NCPA Concerns with PBM Corporations Discussed in Congressional Hearing Examining Health Care Competition:  At a Judiciary subcommittee hearing this week examining consolidation in the health care market, House lawmakers took time to hear concerns raised by NCPA and others about problems related to limited competition among pharmacy benefit management (PBM) corporations. Rep. Doug Collins (R-Ga.), cosponsor of H.R. 244, The MAC Transparency Act, and a community pharmacy champion, started the discussion and posted this online video of the exchange, entitled "Collins calls out PBMs on anti-competitive actions." He asked the hearing's witnesses what can be done to ensure independent community pharmacists and PBMs can operate on a level playing field? And could the FTC do more? Witness Thomas Greaney, Professor of Law, St. Louis University School of Law, said it may be time for the Federal Trade Commission (FTC) to review the PBM market and the effects of recent consolidation.   Another witness discussed the concentrated market of PBMs and how health plan consolidation will make it harder for smaller PBMs to continue to grow and will potentially give more market share to some of the existing large PBMs. Another witness, a physician from New Mexico, spoke to the difficulty in trying to find needed care for patients from a large consolidated company a thousand miles away.  NCPA appreciates the leadership of Rep. Collins and others in Congress and will continue to press these pro-patient, pro-pharmacist issues with policymakers.

With Congress returning, here is the current status of NCPA Priority Federal Legislation:

• H.R. 592—Rep. Brett Guthrie (R-Ky.), 196 cosponsors.
• S. 314—Sen. Chuck Grassley (R-Iowa), 28 cosponsors.

Any willing pharmacy in preferred networks

• H.R. 793—Rep. Morgan Griffith (R-Va.), 57 cosponsors.
• S. 1190—Sen. Shelley Moore Capito (R-W.Va.), 10 cosponsors.

MAC pricing reform and transparency

• H.R. 244—Rep. Doug Collins (R-Ga.), 24 cosponsors.

Check the Federal Advocacy section under the Advocacy tab on the NCPA website for fact sheets and more information. In addition, find valuable info pertaining to NCPA’s Political Action Committee (PAC) in the "Documents to Download" section below this article.

TRICARE Changes Coming October 1st:  As previously reported, starting October 1, 2015, a new law requires all TRICARE beneficiaries, except active duty service members, to get select brand name maintenance drugs through either TRICARE mail order or from a military pharmacy. Beneficiaries who keep using a retail pharmacy for these drugs will have to pay the full cost. This is an extension of the current TRICARE for Life pilot program that started in March 2014.  NCPA has expressed its strong opposition to this provision in law and our previous letter to leaders of congressional military affairs committees asked that before implementing any new policies with such a broad impact, the results of the pilot program should be fully disclosed, and its impact fully understood.  NCPA will be providing additional written comments to the interim final rule implementing these changes.  Further info can be obtained via this link: http://www.tricare.mil/CoveredServices/BenefitUpdates/Archives/09_01_15_EMM.aspx

CMS Releases 'Any Willing Pharmacy' Guidance for Drug Plans: CMS provided the guidance to Part D plans in August, telling them that by Sept.15 they should have standard contracting terms and conditions available for community pharmacies promptly upon request for the 2016 plan year. Such a requirement was among the list of suggested reforms that NCPA proposed earlier this year. Plans have to reply to inquiries from pharmacies within two days. In addition, plan sponsors must also make this information available to CMS upon request so the agency can actively monitor compliance with the new policy. This requirement should help reduce the likelihood of repeating the 2015 problems with Aetna that affected approximately 400,000 Medicare beneficiaries.  For a more comprehensive solution, NCPA continues  to urge application of the 'any willing pharmacy' policy more broadly, including to so-called 'preferred pharmacy' networks so that patients can use the pharmacy of their choice if it's willing to accept the drug plan's contract terms and conditions.

NCPA DIR Resource Available:  NCPA has developed a new resource examining direct and indirect remuneration (DIR) fees that have prompted questions from many pharmacy owners during discussions with NCPA officers and staff. These veiled charges imposed by PBM corporations are increasingly eating into the bottom line revenue that community pharmacies need to remain viable and serve patients. Please review the FAQ resource which also includes info about NCPA's ongoing advocacy efforts at the federal level.

OMB Has Started Review of Medicaid “AMP” Final Rule:  The White House Aug. 4 started its review of a final rule on Medicaid outpatient drug reimbursement.  The Office of Management and Budget (OMB) said the final rule from the Department of Health and Human Services “revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act.” A proposed version was issued in early 2012.  NCPA has multiple concerns with the proposed rule, which would use the average manufacturer price (AMP) model to calculate Federal Upper Limits (FULs), which set caps on federal reimbursement to states for dispensing outpatient generic medications through Medicaid programs.  OMB ordinarily has 90 days to complete its review, with the possibility of one 30-day extension with the written approval of the Director of OMB.  NCPA will keep members apprised each step of the way as we ready for the impending release of the final rule. 

NCPA Represents Independent LTC Pharmacy Owners at FDA Listening Session:   NCPA recently met with the FDA concerning the agency’s Draft Guidance on the Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. NCPA has concerns with the impact the guidance will have on LTC repackaging practices and was able to provide FDA with helpful background information and pictures of a variety of repackaging materials and emergency kits.  Our LTC pharmacy members, as a common practice, regularly prepackage commonly dispensed non-sterile tablets and capsules into specialized packaging, exceeding 14-day supplies, and prior to receipt of a valid prescription or chart order. To require more frequent repackaging would run counter to continued safety associated with the current processes. NCPA is asking that FDA address LTC pharmacy practice within the Guidance, and clarify that LTC pharmacies are permitted to repackage medications in compliance with state pharmacy laws.

Federal Court Dismisses PBM Lawsuit against Iowa Drug Pricing Transparency Law: This week, a U.S. District Court granted the citizens of Iowa and the community pharmacists who care for them a significant victory in defense of MAC transparency legislation.  In September 2014, PCMA filed a lawsuit challenging the legality of H.F. 2297, a bill passed unanimously by the Iowa state legislature. In February 2015, the court rejected many of the claims PCMA had made about ERISA with respect to PBM reform issues. This week, the court dismissed PCMA's remaining claims in a strongly worded opinion, concluding that the state has a legitimate interest in regulating PBMs in order to preserve the health of its citizens. The court's dismissal of PCMA's entire case should serve as an extremely helpful precedent against PCMA's claims challenging the legality of similar transparency laws throughout the country and in support of states' ability to regulate PBMs. Throughout the District Court proceedings, NCPA worked closely with the Iowa Pharmacists Association and the state in its defense of H.F. 2297. This collaboration resulted in a huge victory for the state of Iowa and its pharmacists.

340B “Mega Guidance” Finally Released:  On August 28, the Health Resources and Services Administration (HRSA) published its long-awaited “mega guidance” in the Federal Register. The proposed guidance would provide a more restrictive definition of covered patient by increasing the number of conditions for patients to be eligible for discounted drugs from 3 to 6. While the proposed guidance would not materially limit or alter the 340B Program contract pharmacy model, it would clarify that drugs would only be eligible for program discounts if they are billed to insurers as outpatient prescriptions. HRSA has had a longstanding concern about the risk of duplicate discounts in the contract pharmacy setting, so the proposed guidance would require that covered entities that wish to dispense 340B drugs to its Medicaid fee-for-service or Medicaid managed care patients through a contract pharmacy will have to “provide HHS a written agreement with its contract pharmacy and State Medicaid agency or MCO that describes a system to prevent duplicate discounts.” The proposed guidance also includes an updated standard for records retention for all covered entities, including 340B contract pharmacies, for a period of at least 5 years.  Previously, no formal record retention standard existed, leading to disparate approaches that varied by covered entities and manufacturers.

Regulatory guidance is different than an official regulation. It does not have the full force of law, but provides information concerning how the agency intends to administer the program. HRSA had attempted to issue regulations in 2014, but withdrew the proposed rule after a federal judge ruled in a separate suit filed by PhRMA that HRSA lacked statutory authority to regulate orphan drugs. This called into question HRSA’s authority to issue regulations on many aspects of the 340B program. HRSA has established a 60-day public comment period (October 27) and NCPA will be submitting comments on behalf of our members.

First U.S. 'Biosimilar' Launched as FDA Releases Naming Guidance:  On September 3, Sandoz (a Novartis Company) introduced the first "biosimilar" copy of a biological product approved in the United States, a product named Zarxio (filgrastim-sndz), from living cells that boosts white blood cell counts. The biotech originator drug is Neupogen, manufactured by Amgen. It is important to note this is not an approved interchangeable product.  Naming of biosimilars is a hotly contested topic that is still unresolved.  The FDA Aug. 27 released a draft guidance on the nonproprietary naming of biological products, including biosimilars. The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names in the guidance) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters that won't carry any meaning. NCPA has long held the position that biologics and biosimilars should be required to have the same international nonproprietary name (INN).  NCPA will be commenting on the naming guidance by the October 27 deadline.