The U.S. Department of Health
and Human Services Office of Inspector General's (OIG) Work Plan for Fiscal Year 2014 indicates that the OIG will be examining Medicare Administrative Contractor (MAC) policies and procedures for reviewing and processing Medicare Part B claims for compounded drugs in light of the fact that Medicare pays only for compounded drugs that are produced in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA). This initiative suggests that greater scrutiny will be applied to Medicare program payments for compounded drugs. If a compounder is not strictly complying with the FDCA or applicable exemptions thereto, it may find that its drugs are no longer reimbursed by MACs, who pay claims on behalf of the Medicare program. In addition, it is possible that MACs or the Centers for Medicare and Medicaid Services (CMS) may seek recoupment for claims previously paid for drugs compounded in violation of the FDCA
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t was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, enacted by President Theodore Roosevelt less than 32 years before on June 30, 1906. Clocking in at just under 20 pages of text, the Public Law version of the 1938 FDC Act, 52 Stat. 1049, is a far cry from the 700-plus page behemoth statute of today. (The June 11, 1938 Conference Report on S. 5, which became the FDC Act, was also quite short – just 24 pages in length. See our previous post on the expansion of the FDC Act and FDA regulations.) And the statute will continue to expand with likely changes to the law concerning drug compounding and drug supply chain (i.e., track and trace) currently being debated by Congress.
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June 20, 2013
The Honorable Morgan Griffith
U.S. Congress
1108 Longworth House Office Building
Washington, D.C. 20515
RE: Discussion Draft to amend section 503 A of the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding
Dear Representative Griffith:
The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to be included in your efforts to distinguish the compounding process followed by licensed pharmacies and pharmacists from other uses and users involved in the compounding process. Compounding gives physicians the ability to prescribe a more precise therapy to meet a patient’s specific need and thus is integral to all aspects of pharmacy practice, including managed care pharmacy.
AMCP is a national association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy’s nearly 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit.
AMCP recognizes and supports the efforts by Congress to address the unauthorized manufacturing of drug products. Last year’s fungal meningitis outbreak due to contaminated injectable products was the direct result of an entity engaging in the unauthorized manufacturing of drug products, not traditional pharmacy compounding. AMCP is sympathetic to the suffering and death of patients and families affected by this tragedy and is especially sensitive to this issue because our members work in a highly regulated environment designed to minimize such occurrences. AMCP members are dedicated to ensuring patient safety and access to quality medications that meet patients’ needs.
Compounding is a legitimate, long-established practice of the profession of pharmacy where the pharmacist combines drug products and excipient ingredients to produce medications in a form that may be more convenient or in a unique dosage form. Compounded medications, which must be prescribed by authorized medical practitioners and prepared by licensed pharmacists, allow physicians and pharmacists to customize drug therapy to a specific patient’s unique needs when that patient is unable to utilize commercially available drug products. Compounded medications can range from making dosages more specific and palatable for a small child to combining several medications, such as chemotherapy agents for IVs for hospital patients.
It is AMCP’s opinion that your legislative proposal adequately maintains the ability of pharmacists to compound medications. We also believe it upholds the authority of state boards of pharmacy to oversee one of the traditional practice components of the profession of pharmacy. AMCP believes the Food and Drug Administration (FDA) has clear, existing authority to pursue and prosecute those individuals whose activities fall outside the parameters of legitimate compounding and use the guise of compounding to avoid compliance with federal requirements for the manufacturer of prescription medications. AMCP supports providing the FDA with additional resources to carry out this responsibility.
Thank you for including AMCP in this process and AMCP looks forward to working with you as you continue to refine this proposal. If you have any comments or questions, please feel free to contact me or AMCP’s Vice President of Government Affairs, Lauren Fuller, at 703-683-8416 ext. 625 or via email at lfuller@amcp.org.
Sincerely,
Edith A. Rosato, R.Ph., IOM Chief Executive
A wonderful resource regarding researching Food, Drug, and Cosmetic Law Research Guide in the United States can be found at Georgetown's Law Library website. Click here to view the list.