Re: Comments on Proposed Rule CMS–5517–P, RIN 0938-AS69
Medicare Program: Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
Dear Acting Administrator Slavitt,
The Association of American Physicians & Surgeons (“AAPS”) is a non-profit membership organization of physicians and surgeons who are mostly in small, independent practices.
Founded in 1943, AAPS defends and promotes the practice of private, ethical medicine. We have members in virtually every specialty and state. Our legal filings have been cited favorably by the U.S. Supreme Court and appellate state and federal courts, and HHS cited certain comments by AAPS favorably when HHS promulgated the landmark Privacy Rule. 65 FR 82462, 82468 (Dec. 28, 2000).
Members of AAPS, most notably Kristin S. Held, M.D., Jane Orient, M.D., Melinda Woofter, M.D., and the Florida Chapter of AAPS led by David McKalip, M.D., have separately submitted detailed comments and objections to CMS-5517-P (the “Proposed Rule”), with which AAPS concurs and incorporates as its own. To avoid duplication, AAPS focuses here on only four specific objections to the Proposed Rule, which AAPS respectfully submits on behalf of its members.
First, the Proposed Rule is unfair to physicians in small medical practices, and this inequitable treatment based on practice size is not authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Second, the Proposed Rule exposes patients to invasions of privacy in violation of the Constitution and, with respect to gun ownership, is in conflict with federal statutory law. Third, the Proposed Rule unlawfully interferes with the practice of medicine. Fourth, the Proposed Rule is arbitrary and capricious in imposing new regulatory burdens without adequate benefit. Overall, the Proposed Rule should be withdrawn in its entirety.
1. The Proposed Rule is unfair to physicians in small private practices.
By its own admission in Table 64, the Proposed Rule will have a substantially negative effect on small medical practices. The smaller the practice, the harsher the effect. For example, as set forth in this Table 64, 87% of solo practices will be harmed by a negative adjustment under the Proposed Rule, while only 18% of practices having 100 or more eligible clinicians will be. This disparate economic impact probably has a racially discriminatory effect, as many minority physicians tend to practice in small groups rather than in large ones.
MACRA does not authorize this economic discrimination against small practices, and there is no legitimate basis for it. Patients obtain as good medical care, and perhaps better, from a small medical practice as they do from a large practice. The majority of physicians who are in private practice are solo or in small groups, and they would be hit particularly hard by the Proposed Rule and its false incentive to join large groups. This distortion will detract from the quality of patient care, rather than improve it.
AAPS disagrees with the comments submitted by the Wisconsin Medical Society, which tried to downplay this gross inequity by asserting that “the data assumptions used to determine the percentage of certain eligible clinicians who would be penalized were flawed.” (Letter to Andrew M. Slavitt dated June 23, 2016) There is no reason to doubt the validity of the estimates by CMS of the disparate impact of its regulation, and the real inequities could be even worse under the Proposed Rule once it is implemented. Bigger medical practices tend to have greater political influence, and may end up doing even better under the Proposed Rule than predicted.
This disparate economic and potentially even racial impact is not authorized in any way by MACRA. Nothing in MACRA justifies such a disparate impact of the regulation based on the size of medical practices. The underlying methodology of the Proposed Rule has a bias concerning medical practice size, which must be eradicated before a final rule is promulgated.
2. The Proposed Rule exposes patients to invasions of their privacy, in violation of the Constitution and federal appellate decisions.
The Proposed Rule is an unconstitutional invasion of the privacy of patients with respect to medical records, and a massive interference with the patient-physician relationship. The Proposed Rule coerces physicians to convert to Electronic Health Records (EHR), even for highly confidential psychiatric records, and then grants access to those records by government without prior specific consent by individual patients. This is contrary to the privacy rights of patients implicitly acknowledged by the U.S. Supreme Court in Whalen v Roe, 429 U.S. 589 (1977) and, with respect to psychiatric records, in Jaffee v. Redmond, 518 U.S. 1 (1996). The Proposed Rule is also contrary to the recent ruling by the U.S. Court of Appeals for the Fifth Circuit in United States v. Zadeh, 820 F.3d 746 (5th Cir. 2016), which imposed substantial restrictions on access by the DEA to medical records of patients, in the absence of a warrant.
There is much discussion of mental health treatment in the Proposed Rule (see, e.g., pp. 884-86), yet there is inadequate protection of the mental health records of patients as their personal, highly private medical information is converted to electronic form. The Proposed Rule lacks adequate safeguards to protect EHR against unauthorized access, hacking, erroneous disclosures, and even mistaken postings of personal health information on publicly accessible websites.
In addition, for more than a decade physicians have been urged by pro-gun-control medical societies to ask patients, including children, about gun ownership in their homes. Since 2000, for example, the American Academy of Pediatricians has recommended that “pediatricians incorporate questions about guns into their patient history taking and urge parents who possess guns to remove them, especially handguns, from the home.” See Brian Falls, “Legislation prohibiting physicians from asking patients about guns,” Journal of Psychiatry & Law (Fall 2011) [hereinafter, “Brian Falls article”] (citing American Academy of Pediatrics Committee on Injury and Poison Prevention, 2000, p. 893). Similarly, the American Psychiatric Association issued guidelines in 2003 insisting that physicians ask any patient who might be suicidal whether they have a gun at home or at work. “[S]uch discussions should be documented in the medical record, including any instructions that have been given to the patient and significant others about
firearms or other weapons.” See Brian Falls article, in its section on “Standards of care” (citing American Psychiatric Association Workgroup on Suicidal Behaviors, 2003, p. 23).
Accordingly, many physicians are improperly inserting information into medical records about the ownership of guns by patients, which can be incriminating to the patients. The Proposed Rule, by pushing for such medical records to be stored as EHR, has the effect of creating an electronic database of gun owners without congressional authorization. It is contrary to the Second and Fourth Amendments, and at odds with existing federal statutory law (such as 18 U.S. Code § 926(a)), to create a de facto electronic federal registry of gun ownership in the form of government-accessible EHR. Federal agents and Medicare contractors should not have sweeping access to patient medical records without specific, individualized patient consent.
3. The Proposed Rule unlawfully interferes with the practice of medicine.
Federal law generally prohibits interference with the practice of medicine by the Medicare program. See 42 U.S. Code § 1395 (nothing in the Medicare statute “shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided”).
The Proposed Rule admits that its complex system of new regulations are designed for “driving significant changes in how care is delivered and changes in the health care system to make it more responsive to patients and families.” (p. 20) Accordingly, the Proposed Rule impermissibly attempts to exercise some degree of control over physicians in their practice of medicine.
Taken as a whole, the 962-page Proposed Rule is in violation of federal law by intruding too much into the day-to-day details of medical practice. Congress has not authorized such micromanagement of the practice of medicine, whether based on financial incentives or not.
4. The Proposed Rule is arbitrary and capricious in imposing new regulatory burdens without adequate benefit.
The Proposed Rule arbitrarily introduces a layer of intermediaries that will substantially increase expense without creating any real benefits. The unnecessary additional bureaucracy added by the Proposed Rule will inject further regulatory burdens into the practice of medicine, without any accompanying benefit or rational basis. The Proposed Rule is thereby arbitrary and capricious, and should be withdrawn.
In addition, the Proposed Rule is also arbitrary and capricious in that there has been inadequate testing and vetting of its proposed requirements and methodologies prior to implementation.
There has not been sufficient field testing for this massive new regulatory system, and there is no evidence that the Proposed Rule will provide any benefit commensurate with the costs.
Conclusion
For the foregoing reasons and for those set forth in the comments submitted by members of AAPS, including Drs. Kristin Held, Jane Orient, Melinda Woofter, and David McKalip (the latter on behalf of the Florida Chapter of AAPS), the Proposed Rule should be withdrawn in its entirety.
Dated: June 27, 2016
/s/ Andrew L. Schlafly
Andrew L. Schlafly General Counsel
Association of American Physicians & Surgeons 939 Old Chester Rd.
Far Hills, NJ 07931 908-719-8608
[email protected]
