What’s next in the pharmacy DIR fight?

Thanks in large part to the relentless advocacy efforts of NCPA and our industry allies, the unfairness of pharmacy DIRs is on the radar of policymakers. Next steps will become clearer later this fall, but here’s where things currently stand:

• As a result of our congressional outreach and visits, as well as nearly a dozen high-level meetings with Trump administration officials at HHS, CMS and the White House, policymakers are well informed about the negative effects of pharmacy DIR fees on community pharmacies. In every case, officials are sympathetic, and have reaffirmed their commitment to tackling this issue.
• We've negotiated consensus across the retail pharmacy community on how to address pharmacy DIRs, including eliminating the fees and supporting fair pharmacy-specific quality measures. This means independents and chains and specialty pharmacies are speaking with one voice when it comes to DIRs.
• The most likely vehicle for addressing pharmacy DIR fees is the 2020 Part D rule, currently under review for clearance at the White House OMB, because it can address parts of regulation over which CMS has clear authority. Through our continuing dialogue with CMS, we're aiming to make that happen in the next several months. NCPA expects the release of that proposed rule this fall.
• Indirectly related to our DIR work, another rule under review for clearance at the White House OMB proposes to eliminate the "safe harbor" protection for rebates to plans or PBMs involving prescription drugs. That rule could drastically change the current rebate structure between manufacturers and PBMs in the drug supply chain and impact the current DIR structure within the Part D program.
• All your efforts – meeting with your members of Congress, submitting comments to the docket on the president's drug pricing blueprint and the Part D 2019 rule – have propelled pharmacy DIR fees to the forefront of policymakers' priorities. This outreach continues to be a key pillar of our advocacy efforts.

NCPA continues to advocate strongly for complete elimination of pharmacy DIR. Through your meetings with your members of Congress, you can help educate policymakers and reinforce the message. For now DIR continues to be NCPA's top priority, and we, and our industry allies, are working hard for you on it.

E&C Committee chairman Greg Walden
visits Grants Pass Pharmacy

This week, house E&C Committee chairman Greg Walden (R-Ore.) visited Michele Belcher, NCPA board member and owner of Grants Pass Pharmacy in Grants Pass, Ore. Walden was instrumental in the passage of opioid legislation (H.R. 6, the SUPPORT for Patients and Community Act), Patient Right to Know Drug Prices Act and the Know the Lowest Price Act, all of which were endorsed by NCPA and are awaiting the president’s signature as they recently passed the House and Senate.

Walden also became the latest high ranking key committee member of Congress to visit a community pharmacy this year. In the past twelve months, Ways and Means Committee chairman Kevin Brady (R-Texas), E&C Committee ranking member Frank Pallone (D-N.J.), Ways and Means Health Subcommittee chairman Peter Roskam (R-Ill.) and E&C Health Committee chairman Michael Burgess (R-Texas) have also visited a community pharmacy or met with constituent pharmacists in the district.

Congress sends opioid legislation to President Trump

This week, NCPA applauded the final passage of bipartisan legislation to address America's ongoing opioid crisis. The final package passed the Senate this week after passing the House on Sept. 28 and now heads to President Trump to be signed into law. Among other provisions, the final package includes the NCPA-endorsed Empowering Pharmacists in the Fight Against Opioid Abuse Act, introduced by Reps. Buddy Carter (R-Ga.) and Mark DeSaulnier (D-Calif.), which would require federal agencies to develop and distribute materials to train pharmacists on the circumstances in which they are allowed by law to decline to fill a prescription for a controlled substance. These circumstances may include the suspicion of fraud, forgery, or other forms of modification. The package also includes the NCPA-endorsed Every Prescription Conveyed Securely Act, introduced in the Senate by Sens. Michael Bennet (D-Colo.), Dean Heller (R-Nev.), Elizabeth Warren (D-Mass.), and Pat Toomey (R-Pa.), and introduced in the House by Reps. Katherine Clark (D-Mass.) and Markwayne Mullin (R-Okla.). To prevent fraud and abuse, this provision would require e-prescribing for Schedule II through V controlled substances under Medicare Part D. Due to NCPA's advocacy efforts this legislation maintained provisions to exempt long-term care patients in nursing facilities and to ensure that patients' choice of pharmacy is respected.

E&C Health Subcommitte Chairman Michael Burgess
references NCPA member on House floor

During the debate on “gag” clause legislation on the House floor, E&C Health subcommittee chairman Michael Burgess (R-Texas) referenced his constituent and NCPA member Kelly Selby. Selby owns Community Pharmacy in Denton. In his remarks, Burgess noted “even pharmacists have what is in the best interest of their customers at heart, Mr. Selby told me that overnight he could lose 40% of his business, taken away by the power of pharmacy benefit managers.” Rep. Burgess’ full remarks are available here.

Legislation banning “gag” clauses passed both the House and Senate and could be signed into law by President Trump as early as next week.

“Advocacy in Action” report recaps impressive year
for community pharmacy

NCPA highlighted advocacy successes in a feature in the October issue of America’s Pharmacist. The “Advocacy in Action” report is also available as a standalone piece and provides a recap of some of the community pharmacy’s achievements over the Sept. 1, 2017-Aug. 31, 2018 timeframe. Some of the highlights include NCPA being invited to testify at three separate hearings before the Energy and Commerce Committee exploring the drug supply chain, compounding and fighting the opioid epidemic as well as the efforts of the pharmacy community in advocating for elimination of DIR fees in the 2019 Part D rule and the administration’s drug pricing blueprint and RFI. The report also captures successes at the state level as well as other legislation at the federal level, particularly as it relates to opioids. The report sets a high bar and NCPA will continue its relentless advocacy efforts on behalf of community pharmacists. For those attending the NCPA Annual Convention, there will be some hardcopies of this report available at the NCPA PAC booth and the NCPA pavilion.

NCPA asks Treasury Department for clarifications
in pass-through regulations

This week, NCPA sent a letter to Treasury Secretary Steven Mnuchin providing comments and suggestions on behalf of community pharmacy in regards to small business pass-through deductions that were included in the 2017 Tax Cuts and Jobs Act. The legislation and its purported tax relief for community pharmacy owners had NCPA's strong support, but a recent proposed rule may undermine protections for community pharmacies by including pharmacists as a specified service trade or business ("SSTB"), a category of health care professionals potentially not eligible for the pass-through deduction.

NCPA argues that pharmacists do not fall into the SSTB category because health care professionals in the SSTB category solely perform medical services, whereas community pharmacists, who are often the pharmacy owner and the pharmacist, make revenue from selling pharmaceuticals or medical devices that should not qualify their business as an SSTB. With decreased reimbursement rates for medications and other post-transaction fees, NCPA applauded the TCJA's reduced tax burden as needed relief for community pharmacy owners.

NCPA takes “eliminate DIR” message
to Small Business Administration

This week, NCPA staff met with the Small Business Administration's Office of Advocacy to highlight potential changes to pharmacy DIR fees that may be included in the upcoming 2020 Proposed Part D Rule. Attorneys in the SBA's Office of Advocacy champion small business interests in front of the Office of Management and Budget during the review of proposed rules. This meeting was just another step in NCPA's ongoing efforts to eliminate pharmacy DIR fees.

NCPA submits comments to USP on <1079>

On September 28, NCPA submitted joint comments to USP on the revisions General Chapter <1079> Good Storage and Distribution. Along with our fellow industry stakeholders, we argue that the proposed revisions are overly broad and conflict with existing regulatory provisions in the compounding space. We also addressed specific concerns with the following: (1) the proposed language asserts authoritative requirements even though the chapter’s stated intent is not meant to be prescriptive; and (2) the chapter does not specifically address individual entities, but instead broadly applies to a variety entities, from manufacturing facilities to retail pharmacies. NCPA will continue to monitor revisions to USP’s general chapters that affect compounding in community pharmacy.

MedPAC discusses opioid prevention measures
at monthly meeting

This week the Medicare Payment Advisory Commission (MedPAC) held its monthly meeting in Washington, D.C. MedPAC is a nonpartisan legislative branch agency that provides Congress with analysis and policy advice on the Medicare program. NCPA staff monitored this month’s meeting in which MedPAC commissioners discussed current initiatives to manage prescription opioid use in the Medicare Part D Program, including some pharmacy-specific initiatives outlined in the 2019 Call Letter: hard/soft edits at the pharmacy counter, pharmacy lock-ins, and the provider preclusion list. NCPA will continue to monitor this body for opportunities to influence Congress on community pharmacists’ role in appropriate opioid management initiatives.

NCPA attends drug shortages meeting at the FDA

On Monday, NCPA was invited to participate in FDA’s Drug Shortages Listening Session with other industry stakeholders to discuss the cause of drug shortages and collaborate with the agencies, including the FDA and CMS, to identify possible solutions. The FDA has recently made a concerted effort to resolve drug shortages that are heavily impacting patients, hospitals, and pharmacies. NCPA, along with other pharmacy groups, stressed the importance of compounding as a solution and ensuring appropriate payer coverage, as well as provider reimbursement during the development of any new policies to address shortages. The hospital representatives discussed the lack of manufacturer transparency in the quality of products and timeline of shortages. NCPA will continue to advocate for community pharmacy and help the agencies understand the importance of our role in resolving drug shortages.

Due to the NCPA Annual Convention, the Advocacy Center Weekly Update will not be sent on Oct. 12 and will resume on Oct. 19.

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.