APhA Legislative & Regulatory
Update
August 25, 2006
In this issue:
On Thursday, August 24th, the Food and Drug Administration (FDA) announced its approval of the emergency contraceptive Plan B for over-the-counter sales to women 18 years and older. The drug product, however, will remain prescription only for women 17 and younger. The FDA’s decision is significant because it is the first time a drug product will have dual status as both a prescription and OTC and be sold in the same package, for the same indication. This approval essentially creates a third category of drug products available only behind pharmacy counters or at clinics, something APhA has suggested the APhA create since the mid-1960’s. While APhA does not take a position as to whether specific products should move from prescription to over-the-counter status, this regulatory development is a recognition that pharmacists and pharmacy practices can help provide a middle-ground between prescription and over-the-counter access.
Duramed, a subsidiary of Barr Pharmaceuticals, intends to make the new dual-label “behind the counter” package later this year. Until that time, Plan B is available only by prescription. Plan B will only be sold at licensed clinics and pharmacies and must be kept behind the pharmacy counter. Women 18 and older will be required to show proof of age in order to obtain the product as an OTC. Women 17 and younger will still be required to obtain a prescription from their physician; however, in the nine states where pharmacists have explicit authority to prescribe and dispense emergency contraception under collaborative drug therapy management (AK, CA, HI, ME, MA, NH, NM, VT, WA), they may, when medically appropriate, access it directly from their pharmacist. Men may also purchase the product if they meet the age restrictions.
Barr has committed to operating the Convenient Access, Responsible Education (CARE) program to support efforts to ensure that Plan B is used appropriately. In addition to the age and distribution restrictions, the CARE program also includes education for consumers and health care professionals, a toll-free information line for questions, and monitoring of the effectiveness of the age and distribution restrictions.
Additional information on the FDA’s decision and Plan B is available on the FDA website. A copy of APhA’s statement on the Agency’s decision is available on the APhA website.
Back to TopThe Drug Enforcement Administration (DEA) released training materials that pharmacies must use to train employees on new restrictions related to the sale of ephedrine, pseudoephedrine, and phenylpropanolamine products. Retailers – including pharmacies – are required to train their employees on the new restrictions by September 30th in order to continue selling these products.
The DEA developed two sets of training materials – one for mobile retailers such as temporary kiosks at airports and another set for non-mobile retailers such as pharmacies. The training materials take the form of a short PowerPoint presentation and consist of a brief overview of the Combat Methamphetamine Epidemic Act of 2005 (‘Combat Meth Act’) – which created the sales restrictions on precursor products that can be used to manufacture methamphetamine, information on the 3.6 gram daily sales limit and 9 gram monthly purchase limit, and a new logbook requirement. Retailers must use the content in the DEA materials to train their employees. However, retailers may supplement the DEA training materials with additional materials of their own.
Copies of the DEA training materials as well as additional information on the sales restrictions and logbook requirement are available on the APhA website. The Agency has not yet released draft regulations to implement the log-book requirement and other elements of the Combat Meth Act, although many other provisions are effective as of September 30th as well. APhA will update you as soon as the draft regulations or additional guidance is provided.
Back to TopThe Centers for Medicare and Medicaid Services (CMS) released a new set of quality standards for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) . The quality standards contain general business, customer service, and product safety requirements as well as some product-specific service standards. In response to suggestions from APhA and others, the final quality standards, which are 14 pages long, contain more generalized, less complex requirements than the 108 page draft standards that were released last September for public comment.
In related news, CMS also released a final regulation that establishes requirements for accreditation of DMEPOS suppliers. The regulation explains the application process for independent accrediting organizations that will accredit DMEPOS suppliers. Independent accreditation organizations must submit an application to CMS by October 2nd in order to become a CMS-approved accrediting body for DMEPOS suppliers.
In the future, all DMEPOS suppliers will be required to obtain accreditation in order to obtain a Medicare supplier number and obtain reimbursement under Medicare Part B. Suppliers must be compliant with the quality standards in order to obtain accreditation. CMS plans to phase-in the accreditation requirement. Suppliers who want to participate in the first phase of the upcoming DMEPOS competitive bidding program – which will only allow suppliers who submit a bid and contract with CMS to bill Medicare for DMEPOS items supplied to Medicare beneficiaries – will need to be accredited in early 2007. Suppliers who participate in the second phase of the competitive bidding program will need accreditation in winter 2007. CMS has not yet set a date for accreditation of all suppliers or released the details on the competitive bidding program. According to CMS, the final regulations to implement the competitive bidding program will be released on October 1st.
The final quality standards, an APhA summary of the accreditation regulation, and background information on the competitive bidding program are available on the APhA Resources: Medicare website.
Back to TopSeveral Members of Congress have recently expressed concerns with pharmacy compounding. First, Senator Kennedy (D-MA) and Rep. Waxman (D-CA) held a July briefing for Hill staff to educate them about the practice. Then Senator Grassley (R-IA), chairman of the Senate Finance Committee, sent a letter to the FDA and CMS expressing his concerns with the practice. This week, those activities produced their first official response from a regulatory agency.
An August 22nd letter from CMS to Sen. Grassley addressed some of the Senator’s concerns. Mr. Grassley was particularly concerned with the reimbursement structure for inhalation drugs. Under Medicare, CMS has historically reimbursed compounded and manufactured inhalation drugs at the same rate, which according to the Senator, creates an inappropriate financial incentive for pharmacists to provide a compounded inhalation drug. To address this concern, CMS has indicated that it will change how it reimburses for compounded inhalation products under Medicare. Under the new payment system, manufactured products will continue to be paid based on the Medicare Part B formula of Average Sales Price (ASP) plus six percent. However, reimbursement for compounded inhalation products will be based on new payment codes to distinguish compounded products from non-compounded products and which will rely upon invoices submitted by suppliers — something that will require special claims processing. CMS anticipates initially concentrating on the highest volume compounded inhalation products. Further details will be provided in CMS’ instructions and code revisions, which will be released by the end of October in anticipation of a January 1, 2007 implementation date. CMS plans to wait to see the results of this first step before considering additional action.
The FDA has not yet responded to the Senator’s letter or to either of the two citizens petitions submitted in 2005 expressing concern about compounded inhalation drugs and bio-identical hormone replacement therapy. However, earlier this month the Agency did order three firms (RoTech Healthcare Inc., CCS Medical, and Reliant Pharmacy Services) to stop making mass-produced inhalation products. In the months ahead, there is still an opportunity for Congress to proceed with legislation although reports that Sen. Grassley supports CMS’ proposed changes as a good first step toward gathering data that will provide a better picture of the magnitude of compounded products may delay any immediate action. APhA will continue to oppose any attempts to grant FDA authority to regulate the practice of compounding (what could be interpreted as the underlying theme of Senator Grassley’s communication).
Back to TopIf you have any questions about the information in the Legislative & Regulatory Update, do not hesitate to contact a member of the APhA Policy & Advocacy Staff.
Susan K. Bishop,
MA
Director, Federal Regulatory Affairs
202/429-7538
SBishop@APhAnet.org
Hrant Jamgochian, Esq.
Director, State Relations and Political
Action
202/429-7575
HJamgochian@APhAnet.org
Kristina E. Lunner
Senior Director, Government
Affairs
202/429-7507
KLunner@APhAnet.org
Susan C. Winckler, RPh, Esq.
Vice President, Policy & Communications and Staff
Counsel
202/429-7533
SWinckler@APhAnet.org