March 25, 2013
Marilyn B. Tavenner
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–3267–P
Mail Stop C4–26–05
7500 Security Boulevard
Baltimore, MD 21244–1850
Re: Medicare and Medicaid Programs; Part II—Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction: Proposed Rule CMS–3267–P
Dear Acting Administrator Tavenner,
The American College of Radiology (ACR), representing more than 34,000 diagnostic
radiologists, interventional radiologists, radiation oncologists, nuclear medicine physicians and
medical physicists, appreciates the opportunity to submit comments to the Centers for Medicare
& Medicaid Services’ (CMS) proposed rule on Regulatory Provisions To Promote Program
Efficiency, Transparency, and Burden Reduction.
In this comment letter, the ACR provides comment on the following important issues:
1) Proposal to change the supervision requirement that diagnostic tests must be supervised
by radiologists at ambulatory surgical centers (ASCs).
2) CMS proposal to revise the nuclear medicine services Hospital Condition of Participation
(CoP) requirement that in-house preparation supervision be direct.
3) Proposal to remove the requirement that a physician to be on the hospital governing
board.
4) CMS proposal to lower time restrictions for supervision in CAH hospitals.
Proposal to Change the Supervision Requirement that Diagnostic Tests Must be
Supervised by Radiologists at Ambulatory Surgical Centers
CMS proposes to reduce the requirement that radiologists must supervise radiologic services that
are provided in Ambulatory Surgical Centers (ASCs). ASCs are currently subject to the full
hospital requirements for radiology services even though they are only permitted to provide
limited radiologic services integral to the performance of certain surgical procedures.
The ACR recommends that the supervision rules for ASCs be the same as those for the Physician
Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (HOPPS). This
policy change would allow for radiology studies to be performed under general, direct and
personal supervision as defined in §§ 410.32(b) (3) (i) through (b) (3) (iii) by a physician who is
knowledgeable in these studies. This would allow for the physician who is providing a radiology
service (e.g. ultrasound guidance) to supervise when integral to the service provided (e.g. needle
placement). There are many radiology groups who want to and have contractual relationships
with ASCs. Radiologists are the specialists who are the most knowledgeable and educated in the
performance and interpretation of radiology studies and these arrangements should be allowed
and encouraged. When the modalities of CT, MR and nuclear medicine studies are done in
ASCs, it is the radiologists’ expertise to know appropriate test selection and protocoling to insure
the right kind of study is performed (i.e. with or without contrast). Their supervision also affects
the quality of the image taken and thus the quality of the interpretation. The ACR believes that
application of the supervision rules to all three settings (PFS, HOPPS and ASCs) is the most
direct and consistent way to address the issues raised in this proposed rule.
Proposal to Revise the Nuclear Medicine Services Hospital Condition of Participation
Requirement that In-house Preparation Supervision be Direct
CMS proposes to revise the nuclear medicine services condition of participation (CoP) to remove
the modifier ‘‘direct’’ from the in-house preparation supervision requirement. The presence of a
pharmacist, MD, or DO would no longer be required during the delivery of off-hour nuclear
medicine tests.
The ACR supports the recommendations made by the Society of Nuclear Medicine and
Molecular Imaging and thus CMS’ proposal.
Proposal to Remove the Requirement that a Physician to be on the Hospital Governing
Board
CMS is proposing to add a new provision to the ‘‘medical staff’’ standard of the governing body
CoP. This new provision would require a hospital’s governing body to directly consult at least
periodically throughout the calendar year or fiscal year with the individual responsible for the
organized medical staff of the hospital, or his or her designee. CMS is also proposing to remove
the requirement for a medical staff member, or members, to be on a hospital’s governing body.
Although the ACR supports continued communication between the hospital governing board and
medical staff, the ACR strongly opposes the proposal to remove the requirement that a medical
staff member(s) be on a hospital governing board. Given the changes in the health care
landscape with the development of accountable care organizations (ACOs), a rising number of
hospital-employed physicians, etc., it is now more important than ever that physicians have a
seat at the governing board level. Physician involvement in healthcare management is critical to
a hospital’s success in the future. The ACR is aware of many radiologists who have participated
on hospital governing boards. They do so to have a voice, provide input and often on their own
personal time and expenses. As more and more members of hospital boards come from outside
clinical medicine they often appreciate a physician explaining some of the issues, like decisions
about new technology and what some of their decisions mean to patients and patient
management. With the creation of ACOs and integrated health systems, physicians at the table
are advocates for patients and provide valuable guidance to non-clinical board members.
Proposal to Lower Time Restrictions for Supervision in CAH Hospitals
CMS proposes to revise the CAH and RHC/FQHC regulations to eliminate the requirement that
a physician must be onsite at least once in every 2-week period.
The ACR supports the CMS proposal to remove the specific time-defined period in which a
physician must be onsite. The ACR agree that the physician should have the discretion to be
onsite at intervals that they feel are appropriate to meet the needs of the hospital and the
department for which they supervise. This very well may occur on a more frequent basis or
around or after the period previously defined.
Conclusion
Thank you for the opportunity to comment on the Proposed Rule. If you have any questions
about our comments please feel free to contact Pam Kassing at 800-227-5463 ext. 4544 or via
email at pkassing@acr.org.
Respectfully Submitted,
Harvey L. Neiman, MD, FACR
Chief Executive Officer
Cc: Lauren Oviatt, CMS
Geradine McGinty, MD, MBA, ACR
Zeke Silva, MD, ACR