The last few months have been very active for the pharmacy community in Congress and in state legislatures. AmerisourceBergen continues to work with pharmacy partners by advocating together on key legislative priorities. We have seen positive steps forward on many of independent pharmacy’s key issues, including DIR fees, the opioid crisis, drug price transparency and provider status.
President Trump Nominates Alex Azar to Head the Department of Health & Human Services (HHS)
recently nominated Alex Azar to replace Tom Price
as the Department of Health and Human Services (HHS) Secretary. Azar spent many years as an executive at Eli Lilly where he was most recently their President of United States operations. Azar has also served as HHS general counsel and deputy secretary under the Bush administration. The U.S. Senate will hold the first confirmation hearing for Azar on November 29, 2017.
The White House, Congress, States & Localities Focus on Opioid Crisis
President’s Opioid Commission
In November, the President’s Opioid Commission (Governor Christie (R-NJ) – Chair; and Governors Baker (R-MA) and Cooper (D-NC); former Congressman Patrick Kennedy (D-RI); Professor Bertha Madras, PhD; and Florida Attorney General Pam Bondi (R-FL)) released and approved its final report including over 50 recommendations on how to respond to the opioid crisis. Some of the recommendations include:
• Increasing access to drug disposal options, including drug deactivation pouches;
• Revision of DEA's e-prescribing regs.;
• Training of pharmacists by HHS, DOJ/DEA, ONDCP, and pharmacy associations on best practices to evaluate legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescriptions; and
• PDMP Enhancements, including: federal agencies to mandate PDMP checks, PDMP data integration with e-health records, and increased e-prescribing;
Congress, federal agencies, states and local governments will need to decide if and how they will fund and implement these recommendations.
Top Medicare Officials Hear Pharmacy’s Solutions to Opioid Epidemic
CMS Administrator Seema Verma and CMS Principal Deputy Administrator for Operations Kim Brandt recently hosted a listening summit on the opioid crisis. Representatives from the pharmacy, pharmaceutical distribution, health plan and pharmacy benefit manager (PBM) industries participated. Several pharmacy groups, including NCPA and NACDS, provided practical solutions on how to address the opioid crisis. Attached are several proactive policy solutions from the pharmacy and wholesale distribution industries.
CMS is also meeting with health plans, medical device companies, State Medicaid Directors and prescribers.
Congressional Activity re: Opioid Epidemic
Congress is focused on the opioid epidemic and is considering numerous legislative solutions to address the crisis. The House Energy & Commerce and Education and Workforce Committees and the Senate HELP Committee have held congressional hearings focusing on the opioid crisis over the last several months. Over 47 pieces of legislation have been introduced in Congress this year to address the opioid epidemic – many of these proposed solutions would impact pharmacy.
Recent Federal Opioid Activity Highlighted by NCPA:
• Reps. Carter (R-GA) and DeSaulnier (D-CA) introduced legislation (H.R. 4275), endorsed by NCPA, to require federal agencies to develop and distribute materials to better educate pharmacists on when they are allowed by law to decline to fill a prescription for a controlled substance.
• Rep. Fitzpatrick (R-PA) (original cosponsors include Reps. Kuster (D-NH), MacArthur (R-NJ), and Norcross (D-NJ)) recently introduced the MONITOR Act (H.R. 4236) which would require states to allocate some of their federal PDMP grants toward enhanced interoperability and ease of use by prescribers. NCPA supports this legislation.
• GAO released a report recommending CMS expand criteria used to identify and track beneficiaries at risk of harm from opioids.
• GAO released a report on findings of pharmacy participation in drug take-back programs.
• NCPA outlined recommendations to the opioid epidemic on The Hill.com, an influential media outlet.
Federal Trade Commission (FTC)/Food & Drug Administration (FDA) Host Workshop on Prescription Drug Markets
In November, the FTC and FDA held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop sought public comments to understand generic drug markets, intermediaries in the supply chain, and how contractual relationships affect prices that consumers pay for prescription drugs. Representatives from several segments of the supply chain, including community pharmacists, presented during the workshop. Several key policy issues for pharmacists were raised with FTC and FDA including: PBM transparency; DIR fees; rebates; generic drug entry; generic drug competition; & the role of intermediaries in the supply chain.
Community Pharmacies, PBMs, & Employers Debate Supply Chain & Drug Pricing
On November 14, Real Clear Politics hosted a forum entitled “Examining the Pharmaceutical Supply Chain from Production to Patient.” The CEOs for the National Community Pharmacists Association (NCPA), the Pharmaceutical Care Management Association (PCMA), and the Midwest Business Group on Health served on a panel where they discussed state legislative efforts to combat drug costs; PBM transparency; rebates; market complexity; and the role of each participant in the supply chain/impact to drug prices. Click here to read the Real Clear Politics article summarizing this forum.
DIR Fees Continue to Gain Attention from Congress and CMS
Seeking greater transparency and fairness for pharmacies from retroactive DIR Fees remain a top priority for the pharmacy community, Good Neighbor Pharmacy and AmerisourceBergen. The many advocates and pharmacists who have been advocating for relief from these fees are being heard by Congress and the Centers for Medicare and Medicaid Services (CMS), but there is still continued advocacy work required in order to see legislative or regulatory action to address this issue. The Improving Transparency and Accuracy in Medicare Part D Spending Act (S. 413/H.R. 1038) is up to 13 bipartisan Senate and 64 bipartisan House cosponsors.
In addition, CMS and HHS have clearly heard the need for changes to the DIR fee program given that in November, CMS issued their long-awaited Medicare Part D proposed rule (over 700 pages). The proposed rule covers many topics including proposing to account for all pharmacy DIR fees at the point-of-sale for both pharmacies and manufacturers; clarifying “any willing pharmacy;” define mail-order pharmacy; reaffirmation of Part D policy on access to specialty drugs and opposition to PBM-specific credentialing requirements; long-term care transition days’ supply; etc. View the CMS Fact Sheet on the proposed rule here.
AmerisourceBergen Government Affairs will continue to advocate for fair, accurate and timely reimbursement for its pharmacy partners.
Provider Status – Extensive Bipartisan Support in Congress
AmerisourceBergen continues to support its pharmacy customers by seeking Congressional co-sponsorship for the provider status legislation, S. 109/H.R. 592, to ensure pharmacists are recognized as providers and reimbursed by Medicare Part B for providing health care services (e.g. immunizations, flu tests, etc.) in medically underserved areas. As of November 19, 2017, pharmacy provider status legislation has 47 bipartisan Senate/234 bipartisan House cosponsors in Congress and has strong support in the pharmacy community. The Patient Access to Pharmacists’ Care Coalition (PAPCC), of which AmerisourceBergen is a member, is working to coordinate advocacy for bill passage in an end of the year, must pass legislative vehicle. While the bill has overwhelming bipartisan support in both the House and Senate, the cost of the legislation to the government continues to be a challenge. The PAPCC is working to lower the cost of the bill and seek passage.
Thank you to all of the pharmacy advocates who are engaging on key issues impacting pharmacies and patients. We look forward to continuing to work together on many legislative issues for the rest of this year and looking ahead to 2018!