PCCA and seven additional medical and pharmacy organizations today asked top government officials to provide more meaningful access to drugs in shortage and not readily available to patients, and provide reimbursement for medications compounded from bulk drug substances when commercially available products are on shortage during the COVID-19 Public Health Emergency (PHE).
Alliance for Pharmacy Compounding, American Academy of Dermatology, American College of Rheumatology, Arthritis Foundation, Lupus Foundation of America, National Alliance of State Pharmacy Associations, National Community Pharmacists Association and PCCA requested the following policy changes:
The FDA should allow for drugs in shortage to include those that appear on the FDA drug shortage list or those identified by the American Society of Health-System Pharmacists (ASHP). The ASHP listing is more robust than the FDA’s drug shortage list – and more accurately illustrates the scope of unmet needs in the country.
The Centers for Medicare and Medicaid Services (CMS) should require Medicare Part D to reimburse pharmacies for drugs that must be compounded from bulk drug substances due to shortages for the remainder of the COVID-19 PHE. This is especially important given that many public and private plans follow Medicare reimbursement policies.
The Department of Health and Human Services (HHS) should designate pharmacies as entities that can apply for funds from the Public Health and Social Services Emergency Fund for COVID-19 related medications that are not covered by a patient’s health insurance.
Patients with autoimmune diseases, such as lupus and rheumatoid arthritis, depend on hydroxychloroquine, a drug that is now in short supply due to its emerging use in treating COVID-19. Compounding pharmacists have the ability to provide hydroxychloroquine compounded from bulk ingredients to these patients, but currently, Medicare patients must pay for this out of pocket because Medicare does not pay for medications compounded from bulk substances. To view the requests from the eight organizations in detail, go to bit.ly/PA-Letter-0420.
"Compounding pharmacies are working hard during the pandemic to fill the gaps to provide the essential medications that patients need," said U.S. Rep. Earl L. "Buddy" Carter, R-Ga., the only pharmacist serving in Congress. "I applaud these professionals on the work they are doing. The FDA and CMS through Medicare should recognize the value and importance of compounding medications, especially while there is a strain on the supply chain."
PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education and support to more than 3,500 pharmacy members throughout the United States, Canada, Australia and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for more than 39 years. Learn more at www.pccarx.com.
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Kim Speairs, APR, MBA, Director of Communications and Engagement, PCCA, 281.709.8277, firstname.lastname@example.org