NCPA Advocacy Center Update – Week Ending July 27, 2018

  • Energy and Commerce Committee Leaders Request FTC Review PBM Mergers
  • NCPA staff discusses pharmacy reimbursement and managed care with Medicaid officials
  • NCPA continues cost parity dialogue with TRICARE
  • NCPA staff participates in opioid discussion with CMS
  • Senate HELP Committee advances “gag” clause bill
  • House votes to delay health insurance tax
  • House passes bill to expand access to over the counter medications
  • FDA updates bulk substances list for compounders
  • USP General Chapters <797> and <825> Open for Comment
  • CMS regional offices can be key resources


Energy and Commerce Committee Leaders Request FTC Review PBM Mergers

This week, House Energy and Commerce Committee leaders, Chairman Greg Walden (R-Ore.), Oversight and Investigations subcommittee Chairman Gregg Harper (R-Miss.), and Health subcommittee Chairman Michael C. Burgess, M.D. (R-Texas), sent a letter to the Federal Trade Commission requesting they conduct a retrospective review of pharmacy benefit manager (PBM) mergers, and how they have affected prescription drug prices for consumers. In part, the committee leadership noted “Consolidation in the PBM industry is part of a larger trend of consolidation in the health care market more generally. PBMs play a significant role in the health care market and are likely to influence health care costs.”

NCPA staff discusses pharmacy reimbursement and managed care with Medicaid officials

This week, NCPA staff met with leadership of the CMS Center for Medicaid, Division of Pharmacy as well as staff from the Division of Managed Care Plans.  NCPA conveyed our appreciation of their work to require states move their fee for service Medicaid pharmacy programs to an acquisition based model of reimbursement that ensures pharmacies are reimbursed a fair and equitable rate taking into account their ingredient cost and a professional dispensing fee that reflects the cost to dispense the drug product. However, NCPA urged CMS to act quickly to bring those states who have not updated their reimbursements to come into compliance and asked they continue to work closely with our members when NADAC data is not reflective of independent pharmacy costs.  We shared our comments to the President’s Blueprint and HHS’ RFI that any efforts to control drug pricing through redefining AMP would severely affect pharmacy reimbursement and undermine Congressional and CMS intent. Finally, we shared an update of state activity regarding oversight of Medicaid managed care programs and how pharmacy costs are being scrutinized.  CMS reiterate their primary role is to ensure contract compliance with federal rules, but they are aware of concerns related to pharmacies dispensing below cost and will continue to monitor the situation.

NCPA continues cost parity dialogue with TRICARE

This week, NCPA staff met with the TRICARE Pharmacy Operations Division Chief to continue dialog surrounding a TRICARE acquisition cost parity pilot program for retail pharmacy.  TRICARE is looking at ways to logistically manage a pilot and wants specific input from industry, including retail pharmacy and pharmaceutical manufacturers.  NCPA will continue to work with stakeholders on parameters for a pilot and how to best operationalize.  TRICARE also said the retail pharmacy program is in compliance with Sec. 714 of the FY18 National Defense Authorization Act that requires regular updating of prescription drug pricing standards under the program.

NCPA staff participates in “opioid edits” discussion with CMS

This week, NCPA staff attended an invite-only session with CMS and industry stakeholders to discuss opioid edits that will be implemented in Medicare Part D in 2019. The first is a hard edit for a 7 day supply limit on all initial fills for the treatment of acute pain. The second is a real-time safety edit at 90 MME (morphine milligram equivalent) per day at the time of dispensing. This formulary-level safety edit would trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME. NCPA brought up a number of concerns with these edits including industry education and the need for CMS to work with NCPDP to implement fields to assist pharmacies with these edits.

Senate HELP Committee advances “gag” clause bill

This week, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed S. 2554, the Patient Right to Know Drug Prices Act, sponsored by Sens. Susan Collins (R-Maine), Claire McCaskill (D-Mo.), John Barrasso (R-Wyo.), Debbie Stabenow (D-Mich.) and Bill Cassidy (R-La.).  The legislation would outlaw PBM contracts that restrict pharmacists from telling consumers if they could save money by buying a drug directly rather than using their insurance co-pay. It will now be put on the calendar for a Senate vote. NCPA had previously endorsed the bill.

House votes to delay health insurance tax

This week the House of Representatives passed H.R. 6311, the Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act which included a two year delay of the health insurance tax. The delay in the tax will result in cost savings for small businesses and their employees in the small group market. NCPA supported this bill through its involvement with the Stop the HIT Coalition. The attention now turns to the Senate which has yet to pass a companion bill.

House passes bill to expand access to over the counter medications

This week, the House of Representatives passed H.R. 6199, the Restoring Access to Medication Act which included provisions to make over the counter products more accessible to patients using health savings accounts or flexible spending arrangements. Currently, patients are required to have a prescription to use their HSA or FSA benefits to purchase over the counter products. This legislation would remove that requirement, making it easier for patients to purchase the health products they rely on as their primary remedy for common ailments. NCPA endorsed this legislation and joined a recent support letter led by the Health Choices Coalition.

FDA updates bulk substances list for compounders

The Food and Drug Administration recently updated the lists of bulk drug substances that can be used in compounding for 503A and 503B facilities. The FDA has interim policies in place dealing with compounding from bulk drug substances while these lists are being developed, and it does not intend to object to compounding with bulk drug substances that are nominated with adequate support and do not present significant safety risks (Category 1). The next FDA Pharmacy Compounding Advisory Committee meeting to discuss bulk drug substances for compounding in 503A facilities is scheduled for Sept. 12. NCPA will attend and present at the next FDA PCAC meeting defending the substances we nominated and educating advisory committee members about compounding practices.

USP General Chapters <797> and <825> open for comment

The proposed revisions to USP General Chapters <797> Pharmaceutical Compounding – Sterile Preparations and <825> Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, and Repackaging are now available for public comment. General Chapter <797> will remove the section Radiopharmaceuticals as Compounded Sterile Preparations (CSPs) and replace it with a reference to General Chapter <825>. General Chapter <825> will identify compounding activities for radiopharmaceuticals and provide standards associated with these activities. The comments for both proposed revisions are due November 30, 2018, and can be submitted here for <797> and here for <825>.

CMS regional offices can be key resources

Are you or one of your patients having problems with a Medicare Part D plan? The Centers for Medicare & Medicaid Services has regional offices that might be able to help. You can view a map here to determine the region you are in and PDF documents of contacts for each regional office are available on this page. Commenting and meeting with these regional contacts is an effective way to convey any issues you are confronting in the Medicare or Medicaid programs.

NCPA to be represented at NCSL annual meeting

NCPA staff member Scott Brunner will be attending the National Conference of State Legislatures 2018 Legislative Summit in Los Angeles July 30-August 2. While at the NCSL meeting, Brunner will be meeting with state legislators and representatives from pharmacy and consumer stakeholder organizations to advance the issues important to community pharmacy.

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. 

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