A Peek Into ASHP's Regulatory Affairs Playbook For 2008

Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry
Article Date: 14 Feb 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Adequate reimbursement for both inpatient and outpatient pharmacy services, patients' timely access to medications, and smooth transitions in care are among the issues that ASHP will be pushing for with officials at the federal regulatory agencies like the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) this year.

The Society closely monitors the Federal Register, a daily publication that announces proposed rules and other notices from federal agencies, for issues that impact pharmacists practicing in hospitals and health systems. When CMS, FDA, and other agencies release proposed rules and guidelines, ASHP responds with written and oral comments that communicate the concerns of members.

The regulatory arena is very different from the legislative process," said Justine Coffey, J.D., LLM, director of ASHP's federal regulatory activities. "When a proposed rule is issued by a government agency, we usually have just one opportunity to provide the agency with a written document that not only captures the impact that regulation will have on pharmacy practice, but also persuades the agency to make necessary changes in its final rule."

ASHP's enhanced advocacy initiative has allowed the Society to be more proactive in its approach to the federal regulatory agencies. In recent months ASHP has participated in agency-sponsored forums, been called on to serve as experts, and nominated members to serve on advisory committees. "Our participation beyond commenting on Federal Register notices showcases our expertise and provides policymakers with a more thorough understanding of the impact that their rules have on practitioners," said Coffey.

ASHP is set to testify before a CMS advisory panel next month about a proposed rule for the outpatient prospective payment system. The Society is also monitoring the FDA's implementation of the Prescription Drug User Fee Act, improvements to the MedWatch system, and will keep an eye out for the agency's next steps on a potential "behind-the-counter" classification. ASHP also will monitor the Health Resources and Services Administration, which is expected to release new guidelines for the 340B program.

Follow ASHP's progress on these and other regulatory issues by adding the Government Affairs area of ashp.org to your list of favorite bookmarks. Visit the site often for updates and opportunities to become involved in the Society's efforts.

American Society of Health-System Pharmacists