AAPS Objects to Proposed CMS Regulations on Antibiotic Use


AAPS Submitted the Following Comments to CMS on August 13, 2016

Re: Comments on Proposed Rule CMS-3295-P
Medicare and Medicaid Programs: Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

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. AAPS has members in virtually every specialty and State, and AAPS speaks out frequently about issues concerning patients and medical practice. HHS favorably cited a comment by AAPS in connection with the landmark Privacy Rule. 65 FR 82462, 82468 (Dec. 28, 2000). Our legal filings have also been cited favorably by the U.S. Supreme Court and appellate state and federal courts.

AAPS strongly objects to how CMS-3295-P (the “Proposed Rule”) attempts to subject Medicare recipients to guidelines controlled by private, unaccountable organizations such as the Infectious Disease Society of America (“IDSA”). Medicare is a taxpayer-funded program, and participation in Medicare should not depend on compliance with guidelines set by private organizations having their own hidden agendas and undisclosed conflicts-of-interest, and which lack any political accountability.

The Proposed Rule makes express reference to IDSA seven times, and yet includes no mention of the investigation into IDSA by the State of Connecticut, as conducted by now-U.S. Senator Richard Blumenthal. That investigation focused on undisclosed conflicts-of-interest by IDSA as it promulgated guidelines which had the effect of benefiting certain financial interests, such as the insurance industry. The settlement between Connecticut and IDSA required it to strengthen its rules against conflicts-of-interest, but IDSA continues to work to the advantage of insurance companies by denying the extent of chronic Lyme disease and the benefits of long-term use of antibiotics to help patients who suffer from Lyme disease.

Private standard-setting organizations, such as IDSA, should not be granted the authority of federal law through the back door of regulations promulgated under the Medicare program. Patients should be treated until they are restored to good health, and not face premature termination of antibiotic use based on private guidelines developed for the benefit of insurance companies.

The Proposed Rule makes reference to “nationally recognized guidelines” a remarkable twenty- one (21) times, and expressly requires adherence to unspecified privately developed guidelines in the proposed regulations. AAPS strongly objects to this reliance on privately controlled guidelines as a condition for participation in the Medicare program.

Specifically, AAPS objects to each of the following proposed regulations that expressly require adherence to unidentified nationally recognized guidelines:

(42 CFR chapter IV) § 485.640(b)(3) would require that “The antibiotic stewardship program adheres to nationally recognized guidelines, as well as best practices, for improving antibiotic use.”

§ 485.640(c)(2)(i) would require “The development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines.”

§ 485.640(c)(3)(i) would require “The development and implementation of a facility- wide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics.

Physicians are the proper decision-makers with respect to antibiotic use, and their judgments should be made on an individual basis for each patient. AAPS urges removal of the foregoing requirements of compliance with privately developed, unidentified guidelines. As a taxpayer- funded program, Medicare should remain available to all without limiting participation based on guidelines dictated by politically unaccountable organizations.

The negative effect of the Proposed Rule is apparent from a survey done by The Pew Charitable Trusts entitled “Antibiotic Use in Outpatient Settings” (May 3, 2016).1 Based on data set forth in that report, there could be a decrease in 47 million prescriptions if the goals of “experts” to reduce “unnecessary” antibiotics were to occur. Patients could suffer immense harm, and physicians could bear needless liability, if there were a recrudescence in post-surgery infections and severe conditions such as rheumatic fever and mastoiditis, which have been nearly eliminated in the United States thanks to antibiotics.

An antibiotic may be the best treatment in an individual case, particularly when follow-up monitoring is difficult, when there is inadequate access to diagnostic tests, or when test results cannot be received quickly enough to prevent immediate potential complications from occurring. Interfering with the best medical judgment of physicians for individual patients can obviously have tragic consequences. Such interference by way of guidelines should not be imposed.

Simply put, the Medicare program should not be impeding individualized medical judgments by imposing a one-size-fits-all requirement of guidelines created by a private group that is politically unaccountable and potentially rife with conflicts of interest. The U.S. Constitution does not grant the federal government authority to regulate medicine in this manner, and the guidelines-based requirements of the Proposed Rule should be omitted in the final rule.


For the foregoing reasons, the Proposed Rule should withdraw all references to and reliance on unspecified nationally recognized guidelines with respect to antibiotic use.

1 http://www.pewtrusts.org/en/research-and-analysis/reports/2016/05/antibiotic-use-in-
outpatient-settings (viewed Aug. 13, 2016).

Dated: August 13, 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]

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