NCPA Advocacy Center Update – Week Ending May 13, 2017

NCPA CEO Discusses Prescription Drugs with HHS Secretary Price:  This week NCPA CEO Doug Hoey represented the organization in a meeting with the Health and Human Services (HHS) Secretary, Dr. Tom Price. Earlier this year NCPA requested a meeting with the Secretary to talk about the role of PBMs in rising prescription drug spending and how community pharmacists can help lower those costs and improve health outcomes. We were honored to receive an invitation to a roundtable with a few pharmacy and pharmacist association colleagues to meet with the Secretary. NCPA  was able to talk directly to the Secretary and CMS Administrator Seema Verma and share with them some suggestions for solutions that would benefit consumers, taxpayers, and the pharmacy small business owners who serve them. NCPA will continue to make the case to HHS, CMS, Congress and elsewhere on behalf of community pharmacies and the patients they serve. Here is a link to a photo of the HHS meeting:

NCPA Urges Senate to Retain Key Prescription Drug Benefit Provisions of ACA:  NCPA sent the attached letter to Senate Majority Leader Mitch McConnell (R-Ky.)  and 12 other members of a working group of Republican senators developing legislation in response to House passage of H.R. 1628, the American Health Care Act. NCPA recommended the following:

  • Support patient access to medication and ensure reasonable pharmacy reimbursement that includes both a community pharmacy’s medication acquisition and dispensing costs in any Medicaid reforms (Section 2503)
  • Expand patient access to community pharmacists to help manage chronic conditions (Section 10328)
  • Assure greater oversight of and transparency from PBMs in federal health care programs (Section 6005)
  • Maintain regulatory relief for small business community pharmacies (Section 3109)

In addition to Sen. McConnell (R-Ky.) the members of the working group are Sens. Lamar Alexander (R-Tn.), John Barrasso (R-Wy.), John Cornyn (R-Tx.), Tom Cotton (R-Ar.), Ted Cruz (R-Tx.), Michael Enzi (R-Wy.), Cory Gardner (R-Co.), Orrin Hatch (R-Ut.), Mike Lee (R-Ut.), Rob Portman (R-Oh.), John Thune (R-S.D.) and Pat Toomey (R-Pa.).  NCPA will continue to engage lawmakers to champion priorities for community pharmacies during this process.

NCPA Meets with CMS Medicare Part D Leadership Team:  This week NCPA staff and members were able to update key CMS Part D leadership on the challenges being encountered on the front lines of patient care and discuss potential solutions.  Topics discussed included DIR, MAC Updates, Access to Preferred Cost Sharing Pharmacies, Implementation of Opioid “Lock-ins” , Use of Quality Measures to Evaluate Pharmacies, Specialty Pharmacy Access, LTC Concerns and Provider Status.  CMS is working on a rule to set forth changes to the  Medicare Advantage and prescription drug benefit programs for contract year 2019, where these concerns could be addressed via formal rulemaking.  NCPA will continue to push for changes in the Part D program that CMS already has the authority to implement.

NCPA Presents Discrepancies in FDA Inspections at FDA Pharmacy Compounding Advisory Committee Meeting:  This week the FDA convened the 7th meeting of the Pharmacy Compounding Advisory Committee (PCAC).  The Committee reviewed and voted on substances to be added to the 503A “bulks” list, which would mean the bulk drug substances could still be used in compounding.  All of the six substances reviewed (Nicotinamide Adenine Dinucleotide, Nicotinamide Adenine Dinucleotide Disodium Reduced, Nettle, Ubiquinol, Vanadyl Sulfate, and Artemisinin) were voted NOT to be included on the list. It is important to note this is not a final determination and in the meantime FDA will use enforcement discretion regarding these substances.   In addition, NCPA was able to present to the Committee and FDA the discrepancies that are noted between inspections of manufacturers and compounders.  The information posted to the FDA website pertaining to inspections of compounding pharmacies are much more detailed and in depth than those posted for FDA registered manufacturers, when in fact many of the same observations found in compounding pharmacies are the exact same ones found in FDA registered manufacturing facilities.  While FDA publicizes Form 483s and photographs from compounding pharmacy inspections, there is evidence of several of the same observations from cGMP manufacturers, with no corresponding publicity.  NCPA will continue to work diligently to protect the profession of compounding.

FDA User Fee Bill Moved out of Committee:  The Senate HELP Committee agreed overwhelmingly to advance the FDA user fee reauthorization, voting 21-2 to move it out of committee with minimal changes. The committee also voted 13-10 to table a controversial amendment offered by Senator Bernie Sanders (I-Vt.) that would have allowed drug importation from Canada, delaying its consideration until the bill reaches the Senate floor.

Senate Confirms Gottlieb:  In a 57-42 vote, the Senate approved Dr. Scott Gottlieb’s nomination to lead the FDA. He was subsequently sworn in as Commissioner.  Gottlieb, a former FDA and CMS official in the George W. Bush administration, will now be a key player in the heated debate over rising drug costs as the head of a 15,000 person, $5 billion agency that approves drugs, vaccines, medical devices and regulates tobacco, cosmetics and food.  A physician, investor, and consultant to the drug industry, Gottlieb drew criticism from some Democrats and consumer advocates who disapproved of his financial ties to the industry he will regulate. But his nomination also garnered much praise; supporters said his long experience working with drug makers would help him administer the FDA smartly and sensibly.  He’ll also have to tackle other major tasks, such as implementing the 21st Century Cures Act, a complex directive requiring FDA to speed up and modernize its approval process for drugs and medical devices, among other priorities.

NCPA Member Summary of Anti-Kickback Safe Harbors Law Revision:  On December 7th, 2016, the Office of Inspector General (OIG) of the Department of Health and Human Services published a final rule to update existing and add new safe harbor regulations to apply protections and further facilitate federal health care program beneficiaries’ access to care (Unless otherwise stated, federal health care programs include, but are not limited to: Medicare, Medicaid, and TRICARE but excludes the Federal Employees Health Benefits Program). The regulation is applicable to pharmacy and affects pharmacies who serve various federal health care program beneficiaries. The Final Rule went into effect January 6th, 2017 but some provisions may not take effect until 2018. Please find the Fact Sheet for Pharmacies attached.

In the States: 

  • Oregon: H.B. 2388 has passed both the House and Senate and now awaits the Governor’s signature. H.B. 2388 allows the Department of Consumer and Business Services to deny, revoke or suspend registration of a PBM if the PBM engages in specified conduct. The bill also authorizes the department to adopt a fee structure for registration.

NCPA calls out PBMs on drug costsSee the latest examples below.

Reader Response
By B. Douglas Hoey
Drug Topics

Reader’s view: PBMs driving up prescription drug costs
By B. Douglas Hoey
Duluth New Tribune

It’s Time to Switch Our Pharmacy Benefit Manager
By Wayne Winegarden