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1/25/2002

HHS to Focus on Burdensome Regulations

Last spring, Health and Human Services (HHS) Secretary Tommy G. Thompson announced a departmentwide initiative to reduce the regulatory burdens in health care and respond faster to the concerns of providers and patients affected by the rules issued by the department's agencies, such as the Food and Drug Administration and the Centers for Medicare & Medicaid Services. As part of this initiative, Thompson created the Advisory Committee on Regulatory Reform, which held its first meeting in January.

ASHP is pleased that one of our members, Michele M. Evink, M.S., FASCP, of the Clarke County Hospital in Osceola, Iowa, has been appointed to the Secretary's advisory committee. Her presence on the committee will give pharmacists a voice in improving patient care.

Below is the text of the letter, dated Jan. 18, that ASHP sent Evink congratulating her on the appointment.

 

Dear Michele:

On behalf of the American Society of Health-System Pharmacists (ASHP) and the ASHP Board of Directors, I would like to formally extend congratulations to you on your appointment to the Secretary’s Advisory Committee on Regulatory Reform by Secretary Tommy G. Thompson of the Department of Health and Human Services (DHHS).

As you are well aware, regulations issued by DHHS agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, have a great impact not only on the day-to-day practice of pharmacy but, more significantly, on the outcome of patient care. The advisory committee’s mandate – to determine how agency rules may interfere with the operation of HHS programs relating to how health care practitioners provide patient care – will have a significant role to play in future reforms in the nation’s health-care system.

ASHP commends you for your dedication and commitment to the profession of pharmacy. As the only pharmacist appointed to this important committee, I believe this recognition speaks highly of your professional commitment and others’ recognition of this dedication. I am aware that you have been in contact with ASHP staff in the Government Affairs Division since your appointment. I hope you will continue to use ASHP as a resource and will contact us at any time when we can be of assistance.

ASHP wishes you the best of luck in this important endeavor. Your work on the committee is not only a great responsibility, but also a great opportunity to substantiate the importance of pharmacists’ involvement in providing patient care. All involved in the health care world will eagerly anticipate the resulting outcome of this project.

Sincerely,

Henry R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President/Chief Executive Officer
American Society of Health-System Pharmacists

 

To assist the advisory committee in identifying burdensome regulations and recommending improvements, HHS has given the public an opportunity to provide input on the hardships imposed by departmental regulations. ASHP is soliciting comments from members (see the letter below), but anyone who wants to submit individual comments to HHS may do so by March 5. The official notice requesting comments from the public appeared in the Jan. 4 Federal Register.

 

January 10, 2002

MEMORANDUM

TO: Members, Council on Legal and Public Affairs
Members, Council on Professional Affairs
Members, Council on Administrative Affairs
Members, Executive Committee, ASHP Section of Clinical Specialists
Members, Executive Committee, ASHP Section of Home Care Practitioners

FROM: Gary C. Stein, Ph.D.
Director, Federal Regulatory Affairs

SUBJECT: Department of Health and Human Services Notice and Request for Comments: Secretary's Advisory Committee on Regulatory Reform

Enclosed for your review and comment is a Department of Health and Human Services (DHHS) notice and request for comments published in the Federal Register on January 4, 2002, requesting comments for review by the new HHS Advisory Committee on Regulatory Reform.

Last Spring, DHHS Secretary Tommy G. Thompson announced a department-wide initiative to reduce regulatory burdens in health care and respond faster to the concerns of providers and patients who are affected by rules issued by DHHS agencies such as the Food and Drug Administration and the Centers for Medicare & Medicaid Services. As part of this initiative, Secretary Thompson created the Advisory Committee on Regulatory Reform, which held its first meeting in January 2002. The advisory committee is reviewing HHS regulations to identify agency rules that "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."

To assist the advisory committee in identifying burdensome regulations and recommend improvements in those regulations, the January 4 Federal Register notice announced an opportunity for public input on what regulatory burdens exist in health care delivery, health care operations, development of drugs and other medical products, and biomedical and health services research. HHS wants input on how "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." Comments should be as detailed as possible in relation to specific regulations, and should include your thoughts on how agency regulations are confusing, conflicting, or obsolete; impose unnecessary or excessive costs; require unreasonable recordkeeping; or impede patient access to care or your ability to provide care.

You should also include your thoughts about alternative approaches that could be taken to achieve or accomplish the same regulatory goal but with a lesser burden.

To help ASHP develop its comments on the January 4, 2002, Federal Register notice, please provide me with your input no later than Monday, February 11, 2002. Written comments may be sent to my attention at ASHP, 7272 Wisconsin Avenue, Bethesda, MD 20814; you may fax your comments to me at 301-657-1615, or e-mail them to me at gstein@ashp.org.

Please read the enclosed Federal Register notice carefully. ASHP is relying on your expertise, and your analysis will be central to ASHP's input to DHHS. Thank you for your cooperation.