AAMC Letter to HHS Regulatory Reform Committee
March 5, 2002
Christy Schmidt
Executive Coordinator
Regulatory Reform Initiative
Office of the Assistant Secretary for Planning and Evaluation
200 Independence Avenue. SW
Washington, DC 20201
Dear Ms. Schmidt:
The Association of American Medical Colleges welcomes the opportunity
provided by Secretary Thompson to bring to your attention regulatory and
related burdens that should be revised (see Request for Public Input,
67 Federal Register 599) to improve healthcare operations and delivery
and biomedical and health services research. The AAMC represents approximately
400 major teaching hospitals; all 125 accredited allopathic U.S. medical
schools; nearly 100 professional and academic societies; and the nation’s
medical school faculty, students and residents.
Counting Residents for Purposes of Direct Graduate Medical Education
Reimbursement: The Preliminary Year vs. the Transition Year
Section 1886 of the Social Security Act (42 U.S.C. 1395ww) provides for
payments to teaching hospitals that train medical residents for the direct
costs of graduate medical education (DGME). The regulation that implements
this portion of the statute is found at 42 C.F.R. §413.86. For a
hospital to receive a DGME payment, it is necessary that it count the
number of residents it trains according to rules set out by statute. Every
resident who is training in an approved program is counted by the hospital
as a 1.0 full time equivalent (FTE) for what the statute terms the “initial
residency period” (IRP). For any training in an approved residency
program that extends beyond the IRP, the hospital counts the resident
as a 0.5 FTE for DGME purposes. Section 1886(h)(f)(F) of the Social Security
Act states that the IRP “shall be determined, with respect to a residency,
as of the time the resident enters the residency training program.”
According to a memorandum dated February 3, 1998 and signed by Charles
R. Booth, CMS, and sent to ARAs for Financial Management, Regions I –
VI, VIII-X, and ARA for Beneficiary Services, Region VII, “the resident’s
initial residency period is determined based on the specialty in which
the resident begins training regardless of whether they ultimately intend
to train in another specialty.” The letter continues to describe
several scenarios and discusses how residents in various situations are
to be counted.
While the interpretation of the statute presented by CMS seems generally
reasonable, its inflexibility--and incorrect interpretation of one particular
section of the statute--results in inconsistent and illogical hospital
reimbursement in one specific circumstance. Some specialties, such as
radiology, require that a resident complete a broad-based clinical year
of training as a prerequisite to entering training in the resident’s
chosen specialty. This requirement can be met in several ways. Every year
there are a limited number of spaces available in “transition year
programs” (approximately 1,031 slots in 2001; AAMC 2001 Data Book,
Table F-1), programs designed to provide a resident with broad-based training
prior to completion of further training. Transition year programs are
accredited by the Accreditation Council on Graduate Medical Education
(ACGME), but do not lead to board eligibility. If a resident enters a
transition year program, CMS will look to the resident’s second year
of training to determine the correct IRP.
However, not every resident chooses—or is able to choose—to
complete the broad-based clinical year in a transition year program. Many
residents fulfill this requirement by entering an internal medicine or
other residency program. They enter these programs with the specific intent
of fulfilling the requirement of completing the broad-based clinical year
prior to entering their chosen residency. In most cases when a resident
uses an internal medicine residency to fulfill this requirement, the resident
is considered to be in a preliminary internal medicine program rather
than in a categorical internal medicine program.
According to the CMS interpretation of the law, the IRP for someone completing
a transition year program is determined by the resident’s specialty
in the second year of training, whereas the IRP for a resident completing
the required broad-based year of training in internal medicine is determined
by IRP for the specialty the resident first enters—in this case,
internal medicine-- despite the fact that the only reason the resident
entered an internal medicine residency was to complete a requirement for
the residency of his/her choice. The AAMC believes that CMS’s interpretation
of this provision of the Social Security Act is incorrect and results
in inconsistent reimbursement for similarly situated residents. When a
resident’s second year of training is in a specialty that requires
an initial broad-based clinical year, CMS should look to the resident’s
second year of training to determine the correct IRP, regardless of whether
the resident completed a transition year program or a broad-based year
in internal medicine or another specialty. This situation is very different
from one in which a resident enters a training program and then decides
that he/she wishes to train in a different specialty and thus switches
programs. In that case, as required by law, the resident’s IRP should
be determined by the initial residency program that the resident entered.
The Association urges the Secretary to change the CMS policy so that
it comports with the meaning of the statute and no longer penalizes hospitals
by providing less reimbursement for residents who complete a required
initial year of training in a program other than a transition year program.
Annual Publication of IRP List
In the preamble to the final GME rule, CMS stated that “we plan
to publish in the Federal Register before July 1 every year listing the
limits on initial residency period for the various specialty and subspecialty
programs for the academic year beginning on July 1.” (54 Federal
Register 40305, col. 1). This information is very important to hospitals
so that they can correctly count their residents. However, CMS has not
published a list of limits on IRPs since 1996. The AAMC requests that
CMS publish a list this year and every year hereafter.
IRIS Diskette Should Be Updated
In addition to submitting an annual cost report, teaching hospitals are
required to complete and submit a diskette that is known as IRIS (Intern
and Resident Information System). The current diskette is based on old
technology, is difficult to use, and is flawed. CMS should quickly update
the diskette to make it more user-friendly for providers. In addition,
there seems to be confusion among some fiscal intermediaries and Office
of Inspector General auditors as to the purpose of the information on
the IRIS diskette. CMS should clarify that the purpose of the diskette
is to identify residents who have been “double counted,” (i.e.,
counted by two different hospitals for the same period of time), not to
determine the correct number of residents to be claimed on the cost report.
IRIS does not even contain a function that allows the number of residents
to be correctly weighted and totaled, something that is necessary for
cost reporting purposes.
Changes Needed in the Teaching Physician Regulation’s Primary
Care Exception
Requirements for teaching physicians who wish to bill for a service in
which a medical resident is involved are found at 42 C.F.R. § 415.150
et seq. The AAMC urges HHS to consider expanding the primary care exception
(42 C.F.R §415.174) which currently allows payment for a service
furnished by a resident without the presence of a teaching physician under
very limited circumstances. According to the preamble to the final regulation
(60 Federal Register 63146, col. 2), “. . . the types of GME programs
most likely to qualify for these exception include: family practice and
some programs in general internal medicine, geriatrics, and pediatrics.”
The regulation should be change to expand the exception to all specialties.
This will provide consistency in the degree of work performed and documented
by teaching physicians across all ambulatory care specialties.
Teaching Physician Documentation Requirements Should Be Revised Promptly
Clarification of the teaching physician regulation, and particularly
the amount of documentation that is required, is found in the Medicare
Carrier Manual §15016. The teaching physician community has long
maintained that the amount of documentation required is excessive and
that what the teaching physician must write often is redundant of the
note written by the resident. In recent months AAMC has engaged in discussions
with CMS about simplifying the teaching physician documentation requirements.
While the Agency has been working on changes, none have yet been finalized.
The Association urges HHS to ensure that changes to the documentation
requirements are forthcoming in the near future.
Streamlining the Process for Enrolling Teaching Physicians in Medicare
and Reducing the Number of Provider Identifiers That Are Needed
To enroll in Medicare, a provider must complete and submit a HCFA 855
form. According to the CMS website, the application process for most applicants
is 60 days; ninety-nine percent of applications should be processed within
120 calendar days of receipt. Even if a provider has a signed contract
that states that he/she will be starting with a physician group on a certain
date, applications will only be accepted 90 days before the actual work
start date. The credentialling processes in many hospitals, and for many
payers, frequently are tied to the Medicare UPIN; for example, a Medicaid
program may not allow a provider to enroll without a Medicare number.
Physicians and their staffs often are forced to accept provisional status
from these payers while awaiting the assignment of a UPIN. Once a UPIN
is obtained, there is additional, often duplicative work, in ensuring
provider enrollment with the other payers.
For teaching institutions, this is a particularly difficult issue. Typically,
at teaching institutions, there is an influx of faculty members, and fellows
(some of whom should be able to bill) on July 1. Although the arrival
of each of these individuals has been known for many months, none of them
can submit an application for enrollment until 90 days prior to the start
date of their employment. This causes a large loss of revenue, as none
of these people can bill until they are properly enrolled. The AAMC requests
that if a signed employment contract exists, physicians be allowed to
enroll in Medicare 150 days prior to arriving at their new place of employment.
In that case, the UPIN should not become effective until the date on which
employment begins.
A second issue related to provider enrollment is that unique identifiers
are required for providers for each specific geographic and practice site
(e.g., community-based clinic, free standing clinic, or federally qualified
health center). It is quite common for academic physicians to practice
at multiple sites, though at each site they typically continue to practice
as a member of the faculty practice plan. While some differential of practice
sites may be necessary, the AAMC urges CMS to consider simplifying the
system to reduce the number of unique identifiers required for a faculty
physician who is working as a member of a faculty practice plan, regardless
of the practice site.
Medicaid Managed Care and Payments to Teaching Hospitals
We understand that CMS is interpreting a provision (42 C.F.R. §438.60)
in a proposed rule for Medicaid managed care programs [66 Fed. Reg. 43614
(August 20, 2001)] that would greatly reduce financial support to America’s
teaching hospitals. The interpretation could preclude state Medicaid programs
from making payments directly to teaching hospitals that are under contract
with Medicaid managed care plans to help offset the higher costs associated
with the special missions of teaching hospitals. No clarifying or preamble
language was included in the August 20 proposed rule. In fact, neither
teaching hospitals nor graduate medical education was identified as possibly
being affected by this provision.
The Medicare managed care programs “carves out” Medicare’s
special payments to teaching hospitals and makes those payments directly
to teaching hospitals, as do many Medicaid managed care programs. We urge
that the final Medicaid managed care rule and/or preamble clarify that
42 C.F.R. §428.60 does not affect the special payments made by state
Medicaid programs to teaching hospitals.
HIPAA Privacy Regulation (45 C.F.R. Parts 160 and 164): Research and
Fundraising
We strongly urge the Task Force to consider the significant regulatory
burden that the new federal medical privacy (HIPAA) rule will impose upon
research and patient care. While recognizing that the rule enhances patient
privacy, we have emphasized nonetheless that certain elements of the rule
needlessly encumber research and treatment, jeopardizing medical progress
and efficient, effective medical care. In particular, we have explained
in our comment letters and in testimony before the National Committee
on Vital and Health Statistics ways in which the waiver, authorization,
minimum necessary, and de-identification provisions of the rule must be
modified to avoid serious harm to vital medical and public health research.
Echoing this concern, in November of 2001 more than 200 (verify number)
academic research institutions, teaching hospitals, and professional societies
jointly signed a letter to Secretary Thompson asking the Department to
modify the rule to avoid its foreseeable and deleterious impact upon research.
It also is essential that changes be made to the HIPAA fundraising requirements
[§164.514(f)(1)]. As currently written, the only information that
may be used or disclosed for fundraising purposes is demographic information
about an individual, or dates of health care provided. Disclosure of any
additional information requires an authorization. When patients come to
academic institutions, it is generally with the expectation that they
will be cared for in a particular department or division that has expertise
and renown for treating the condition from which the patient suffers.
It is through these departmental and divisional centers that critical
funds are raised to foster future teaching and research. The chief of
the department, division chairs and the attending physicians all play
a part in appeals to their patients to support the vital work of the departments.
It is essential to change the rule to also allow disclosure of the name
of the physician, department or division of the covered entity from which
the individual received treatment. In this way, institutions will be able
to continue essential targeted fundraising efforts without the need for
obtaining an authorization from the patient.
Regulatory Burdens Related to the NIH Also Should Be Reduced
Biomedical and health research faces a broad and complex array of regulations
in addition to those noted here. An editorial in the journal Science (1995;
267:1247) estimated that each research proposal submitted by an academic
institution for federal funding must be accompanied by more than 60 certifications
in compliance with regulations on fraud, hazardous materials, occupational
health, conflict of interest or commitment, and many other matters. The
conduct of this research entails numerous other obligations for reporting
or other compliance. Clearly, such regulations often serve compelling
social interests or provide important protections, and many serve as indispensable
vehicles for scientific accountability. Frequently, it is the accumulation
of regulations each mandating distinct or duplicative requirements that
has greatly increased the burden of compliance. The Department should
look for opportunities to harmonize reporting requirements or other procedures
where appropriate. A working group of the National Institutes of Health
identified several options for reducing regulatory burden and we commend
its report to the attention of the Secretary’s Task Force. (http://grants2.nih.gov/grants/policy/regulatoryburden/index.htm#toc,
released 1999, accessed Feb. 26, 2002).
If you would like to discuss any of these suggestions, please contact
Ivy Baer of my staff at 202-828-0490 or ibaer@aamc.org.
Sincerely,
Jordan J. Cohen, M.D. |
