Congress Passes Budget Deal… Paul Ryan Becomes Speaker of the House: The Senate advanced a two-year budget deal that was negotiated between top Hill leaders and the White House this week. The deal eases spending caps on domestic and defense programs while lifting the nation's debt limit until March 2017 and is the final legislative accomplishment of now-former Speaker of the House John Boehner (R-OH), who officially handed the reins of the House to Paul Ryan (R-WI) on Thursday. In addition, Rep. Sam Johnson (R-TX) will temporarily take the helm the House Ways and Means Committee until a replacement is chosen. The Texas lawmaker, the senior Republican on the panel, was named to the top slot on Thursday after newly elected Speaker Paul Ryan (R-WI) resigned as chairman of the committee. The Republican Steering Committee is expected to meet soon to determine the next chairman of the committee. So far, Reps. Kevin Brady of Texas (current chair of the Ways and Means Subcommittee on Health) and Pat Tiberi of Ohio (current chair of the Ways and Means Subcommittee on Trade) are running to replace Ryan. Once a new chairman is selected, Johnson will resume his duties as chairman of the panel's Subcommittee on Social Security.

New NCPA, NACDS Study Finds $10.55 Cost of Dispensing Nationwide: A study jointly commissioned by NCPA and the National Association of Chain Drug Stores calculated a community pharmacy's average cost of dispensing nationally – not including pharmacy profit – at $10.55 per prescription. The survey encompassed approximately 19,000 community pharmacies and reviewed 1.2 billion prescriptions. It is available to NCPA members online. Many states have moved to, or are considering, a reimbursement model based on the pharmacy's average acquisition cost for medication plus a dispensing fee. The new data will play an important part of community pharmacy's efforts to ensure dispensing fees are adequate under such an approach.

FDA Puts Off Product Tracing Enforcement Again: In a surprise announcement, the FDA on October 30 once again postponed enforcement of the product traceability requirements for dispensers under the Drug Supply Chain Security Act. Originally enforcement was set to begin July 1, 2015, but NCPA advocated for an extension that FDA granted. That delay was scheduled to expire Sunday. The new enforcement date is March 1, 2016. Then, dispensers must not accept ownership of a product without receiving tracing information, prior to or at the time of a transaction, and must capture and maintain that information for six years. Dispensers can use third parties to capture and store this information. Most wholesalers are offering this service. According to the FDA guidance document, the agency granted this latest extension because “some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time." Click here to see the guidance.

NCPA Statement on Walgreens-Rite Aid Deal: This week NCPA expressed our concerns with the media, including USA TODAY and Associated Press, as well as issued the following statement in response to the announcement that Walgreens Boots Alliance, Inc. would purchase Rite Aid Corp.:

NCPA MAC Efforts Get Boost from NPR Segment: One of NCPA’s priority bills –H.R. 244, the MAC Transparency Act– got a boost when National Public Radio's program All Things Considered aired a segment called "How Generic Drugs Can Cost Small Pharmacies Big Bucks" on Oct. 22. It carefully explains how the "buy high-sell low" dynamic of rapidly rising acquisition costs for generic prescription drugs not being matched by updated reimbursements from PBM corporations is so problematic. The segment starts by focusing on Narender Dhallan of RiverRx, an independent community pharmacy owner in Bethesda, Md., who faces daily decisions about whether or not to fill certain prescriptions at a loss. Next the segment shifts to NCPA CEO Doug Hoey, RPh, MBA, describing the frequency and magnitude of such losses. The segment then examines the cause – the inordinate amount of leverage PBM corporations wield through their take-it-or-leave-it contracts with pharmacies who want in-network access to patients. As independent community pharmacist’s press for H.R. 244 or other solutions, urge people to listen to this NPR segment.

More Light Shed on DIR Fees: NCPA continues to work on the issue of DIR fees in response to member concerns. Recently, NCPA helped facilitate a story in The Wall Street Journal exposing these unfair claw backs. In addition, as previously reported, NCPA thanks the eleven members of Congress who wrote to CMS, supporting the CMS proposed DIR guidance and asking it to be finalized in the near future. This letter to CMS was publicized and generated positive articles in key Beltway news outlets, including Inside Health Policy and Bloomberg BNA.

NCPA Comments on 340B “Mega Guidance”: On October 27, NCPA joined more than 800 trade associations, health systems, drug manufacturers, patient advocates and individuals submitting comments to the Health Resources Services Administration (HRSA) in response to its "mega guidance" that was initially proposed in August. NCPA encouraged HRSA to ensure that patients needing 340B discounted medication and treatments have the ability to receive this medication in all settings and locations for which they receive care, and raised some concerns with the guidance as currently written, particularly the new 6-pronged definition of eligible patient and definition of outpatient drug that could bar 340B discounts for infusion drugs if they are prescribed outside of the hospital setting, or outpatient drugs when patients are admitted to the hospital for treatment. NCPA also expressed concerns with a provision that would prohibit contract pharmacies from being able to dispense 340B drugs for Medicaid FFS or Medicaid managed care patients unless there is a written agreement between the pharmacy and the Managed Care Organization (MCO). This likely means that contract pharmacies will have to exclude all Managed Medicaid like they currently do for Fee for Service. The proposed guidance was not all negative, as written, it would continue allowing covered entities to contract with multiple pharmacies to dispense 340B drugs to eligible patients, regardless of the availability of an in-house pharmacy.

NCPA Raises Concerns with FDA Proposed Biosimilar Naming Policy: This week NCPA went on record with the FDA, outlining concerns with the FDA’s proposed biosimilar naming convention. Primarily that confusing and complex naming conventions may lead healthcare providers to question the perceived safety and efficacy of these products, decreased patient access to these products may occur, and there may be an increased opportunity for medication errors related to the dispensing and use of these products. To avoid a naming convention that may create confusion, NCPA recommends that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes. We ask that before finalizing any naming convention that FDA conduct a public hearing in accordance with part 15 (21 CFR Part 15) in order to permit all stakeholders to state their concerns about the potential impact of the naming proposals.

Veterinary Compounding Survey… NCPA Member Input Needed: FDA has released a Draft Veterinary Compounding Guidance Document explaining its enforcement policies related to veterinary compounding using bulk ingredients. Of concern to community pharmacists, there are new labeling requirements as well as a prohibition on office use compounding. NCPA is preparing comments to submit to the FDA and it is vital that your experiences with veterinarians, veterinary patients, and veterinary compounding are captured so we can share survey results with the FDA.

TAKE THE SURVEY

Study Raises Mail Order Pharmacy Patient Adherence, Dispensing Questions: Recent research funded by a grant from the Community Pharmacy Foundation (CPF) offers further evidence of medication waste resulting from prescriptions filled by mail order pharmacies and raises questions on supposed cost savings. The study examined more than 6,500 prescriptions consumers returned for disposal at pharmacies participating in the National Community Pharmacy Association's (NCPA) Dispose My Meds™ program between June 2012 and June 2013. It found that those originating through mail order were more likely to have in excess of 80% of the medication remaining when compared to retail pharmacies (58% of mail order disposals compared to 37% for retail). Furthermore, mail order disposals were also more likely costly brand medications when compared to retail. The results from this study reinforce examples of mail order waste provided by community pharmacists nationwide and featured in NCPA's "Waste Not, Want Not" presentation. In addition to the waste created, patients have expressed dissatisfaction with mail order pharmacies, leading the Centers for Medicare and Medicaid Services (CMS) to release documentation of beneficiary complaints with mail order pharmacy in December of 2013.

New Study: Community Pharmacist Network Demonstrates Improved Medication Use: Independent community pharmacists can network together across diverse practice settings to achieve dramatically improved patient health, according to a landmark study with direct application to a health care system transitioning toward value-based reimbursement for pharmacists and other providers. The year-long study measured the collective impact of appointment-based medication synchronization (ABMS) services provided by 82 participating community pharmacies across Arkansas. Patients who received ABMS services were over 2.5 times more likely to stick with their medication as prescribed by their doctor. By contrast, patients who did not receive ABMS services were 21 percent more likely to discontinue their prescription drug regimen. ABMS services, offered in many pharmacies across the country, create greater efficiency for pharmacies and more convenience for patients. All patient medication refills are consolidated to a once-a-month pick-up with the opportunity for a more extensive pharmacist consultation, prescription drug regimen review and to address any barriers to medication adherence.