NCPA endorsed legislation to address opioid abuse
moving through Congress

As part of Congress’ ongoing efforts to combat the opioid epidemic, there was movement on two pieces of legislation that have been endorsed by NCPA (click to view support letters here and here).

This week, the Senate Finance Committee passed S. 2460, the Every Prescription Conveyed Securely Act, introduced by Sens. Michael Bennet (D-Colo.), Dean Heller (R-Nev.), Elizabeth Warren (D-Mass.) and Pat Toomey (R-Pa.) that would require electronic prescribing for Schedule II through V controlled substances prescriptions covered under Medicare Part D. Due to NCPA’s advocacy efforts this legislation maintained provisions to exempt long-term care patients and to ensure that patients’ choice of pharmacy is respected.

Also, the House of Representatives began its two-week long consideration of dozens of bills to combat the opioid crisis and passed 25 bills. Of these, H.R. 4275, the Empowering Pharmacists in the Fight Against Opioid Abuse Act, introduced by Reps. Mark DeSaulnier (D-Calif.) and Buddy Carter (R-Ga.), will help pharmacists detect fraudulent prescriptions. H.R. 4275 was endorsed by NCPA and would require federal agencies develop and disseminate materials, giving pharmacists greater understanding and ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion.

Sec. Azar testifies on drug pricing

In a hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday, HHS Secretary Alex Azar said several drug companies "are looking at substantial, material decreases in drug prices," but he indicated it could take time for the cuts to happen. In questions to Azar, Sen. Susan Collins (R-Maine) stated the drug pricing system is opaque and incentives are perverse, which gives PBMs huge leverage and incentives for higher list prices. Sen. Bill Cassidy (R-La.) asked about gag clauses, and Azar responded that if anyone knows of a pharmacist being told they cannot share information with Medicare Part D patients they should contact CMS immediately. Collins also discussed gag clauses and made a push for passage of her bill, S. 2554, the Patient Right to Know Drug Prices Act, which NCPA has endorsed.

Senate Judiciary Committee advances CREATES Act

This week, the Senate Judiciary Committee advanced the CREATES Act, a bill that would enable generic drug companies to obtain samples of certain brand drugs in order to create generic versions, on a bipartisan 16-5 vote. The bill sets up a pathway for generics companies to sue to obtain samples. This legislation was included in the Trump administration’s blueprint and RFI on lowering drug prices and CBO estimates it would save $3.8 billion over a decade through greater availability of lower-cost generic and biosimilar medications.

Pennsylvania’s auditor general announces review of PBMs

Joined by members of the General Assembly, Pennsylvania Auditor General Eugene DePasquale held a press conference announcing that his office will be launching a review of PBMs in an effort to bring transparency and accountability to prescription drug pricing. The auditor general remarked that the state’s Medicaid program paid PBMs $3.4 billion in 2017, up from $1.8 billion in 2013. Despite the huge increase in payments to PBMs, the PBMs have been systematically cutting reimbursement rates to community pharmacies. The auditor general plans to hold at least three regional hearings throughout the state during the investigation.

8th Circuit panel determines Arkansas PBM law
preempted by ERISA

The U.S. Court of Appeals for the 8th Circuit has issued a decision holding that ERISA and Medicare Part D preempts an Arkansas statute enacted in 2015 that sought to impose common-sense regulations upon pharmacy benefit managers. Pharm. Care Mgmt. Ass'n v. Rutledge, No. 17-1609 (8th Cir.). Although NCPA continues to study the decision, we are disappointed with the outcome. The Arkansas law was meant to ensure that Arkansans continue to have fair access to their prescription drug benefits and bring transparency to a PBM industry that has exploited secrecy to reap record profits at the expense of hardworking Americans.

The lawsuit itself involved a dispute between PCMA, the PBMs' trade association and the state of Arkansas, but NCPA worked to protect its members' interests by filing a friend-of-the-court brief with the 8th Circuit together with the Arkansas Pharmacists Association explaining the virtues of the Arkansas statute – a point that the court largely did not dispute – and why it was not preempted by ERISA and Medicare Part D.

NCOIL drafting model PBM legislation

NCPA submitted comments to the National Council of Insurance Legislators in support of the proposed “Pharmacy Benefits Manager Licensure and Regulation Model Act.” Modeled on the “Arkansas Pharmacy Benefits Manager Licensure Act,” which was enacted on March 20, 2018. The model legislation includes provisions requiring PBM licensure, MAC transparency, greater oversight over PBM provider networks and compensation programs, and other important PBM regulations. NCPA’s Vice President of Pharmacy Affairs, Ronna Hauser, will be attending an upcoming NCOIL meeting and providing in-person input on the model act before the Health, Long-Term Care & Heath Retirement Issues Committee.

NCPA staff presents at DIR forum

This week NCPA Director of Policy and Regulatory Affairs, Kala Shankle, presented at a forum on DIR fees sponsored by CBI and provided a "Deep Dive into Policy Approaches and the Current Regulatory Landscape" into the subject. The presentation focused on the impact DIR fees have had on community pharmacies and the policy solutions that NCPA is pushing at the legislative and regulatory level.

NCPA attends Republican Attorneys General Association summer meeting

NCPA staff attended the RAGA Summer Meeting in Pinehurst, NC earlier this week. Several conversations during the event centered around federal and state health care policy and the opioid epidemic. NCPA will continue to dialogue with state attorneys general about priority issues affecting community pharmacists and their patients.

CMS rolls out plan to fight opioid crisis

This week the Centers for Medicare & Medicaid Services (CMS) identified three key focus areas to address the opioid epidemic: preventing new opioid use, expanding treatment access, and utilizing national data for targeting prevention and treatment. According to CMS, opioids killed 116 people per day in 2016, with 40 percent of those deaths attributed to prescription opioids. CMS rolled out this comprehensive roadmap detailing best practices, innovations and helpful resources.

USP <795> comment period

USP Chapter <795> is undergoing revisions and is open for public comment until July 31, 2018. This chapter provides standards for compounding quality nonsterile preparations. It describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations. Major revisions of this chapter include:

• Reorganized existing chapter to improve clarity and to place key procedural information in boxes.
• Removed information on handling of hazardous drugs and added references to General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
• Expanded guidance for assigning beyond-use dates (BUD) for compounded nonsterile preparations (CNSP) in the absence of stability information.
• Removed the existing categories of compounding.
• Defined personnel and facility requirements.

NCPA will be commenting on the proposed revisions to ensure community pharmacy’s concerns are addressed. NCPA encourages its members to submit comments as well through this link: http://www.usp.org/compounding/general-chapter-795.