NCPA Continues to push for DIR Reform
in Senate Finance Committee Drug Pricing Package
Following last week’s Senate Finance Committee markup of the Prescription Drug Pricing Reduction Act, NCPA is engaged with the committee to urge inclusion of pharmacy DIR reform before the bill advances to the Senate floor. Continue advocating with your Senators that they voice support to the Senate Finance Committee for inclusion of legislative language pertaining to pharmacy DIR fees.
The House of Representatives is likely to hold committee hearings to move its own drug pricing legislation shortly after legislators return to Washington in September. Contact your Representative and urge them to cosponsor, H.R. 1034 the Phair Pricing Act, sponsored by Reps. Doug Collins (R-Ga.) and Vicente Gonzalez (D-Texas). The more cosponsors this bill has, particularly Democrats, the better its chances to be considered for inclusion in the House drug pricing package.
NCPA video highlights advocacy wins
NCPA updated its advocacy wins video to include recent highlights of members of Congress speaking of PBM abuses and the importance of community pharmacy. The video also features highlights from this year’s Congressional Pharmacy Fly-in. While much work still remains, the video is evidence that policymakers are starting to understand the role PBMs play in increasing prescription drug costs for consumers and how they use their market power to the detriment of community pharmacies and that legislative solutions are necessary to address these practices.
House and Senate out of session until Sept. 9
The Senate and House of Representatives are both out of session until Sep. 9. During this period, many legislators will be looking for opportunities to connect with constituents, so why not invite them to visit your pharmacy or schedule a group meeting with multiple community pharmacists with legislators and discuss priority issues, such as the Phair Pricing Act. These carry extra value if your legislator is new to Congress so you can familiarize them with community pharmacy and our issues or if they are a member of the Energy and Commerce or Ways and Means health subcommittees, the starting points for much of community pharmacy’s legislation in the House. Pharmacy visits and face-to-face meetings are tremendously effective ways to communicate with legislators and to establish yourself as a resource to them as issues arise. Visit NCPA’s pharmacy visits webpage or contact Michael Rule at michael.rule@ncpanet.org for tips on arranging a visit with your legislator.
NCPA meets with CMS
This week NCPA government affairs staff met with high ranking CMS policy advisor to discuss the regulatory and legislative outlook on pharmacy DIR fees in Medicare Part D and the unsustainable impact of these fees on small business community pharmacies. The meeting also touched on the dire need for the agency to standardize quality metrics in Part D.
Trump administration announces
dual-path importation plan
This week, the Trump Administration announced a plan to allow a way for importation of foreign pharmaceutical drugs into the United States. There are two pathways announced in the plan: Pathway 1) FDA would release a proposed rule that would provide a way for states, wholesale distributors, and pharmacies to propose pilot projects that provide for the importation of Canadian drugs into the U.S.; and Pathway 2) FDA would issue guidance that would allow pharmaceutical manufacturers who sell the same version of a product to U.S. and foreign markets to use a new NDC for the foreign version of the drug and import that drug into the U.S. at potentially lower prices. Neither of these regulatory actions have been formally released to the public. NCPA participated in an agency call with industry stakeholders on Wednesday, where the FDA hinted that Pathway 1 (the proposed rule) is a few months away from formal release and Pathway 2 (the guidance) is more imminent and will most likely come out before the proposed rule.
Troy Trygstad nominated to participate
in the HHS Quality Summit
This week NCPA nominated Dr. Troy Trygstad, PharmD, PhD, M.B.A. to be a participant on the U.S. Department of Health and Human Services Quality Summit (“HHS Quality Summit”). The HHS Quality Summit seeks to bring together external stakeholders and government leaders to discuss the current portfolio of government quality programs. In NCPA’s nomination letter, NCPA highlighted that Dr. Trygstad would be an exceptional addition to the HHS Quality Summit based on his extensive experience with federal healthcare programs, quality measurement, transparency, innovative practice models, novel analytics, policy formation, and a demonstrated passion in coordinated care.
Senate Agriculture Committee hears testimony on CBD
Last week, the Senate Agriculture Committee held a hearing on hemp and the 2018 Farm Bill. Among the witnesses was FDA Principal Deputy Commissioner Amy Abernethy, who co-chairs the agency’s CBD working group. At the hearing, she stated that FDA is working quickly to move the process forward, but still has concerns about the intrinsic safety of CBD as well as potentially unsafe manufacturing processes for products containing CBD. She emphasized that FDA will only consider creating legal pathways for CBD if the agency is confident that it can develop a framework that addresses safety concerns. Dr. Abernethy had also recently tweeted that FDA expects to issue a progress report early this fall.
Medicaid Managed Care transparency legislation
signed into law in Massachusetts
Massachusetts Gov. Charlie Baker (R) signed H.4000 into law. This bill increases Medicaid managed care transparency. Under the bill, PBMs must disclose information regarding income and reimbursements, and the secretary of health and human services must investigate and develop a report regarding methods for increasing transparency on pharmacy services provided by PBMs in the managed care program.
North Carolina pharmacists
host legislative town hall
This week, NCPA’s Vice President of Federal and State Government Affairs Anne Cassity participated in a legislative town hall in Raleigh, North Carolina. Over 100 independent pharmacists attended the event which featured State Senators Danny Britt and Jay Chaudhuri and State Representative and pharmacist Wayne Sasser. These legislative pharmacy champions discussed pending legislation in the current legislative session, as well as, effective ways to make your voice heard. Just as important, it was announced that an independent pharmacy network would be created under the North Carolina Association of Pharmacists (NCAP) to focus on issues impacting independent pharmacies.
NCPA cautions against unit-of-use packaging
This week, NCPA submitted comments to the FDA on its notice to possibly require fixed-quantity unit-of-use blister packaging for certain immediate-release opioid analgesics under the Opioid Analgesic (OA) REMS. Based on available data, the agency suggested 5-, 10-, or 15-count blister package configurations for certain commonly prescribed immediate-related opioid analgesics for acute pain to “help prescribers to more carefully consider the amount of opioid pain medication they prescribe." NCPA asked the FDA to carefully consider the implications on the LTC community, as many LTC pharmacists conduct their own unique packaging of medications to best serve their patients. NCPA also asked the FDA to clarify that any blister packaging requirements would not affect current manufacturer bulk packaging practices.
NCPA reiterates compounding concerns with the FDA
This week, NCPA submitted a formal statement to the FDA in response to the FDA listening session NCPA attended to discuss community pharmacy concerns with the Draft Memorandum of Understanding (MOU) and the Insanitary Conditions Revised Draft Guidance. We reiterated the problematic distribute and dispense definitions in the MOU, as well as the inconsistencies in the Insanitary Conditions Revised Draft Guidance that conflict with USP standards. In addition, NCPA submitted a letter to the FDA in response to its most recent announcement to allow the use of Oxitriptan to compound oral drug products for tetrahydrobiopterin (BH4) deficiency. Because the FDA altered its decision about Oxitriptan’s inclusion on the 503A bulks list multiple times in recent months, NCPA asked the FDA to remain consistent with its decision-making when including or excluding a drug product from the 503A bulks list to avoid patient, pharmacist, and provider confusion.
In addition, USP <800> will become effective on Dec. 1, 2019. NCPA has developed a blank USP <800> risk assessment template, and a sample template for testosterone, to help you create your own risk assessments for each hazardous drug as required by USP <800>. Access the USP 800 Risk Assessment Templates here.
Help NCPA tell your story by completing
the Annual Census Survey
NCPA’s Annual Census Survey is now open. This is your chance to be part of the bigger story to enable NCPA to communicate to legislators, regulators, the media, and patients the important role independent pharmacies play in their communities. All we need is 8-9 minutes of your time. There are no financial questions, and you can take the census on your mobile phone, tablet, or desktop computer. Your input helps NCPA compile critical statistics about the state of community pharmacy today and tell the larger story about the extraordinary difference you make. The information collected in this year's census will be compiled in the NCPA Digest, sponsored by Cardinal Health, which will be released at the NCPA Annual Convention, Oct. 26-29, in San Diego.
NCPA state legislative activity update
NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Linked below are reports of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.
NOTE: With the Congress in recess, NCPA will not be sending out the weekly update for the remainder of August. However, if events warrant, special informational alerts may be distributed. Regular updates will resume the week ending September 6.
NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC.