Proposed Changes in Conditions of Participation Requirements and Payment Provisions for

Rural Health Clinics and Federally Qualified Health Centers

August 26, 2008

The Honorable Michael O. Leavitt

Secretary

U.S. Department of Health and Human Services

Room 615 F

Hubert H. Humphrey Building

200 Independence Avenue, SW

Washington, DC  20201

RE:  File Code:  CMS-1910-P2/ RIN 0938-AJ17

Dear Secretary Leavitt:

On behalf of the nearly 70,000 clinically practicing physician assistants (PAs) in the United States represented by the American Academy of Physician Assistants (AAPA), I welcome the opportunity to submit comments to the Centers for Medicare and Medicaid Services’ (CMS’) proposed rule changing the conditions of participation requirements and payment provisions for rural health clinics and federally qualified health centers (42, CFR, Parts 405, 410, and 491, Federal Register, Vol.73, No. 125).

 

The AAPA asserts that preserving access to primary medical care should be the overriding objective in the implementation of the RHC program. Given the increase in the number of Americans without health insurance coverage, the growing shortage in availability of primary medical care, and the ongoing fragility of the rural health care safety net, the AAPA believes that the proposed rule must be withdrawn to allow time for the states and RHC community to analyze the impact of the proposed provisions and to develop comments that take the likely effects into account.

The Academy appreciates CMS’ efforts to establish a system of review regarding location requirements and exception criteria for rural health clinics (RHCs), required by the Balanced Budget Act of 1997; require RHCs to establish a quality assessment and performance improvement program; clarify policy on comingling of an RHC with another entity; revise the payment methodology for RHCs and federal qualified health centers (FQHCs); revise RHC and FQHC payment requirements for services furnished to skilled nursing facility patients; allow RHCs to contract with non-physician providers, including PAs; revise the waiver procedure for the RHC staffing requirement; add requirements for RHCs and FQHCs to maintain infection control procedures and to post hours of clinical service; revise requirements under the emergency services standard and patient health records.

 

However, the proposed changes are complex; and, without additional time and information, it is nearly impossible to make a reasonable assessment of the effect of the proposed rules. By CMS’ own estimate, nearly 15% of the current RHC base is likely to lose its designation as a health professions shortage area. Our concern is that proposed changes in the designation process and the Medicare payment methodology, in particular, will have an unintended consequence of forcing many RHCs to close, resulting in reduced access to primary medical care in communities that are already medically underserved.

 

AAPA’s two greatest concerns with the rule are the proposed system of designation review and the change in Medicare payment methodology. At best, the Academy believes that the provisions will result in burdensome (and, costly) administrative requirements. At worst, the Academy believes that the provisions will force clinics to close.

 

Review of Designation Eligibility

The Academy is pleased that the designation review system contains exception criteria that was recommended following the promulgation of the earlier proposed rule (February 28, 2000 Federal Register). However, the newly proposed review system contains a complex, compressed, and rigid timetable for decertification that allows little to no margin for mistake. Integral to the process are information requirements that a RHC has no control over. The RHC’s continued existence is threatened if the state or federal government hasn’t done its job in making eligibility determinations in a timely fashion.

 

Payment

AAPA applauds CMS’ decision to remove the regulatory provision that prohibited RHCs from contracting with PAs and other non-physician health care professionals. Additionally, AAPA welcomes the language clarifying that payment may be made to a PA RHC owner for medical care provided by a PA. AAPA, however, is strongly opposed to the change in the Medicare payment methodology, requiring clinics to compute patient copayment into the 80% Medicare copayment cap and repay CMS for any amount exceeding 80%. The proposed payment change is counterintuitive – Medicare payment to RHCs is already well below the cost of providing care; the cost of care is rising; and the proposed rule imposes new requirements that add cost and administrative burden to the RHC.

 

AAPA strongly urges the Department to withdraw the proposed rule until such a time that information may be provided to the states and RHC community that will enable them to analyze the likely outcome of the proposed rule and provide informed comments.

 

Two provisions in the proposed rule that may be considered in the meantime are the outdated definition of physician assistant (section 405.2401) and the unworkable 48-hour timetable on authentication of medical record review (section 491.10 (v)).

Definition of Physician Assistant

The definition of physician assistant in section 491.2 of the RHC rule is outdated.

 

 

AAPA recommends that CMS use the same definition of physician assistant in the RHC rule that is contained in the March 12, 2002 Transmittal 1744 Revision to the Medicare Carriers Manual. Section 2156 of the manual lists the following criteria for PAs to provide covered Medicare services:

A. Qualifications for PAs. – In order to furnish covered PA services, the PA must meet the conditions as follows:

 

AAPA encourages CMS to replace the current definition of PA in the RHC rule with the qualifications cited in the Medicare Carriers Manual. Use of the Medicare Carriers Manual language would update the RHC rule and provide conformance in Medicare requirements.

 

Patient Health Records Review

 By definition, a rural health clinic is located in an area where there is a shortage of physicians. To require a physician to review the patient record and sign the chart within 48 hours of entry  -- “unless there is a State law that designates a specific timeframe for the authentication of entries” – is onerous and a terrible misuse of the physician’s time at the rural health clinic. The trend in State law is not to prescribe a timetable for review and cosignature of records, but to leave that decision to the physician-PA team.

 

If the Department believes that guidance must be provided to RHCs on chart cosignature, AAPA recommends that Section 485.631 of the regulations implementing critical access hospitals (CAH) be utilized. The CAH regulation requires a periodic review, but not less than two weeks, of the records of inpatients of a CAH cared for by PAs and other non-physician providers. For outpatient care provided by PAs and other non-physician providers, the CAH regulation requires a periodic review of a sample of outpatient records according to the policies of the CAH and State law. The CAH regulation further clarifies that the physician is not required to review and sign outpatient records of the specified non-physician providers where State law does not require record reviews or cosignatures. AAPA encourages CMS to strike the proposed language on 48 hour review of records and replace it with either a straightforward reference to State law or the CAH record review provisions.

 

Rural health clinics have been furnishing primary care services to Medicare and Medicaid beneficiaries in rural, medically underserved communities since Congress passed the Rural Health Clinic Services Act of 1977. From its inception, the RHC program has extended care in rural areas by reimbursing primary and emergency care services provided by physician assistants and nurse practitioners. The American Academy of Physician Assistants supports the goals of the RHC program, considers the program to be an essential component of rural health care delivery, and supports the continuation of the program to meet the goal of improving access to care in rural, medically underserved communities.

 

Thank you for your attention to the issues and concerns raised by the Academy regarding the proposed rule to revise certification and payment requirements for RHCs. Should you have any questions or require additional information on the PA profession, the American Academy of Physician Assistants, or the Academy’s comments on the proposed rule, do not hesitate to contact me or Sandy Harding, AAPA’s Director of Federal Affairs, at (703) 836-2272, extension 3205.

 

On behalf of the American Academy of Physician Assistants, I look forward to working with CMS to fairly implement the changes made to the RHC program through the 1997 Balanced Budget Act.

 

Sincerely,

William F. Leinweber

Executive Vice President, Chief Executive Officer

 

 

 

 

Last Revised: 8/26/08