Letter to Secretary Tommy Thompson, HHS, Concerning HHS Health Care Regulations
Letter from E. Ratcliffe Anderson, Jr., Executive Vice President, AMA
AMA in Washington
- February 13, 2001
February 13, 2001
The Honorable Tommy Thompson
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Thompson:
On behalf of the American Medical Association (AMA) and our 300,000 physician and medical student members, I want to congratulate you on your confirmation as Secretary of Health and Human Services. As I indicated in my recent letter to the President, we look forward to working with the Administration on several important health care issues. One of our most critical concerns is the need to streamline Medicare’s regulatory complexity and simplify its paperwork requirements. Toward that end, we deeply appreciate your recognition during your confirmation hearings that the growing complexity of the Medicare program’s rules and policies is driving physicians away from the program.
We were gratified that one of the President’s first steps following his inauguration was to place a 60-day stay on the mountain of regulations issued in the final weeks of the Clinton Administration, pending their review by the Bush Administration. Several of their recently published rules, and others that were under development by the Clinton Administration but have not yet been published, would add significantly to Medicare’s mushrooming bureaucratic complexity and to the unfunded mandates imposed on physicians and other heath care professionals and providers. Even before these rules were issued, Medicare paperwork requirements were taking vital physician time and resources away from patient care. All of the rules need to be reexamined to some degree, however, several of them implement important statutory provisions that should not be unduly delayed, for example, providing beneficiary protections for patients in Medicaid managed care plans.
The AMA has conducted a preliminary review of the major health care regulations issued in the final weeks of the Clinton Administration. On the basis of this review, we believe a number of significant changes should be made before these regulations are implemented. The remainder of this letter presents the results of our preliminary analysis and makes several recommendations.
Office of Civil Rights Policy Guidance on Persons with Limited English Proficiency:
We strongly urge the Bush Administration to immediately rescind this policy guidance. Other approaches should be considered that will not impose new, unfunded federal mandates on physicians, and that will be considerably less likely to jeopardize patient access. President Bush’s recently announced Community and Faith-based Organizations Initiative provides a much more appropriate avenue for addressing the issues surrounding linguistic and cultural barriers to high quality care than the heavy-handed regulatory approach of this rule.
The AMA firmly believes that effective physician-patient communication and culturally competent care are essential for the best possible clinical outcome. We strongly disagree with the “policy guidance” issued last August, however, that would require physician practices treating Medicaid patients and other public beneficiaries to incur, at their own expense, the cost of hiring trained clinical interpreters to assist the physician’s patients who have limited English proficiency. The cost of retaining an interpreter far exceeds the compensation paid by Medicaid for an office visit. Such a policy, without adequate provisions for compensation, is an unfunded mandate and is likely ultimately to discourage physicians from treating any Medicaid patients, thus further exacerbating problems with patient access to needed physician services. (The HHS Office of Minority Health issued similar proposed standards in December 1999, and we urge that the Bush Administration review these standards as well.)
An alternative approach would be to call for innovative pilot projects under the Administration’s Community and Faith-Based Organizations Initiative that would encourage community-based organizations to help improve health literacy and culturally competent physician-patient-family communication. Even the Clinton Administration (in a separate rule on Medicaid managed care) stated that it would welcome demonstrations or other strategies for evaluating cultural competence in the provision of services.
Pending HCFA Regulations Expanding the Scope of the Emergency Medical and Treatment Labor Act (EMTALA):
We urge you to delay publishing a pending Notice of Proposed Rulemaking on EMTALA. We are aware that to HCFA would like to clarify certain issues for the federal courts regarding EMTALA implementation, but there are several statutory provisions and ongoing studies that should be carefully considered before any new regulations are promulgated. Congress had serious concerns last year about the direction and impact of EMTALA on the physician and provider community, as evidenced by a provision in the Beneficiary Improvement and Protection Act calling for the General Accounting Office to conduct an important assessment of EMTALA by May 2001. In addition, the Department’s Office of the Inspector General (OIG) recently published a report of a survey of hospital emergency departments about EMTALA, which confirms the validity of the Congress’ concerns and those of the hospital and physician community about the expanding scope of the law. HCFA should give ample consideration to all of these developments prior to releasing a new EMTALA regulation that could substantially burden providers and physicians.
Further, we respectfully request that the Department establish a multidisciplinary group of public and private sector representatives to address problems with the EMTALA program before promulgating further regulations. At the most recent meeting of the AMA House of Delegates, an urgent resolution was passed calling for a return to the original congressional intent of EMTALA and opposing the continued judicial and regulatory expansion of its scope. The new AMA policy opposes regulations that expand the scope and reach of EMTALA, including the criminalization of hospitals and physicians, and favors adequate federal funding to pay hospitals and physicians for providing medical screening examinations, stabilization, and any indicated transfers of uninsured patients. The policy also calls for the formation of a coalition of hospitals, physicians, health plans, business coalitions, and patient groups to improve policies and regulations with regard to the application of EMTALA. A second OIG report on EMTALA issued last month suggests the formation of a technical advisory panel to assist on enforcement of EMTALA. Our request is consistent with the OIG recommendation.
HHS Rules on Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act (HIPAA):
The compliance date for all of the various HIPAA Administrative Simplification provisions should be established at two years after the last final rule is published (with the exception of the individual identifier rule, which may be significantly delayed). The AMA strongly supports the principles of standardization embedded in HIPAA’s Administrative Simplification provisions. Those provisions are intended to address the multitude of conflicting rules and requirements imposed by public and private payers which result in physicians spending more time on the administrative requirements of their practice and allow them less time for patient care. Initially, the large body of regulations that comprise the Administrative Simplification provisions of HIPAA will entail a significant expenditure of costs and staff resources by physicians to assure proper compliance. The AMA has consistently advised the Department that an orderly implementation process will be necessary for the goals of administrative simplification to be achieved. Physicians need to know what aspects of their administrative practices need to be modified, as well as how and when. Adjusting to moving targets with rolling compliance dates is neither cost effective nor efficient for small physician practices.
HCFA Final Rule on Hospital Conditions of Participation for Anesthesia Services:
We urge you to take the action necessary to rescind this final rule and construct a new rule that is more sensitive to the legitimate needs of Medicare and Medicaid patients. The Clinton Administration’s rule would eliminate physician supervision of nurse anesthetists from the Medicare/Medicaid Conditions of Participation for hospitals and ambulatory surgical centers. We support the position of the American Society of Anesthesiologists and Anesthesia Patient Safety Foundation that revision of the current physician supervision requirement should be considered only after development and review of current scientific outcomes data. We are deeply troubled by the position of the previous Administration that the elimination of physician supervision can be presumed to be safe – without scientific proof – in light of the overall improvement of anesthesia safety over the past several years during which physician supervision has been required. We believe Medicare and Medicaid beneficiaries deserve better than a mere presumption of safety that has no basis in the scientific literature.
HCFA Final Rule on Restraint and Seclusion in Psychiatric Facilities under Medicaid:
We urge the Administration to withdraw this latest interim final rule for psychiatric residential treatment centers (RTCs), and to conduct meetings with affected physician and provider groups to design a reasonable and consistent policy for use of restraint and seclusion in all facilities. With this latest rule, mental health providers must now comply with at least four different sets of requirements governing the use of restraint and seclusion, including a rule governing the use of restraint and seclusion for behavioral health patients in hospitals that participate in Medicare or Medicaid. Both the RTC and the hospital regulations were originally part of general conditions of participation for the facilities involved. In both cases, however, the Clinton Administration extracted the restraints and seclusion section from the general conditions and issued these as interim final rules. Both rules therefore have isolated a single specific condition and set out sweeping new restrictions for its use. Moreover, in the case of the earlier rule for hospitals, HCFA has never issued a final rule responding to the thousands of comments and strong clinical objections it received. Nor has the agency ever responded to findings from both the Small Business Administration’s Office of Advocacy and a Federal Court that HCFA did not comply with the Regulatory Flexibility Act in its promulgation of this rule. In short, the Clinton Administration has created a myriad of rules that are confusing, often duplicative, extremely costly to implement without any offsetting payment for compliance costs, and may result in less access to important medical care for patients.
HCFA Final Rule on Medicare Coverage of Diabetes Self-Management Training:
We urge the Bush Administration to reverse the provision of this final rule allowing nurse practitioners and clinical nurse specialists to order diabetes education services and develop the patient’s plan of care. Diabetes is a leading cause of death, may cause life-threatening complications, and is an important risk factor for other leading causes of death, such as coronary artery disease. Only fully licensed physicians (M.D. and D.O.) are qualified to develop comprehensive care plans for patients with diabetes and to determine the medical necessity of self-management training services. This is the clear meaning of the Balanced Budget Act statement that diabetes self-management training services are covered “only if the physician who is managing the individual’s diabetic condition certifies that such services are needed under a comprehensive plan of care related to the individual’s diabetic condition…” (emphasis added).
HHS Final Rule on Privacy of Individually Identifiable Health Information:
We urge the Department to revise the regulations to strengthen certain provisions. Patient privacy is a right long advocated by the AMA and, in concept, establishing federal patient protections is a worthwhile endeavor. However, due to the limited scope of HIPAA, the regulation does not apply to many secondary users of health information. In addition, due to the widespread belief that personally identifiable health information should be available for a vast array of seemingly compelling purposes without the explicit consent of the patient, the rule’s protections are inadequate. For example, health plans are not required to obtain consent before using or disclosing protected health information for payment or broadly defined “health care operations.” In addition, secondary users of health information such as law enforcement are able to obtain this information without a court order. Furthermore, the rule imposes unreasonable obligations on physicians and other providers to ensure the compliance of their business associates, while exposing them to increased liability, by creating a new duty to mitigate known privacy violations by these third party contractors.
Due to the ethical obligation to maintain the confidentiality of the physician-patient relationship, most physicians already have policies and procedures in place to protect patient information. Therefore, the substantial costs associated with physician compliance may not be commensurate with any significant improvement in patient protections.
HCFA Final Rule on Physician Self-Referral:
We urge an extension of the comment period on this rule for an additional 60-90 days to ensure that HCFA receives a complete and accurate reading of this regulation from the physician, provider, and supplier communities. The AMA submitted close to 40 pages in comments to the self-referral proposed rule, and HCFA received 12,800 comments. While Phase I of the final rule does provide some helpful tools in addressing self-referral issues, several of the rule’s provisions are problematic. More time is clearly needed to analyze and respond to this very complex final rule.
OIG Proposed Rules on Technical Changes to the CMP Regulations:
We urge you to withdraw the OIG proposed rule related to technical changes in the civil monetary penalty regulations. In this rule, the OIG proposed to issue Medicare exclusions on alleged violations where prosecution is barred because of a specified statute of limitations. This type of authority would allow the OIG to exclude a physician from Medicare in the absence of a prosecutable crime. Indeed, since the prosecution would be prohibited, there would be no means by which a judge or jury could adjudicate whether the alleged offense even occurred. The OIG has also proposed to allow consideration of “similar conduct after the incident in question” to determine civil monetary penalty amounts for EMTALA violations. This is especially troublesome because of the uncertainty surrounding EMTALA, as described above, and what type of conduct would trigger an EMTALA violation.
Medicaid Managed Care Final Rule:
The patient protections included in this final rule, which were enacted as part of the Balanced Budget Act of 1997, should be implemented without undue delay. These protections were published in a proposed rule more than two years ago and are very similar to the protections extended to patients in Medicare+Choice plans through the Balanced Budget Act and its implementing regulations.
Patients should be able to choose whether or not they wish to enroll in a managed care plan, but millions of patients have lost this choice as many states have adopted mandatory managed care enrollment for their states’ Medicaid programs. The inability to choose whether or not to enroll in managed care makes patient protection provisions all the more critical for the Medicaid population. Section 4704 of the BBA extended a series of protections to Medicaid beneficiaries in managed care plans related to emergency services, grievances, patient-physician communications, and assurance that an appropriate range of services and number and mix of physicians are available. The final rule issued by the Clinton Administration merely continues the process begun in the proposed rule of writing implementing regulations for the BBA provisions, but the underlying patient protections come from the BBA, not the regulations. In addition, the final rule improves on the proposed rule in several respects by strengthening the provisions regarding the availability of specialists and preventing plans from using lists of symptoms and diagnoses as a means of denying coverage for emergency services.
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Mr. Secretary, we deeply appreciate your consideration of our concerns and recommendations on these recent rules. If your staff has any questions or wishes to discuss any of these issues or rules further with us, please have them contact Margaret Garikes (202-789-7409), the AMA’s Director of Federal Affairs and Outreach.
Respectfully,
E. Ratcliffe Anderson, Jr., MD
