02-239. Secretary's Advisory Committee on Regulatory Reform; Request for Public Input

ACTION:

Request for public input.

SUMMARY:

This notice seeks input from the public—including individuals and organizations—on ways to reduce current burdens imposed by existing regulations of the Department of Health and Human Services (HHS) that inhibit the delivery of high quality, timely, and efficient health care, inhibit the development of pharmaceuticals and other medical products, or inhibit biomedical research.

FOR FURTHER INFORMATION CONTACT:

Christy Schmidt, Executive Coordinator, Secretary's Advisory Committee on Regulatory Reform, Office of the Assistant Secretary for Planning and Evaluation: [phone].

SUPPLEMENTARY INFORMATION:

On June 8, 2001, Health and Human Services Secretary Tommy G. Thompson announced a department-wide initiative to reduce regulatory burdens in health care and respond faster to the concerns of patients, health care providers, state and local governments, other institutions, and other individual Americans who are affected by HHS rules. On September 4, 2001, the Department published a Notice of Intent in the Federal Register announcing its plans to establish an Advisory Committee on Regulatory Reform to provide findings and recommendations to the Secretary regarding potential regulatory changes. The Advisory Committee will commence its activities early in 2002.

Regulations play an important role in implementing statutes. Regulations establish and communicate rules and procedures for participation in public programs, for approval of products, and for the awarding of grants and contracts. The regulatory process also allows for public examination of proposed rules, comment on those proposals, and an explanation of how those comments were factored into final decisions by government agencies.

At the same time, in accomplishing these important tasks, regulations may impose a burden on individuals and organizations participating in public programs or seeking government approval or support. Some or most of these burdens may be necessary to carry out the statutory requirements and quite reasonable and appropriate in governing the expenditure of public funds and protecting the health and safety of individuals and the nation as a whole. But some of these burdens may be unnecessary, excessive, or inappropriate because they interfere with the operation of the programs to which they relate, are unduly intrusive, or are inconsistent with other requirements and thus unduly reduce flexibility, inhibit innovation, or impede efforts to improve quality of health care and access to health services or other rights and benefits for patients and consumers that are provided by law.

The Advisory Committee's ultimate goal is to (a) identify and prioritize regulations that impose barriers to delivering high quality, safe and effective care services, products and research, and (b) to recommend improvements or other ways to remove these barriers. To help the Committee achieve this goal, we are inviting the public to provide us with written comments on regulatory burdens created by HHS regulations. Those interested in responding to this request are asked to focus their comments on regulatory burdens in one or more of the following areas:

• Health care delivery,
• Health care operations,
• Development of pharmaceuticals and other medical products, and
• Biomedical and health services research

We encourage individuals as well as organizations to respond to this invitation, including but not limited to consumers, patients, researchers, clinicians and other health care professionals, employers, health care administrators, professional societies, trade associations, state and local governments, and universities. We encourage those who wish to respond to consider ways in which regulations or program requirements interfere with the delivery or receipt of care, innovation in health care delivery operations, or research, or the development of new products and treatments. In this regard respondents may find it helpful to consider their most recent interactions with HHS programs in order identify specific issues.

Because of the broad nature of the Committee's charge, it will be essential that comments be as specific as possible and focus on concerns related to burdens imposed by regulations or regulatory processes rather than the underlying statutes enacted by the Congress.

We ask that responses be limited to no more than five (5) one-sided, single-spaced pages and be accompanied by and IBM-compatible 3.5 inch diskette in WordPerfect or MS Word format. Additional attachments can be included but the Committee cannot guarantee that all of these materials can be read and considered. Therefore, major points should be made in the letter.

The Committee would appreciate it if those who respond would consider some or all of the following matters:

1. Which HHS regulations in the above-cited areas impose an unnecessary or unreasonable burden on individuals, groups, or organizations because these regulations:

• Are confusing;
• Impose unnecessary or excessive costs;
• Require an excessive number of reports or unreasonable record keeping;
• Impose requirements on the wrong individual or group;
• Carry excessive penalties;
• Are conflicting (examples include but are not limited to conflicts between HHS and State regulations, public and private sectors);
• Impede access to care or impede delivery of care;
• Impede efforts to innovate
• Are obsolete; and/or
• Interfere with the public or private sector's ability to respond to and prepare for emergencies.

2. What alternative approaches could be taken to achieve or accomplish the same goal with a lesser burden? For example, are there less burdensome approaches that are used by other entities such as state governments or private companies that could be adopted by HHS to achieve its goal with less burdensome requirements?

For each of the regulations discussed, the Committee asks you to include the following whenever possible:

• Citation of regulation involved or description of the regulation in as much detail as possible.
• Citation of relevant statute on which the regulation is based.
• A clear statement of the problem or concern.
• Identification of potential solutions to this problem or concern.
• A statement of how the proposed solutions would maintain the original intent of the statute (if possible, please provide citation of the original statute).

We recognize that many individuals may not be able to provide a full or accurate citation to particular regulations or statutes. That should not stop them from commenting. However, professional organizations and institutions, will probably have access to this information and are encouraged to provide specific citations.

We would also appreciate information on how you interact with the health care system (e.g., Are you a patient/consumer, physician, nurse, researcher, university, employer, health plan, hospital, nursing home, home health agency, pharmaceutical manufacturer, medical device, manufacturer?).

We will accept comments on regulatory reform if we receive them at the appropriate address, as provided below, by 5pm on March 5, 2002.

Individuals or organizations wishing to respond to this request may do so in writing by sending their comments to: Christy Schmidt, Executive Coordinator, Regulatory Reform Initiative, Office of the Assistant Secretary for Planning and Evaluation, 200 Independence Ave., SW., Washington, DC 20201. Responses also can be made electronically on the Committee's website: www.regreform.hh.gov. Those who respond should recognize that their comments would be part of the public record of the Committee and, under the Freedom of Information Act, available to anyone who wishes to read them. The Committee will make attempts to segregate those comments that are of a personal nature but cannot guarantee that all such comments will be recognized.

Comments will be available for public inspection by appointment as they are received, generally beginning approximately January 25, 2002 in Room 801 of the Department's offices at 200 Independence Avenue, SW., Washington, DC on Monday through Friday of each week from 8:30 am to 5 pm. Appointments may be made by telephoning 202-401-5182.

After the close of the comment period, comments that are technically able to convert will be posted on the Regulatory Reform web site specified above.

Dated: December 26, 2001.

Tommy G. Thompson,

Secretary.