In support of Good Medical Practices

http://www.northcountrygazette.org/2008/09/26/womens_health/


On behalf of Governor Paterson and the State of New York, Health Commissioner Richard F. Daines, M.D. this week submitted comments to HHS Secretary Michael O. Leavitt urging the immediate withdrawal of these proposed regulations.

Commissioner Daines said: “Professional standards of medical practice recognize the right of providers to refuse to provide abortion or sterilization services on religious or moral grounds, but they also require providers to assume the responsibility to assure patients access to information and services. The regulations proposed by HHS will disrupt that balance and deprive women of medically necessary health care. In an emergency situation, the consequences could be devastating.”

The proposed regulations were published on Aug. 26.

From: Richard F. Daines, M.D.
Commissioner of Health 9-26-08

To:
Hon. Michael O. Leavitt Secretary United States Department of Health and Human Services Office of Global Health Affairs 200 Independence Avenue, SW, Room 639H Washington, DC 20201

Re: Provider Conscience Regulation
Comments on Proposed Federal Rule: 45 C.F.R. Part 88 73 Federal Register Aug. 26, 2008

Dear Secretary Leavitt:

This is in response to the request for public comment on proposed
45 C.F.R. Part 88, which seeks to implement and clarify the provider conscience provisions of the Church Amendments, the Public Health Service Act, and the Weldon Amendment. After review of the proposal and its likely impact on women’s health care services and their costs, we conclude that implementation of the rule will impede access to quality care and create unnecessary and costly paperwork.

The proposed regulations do not clarify the federal statutes. Rather, they create confusion and leave critical elements open to broad misinterpretation, while providing no protections to ensure that consumers have adequate access to needed health care. They would disrupt access to legal health services, deny timely lifesaving measures and critical care, impede the ability of practitioners and health care entities to comply with current standards of medical practice, and create unnecessary administrative burdens. For these reasons, New York State respectfully requests withdrawal of the proposed rule.

The proposed rule is overbroad, ambiguous and upsets the balance between the rights of providers and the rights of patients.

The proposed rule goes far beyond the federal statutes by expanding its application in two critical ways. First, it appears to permit individuals to refuse to provide care because of personal objections of any nature; and second, it expands the group of employees who may exercise the right to refuse.

In Section 88.1, the regulations outline the proposed rule’s purpose in a manner that expands protection for religious and moral convictions to include the “rights to refuse to perform health care services to which [employees] may object for religious, moral, ethical, or other reasons.” (Emphasis added). The proposed regulation would allow employees and volunteers in federally funded health care settings to refuse to participate in “any part of a health service or research activity,” including providing treatment, information or even referral services, if participating would violate their beliefs.

As a result of this expansion, employers will feel compelled to acquiesce to a wide range of objections or risk legal action or loss of federal funding. Such objections could include participation in implementing end-of-life decisions made by patients and families, aggressive pain management, transfusions, vaccination, HIV/AIDS treatment, infertility treatment, treatment of sexually transmitted diseases and stem cell research. Moreover, the regulation is broad enough to allow workers to refuse services to individual patients or groups of patients whose lifestyles they consider objectionable, such as illegal immigrants, drug and alcohol users, and gay and transgendered individuals. In seeking to prevent discrimination against objecting providers, this rule may inadvertently encourage discrimination against broad classes of health care consumers.

The most likely impact of the rule’s apparent overbreadth is on the provision of women’s reproductive services. While the Health and Human Services Administration has appropriately removed the previous objectionable abortion definition in Section 88.2, the absence of a medically acceptable definition for abortion and sterilization creates ambiguity as to which additional family planning or reproductive health care services are covered. For example, it remains unclear whether providers will be able to refuse to prescribe contraception.

Of additional concern are the new categories of workers who will be able to refuse to participate in practices to which their connection is remote. Section 88.1 and the corresponding supplemental information newly defines “assist in performance” and “workforce” to include anyone connected in any capacity to the health care practice at issue, including, for example, individuals who clean instruments. It will be costly and difficult for hospitals, clinics and private practices to determine whether any particular objecting worker is entitled to the accommodations this rule requires.

Current medical practice standards strive to strike a balance between the rights of the provider and the patient. The ambiguity of this rule will tip the balance away from the needs of the patient. While professional standards of practice support a provider’s right to refuse to provide abortion or sterilization when those services violate moral or religious beliefs, they also require that a provider assume the responsibility to assure patients access to information and services. This balance is widely recognized in the modern American medical community and is a fundamental component of professional practice standards of provider organizations across the country. See, e.g., the American College of Obstetrics and Gynecology Committee Opinion Number 385, November 2007. See also American Medical Association Code of Medical Ethics: Opinions on Practice Matters, E-8.08 Informed Consent.

The rule makes no provisions for emergencies.

We are particularly concerned that the regulations do not include exceptions or accommodations for emergency medical procedures, such as those recognized by the federal Medicaid program. For example, Medicaid will cover the costs of an abortion when “on the basis of [the physician’s] professional judgment, the life of the mother would be endangered if the fetus were carried to term.” 45 C.F.R. § 441.203. No such protection exists here. We believe that without including explicit exceptions, women’s lives could be jeopardized by promulgation of these regulations in their current form. We are concerned and troubled that a woman with an ectopic pregnancy may have to track down a willing provider so that she can get appropriate treatment before it is too late. Similarly disturbing is the prospect that a woman who has been raped may be refused emergency contraception and turned away without assistance to find and obtain it.

Implementation will be administratively burdensome and expensive.

The proposed certification process will create an administrative burden for providers, grant awardees and other sub-recipients receiving federal funds. Recipients of federal funds will find it difficult to certify compliance for themselves and for their sub-recipients, given the rule’s ambiguities. Moreover, the paperwork involved is unnecessary and costly. The certification requirement will make health care more expensive at a time when government should be directing scarce health care dollars to improving health care quality and access.

The cost-benefit analysis performed by the Department of Health and Human Services is inadequate. While it has estimated a cost of $44.5 million for the certification program, this amount represents only part of the picture. The scrupulous provider, attempting to comply with this ambiguous rule, will need legal counsel to determine its application. Employers will have to apply the provisions broadly and engage additional staff in close cases. There will be costly litigation. None of these expenses will improve the quality of health care. The American people have made clear that improved health care and broader access are goals of paramount importance. The wastefulness that will be caused by implementation of this rule is a step in the wrong direction.

In conclusion, the proposed rule is likely to cause irreparable harm to women, ignores current standards of good practice, is unnecessary and costly and creates confusion in the health care system. As indicated above, New York requests that the Secretary withdraw the proposed rule.

Very truly yours,

Richard F. Daines, M.D.
Commissioner of Health 9-26-08