NCPA Advocacy Update

Week ending May 25

Author: APCI Staff/Tuesday, May 29, 2018/Categories: Legislative Affairs

NCPA promotes Karry La Violette to lead Advocacy Center

NCPA announced this week that Karry La Violette has been promoted to senior vice president of government affairs and director of the Advocacy Center. In this role, La Violette will oversee all of NCPA’s policy, advocacy, grassroots, and communications endeavors. La Violette joined NCPA in 2011 and has previously headed NCPA’s federal government affairs programs, the NCPA Political Action Committee (NCPA PAC), and programming for the NCPA Congressional Pharmacy Summit.

NCPA endorses H.R. 5958, the Phair Pricing Act of 2018

Yesterday, Reps. Doug Collins (R-GA) and Vicente Gonzalez (D-TX) introduced H.R. 5958, the Phair Pricing Act of 2018, to lower the cost of prescription medications for patients in the Medicare Part D program. NCPA endorsed Congressman Collins’ bill as a welcomed change that would require all pharmacy DIR fees, including quality payments made to a pharmacy, to be incorporated at the point of sale and ensures pharmacists have meaningful control over the quality measures. Both this bill and H.R. 1038, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, are paths to achieve one solution: Eliminate retroactive pharmacy DIR fees that contribute to high patient drug spend and make it nearly impossible to run a small business.

Last chance to save on 2018 NCPA
Annual Convention registration

What’s better than a long holiday weekend? Saving an additional $100 off of the early bird registration rate for NCPA’s 2018 Annual Convention. If you have not yet taken advantage of this special offer, don’t wait any longer to register because it ends Monday, and this is the lowest rate that will be offered this year. (Fine Print Alert: This special FLASH rate is for owner/managers and staff pharmacists ONLY.)

NCPA meets with CMS Medicare Part D staff

NCPA staff and member George Garmer, owner of Halethorpe Pharmacy in Maryland, met with members of the CMS Medicare Part D staff to discuss issues of vital importance to independent community pharmacy. Issues discussed included NCPA’s top advocacy priority, DIR fees, as well as the President’s blueprint for lowering drug prices and recommendations on addressing pharmacy DIR in an upcoming Part D rule for CY2020. Also discussed was the use of quality measures to evaluate pharmacies in Part D and how CMS should provide more guidance to the plans as to the use of existing PQA measures at the pharmacy level. Lastly, NCPA discussed the use of generic effective rates in the Part D program, as well as implementation of lock-ins and LTC pharmacy issues. NCPA will continue to dialog with CMS staff as the agency works towards policies to address the increasing use of pharmacy DIR.

NCPA hosts DIR briefing call for industry stakeholders

This week, NCPA hosted a briefing call for industry stakeholders to provide an update on the final Part D rule, in which CMS reasserted its authority to address retroactive DIR, and on the Trump administration’s request for information regarding drug pricing. NCPA has created several resources that may be useful to community pharmacists and industry stakeholders, including in-depth analyses of the Final Part D Rule and CMS’ Final Call Letter for 2019 Part D plans, a one page brief of top priorities in the RFI for community pharmacy, and a document outlining various approaches to addressing DIR fees.

NCPA will be submitting comments on the RFI prior to the July 16 deadline and will provide additional resources to members and partners, such as a template for pharmacists to use to submit their own comments for the record. These resources will be finalized in the coming weeks.

NCPA and NACDS joint letter to CMS
on cumulative MME threshold in Part D

NCPA joined forces with NACDS recently to ask CMS to reconsider the requirement for Part D sponsors in 2019 to implement a real-time opioid care coordination safety edit based on a cumulative MME threshold of 90 MME per day. NCPA and NACDS are concerned with the lack of system capabilities and with operational challenges, as well as CMS’ attempt to promulgate new rules without proper notice and comment rulemaking. NCPA and NACDS are asking CMS to look at other solutions, such as using the traditional coverage determination process for conditions considered to be a CMS hard edit and eliminating the prescriber attestation documentation requirement. As an alternative, NCPA and NACDS urged CMS to implement these new requirements through the proper notice and comment rulemaking process.

New cosponsors added to House and Senate DIR bills in May

Both the Senate and House DIR bills picked up additional cosponsors in May. In the Senate, Sen. Cory Gardner (R-Colo.) became the 14th cosponsor of S. 413. In the House, H.R. 1038 was cosponsored by Reps. Mac Thornberry (R-Texas), the Chairman of the House Armed Services Committee, Steve King (R-Iowa), Scott Tipton (R-Colo.), and Chellie Pingree (D-Maine), increasing the number of cosponsors to 75. If you are represented by any of these members, please click here to send them an email thanking them for their leadership and support.

Senate HELP Committee to hold hearing
on drug pricing blueprint

The Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) announced that the committee will hold a hearing on June 12 at 10:00 a.m. EST with Secretary of Health and Human Services Alex Azar to examine President Trump’s drug pricing blueprint. NCPA staff will work with the committee to highlight the need for PBM transparency, as President Trump proclaimed in his drug pricing speech earlier this month.

Advocacy Center staff provides updates
to LTC Division Advisory Council

NCPA Advocacy Center staff this week provided the NCPA Long Term Care Division’s LTC Advisory Council an update on NCPA priority legislation and plans related to the President’s Blueprint to lower drug prices and subsequent Request for Information. In addition, we discussed LTC specific advocacy priorities, including payment rates for Part D beneficiaries in Assisted Living Facilities, as well as the impact of FDA’s track and trace requirements on LTC pharmacy. NCPA is actively engaged as an advocate for both traditional retail community pharmacy as well as both combination and closed-door LTC pharmacies. For more information on the NCPA LTC Division, visit http://www.ncpanet.org/ltc

NCPA attends USP Inaugural Workshop
on Evolution and Advances in Compounding

This week, NCPA representatives virtually attended the USP Inaugural Workshop on Evolution and Advances in Compounding. This workshop brought together several stakeholders to explore regulations for safe compounding and improving patient safety through standardization of commonly compounded medicines. Speakers discussed standardization, factors affecting compounding outcomes, state and federal regulations and initiatives, drug shortages, and personalized medicine trends. The Joint Commission presented on their Medication Compounding Certification program, which is a voluntary accreditation process for compounding pharmacies. Many pharmacists expressed concern about interoperability between a patient’s inpatient and outpatient compounded medications, and the speakers acknowledged that they are looking closely at this issue. NCPA will continue to participate in these USP stakeholder discussions.

NCPA submits comments on FDA’s evaluation
of bulk drug substances under Section 503

NCPA submitted comments to FDA’s draft guidance regarding bulk drug substances in compounding under Section 503B. Section 503B applies to outsourcing facilities who are registered with the FDA. In its draft guidance, the FDA seeks to create a framework to determine which bulk drug substances outsourcing facilities would be permitted to use in compounding. NCPA asserted that this draft guidance should be withdrawn as the FDA is attempting to determine the clinical need of compounded drugs for outsourcing facilities, and the draft guidance could lead to lower quality compounded drugs. Further, NCPA urged FDA to recognize that this draft guidance would detrimentally affect practitioner and patient populations by restricting the amount of bulk substances available to outsourcing facilities, which would lead to insufficient medical treatment options.

NCPA PAC hosts fundraiser for Rep. Steny Hoyer (D-MD)

NCPA PAC co-hosted a fundraising reception this week for Representative Steny Hoyer (D-MD), who serves as the House Minority Whip. NCPA member Surinder Singal graciously hosted the reception at his home in Dunkirk, Maryland. Approximately 26 community pharmacists from Maryland attended the fundraiser to support Congressman Hoyer and to share their concerns about how DIR fees and PBM tactics make it hard to run their small businesses and provide care to the patients they serve.

NCPA endorses opioid bill approved
by Senate Judiciary Committee

This week, the Senate Judiciary Committee approved five bipartisan opioid bills as part of the chamber's larger efforts to address the drug abuse crisis. The bills focus on limiting the supply of opioids in circulation, preventing drug trafficking, and curbing drug diversion through various programs within the Justice Department. The panel's work is expected to be rolled into a wide-ranging opioid package the Senate will vote on later this summer. One of the bills approved by the committee was S. 2645, the Access to Increased Drug Disposal Act, introduced by Senator Joni Ernst (R-IA). NCPA endorsed this bill, which would create a DEA demonstration that provides grants to states to encourage greater participation in prescription drug take-back programs.

In the states

  • Connecticut HB 5384, which concerns prescription drug costs, was passed by both chambers and sent to the governor.
  • Louisiana HB 436, which relates to the regulation of pharmacy benefit managers, passed both chambers and was sent to the governor.
  • Louisiana SB 283, which relates to pharmacy benefit managers, was signed by the governor.
  • Tennessee SB 2025, which allows for partial fills of controlled substances, passed both chambers and was signed by the governor.
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