirement that contracting MSP providers submit a plan for statewide coverage when their coverage in a state is not currently statewide, as this change likely would impact coverage options in rural and underserved areas; tribal organizations opted not to comment. This document contains temporary regulations that provide rules for the definition of a covered entity for purposes of the fee imposed by section 9010 of ACA. The temporary regulations clarify certain terms in section 9010. The temporary regulations affect persons engaged in the business of providing health insurance for U.S. health risks. The text of the temporary regulations also serves as the text of the proposed regulations (REG-143416-14) published in elsewhere in this issue of the Federal Register. This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for FederallyFacilitated Exchanges. It also finalizes additional standards for the individual market annual open enrollment period for the 2016 benefit year, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential 3/20/2014: Summary embedded below. REG-143416-14 analysis 2015-03-18.docx 2/25/2015: See analysis of final rule (as compared to tribal recommendations) to the left 3/18/2015: The two highlighted issues (family Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 32 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 http://www.gpo.gov/fdsys/pkg/FR-2015-0227/pdf/2015-03751.pdf coverage, the rate review program, the medical loss ratio program, and other related topics. A CCIIO fact sheet on this final rule is available at http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/2016-PN-Fact-Sheet-final.pdf. tag-along policy and family plans/cost-sharing protections) will be added to the ACA Policy Subcommittee agenda. Analysis: TTAG submitted comments on the proposed version of this rule on December 22, 2014. A summary of the recommendations from TTAG, as well as the responses from CMS in this final rule, appears below. 1. Requirement on Summary of Benefits and Coverage (SBC): The proposed rule would establish a requirement that QHP issuers prepare an SBC for each plan variation, such as the “zero cost-sharing variation” and the “limited cost-sharing variation”; in regard to this requirement, CMS should: Roster key: a. Retention: Retain this requirement, as to date, information on Indian-specific cost-sharing protections provided by issuers to consumers, if any, often proves confusing or incorrect, prompting some AI/ANs to decide not to enroll in coverage through a Marketplace; b. Encouraging Issuer Compliance: Encourage issuers to prepare SBCs for use during the 2015 benefit year but no later than the first day of the Marketplace open enrollment period for the 2016 benefit year; c. Regulatory Cross-Reference: Add a cross-reference to the requirement to prepare an SBC in the regulation on SBCs (45 § 147.200) by inserting in §147.200 the following language (in brackets and bold): “§147.200 Summary of benefits and coverage and uniform glossary. (a) Summary of benefits and coverage--(1) In general. A group health plan (and its administrator as defined in section 3(16)(A) of ERISA), and a health insurance issuer offering group or individual health insurance coverage, is required to provide a written summary of benefits and coverage (SBC) for [each plan variation of] each benefit package [, as indicated in §156.420(h)] without charge to entities and individuals described in this paragraph (a)(1) in accordance with the rules of this section”; and Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 33 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 d. Examples Regarding Compliance: In the preamble to the final rule, and in subsequent guidance documents, provide examples of when QHP issuers must provide SBCs to comply with the requirements set forth in § 147.200 and § 156.420(h) and the circumstances, if any, under which a single SBC can satisfy the requirement for multiple plans. Response: 2. a. Retention: Accepted. CMS approved this provision as proposed; b. Encouraging Issuer Compliance: Accepted in part. CMS approved the requirement that QHP issuers provide SBCs for plan variations no later than the first day of the next Marketplace open enrollment period for the individual market for the 2016 benefit year, specifying this date as November 1, 2015; c. Regulatory Cross-Reference: Not accepted. CMS did not modify § 147.200 in the final rule; and d. Examples Regarding Compliance: Not accepted. CMS did not address this issue. Hardship Exemption: The proposed rule includes a provision that would codify the newly established process for obtaining the hardship exemption from the tax penalty for IHS-eligible individuals; in regard to this provision, CMS should: a. Retention: Retain this provision (§ 155.605(g)(6)(iii)), which would make agency regulations consistent with revised IRS regulations; and b. Paper-Based Application Process: Refocus attention on fixing the paper-based exemption application process through FederallyFacilitated Marketplaces by allocating sufficient resources and making the current status of individual applications--as well as applications in the aggregate--more transparent. Response: Roster key: a. Retention: Accepted. CMS approved this provision as proposed; and b. Paper-Based Application Process: Not accepted. CMS did not address this issue specifically but stated, “We remain committed to Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 34 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 improving the Exchange exemptions process” [80 FR 10802]. 3. Code Citation to Definition of Indian Under Medicaid: The proposed rule includes a provision that would amend § 155.605(g)(6)(i) by changing the citation from 42 § 447.50 to 42 § 447.51, which cross-references the definition of Indian used for Medicaid purposes; CMS should retain this provision. Response: Accepted. CMS approved this provision as proposed. 4. Network Adequacy and Essential Community Provider Provisions: The proposed rule would codify some of the network adequacy and essential community provider (ECP) provisions that appear in the CCIIO 2015 Issuer Letter and apply solely under the FFM, including 1) codifying the requirement that QHP issuers offer contracts to all Indian health care providers (IHCPs), 2) requiring/encouraging “good faith” offers pertaining to payment rates, 3) adding a requirement that QHP-IHCP contracts apply the special terms and conditions under Federal law pertaining to IHCPs (contained in the QHP Addendum), and 4) applying the requirement that QHP issuers offer contracts to IHCPs; in regard to these provisions, CMS should: Roster key: a. Retention: Retain the requirement that QHP issuers offer contracts to all IHCPs in the QHP service area; b. 30 Percent ECP Standard: At a minimum, maintain the minimum standard of contracting with at least 30 percent of available ECPs until such time as quantitative evidence indicates that enrollees have reasonable and timely access to health care services; c. “Good Faith” Contract Offers: Retain the provision requiring “good faith” contract offers to IHCPs, but 1) clarify that the minimum payment rate provision exists as a requirement rather than an “expectation” and 2) include the minimum payment rate requirement in the final regulations, rather than limiting it to the preamble; d. QHP Addendum Language: Modify the language referencing the QHP Addendum to make it consistent with the wording of the CCIIO 2015 Issuer Letter, as the proposed rule appears to require application of the Indian-specific provisions in Federal law but not (as required in the CCIIO 2015 Issuer Letter) actual use of the Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 35 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Addendum; e. “Alternative Standard” for Issuers: Strengthen the “alternative standard” for QHP issuers to comply with ACA requirements by 1) adding a requirement that they indicate efforts taken to date to meet the ECP standard and 2) making publicly available their narrative description of efforts taken to date, as well as their plan on “how the plan’s provider network will be strengthened toward satisfaction of the ECP standard prior to the start of the benefit year”; and f. State-Based Marketplace (SBM) Standards: Add language to the preamble of the final rule “urging” SBMs to apply the IHCP contracting standards to QHPs offered through SBMs. Response: Roster key: a. Retention: Accepted. CMS approved this provision as proposed; b. 30 Percent ECP Standard: Accepted. CMS approved this provision as proposed. According to CMS, “Based on our QHP certification reviews for the 2015 benefit year and the ongoing strengthening of our ECP list, we believe that specifying the ECP inclusion percentage in HHS guidance for the 2016 benefit year provides desirable flexibility at this time for HHS further examine the adequacy of this inclusion standard for ensuring access to care for low-income, medically underserved individuals for future years” [80 FR 10835]; c. “Good Faith” Contract Offers: Accepted in part. CMS approved this provision as proposed and stated, “We do not intend to prescribe such specificity regarding contract negotiations between parties. Therefore, we are not requiring a minimum payment rate provision, and instead reiterate our expectation that QHP issuers offer contracts in good faith” [80 FR 10838]. In addition, CMS codified the inclusion of IHCPs in the definition of ECP to “emphasize that these providers are among the ECP groups to which issuers must extend contract offers in good faith to satisfy §156.235(a)” [80 FR 10835]; d. QHP Addendum Language: Not accepted. According to CMS, “We believe the requirement that issuers apply the special terms and conditions necessitated by Federal law and regulations as referenced in the recommended model QHP addendum, along with encouraging issuer use of the recommended model QHP addendum in guidance, Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 36 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 5. strikes the desirable balance between allowing the minimal flexibility that issuers have requested while ensuring inclusion of the fundamental provisions of the model QHP addendum within the issuer contractual offers to the Indian health providers. Therefore, while we strongly encourage issuers to use the model QHP Addendum, we are not requiring that they do so” [80 FR 10836]; e. “Alternate Standard” for Issuers: Not accepted. CMS modified this provision but did not address the recommended requirements; and f. State-Based Marketplace (SBM) Standards: Accepted. CMS stated, “We urge State Exchanges to employ the same standard when examining adequacy of ECPs as outlined in §156.235, including the requirement that issuers offer contracts to all Indian health providers in the plan’s service area” [80 FR 10837]. Application of Cost-Sharing Protections for AI/AN Families: Responses from CMS to earlier comments from tribal organizations indicated a willingness to address problems with the application of cost-sharing protections for families with AI/AN and non-AI/AN members beginning with the 2016 benefit year, but the proposed rule does not address this issue; in regard to this concern, CMS should 1) implement tribal recommendations (made on CMS-9964-P in December 2012) to eliminate the potential for an increase in the aggregate premiums and to prevent shifting of out-of-pocket (OOP) liabilities to non-Indian family members or 2) provide as an administrative convenience the ability of other IHSeligible family members to enroll in the same zero cost-sharing variation or limited cost-sharing variation in which Indian members of the family qualify. Response: Not accepted.* CMS did not address this issue. *NOTE: On an ACA Policy Subcommittee call on 2/26/2015, Kitty Marx indicated this issue was addressed in the final rule. She indicated it was addressed in a way that is applicable to all families (not solely Indians) that have persons eligible for different cost-sharing protections. Citation to be provided. 6. Roster key: AI/AN Family Tag-Along Policy: At the request of tribal organizations, CCIIO issued guidance to enrollment assisters on November 15, 2014, Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 37 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 indicating that family members of individuals eligible for the Monthly Special Enrollment Period (SEP) for Indians can enroll in Marketplace coverage with the eligible individuals, and although the proposed rule would make several modifications to SEP regulations (§155.420), it would not codify this provision; in regard to this provision, CMS should add this provision to the final rule by inserting in §155.420(d)(8) the following language (in bold): “(8) The qualified individual who is an Indian, as defined by section 4 of the Indian Health Care Improvement Act, or his or her dependent, may enroll in a QHP or change from one QHP to another one time per month.”’ Response: Not accepted. From the entry by CMS in the regulation preamble, CMS seemed to pull-back from existing CMS policy whereby dependents may access the Indian-specific special enrollment period if a family meets the eligibility requirements. (Kitty Marx stated on an ACA Policy Subcommittee call that the exist CCIIO guidance on this would stay in effect.) CMS stated, “An Indian as provided under section 4(d) of the Indian Self Determination and Education Assistance Act (ISDEAA) and section 4 of the Indian Health Care Improvement Act (IHCIA) is defined as an individual who is a member of an Indian tribe. Both ISDEAA and IHCIA have nearly identical language that refers to a number of Indian entities that are included in this definition on the basis that they are recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians. As such, the statute specifically provides the special enrollment period defined in paragraph (d)(8) of this section as applying to the individual who is eligible for special programs and services because of their status as an Indian, and not their dependents” [80 FR 10799]. 7. Maximum Out-of-Pocket Costs for Individuals: The proposed rule includes language clarifying (for the 2016 benefit year and beyond) that the annual limitation on cost-sharing for self-only coverage applies to all individuals, regardless of whether the individual is covered by a self-only plan or a family plan, with the limit let at $6,850 in 2016; CMS should retain this provision. Response: Accepted. CMS approved this provision as proposed. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 38 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Other Points of Interest: Contract Offers to IHCPs: One (non-tribal representative) commenter recommended that, “if issuers met the ECP standard in the previous year, issuers not be required every year to offer contracts to all Indian health care providers in the service area and to at least one ECP in each ECP category in each county in the service area” [80 FR 10836-7]. Response: Retained provision as preferred by tribal representatives. Additional Requirements for Charitable Hospitals TD 9708 Additional Requirements for Charitable Hospitals; Community Health Needs Assessments for Charitable Hospitals; Requirements of a Section 4959 Excise Tax Return and Time for Filing the Return; Correction http://www.gpo.gov/fdsys/pkg/FR-2015-0311/pdf/2015-05519.pdf Roster key: Released: 3/11/2015 Due date: None Removal of IHCPs as ECPs: One (non-tribal representative) commenter recommended that CMS remove IHCPs as a major ECP category “due to the overlapping requirement that issuers offer contracts to all Indian health providers in the service area” [80 FR 10837]. Response: Retained provision as preferred by tribal representatives. This document contains corrections to final regulations (TD 9708) published in the December 31, 2014, Federal Register (79 FR 78954). The final regulations provide guidance regarding the requirements for charitable hospital organizations added by ACA. This document makes the following corrections to 26 CFR parts 1 and 53: PART 1--INCOME TAXES Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * Par. 2. Section 1.501(r)-0 is amended by revising the heading for the table of contents entry § 1.501(r)-7 to read as follows: § 1.501(r)-0 Outlines of regulations. ***** § 1.501(r)-7 Effective/applicability date. ***** Par. 3. Section 1.501(r)-1 is amended by revising the first sentence of paragraph (b)(23) and revising paragraph (b)(29)(ii)(B) to read as follows: § 1.501(r)-1 Definitions. ***** Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 39 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 (b) * * * (23) Partnership agreement means, for purposes of paragraph (b)(22)(ii)(B) of this section, all written agreements among the partners, or between one or more partners and the partnership, and concerning affairs of the partnership and responsibilities of the partners, whether or not embodied in a document referred to by the partners as the partnership agreement. * * * ***** (29) * * * (ii) * * * (B) Without paying a fee to the hospitality facility, hospital organization, or other entity maintaining the Web site; and ***** Par. 4. Section 1.501(r)-2 is amended by revising the second sentence of paragraph (c) to read as follows: § 1.501(r)-2 Failures to satisfy section 501(r). ***** (c) * * * For purposes of this paragraph (c), a “willful” failure includes a failure due to gross negligence, reckless disregard, or willful neglect, and an “egregious” failure includes only a very serious failure, taking into account the severity of the impact and the number of affected persons. * * * ***** Par. 5. Section 1.501(r)-3 is amended by revising the introductory text of paragraph (c)(2) to read as follows: § 1.501(r)-3 Community health needs assessments. ***** (c) * * * (2) Description of how the hospital facility plans to address a significant health need. A hospital facility's implementation strategy will have described a plan to address a significant health need identified through a CHNA for purposes of paragraph (c)(1)(i) of this section if the implementation strategy— ***** Par. 6. Section 1.501(r)-6 is amended by: 1. Revising paragraph (c)(4)(i)(A). 2. Revising the first sentence of paragraph (c)(4)(iii)(A). 3. Revising the second of paragraph (c)(4)(iv), Example 2. 4. Revising paragraph (c)(6)(i)(C)(1). Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 40 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 The revisions read as follows: § 1.501(r)-6 Billing and collection. ***** (c) * * * (4) * * * (i) * * * (A) Provides the individual with a written notice that indicates financial assistance is available for eligible individuals, that identifies the ECA(s) that the hospitality facility (or other authorized party) intends to initiate to obtain payment for the care, and that states a deadline after which such ECA(s) may be initiated that is no earlier than 30 days after the date that the written notice is provided. ***** (iii) * * * (A) Otherwise meets the requirements of paragraph (c)(4)(i) of this section but, instead of the notice described in paragraph (c)(4)(i)(A) of this section, provides the individual with a FAP application form and a written notice indicating that financial assistance is available for eligible individuals and stating the deadline, if any, after which the hospital facility will no longer accept and process a FAP application submitted (or, if applicable, completed) by the individual for the previously provided care at issue. * * * ***** (iv) * * * Example 2. * * * Y also makes numerous attempts to encourage G to apply for financial assistance, including by calling G to inform her about the financial assistance available to eligible patients under Y's FAP and to offer assistance with the FAP application process. * * * ***** (6) * * * (i) * * * (C) * * * (1) If the individual is determined to be eligible for assistance other than free care, provides the individual with a billing statement that indicates the amount the individual owes for the care as a FAPeligible individual and how that amount was determined and that states, or describes how the individual can get information regarding, the AGB for the care. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 41 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 ***** Additional Requirements for Charitable Hospitals TD 9708 Additional Requirements for Charitable Hospitals; Community Health Needs Assessments for Charitable Hospitals; Requirements of a Section 4959 Excise Tax Return and Time for Filing the Return; Correction http://www.gpo.gov/fdsys/pkg/FR-2015-0311/pdf/2015-05520.pdf Roster key: Released: 3/11/2015 Due date: None PART 53--FOUNDATION AND SIMILAR EXCISE TAXES Par. 8. The authority citation for part 53 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * Par. 9. In § 53.4959-1(c), the paragraph heading is revised to read as follows: § 53.4959-1 Taxes on failures by hospital organizations to meet section 501(r)(3). ***** (c) Effective/applicability date.* * * ***** This document contains corrections to final regulations (TD 9708) published in the December 31, 2014, Federal Register (79 FR 78954). The final regulations provide guidance regarding the requirements for charitable hospital organizations added by ACA. As published, the final regulations contain errors that might prove misleading and need clarification. This document makes the following corrections: 1. On page 78961, first column, the eleventh line of the first full paragraph, the language “only very serious failures, taking into” is corrected to read “only a very serious failure, taking into”. 2. On page 78975, third column, the last line of the column, the language “members of the hospital's community” is corrected to read “members of the hospital facility's community”. 3. On page 78979, third column, the eighth line from the bottom the first full paragraph, the language “co-payments, co-insurance, or” is corrected to read “co-payments, co-insurance, and”. 4. On page 78980, the third column, the seventh line from the top of the page, the language “form of co-payments, co-insurance, or” is corrected to read “co-payments, co-insurance, and”. 5. On page 78981, the second column, the twenty-third line from the top of the page, the language “payments, co-insurance, or deductibles),” is corrected to read “payments, co-insurance, and deductibles),”. 6. On page 78982, the first column, the thirteenth line from the top of the page, the language “obtain such percentages, a hospital” is corrected to read “obtain such percentage(s), a hospital”. 7. On page 78983, the first column, the thirteenth line from the top of the page, the language “required under section 501(r)(6)).” is corrected to read “required by the regulations under section 501(r)(6)).”. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 42 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 8. 9. Medicare Quality Incentive Program CMS-1614-CN Released: 3/13/2015 Medicare Program; Quality Incentive Program; Correction Due date: None http://www.gpo.gov/fdsys/pkg/FR-2015-0313/pdf/2015-05766.pdf Amendments to Excepted Benefits TD 9714 DoL (RIN 1210-AB70) CMS-9946-F2 Released: 3/18/2015 Due date: None On page 78983, the first column, the twelfth line from the bottom of the first full paragraph, the language “facility must refund any amounts the” is corrected to read “facility must refund any amount the”. On page 78997, the first column, the heading “Adoption of Amendment to the Regulation” is corrected to read “Adoption of Amendments to the Regulation”. This document corrects technical errors that appeared in the final rule published in the November 6, 2014, Federal Register (79 FR 66120) and titled “End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.” On page 66184 of the preamble, CMS has found errors in the performance standard, achievement threshold, and benchmark values presented in the Numerical Values for the Performance Standards for the Payment Year (PY) 2017 End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) Clinical Measures Using the Most Recently Available Data table for PY 2017 of the ESRD QIP (Table 23). Specifically, CMS calculated the numerical values published for the Standardized Readmission Ratio clinical measure using only 6 months of data from calendar year 2013 instead of the full 12 months, as specified under its finalized policy (79 FR 66183). This technical correction ensures that these numerical standards align with the finalized policies for the PY 2017 ESRD QIP. This document contains final regulations that amend the regulations regarding excepted benefits under ERISA, the Internal Revenue Code, and the Public Health Service Act to specify requirements for limited wraparound coverage to qualify as an excepted benefit. Excepted benefits generally are exempt from the requirements added to those laws by HIPAA and ACA. 3/18/2015: Final rule. No comments requested. Under review. Amendments to Excepted Benefits http://www.gpo.gov/fdsys/pkg/FR-2015-0318/pdf/2015-06066.pdf Revisions to Payment Policies Under the Physician Fee Schedule, et al. CMS-1612-F2 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Roster key: Released: 3/20/2015 Due date: None This document corrects technical errors that appeared in the final rule with comment period published in the November 13, 2014, Federal Register (79 FR 67547-68092) and titled “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015.” This final rule took effect on January 1, 2015. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 43 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015; Corrections http://www.gpo.gov/fdsys/pkg/FR-2015-0320/pdf/2015-06427.pdf Hardship Exemptions for Persons Meeting Certain Criteria CCIIO (no reference number) Guidance on Hardship Exemptions for Persons Meeting Certain Criteria Released: 3/20/2015 Due date: None http://www.cms.gov/CCIIO/Resources/Regul ations-and-Guidance/Downloads/HardshipExemption-Guidance-3-20-15-FINAL.pdf Medicare Access and CHIP Reauthorization Act of 2015 HR 2 Medicare Access and CHIP Reauthorization Act of 2015 http://thomas.loc.gov/cgibin/query/z?c114:H.R.2: Introduced: 3/24/2015 Due date: None This guidance provides information about (1) hardship exemption criteria pertaining to enrollees in Children’s Health Insurance Program Buy-In coverage and Elite Athlete Health Insurance, which are not classified as minimum essential coverage (MEC), in use by Federally-Facilitated Marketplaces (FFMs) (including State Partnership Marketplaces (SPMs)) and possibly in use by State-based Marketplaces (SBMs) that process their own exemptions; (2) hardship exemption criteria pertaining to individuals who seek categorical Medicaid eligibility under section 1902(f) of the Social Security Act (Act) for “209(b)” states in use by FFMs (including SPMs) and possibly in use by SBMs; and (3) clarification of November 21, 2014, hardship exemption guidance regarding consumers enrolled in Medicaid coverage not classified as MEC provided to medically needy individuals under section 1902(a)(10)(C) of the Act. This bill would amend title XVIII of the Social Security Act to repeal the Medicare sustainable growth rate (SGR) and strengthen Medicare access by improving physician payments and making other improvements, to reauthorize CHIP, and for other purposes. A brief summary of each title of this bill appears below. Final. No comments requested or recommended. 3/26/2015: The House passed this bill and sent it to the Senate. TITLE I--SGR REPEAL AND MEDICARE PROVIDER PAYMENT MODERNIZATION This title would repeal SGR and provide a 5-year period of annual physician payment updates of 0.5 percent to transition to a new system. TITLE II--MEDICARE AND OTHER HEALTH EXTENDERS This title would provide a number Medicare and other health “extenders,” including section 213, which would extend special diabetes programs for type 1 diabetes and for Indians through FY 2017. TITLE III--THE CHILDREN’S HEALTH INSURANCE PROGRAM (CHIP) This title would extend CHIP funding through FY 2017. TITLE IV--OFFSETS This title would establish several Medicare and other offsets, including Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 44 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 section 412, which would delay scheduled Medicaid disproportionate share hospital (DSH) allotment reductions until FY 2018 and add another year of reductions in FY 2025. List of DME Items Requiring Face-to-Face Encounter and Prior Written Order CMS-6062-N Medicare Program; Updates to the List of Durable Medical Equipment (DME) Specified Covered Items That Require a Face-to-Face Encounter and a Written Order Prior to Delivery Released: 3/27/2015 Due date: None TITLE V--MISCELLANEOUS This title includes the Protecting the Integrity of Medicare Act of 2015 (PIMA) and several other provisions. This notice updates the Healthcare Common Procedure Coding System (HCPCS) codes on the Durable Medical Equipment (DME) List of Specified Covered Items that require a face-to-face encounter and a written order prior to delivery. http://www.gpo.gov/fdsys/pkg/FR-2015-0327/pdf/2015-07108.pdf CLIA Exemption for Labs in New York CMS-3308-N Released: 3/27/2015 Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of PermitHolding Laboratories in the State of New York Due date: None This notice announces that laboratories located in and licensed by the State of New York with a valid permit under New York State Public Health Law Article 5, Title V, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years. http://www.gpo.gov/fdsys/pkg/FR-2015-0327/pdf/2015-07113.pdf Establishment of the Multi-State Plan Program for Exchanges OPM (RIN 3206-AN12) Patient Protection and Affordable Care Act; Establishment of the Multi-State Plan Program for the Affordable Insurance Roster key: Released: 3/30/2015 Due date: None This document corrects a final rule that appeared in the February 24, 2015, Federal Register (80 FR 9649). The final rule implemented modifications to the Multi-State Plan (MSP) Program based on the experience of the program to date. This document makes the following corrections to the final rule: 1. On page 9655, in the third column, the heading “List of Subjects in 5 CFR part 800” is revised to read, “List of Subjects in 45 CFR part 800.” Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 45 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Exchanges; Correction 2. http://www.gpo.gov/fdsys/pkg/FR-2015-0330/pdf/2015-07330.pdf ACA Implementation FAQs (Summary of Benefits and Coverage) CCIIO (no reference number) Affordable Care Act Implementation FAQs Released: 3/30/2015 Due date: None http://www.cms.gov/CCIIO/Resources/FactSheets-andFAQs/aca_implementation_faqs24.html On page 9655, in the third column, the last paragraph should be revised to read: “Accordingly, the U.S. Office of Personnel Management is revising part 800 to title 45, Code of Federal Regulations, to read as follows:” This guidance, prepared jointly by HHS and the Departments of Labor and the Treasury (collectively, the Departments) answers an additional Frequently Asked Question (FAQ) regarding implementation of ACA. In a December 2014 notice of proposed rulemaking, the Departments proposed changes to summary of benefits and coverage (SBC) regulations, as well as a new SBC template and associated documents. Changes to the SBC regulations, template, and associated documents would apply beginning September 1, 2015. This guidance answers the question of when the Departments intend to finalize changes to the regulations, SBC template, and associated documents. According to this guidance: “The Departments intend to finalize changes to the regulations in the near future, which are intended to apply in connection with coverage that would renew or begin on the first day of the first plan year (or, in the individual market, policy year) that begins on or after January 1, 2016 (including open season periods that occur in the Fall of 2015 for coverage beginning on or after January 1, 2016). 4/1/2015: This document provides additional information on when and how CMS will finalize the templates for the revised Summary of Benefits and Coverage documents. This includes the new requirement for QHP issuers to prepare SBCs for each of the two Indian-specific costsharing variations. The Departments also intend to utilize consumer testing and offer an opportunity for the public, including the National Association of Insurance Commissioners, to provide further input before finalizing revisions to the SBC template and associated documents. The Departments anticipate the new template and associated documents will be finalized by January 2016 and will apply to coverage that would renew or begin on the first day of the first plan year (or, in the individual market, policy year) that begins on or after January 1, 2017 (including open season periods that occur in the Fall of 2016 for coverage beginning on or after January 1, 2017). Ending Special Enrollment Periods for Coverage During CY 2014 CCIIO (no reference number) Roster key: Released: 3/31/2015 The Departments are fully committed to updating the template and associated documents (including the uniform glossary) to better meet consumers’ needs as quickly as possible.” As of April 1, 2015, CMS will no longer accept new requests that would enable consumers to enroll in a Qualified Health Plan (QHP) with 2014 coverage effective dates through the Federally-Facilitated or State Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 46 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Ending Special Enrollment Periods for Coverage during Calendar Year 2014 Due date: None http://www.cms.gov/CCIIO/Resources/Regul ations-andGuidance/Downloads/Guidance_on_ending_ 2014_SEPs.pdf Q&A Regarding Rate Review Requirements (Rounding Premiums) CCIIO 2015-0001 Insurance Standards Bulletin Series: Questions and Answers Regarding Rate Review Requirements http://www.cms.gov/CCIIO/Resources/Regul ations-andGuidance/Downloads/RR_Guidance_on_Pre mium_Rounding.pdf Released: 3/31/2015 Due date: None Partnership Marketplaces through a Special Enrollment Period (SEP). As of April 1, 2015, all SEP requests to CMS seeking 2014 coverage, with the exception of SEPs issued as a result of an eligibility appeal described below, if eligible for retroactive coverage, will receive a coverage effective date of January 1, 2015. This guidance applies to all SEPs specified in 45 CFR §155.420 and supersedes all existing guidance on SEPs. This guidance does not apply to eligibility appeal requests and does not impact the right of a consumer to request an appeal of their eligibility determination in accordance with 45 CFR §155.505(b). This Bulletin provides guidance on when health insurance issuers can round premium rates to the nearest dollar. Specifically, this guidance answers the question of whether a state can allow issuers to round premiums for nongrandfathered single risk pool compliant plans in the individual or small group (or merged) markets in their respective state to the nearest dollar. According to this guidance: “Yes. Premiums for non-grandfathered plans in the individual or small group (or merged) markets generally are rounded to the nearest penny. However, states enforcing the federal single risk pool and fair health insurance premiums requirements under 45 CFR §§ 156.80 and 147.102 may allow issuers to round premiums to the nearest dollar, as long as all of the following conditions are met: Roster key: The premiums are based on unrounded rates, which are calculated based on an index rate for the market and applicable plan level adjustments and premium rating factors in compliance with the single risk pool and fair health insurance premiums requirements under 45 CFR §§ 156.80 and 147.102. Premiums are rounded to the nearest dollar only based on unrounded rates, plan level adjustments, and premium rating factors. This means that premiums can only be rounded one time and only after all of the permitted plan level adjustments and applicable premium rating factors have been applied to the rate (i.e., after family size, geographic rating factor, age rating factor, and, if applicable, tobacco rating factor are taken into account). Issuers may not round rates at intermediate steps in the rate development process. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 47 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 The practice of rounding premiums is done consistently across the risk pool. If an issuer rounds premiums for one plan in the risk pool, the issuer must round premiums for all plans in the risk pool. Fractions of $0.50 or higher are rounded up to the nearest dollar and fractions of less than $0.50 are rounded down to the nearest dollar. If the rounded premium rates vary by more than 3:1 for like individuals who are age 21 and older who vary in age, or by more than 1.5:1 for like individuals who vary in tobacco use, the issuer must adjust the rates to bring them into compliance with the 3:1 age rating factor limit and the 1.5:1 tobacco rating factor limit. In direct enforcement states, HHS enforces the single risk pool and fair health insurance premiums provisions. In these states, issuers must continue to round premiums to the nearest penny unless instructed otherwise in future guidance.” Medicare Secondary Payer and “Future Medicals” (CMS-6047-P) Received at OMB: 8/1/2013 Influenza Vaccination Standard for Certain Participating Providers and Suppliers (CMS3213-F) Received at OMB: 9/27/2013 CY 2015 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8056-N) Received at OMB: 9/18/2014 Roster key: HEALTH-RELATED AGENCY ACTIONS PENDING AT OMB This proposed rule would announce the intentions of CMS regarding means beneficiaries or their representatives can use to protect Medicare with respect to Medicare Secondary Payer (MSP) claims involving automobile and liability insurance (including self-insurance), no-fault insurance, and workers’ compensation where future medical care is claimed or the settlement, judgment, award, or other payment releases (or has the effect of releasing) claims for future medical care. Approved by OMB on 10/9/2014 but not yet released by the agency. This final rule requires certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless patients or their representative or surrogate declined vaccination. This final rule seeks to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rate from influenza. This final rule also requires certain providers and suppliers to develop policies and procedures that will allow them to offer vaccinations for pandemic influenza in case of a future pandemic influenza event for which a vaccine might become available. Approved by OMB on 4/18/2014 but not yet released by the agency. This annual notice announces the inpatient hospital deductible and the hospital and extended care service coinsurance amounts for services furnished in calendar year 2015 under the Medicare Hospital Insurance Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 48 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Program (Part A). The Medicare statute specifies the formula used to determine these amounts. CY 2015 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8057-N) CY 2015 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8058-N) Mental Health Parity and Addiction Equity Act of 2008; the Application to Medicaid Managed Care, CHIP, and Alternative Benefit Plans (CMS-2333-P) Received at OMB: 9/18/2014 This annual notice announces the premiums for CY 2015 under the Medicare Hospital Insurance Program (Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. Received at OMB: 9/18/2014 Received at OMB: 1/7/2015 No detail provided. Reimbursement Rates for Calendar Year 2015 (IHS RIN 0917-ZA29) No detail provided. FY 2016 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1627-P) Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability (CMS-2390-P) Received at OMB: 1/17/2015 Received at OMB: 2/3/2015 Received at OMB: 3/5/2015 Received at OMB: 3/18/2015 Received at OMB: 3/19/2015 FY 2016 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (CMS-1622-P) Electronic Health Record Incentive Program-Modifications to Meaningful Use in 2015 through 2017 (CMS-3311-P) Received at OMB: 3/20/2015 Received at OMB: 3/24/2015 This annual proposed rule would update the payment rates used under the prospective payment system for skilled nursing facilities for fiscal year 2016. Pre-Existing Condition Insurance Plan Program Updates (CMS-9995-IFC4) Medicaid Mechanized Claims Processing and Information Retrieval Systems (CMS-2392-P) Roster key: This proposed rule would address the requirements under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) to Medicaid Alternative Benefit Plans (ABPs), CHIP, and Medicaid managed care organizations (MCOs). Approved by OMB on 3/26/2015 but not yet released by the agency. No detail provided. No detail provided. This annual proposed rule would update the prospective payment rates for inpatient psychiatric facilities with discharges beginning on October 1, 2015. This proposed rule would align Medicaid managed care regulations with existing commercial, Marketplace, and Medicare Advantage regulations. This rule also would implement certain Indian protections under section 5006 of the American Recovery & Reinvestment Act. 3/20/2015: Once released, it will be important to ensure the AI/AN-specific protections are adequate. No detail provided. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 49 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 DoL and IRS/Treasury Health Insurance Premium Assistance Trust Supporting the Purchase of Certain Individual Health Insurance Policies-Exclusion from Definition of Employee Welfare Benefit Plan (DoL RIN 1210-AB57) OPM None. Received at OMB: 8/24/2013 Summary of Benefits and Coverage and Uniform Glossary REG-145878-14 DoL (RIN 1210-AB69) CMS-9938-P Released: 12/22/2014 Summary of Benefits and Coverage and Uniform Glossary Due date: 3/2/2015 http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30243.pdf Published: 12/30/2014 No detail provided. RECENTLY SUBMITTED COMMENTS This document contains proposed regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under ACA. It proposes changes to the regulations that implement the disclosure requirements under section 2715 of the Public Health Service Act (PHS Act) to help plans and individuals better understand their health coverage, as well as to gain a better understanding of other coverage options for comparison. It proposes changes to documents required for compliance with section 2715 of the PHS Act, including a template for the SBC, instructions, sample language, a guide for coverage example calculations, and the uniform glossary. A CMS fact sheet on these proposed regulations is available at http://www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/SBC-Proposed-Rule-Fact-Sheet-122214.pdf HHS also released a press release describing the proposed rule. HHS Interg Notification SBC 2014-12.pdf Links to a number of proposed supporting materials related the SBC and uniform glossary appear below: Proposed SBC Blank Template: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/blank-template-12-19-14-FINAL.pdf Proposed Uniform Glossary: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Uniform-Glossary-12-19-14-FINAL.pdf Roster key: 12/24/2014: These proposed rules make modifications to the content of the Summary of Benefits and Coverage. Other recent proposed rules pertaining to the Summary of Benefits and Coverage (SBC) documents were contained in CMS-9944-P. Tribal representatives provided comments on CMS-9944-P, which mandates the release of SBC by an issuer for each costsharing variation (including the Indian-specific “zero” and “limited” cost-sharing variations). There are no Indian-specific provisions in this proposed rule. 1/20/2015: Review of the proposed rule in the document below. Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 50 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Proposed SBC Sample Completed Template: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Sample-completed-sbc-12-19-14-FINAL.pdf Proposed Why This Matters language for SBC "No" Answers: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Why-This-Matters-No-Answers-FINAL.pdf Proposed Why This Matters language for SBC "Yes" Answers: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Why-This-Matters-Yes-Answers-FINAL.pdf CMS-9938-P Summary of Benefits and Coverage 2015-01-2 See recommendations in the attached and an additional recommendation in the column the left. TTAG Comments on CMS-9938-P.pdf Proposed Instructions for Completing the SBC--Individual Health Insurance Coverage: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Instructions-Individual-12-19-14-FINAL.pdf Proposed Instructions for Completing the SBC--Group Health Plan Coverage: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Instructions-Group-12-19-14-FINAL.pdf Proposed Guide for Coverage Examples Calculations--Maternity Scenario: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Maternity-Scenario-MarketScan-Data-DRAFT-v4-NHE2.pdf Proposed Coverage Examples Narrative--Maternity Scenario: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/maternity-narrative.pdf 2/12/2015: Draft comments prepared. 2/25/2015: Revised draft comments attached below. Draft TTAG Comments on CMS-9938-P 2015-02-25d.docx Proposed Guide for Coverage Examples Calculations--Diabetes Scenario: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Diabetes-Scenario-MarketScan-Data-DRAFT-v3NHE.PDF Proposed Coverage Examples Narrative--Diabetes Scenario: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/diabetes-narrative.pdf Proposed Guide for Coverage Examples Calculations--Foot Fracture: Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 51 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Foot-Fracture-Scenario-MarketScan-Data-DRAFT-v4NHE.PDF Proposed Coverage Examples Narrative--Foot Fracture: http://www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Coverage-Examples-narrative-foot-fracture.pdf ANALYSIS AND RECOMMENDATION: Analysis: Please see document imbedded in the right column. Recommendations: Tribal organizations did previously submit recommendations –and CMS agreed– on the need for an SBC for each of the Indian-specific cost-sharing variations that a plan is required to offer (limited cost-sharing variation and zero cost-sharing variation). One comment on this Proposed Rule that tribal representatives may wish to submit is that (a) we continue to support the addition of the requirement (as proposed in CMS9944-P) for issuers to prepare and make available SBCs for each Indianspecific cost-sharing variation; (b) modifications to the SBC template may be needed as issuers work to incorporate the required plan information into SBCs for the Indian-specific cost-sharing variations; (c) tribal representatives encourage CMS to review the SBCs that are prepared by issuers for the Indian-specific cost-sharing variations and engage with tribal representatives to determine if modifications to the SBC template are needed; and ADDITIONAL RECOMMENDATION: (d) tribal representatives recommend that CMS provide sample language—for use by QHP issuers in the preparation of the SBCs—to describe how the “zero” and “limited” costsharing variations impact deductibles, co-insurance, etc., for in-network and out-of-network providers. There has been confusion on the part of some issuers on the fact that the Indian-specific cost-sharing protections apply uniformly to in-network and out-of-network providers, except for the issue of balance billing. Comments submitted: TTAG Comments on CMS-9938-P.pdf Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 52 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Solicitation of New Safe Harbors and Special Fraud Alerts OIG-123-N Solicitation of New Safe Harbors and Special Fraud Alerts Released: 12/30/2014 Due date: 3/2/2015 In accordance with section 205 of HIPAA, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new HHS OIG Special Fraud Alerts. 12/30/2014: This request for comments provides another opportunity to tribal representatives to make a case for I/T/Uspecific safe harbors. Comments submitted: http://www.gpo.gov/fdsys/pkg/FR-2014-1230/pdf/2014-30156.pdf TTAG Comments on OIG-123-N.pdf Expanded Access to Non-VA Care Through Veterans Choice Program VA (RIN 2900-AP24) Expanded Access to Non-VA Care Through the Veterans Choice Program http://www.gpo.gov/fdsys/pkg/FR-2014-1105/pdf/2014-26316.pdf http://www.gpo.gov/fdsys/pkg/FR-2014-1121/pdf/2014-27581.pdf Released: 11/5/2014 Due date: 3/5/2015 VA amends its medical regulations concerning its authority for eligible veterans to receive care from non-VA entities and providers. The Veterans Access, Choice, and Accountability Act of 2014 directs VA to establish a program to furnish hospital care and medical services through non-VA health care providers to veterans who either cannot receive care within the waittime goals of the Veterans Health Administration or who qualify based on their place of residence (the Veterans Choice Program, or the “Program”). The law also requires VA to publish an interim final rule establishing this program. This interim final rule defines the parameters of the Veterans Choice Program and clarifies aspects affecting veterans and the non-VA providers that will furnish hospital care and medical services through the Veterans Choice Program. Analysis: Under “eligible entities and providers”, the following definition is provided” “Section 17.1530 defines requirements for non-VA entities and health care providers to be eligible to be reimbursed for furnishing hospital care and medical services to eligible veterans under the Program. Paragraph (a) of this section provides that an entity or provider must be accessible to the veteran and be one of the four entities specified in section 101(a)(1)(B) of the Act. These include any health care provider that is participating in the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), including any physician furnishing services under such program; any Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act (42 U.S.C. 1396d(l)(2)(B)); the Department of Defense; or the Indian Health Service. Outpatient health programs or facilities operated by a tribe or tribal organization under the Indian Self- Roster key: 1/21/2014: Myra and Elliott may re-draft and resubmit previously submitted recs. Possibly ask OIG attend TTAG meeting. 11/6/2014: This interim final rule was issued by the VA to implement the new private care option authorized by Congress. 11/12: Sam to review with Myra on eligibility criteria to confirm all I/T/Us are included. 1/20/2015: Comments submitted by TSGAC on a related VA request for tribal consultation show below: TSGAC Comments VA Agreements dated 1-14-15.pdf 1/21/2015: Myra to prepare first draft of comments. 3/5/2015: NIHB filed Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 53 of 54 2015-04-01 Roster of Pending Health-related Federal Regulations – as of 4/1/2015 Determination and Education Assistance Act or by an urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act are defined as Federally-qualified health centers in section 1905(l)(2)(B) of the Social Security Act and would be eligible providers under section 101(a)(1)(B).” comments. NIHB Comments on VA CHOICE.pdf Under this definition, I/T/U are included as eligible providers either as being a Medicare participating provider or as an FQHC under SSA 42 U.S.C. 1396d(l)(2)(B). Notice of start date (11/21/2014): In the interim final rule, VA established start dates for participation in the Veterans Choice Program (the “Program”) for different groups of veterans depending upon their basis of eligibility to participate. In those regulations, VA stated that veterans eligible based upon their inability to schedule an appointment within the wait-time goals of the Veterans Health Administration can start receiving hospital care and medical services under the Program no later than December 5, 2014. VA also stated that, if these veterans had a start date earlier than December 5, 2014, VA would publish a notice in the Federal Register advising the public of the faster implementation schedule. This notice announces that November 17, 2014, serves as the start date for veterans eligible to participate in the Program. Roster key: Highlighted in yellow are potentially top priority; highlighted in blue are the newest entries; not shaded/not struck-through are items that may be of interest to Tribes; struck-through are lowest priority. Page 54 of 54 2015-04-01