NCPA Advocates for Compounding Pharmacists as FDA PCAC Meets for Second Time: The FDA Pharmacy Compounding Advisory Committee (PCAC) met for two days this week and discussed various issues related to implementation of the Drug Quality and Security Act (DQSA). On the first day of the meeting, the committee discussed four drugs being considered for inclusion on the list of drug products that may not be compounded because they have been withdrawn or removed from the market because they have been found to be unsafe or not effective (withdrawn/removed list): aprotinin, ondansetron hydrochloride single dose IV drug products greater than 16mg, bromocriptine mesylate for prevention of lactation, and acetaminophen drug products greater than 325 mg of APAP per dosage unit. The committee voted to add all of these products to the do not compound list. It’s important to note the drugs on this list can be qualified based on dose/route of administration/indications, etc.

The committee next discussed four substances nominated for inclusion on the list of bulk drug substances that are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs and that may still be used to compound drugs in accordance with section 503A of the Act (503A bulk positive list). NCPA thanks member Cheri Garvin, RPh, Owner and CEO, The Compounding Center, Leesburg, Virginia, for representing NCPA members while speaking to the merits of substances being debated by the committee. Ultimately, of the four substances being discussed, Brilliant Blue G, tranilast (topical use only), and n-acetyl-d-glucosamine (topical use only) were voted to be placed on the 503A bulk positive list. Oxitriptan was voted NOT to be added to list.

FDA said they were going to be reviewing 64 products total for the bulk positive list and only 10 have been voted on at this point. FDA will publish the first proposed rule addressing the 10 substances later this year. Also, FDA is working on a guidance describing an interim policy regarding compounding with bulk drug substances while FDA is developing the list. They said they are not taking action at this point unless there are safety concerns raised such as with domperidone. On day 2 the focus was on the difficult to compound list and what the criteria for that list would be. FDA has identified six criteria for the list. FDA received 71 nominations for drug products and categories and will be discussing this list at upcoming committee meetings. NCPA continues to advocate for compounding pharmacists related to the many ongoing processes underway to implement the compounding provisions within DQSA.

CVS/Target Deal Bolsters Case for 'Any Willing Pharmacy' Legislation: This week’s announcement that CVS Health will acquire, rebrand, and operate mass merchandiser Target's pharmacy and clinic business in a $1.9 billion deal, "reinforces the need and strengthens the case for allowing patients to use 'any willing pharmacy' that accepts a drug plan's terms and conditions, such as reimbursement," said NCPA CEO B. Douglas Hoey, Pharmacist, MBA. Further consolidation in the retail setting means pharmacy services are increasingly available only from a fewer number of larger entities and patients in underserved rural and inner-city areas rely on access to independent community pharmacies for prescription medication and counseling whereby national pharmacy chains are not a practical option. The Ensuring Seniors Access to Local Pharmacies Act (H.R. 793/S. 1190) would allow patients in underserved areas to access discounted copays at their local pharmacy. NCPA continues to encourage House and Senate lawmakers to cosponsor and enact this legislation. Currently H.R. 793 has 52 cosponsors and S. 1190 has 6 cosponsors.

HRSA Proposes 340B Civil Monetary Penalties Rule: On June 17, the Health Resources and Services Administration (HRSA) published a proposed rule impacting the 340B Drug Pricing Program. The proposed rulemaking, required under the Affordable Care Act, address 340B drug ceiling price calculations and penalties that may be imposed on drug manufacturers that overcharge providers participating in the 340B Program. Public comments on the proposed rules are due by August 17, 2015.

MedPAC Issues June Report to Congress: On June 15, the Medicare Payment Advisory Commission (MedPAC) released its June 2015 Report to Congress: Medicare and the Health Care Delivery System. Among the 5 recommendations, the commission recommended that policies be better aligned across Medicare's three payment models: fee-for-service, Medicare Advantage plans and accountable care organizations. MedPAC also issued recommendations on payment policies for Part B drugs. "Given the high level of Medicare payments relative to 340B hospitals' drug acquisition costs, policymakers might consider whether Medicare should pay less than average sales price + 6 percent for Part B drugs purchased by those hospitals," the report stated. Alternatively, if the payment rate does not change, beneficiaries' cost sharing for 340B drugs could be reduced.

In the States:

• New Jersey: This week NCPA State Government Affairs staff traveled to Trenton, NJ to testify before the Committee on Financial Institutions and Insurance in support of A.3331. This bill would allow for Medication Synchronization. This service will be provided by licensed pharmacists and help to coordinate a patient’s prescribed medications for chronic conditions to allow all of a patient’s prescriptions to be refilled on the same date each month. NCPA staff also testified before the committee on A.B.3522, representing MAC transparency legislation to both the pharmacy and plan, but also on a number of other PBM reform practices. NCPA looks forward to working with our state partners in New Jersey on all of these legislative priorities.
• Oregon: This week Oregon Governor Kate Brown signed into law House Bill 2028, establishing provider status for Oregon pharmacists and expanding opportunities and venues for pharmacists to meet critical patient needs. The success of this legislation resulted from the hard work of many state partners representing pharmacy interests in Oregon. HB 2028 provides recognition of pharmacists as healthcare providers and expands opportunities for pharmacists to provide clinical services for which they can be reimbursed. NCPA congratulates all those in Oregon who made this legislation a success.