HOT REGULATORY TOPICS JUDI LUND PERSON, MPH NHPCO 1 2 Eligibility Eligibility for Admission Medicare Hospice Benefit 3 § 418.20 Eligibility requirements. In order to be eligible to elect hospice care under Medicare, an individual must be- (a) Entitled to Part A of Medicare; and (b) Certified as being terminally ill in accordance with Sec. 418.22. Compliance “Hot Spots” 4 Eligibility of hospice patients Initial Ongoing Physician narrative Certain non-cancer diagnosis Dementia/ Alzheimer's Debility unspecified Level of care documentation GIP MAC Compliance “Hot Spots” 5 Eligibility of hospice patients Ongoing Physician narrative Certain non-cancer diagnosis – evidencing 6 month or less prognosis Dementia/ Alzheimer's Debility unspecified Level of care documentation GIP – eligibility for all days billed at GIP Opportunities to document eligibility 6 Certification Verbal certification Written certification Physician narrative statement Admission Comprehensive assessment Ongoing hospice service Every note by the IDT Update to the comprehensive assessment Recertification F2F encounter Physician narrative statement Eligibility assessment 7 Definitely eligible Probably eligible Not eligible Eligibility - 1st 90-day period 8 Demonstration of eligibility at admission Information/ consultation between attending physician and hospice physician Procurement of medical history and recent clinical documentation For the clinical record For use in the certification process Attending physician and hospice physician certify patient based on their medical judgment of the disease progression Eligibility - 1st 90-day period 9 Demonstration of eligibility at admission Physician narrative should concisely describe why the patient is initially eligible for hospice Comprehensive assessment documentation by IDG should evidence the details of the patient’s eligibility Eligibility – Continued and at Recertification 10 Demonstration of eligibility at recertification Physician narrative should concisely describe why the patient is continues to be eligible for hospice Clinical note from face-to-face visit demonstrates eligibility (if 3rd of subsequent benefit period) Update to the comprehensive assessment documentation by IDG should evidence the details of the patient’s continued eligibility Certification/ Recertification 11 NHPCO Certification/ recertification Process Maps available for purchase in NHPCO’s Marketplace Co-morbidities 12 Although not the primary hospice diagnosis, the presence of disease such as the following…should be considered in determining hospice eligibility Chronic obstructive pulmonary disease Congestive heart failure Ischemic heart disease Diabetes mellitus Neurologic disease (CVA, ALS, MS, Parkinson’s) • • • • Renal failure Liver Disease Neoplasia Acquired immune deficiency syndrome • Dementia Local Coverage Determination Policies (LCDs) 13 GUIDELINES, not regulations: Developed by each MAC (CGS, NGS, NHIC, Palmetto) Outline guidelines for condition-specific determination of eligibility Discuss documentation of secondary diagnoses and co morbid conditions to support terminal prognosis Local Coverage Determination Policies (LCDs) 14 More emphasis on functional decline in the updated LCDs Must have details to document the extent of decline Need to consider the impact of disease on patient’s quality of life Be familiar with the LCDs that are used in medical review for your region Documentation Using LCDs 15 Documentation needs to address: Impairments in function & structure Activity limitations Participation restrictions Secondary diagnoses Co-morbid conditions Documentation Using LCDs 16 Address the patient’s activity level, self care, communication, and mobility Give a historical perspective of what the patient’s ability was in the previous time period and then document current status BUT REMEMBER… Decline eligibility Decline necessary or sufficient 67 Documentation Using LCDs 17 Use specifics to show the extent of the symptoms and limitations Use the term “as evidenced by” to qualify the problems Include symptoms such as wt loss, decubitus ulcers, & edema Co-morbid conditions such as CHF, COPD and diabetes affect prognosis The physician narrative 18 Components of a comprehensive and adequate physician narrative should include: Explanation of the clinical findings that supports a life expectancy of 6 months or less Reference Reference to specific LCDs as appropriate to prognostic indicators or symptom management sales as appropriate The physician narrative 19 Components of a comprehensive and adequate physician narrative should include: Reference to functional status PPS - Validated in palliative care ECOG - Cancer Karnofsky - Cancer FAST - Dementia Being specific is the most important thing: don’t say that the patient has lost weight – state that there has been a 15 pound weight loss in the past 2 months and 45 pounds in the last 6 The physician narrative 20 Components of a comprehensive and adequate physician narrative should include: Evidence of a decrease in anthropomorphic measurements Recent hospitalizations Information about other significant complications in addition to the LCD specific criteria appropriate for that particular diagnosis Statement should be concise, but adequate Statement should contain prognostic indicators 21 Quality Reporting CY2013 QUALITY REPORTING 22 Measures for quality reporting: NQF #0209 Pain Measure Structural Measure CY2013 QUALITY REPORTING 23 NQF #0209: Comfortable Dying (NHPCO) Percentage of patients who were uncomfortable because of pain at the initial assessment (after admission to hospice services) whose pain was brought to a comfortable level within 48 hours. CY2013 QUALITY REPORTING 24 Structural Measure: Participation in a QAPI program that includes at least 3 quality indicators related to patient care CY2013 QUALITY REPORTING 25 QAPI Structural Measure Submission = Indication if hospice has a QAPI program that includes at least three indicators related to patient care; and Measures are used during reporting period Description of all quality indicators related to patient care. CY2013 QUALITY REPORTING 26 QAPI Structural Measure No results are submitted -- only the patient care measure descriptions Hospice Quality Reporting 27 The data collection period is January 1 – December 26 of each year Reporting is mandatory Data due April 1 of each year 2013 measures remain the same as 2012 Miss the deadlines? 28 Mandatory reporting Measures required – no choice in what measures should be reported Miss the 2013 reporting deadlines? Deadlines HAVE NOT been extended 2% cut in hospital market basket increase (hospice reimbursement rate “inflation adjustment”) in FY2014 CMS RESOURCES 29 CMS Hospice Quality Reporting web page Information posted on CMS web site as it becomes available https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/Hospice-QualityReporting/index.html Download PowerPoint presentations and hospice quality questions and answers: http://www.cms.gov/Hospice-Quality-Reporting/ Help Desk: help.hospicequality@rti.org or by phone at 1.800.647.9670. NHPCO RESOURCES 30 Basic Information and Materials www.nhpco.org/outcomemeasures www.nhpco.org/qualityreporting Questions – send email to: research@nhpco.org 31 THE FUTURE OF HOSPICE QUALITY REPORTING Payment Year FY2015 32 NQF #0209: Percentage of patients who report being uncomfortable because of pain on the initial assessment (after admission to hospice services) who report pain was brought to a comfortable level within 48 hours Structural measure: Participation in a Quality Assessment and Performance Improvement (QAPI) program that includes at least three quality indicators related to patient care. Hospices would report whether or not they have a QAPI program with at least three indicators related to patient care. Data Collection Period 33 Calendar year – January 1, 2013 through December 26, 2013 Hospices submit data in the fiscal year prior to the payment determination. For FY2015 and beyond: Data submission deadline of April 1of each year. Payment Year FY2015 34 No additional measures Creation of a hospice patient-level data item set Target date for implementation: CY2014 Data items included in standardized data set to support possible measures Patient level data collection 35 Mandatory data collection process being designed to collect data on individual hospice patients – demographics, diagnoses, symptoms Used to collect data for future quality reporting Expect to see a form and process in 2014 or 2015 STANDARDIZED DATA ITEM SET 36 CMS developing standardized assessment instrument Many items standardized and used by other providers Some items developed specifically for hospice Developed to collect information for hospiceappropriate quality measures Pilot testing with 9 hospices summer/fall 2012 Propose to implement hospice patient-level data item set as early as CY 2014 Payment Determinations beyond FY2015 37 Possible measures – implemented in future rulemaking 1617 Opioid with bowel regimen 1634 Pain screening 1637 Pain assessment 1638 Dyspnea treatment 1639 Dyspnea screening 0208 Family Evaluation of Hospice Care Experience of Care Survey 38 Similar to FEHC CAHPS survey being developed now VALUE BASED PURCHASING 39 Value based purchasing – pilot testing Utilize already implemented measures Implement pilot by January 1, 2016 40 Part D and Hospice Part D and Hospice 41 OIG report issued in 2012 Some Medicare hospice beneficiaries receiving hospice care also had drugs paid for under Part D Scope of the problem: 198,543 hospice beneficiaries 677,022 prescription drugs through Part D Drugs should have been covered by the hospice? Part D paid pharmacies $33,638,137 Beneficiaries paid $3,835,557 in copayments Expect additional scrutiny for Part D payments Recent Analysis 42 Analgesics only 2010 information 773,168 Medicare hospice beneficiaries enrolled in Part D 112,555 (14.6%) received 334,387 analgesic prescriptions through Part D during hospice enrollment Gross costs -- $13,000,430 Examples of drugs: Fentanyl, oxycodone, morphine, hydrocodone, hydromorphone…. Recent Analysis 43 Location of patients? 63% in nursing facilities and assisted living 35% at home Which hospices? 96.7% of hospices billed some analgesics to Part D Which pharmacies? 40.9% of pharmacies CMS Draft 2014 Call Letter 44 Questions about eliminating Part D payments for Medicare hospice patients Comments submitted March 1 2013 Proposing January 2014: Part D sponsor who receives report that a beneficiary has elected the Medicare Hospice benefit Sponsor place beneficiary-level prior authorization requirement for four categories of prescription drugs Four categories: Analgesics antinauseants (antiemetics) Laxatives antianxiety 45 Multiple Diagnoses on Claim Form Multiple diagnoses on claim form 46 Requirement is not new Clarification in FY 2013 Final Hospice Wage Index Rule Analyses by CMS hospice contractor, showed that 77.2% of hospice claims from 2010 only reported a principal diagnosis CMS believes that hospice claims which only report a principal diagnosis are not providing an accurate description of the patients’ conditions Multiple diagnoses on claim form 47 Providers should code and report coexisting or additional diagnoses to more fully describe the Medicare patients they are treating CMS’ Hospice Claims Processing manual requires that hospice claims include other diagnoses “as required by ICD9-CM Coding Guidelines” (IOM 100-04, chapter 11, section 30.1, available at http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/clm104c11.pdf) Multiple diagnoses on claim form 48 CMS clarifies that all of a patient’s coexisting or additional diagnoses s should be reported on the hospice claim paper UB-04 claim allows for up to 17 additional diagnoses electronic claim allows for 24 additional diagnoses Hospices should not report diagnoses which are unrelated to the terminal illness on their claims Mixed messages from CMS 49 CMS is asking for all coexisting diagnoses and comorbidities Often significant and used to make the case in the narrative for 6 month life expectancy Example: Patient with heart failure Significant COPD and Parkinson’s disease COPD and Parkinson’s contributing to decline “Unrelated” to the heart failure Previously instructed not to include these very significant but unrelated diagnoses on claim form The issues 50 Diagnoses definition inconsistency by CMS Related Co-morbid Secondary Many EMR software solutions do not allow more that one diagnosis (5010 allows 25 spaces) Payment for non-related dx; concern of providers Corollary issues 51 If diagnosis on claim form…. Hospice responsible for paying for drugs, DME, supplies related to diagnosis CMS will expect hospice to pay for all or nearly all drugs, DME, supplies for broad diagnoses Debility Adult Failure to Thrive Others Determining relatedness….. Joint task force – NHPCO & NAHC 52 Task force goals Refine diagnoses definitions and seek clarification from CMS Develop a resource to assist hospice providers to determine relatedness Diagnoses Medications Other supplies and services 53 Illegal Aliens Provider responsibility 54 Medicare does not pay for medical items/services furnished to an alien beneficiary who was not lawfully present in the United States on the date of service that the items/services were furnished Common Working File will indicate alien status for unlawfully present in the US MAC will retroactively adjust previously paid claims 55 2013 PEPPER report PEPPER Report 56 The Program for Evaluating Payment Patterns Electronic Report (PEPPER) second report Available April 2013 FedEx to the hospice CEO Hospice-specific data statistics PEPPER Details 57 CMS sets PEPPER focus areas Services at risk for improper payments Three years of claims data Hospices can use the data to support internal auditing and monitoring activities PEPPER compares a hospice’s Medicare billing practices with other hospices in the: State Medicare Administrative Contractor (MAC) jurisdiction US PEPPER Details 58 Time frame for claims: October 1, 2009 – September 30, 2012 Additional claims for period October 1, 2007 – September 30, 2009 included for episodes of service beginning prior to the reporting period PEPPER Details 59 Each hospice receives only its PEPPER Not available to the public Contractor provides Access database with PEPPER data to MACs, Recovery Audit Contractors Pay attention to any findings at or above the national 80th percentile Focus of PEPPER Report 60 Beneficiaries whose episode of service ends in the reporting year, either by live discharge or death. Two focus areas: “Live Discharges” includes all episodes where the beneficiary was discharged alive with a length of stay less than 25 days “Long Length of Stay” counts beneficiary episodes of service that had a long length of stay -- greater than 180 days PEPPER Resources 61 www.pepperresources.org 62 HIPAA Omnibus Rule The final omnibus rule 63 The final omnibus rule was published in the January 17, 2013 Federal Register http://www.gpo.gov/fdsys/pkg/FR-2013-0125/pdf/2013-01073.pdf Compliance with most of the new requirements introduced in the Final Rule is required by September 23, 2013 An extended compliance period is provided for the modification of certain existing business associate agreements When is compliance required? 64 Effective date: This final rule is March 26, 2013 Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013 New rule 65 Changes greatly enhance a patient's privacy rights and protections Strengthens the ability of Office of Civil Rights to vigorously enforce the HIPAA privacy and security protections New Breach Standard 66 Substantial change to the definition of a “breach” of protected health information (PHI) New standard defines any impermissible acquisition, access, use or disclosure of PHI under the Privacy Rule is a breach unless a covered entity or business associate can demonstrate that there is a low probability that the PHI has been compromised Entities determine whether there is a low probability that PHI has been compromised by performing a risk assessment New Breach Standard 67 This modification to the definition of breach will make it more difficult for covered entities and business associates to justify a decision not to provide notification following a suspected breach incident Following a breach, covered entities are still required to notify affected individuals, the Secretary of HHS, and the media (if a breach affects more than 500 residents of a State or jurisdiction) The current timing, content and methods for notification also remain unchanged New Breach Standard 68 HHS intends to issue guidance to aid covered entities and business associates in performing risk assessments and to assist with the individual notification requirements at a future date Expanded Individual Rights 69 Individuals’ rights expanded with respect to their PHI in two important ways 1. 2. It provides them with the right to receive certain PHI electronically It allows them to restrict certain disclosures of PHI to their health plans Hospice providers will have to revise their current policies and procedures and evaluate current system capabilities to ensure compliance with these new requirements Expanded Individual Rights 70 The Final Rule also provides individuals with the right to request that covered entities and business associates provide a copy of their PHI directly to a designated individual This right applies to both paper and electronic information Any such request must be in writing, signed by the individual, and must clearly identify the designated recipient and where the information should be sent Expanded Individual Rights 71 Restriction of certain disclosures of PHI to their health plans Hospice providers will likely need to develop a method to flag or include a notation in the record of any individual who has exercised this right to restrict disclosures regarding services paid for out of pocket, in order to ensure that specific records are not sent or made accessible to health plans Modifications to Notices of Privacy Practices Required 72 Privacy notices must include a statement regarding the right of affected individuals to be notified following a data breach and must describe certain uses and disclosures of PHI that require patient authorization related to psychotherapy notes, marketing, and the sale of PHI The Notice must also inform patients of their right to restrict certain disclosures of PHI to health plans where the individual pays out of pocket in full Direct Liability for Business Associates and Amendments to Business Associate Agreements 73 Business associates and business associate subcontractors will now be directly subject to applicable HIPAA rules including the HIPAA Security Rule and certain provisions of the Privacy Rule HHS modified the definition of business associates to specifically include several new entities, including subcontractors that create, receive or transmit PHI on behalf of business associates and entities that provide data transmission of PHI Direct Liability for Business Associates and Amendments to Business Associate Agreements 74 Data storage vendors that maintain PHI (both hardcopy and electronic), are business associates even if the vendor never actually views or accesses the PHI Business Associate Agreements 75 Business associate agreements will need to be modified to meet additional requirements The Final Rule provides an extended transition period up to September 22, 2014 for amending existing business associate agreements only for an existing business associate agreement meeting the following conditions: was in place prior to January 25, 2013 and complies with current HIPAA business associate agreement requirements; and is not modified or renewed during the period from March 26, 2013 to September 23, 2013 Business Associate Agreements 76 Business associate agreements not eligible for the extended transition period must be compliant with the Final Rule as of the September 23, 2013 compliance date HHS recently issued guidance on the revised business associate agreement requirements and provided sample terms. This guidance is available at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/cove redentities/contractprov.html New Fundraising Requirements 77 Expansion of the type of information covered entities may use to target fundraising appeals to include the department of service, the treating physician and outcome information Permits the use only of demographic information and dates of health care provided to the patient Fundraising communications must provide recipients with a clear opportunity to opt-out and the method provided for the opt-out may not cause undue burden or more than nominal costs Decedent information 78 A covered entity only has an obligation to comply with the requirements of the Privacy Rule with respect to the PHI of a deceased individual for 50 years following the individual’s death Rule permits covered entities to disclose PHI to a family member or other individual involved in a decedent’s care or payment for such care, unless such a disclosure is inconsistent with a prior expressed preference of the decedent New Enforcement Authority 79 Enforcement changes effective March 26, 2013 Civil and criminal penalties can now be applied directly to business associates HHS must investigate any complaint and conduct compliance reviews in all cases where a preliminary review of the facts indicates a possible violation due to willful neglect HHS must impose a civil money penalty for violations due to willful neglect New Enforcement Authority 80 HHS is not required to attempt to resolve cases of noncompliance due to willful neglect by informal means The tiered penalty structure based on different levels of culpability has been finalized. Penalties now range from $100 to $50,000 per violation depending on the level of knowledge/willfulness with a $1.5 million cap per calendar year for multiple violations of identical provisions New Enforcement Authority 81 Covered entities and business associates can be subject to liability for a violation by their business associate agents and subcontractor business associate agents respectively HHS may disclose PHI obtained in connection with a compliance review or investigation if permitted under the Privacy Act, thereby giving it the ability to share information with other law enforcement agencies (e.g., state attorneys general or the Federal Trade Commission) Other Important Changes 82 Expansion of Prohibited Marketing Activities HIPAA prohibits the use or disclosure of PHI for marketing to individuals without obtaining an authorization, with certain important exceptions Prohibition on the Sale of PHI Prohibits the receipt of direct or indirect remuneration (including in-kind benefits) in exchange for PHI This new restriction includes several exceptions, including disclosures to business associates, as required by law, and for treatment and payment purposes Other Important Changes 83 New Research Authorizations Permitted allows researchers to obtain authorizations to use PHI for future research, provided that the future research is adequately described 84 84 FY 2013 OIG Work Plan FY2013 OIG Work Plan 85 Acute-Care Hospital Inpatient Transfers to Inpatient Hospice Care Hospice Marketing Practices and Financial Relationships with Nursing Facilities Review Medicare claims for inpatient stays when beneficiary was transferred to hospice care and examine the relationship between the acute-care hospital and the hospice provider. Review hospices’ marketing materials and practices and their financial relationships with nursing facilities. Medicare Hospice General Inpatient Care Use of GIP from 2005 to 2010. Assess appropriateness of GIP claims and beneficiary drug claims billed under Part D. 85 FY2013 OIG Work Plan 86 Medicaid: Hospice Services: Compliance With Reimbursement Requirements We will determine whether Medicaid payments for hospice services complied with Federal reimbursement requirements. 86 Regulatory and Compliance Team at NHPCO 87 Jennifer Kennedy, MA, BSN, RN Regulatory and Compliance Director Judi Lund Person, MPH Vice President, Compliance and Regulatory Leadership Email us at: regulatory@nhpco.org Q&A NHPCO members enjoy unlimited access to Regulatory Assistance Feel free to email questions to regulatory@nhpco.org