NCPA Advocacy Update

Week ending Jan. 25

Author: APCI Staff/Monday, January 28, 2019/Categories: Legislative Affairs

CMS’ DIR proposals receive overwhelming support

While there are still a few hours remaining to comment on the proposed drug pricing rule, it is clear that the proposed provisions addressing pharmacy price concessions, or pharmacy DIR, received overwhelming support. More than 150 pharmacy stakeholder organizations representing diverse interests, unified their voice and submitted a joint letter to CMS in support of the proposed DIR fix. Nearly all of the major national pharmacy organizations were among the signatories. Additionally, more than 3,300 pharmacists voiced their support. Moreover, two dozen patient advocacy organizations supported the rule on the premise that, if finalized, the proposed DIR fixes will save the average patient nearly $200 per year on their out-of-pocket costs.

In addition to NCPA’s own comments, we joined forces with NACDS and NASP on a joint comment letter asking for a DIR fee fix and standardized pharmacy metrics. NCPA also joined forces with ASCP and SCPC in a joint comment letter focused on harm to seniors with the proposed protected class changes and the need for a new definition of negotiated price and standardized pharmacy measures.

While the public comment period is coming to a close, efforts to support the rule are gaining momentum on Capitol Hill. Sens. Shelley Moore Capito (R-W.Va.) and Jon Tester (D-Mont.) are circulating a bipartisan letter to HHS Sec. Azar to voice support for CMS’ efforts among their Senate colleagues. NCPA has grassroots messaging available to encourage Senators to sign on-to this letter. Please shares this link with your stakeholders and encourage them to take action before the Jan. 30 deadline for Senators to sign on.


Reps. Welch and Griffith reintroduce DIR legislation
and send letter to Sec. Azar

Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.) have reintroduced the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act. In the previous Congress, this legislation garnered wide bipartisan support, with 89 cosponsors. The legislation, which is still awaiting a bill number, would ensure that community pharmacists receive reimbursement at the rate posted at the time prescriptions are filled by prohibiting Medicare Part D plan sponsors and PBMs from retroactively reducing payments on accurate reimbursement claims submitted by pharmacies. Additionally, Reps. Welch and Griffith sent a letter to HHS Sec. Azar supporting the DIR aspects of the proposed Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses rule. This is the first Congressional letter of several that will be sent to Sec. Azar on the issue.


Grassley Announces First Finance Committee Hearing
of 116th Congress

The Senate Finance Committee will hold a drug pricing hearing on January 29, 2019. Chairman Charles Grassley (R-Iowa) noted that the hearing will be the first “of several,” to examine “prescription drug pricing,” as well as consider “policy and oversight solutions to lower costs for American patients.” Chairman Grassley emphasized the need to “look at bipartisan solutions and work to turn them into law.” The hearing will include testimony from: Kathy Sego, patient advocate; Douglas Holtz-Eakin, Ph.D., President, American Action Forum; Mark E. Miller, Ph.D., Vice President of Health Care, Laura and John Arnold Foundation; and Peter B. Bach, MD, MAPP, Director, Memorial Sloan Kettering Center for Health Policy and Outcomes.


Want Congress to enact pro-pharmacy legislation?
Tell them directly at NCPA’s Congressional Fly-in!

Would you like Congress to enact pro-pharmacy and pro-patient legislation? Deliver that message in person by attending NCPA's Congressional Pharmacy Fly-In, April 10-11 in Alexandria, Va. and Washington, D.C. This is your opportunity to meet with your members of Congress, or their staff, and personally ask them to support a pro-community pharmacy legislative agenda. Plus, you can earn up to 3.5 hours of CE credit at briefings on a range of issues, including DIR fees and potential changes to Medicaid. Registration is open, so don’t delay, register now online or by calling 1-800-544-7447, and plan to make your voice heard.


White House taps Joe Grogan to head
Office of Domestic Policy Council

This week, the President Trump named Joe Grogan to head the Office of Domestic Policy Council. Grogan served in the White House Office of Management and Budget as a senior health care official. He is also an ally of acting White House Chief of Staff and Director of OMB Mick Mulvaney. Grogan has worked extensively on White House health care priorities, including efforts to reduce drug prices and rollback the Affordable Care Act, and will likely continue to play a large role in those areas. Prior to joining the Trump administration in 2017, Grogan worked as a lobbyist for drug manufacturer Gilead Sciences.


New York releases analysis of PBM spread pricing
in state Medicaid program

A study from New York released this week quantified the issue of spread pricing by PBMs in the state Medicaid program. The study was sponsored by the Pharmacists Society of the State of New York. Its findings are consistent with those uncovered in an audit of Ohio’s state Medicaid agency last year. Middlemen “are taking an increasing share of the margin on generic drugs” in New York, said Eric Pachman, a former pharmacy executive who conducted the survey for PSSNY. Read Bloomberg’s report on the study results here.


FDA Issues REMS Assessment Draft Guidances

On Thursday, the FDA released two REMS assessment draft guidances providing a framework for drug and biologic companies to evaluate their REMS programs. The first guidance, titled REMS Assessment: Planning and Reporting Guidance for Industry, explains how drug companies can develop an assessment plan; specifically, how the REMS program objectives may impact the selection of metrics and data sources which assess whether the program is meeting its goals. The FDA proposes that REMS assessment metrics be identified for all assessment categories. Examples of assessment categories include: program outreach and communication; program Implementation and operations; stakeholder knowledge; safe use behaviors; and health outcomes and/or surrogates of health outcomes.

The second guidance, titled Survey Methodologies to Assess REMS Goals That Relate to Knowledge, recommends ways to evaluate health care provider knowledge of REMS-related information by conducting surveys. The FDA states that to be an eligible pharmacist participant for the suggested REMS assessment knowledge survey, the pharmacist should:

  • Be certified and/or enrolled to prescribe or dispense the drug or have prescribed or dispensed the drug within a reasonable timeframe
  • Not have participated in a previous REMS assessment survey for the same drug
  • Not be currently employed by the applicant, FDA, or the third party conducting the REMS knowledge assessment survey, or have other conflicts of interest that might affect their answers.

NCPA state legislative activity update

NPCA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Attached is a report of bills that have been introduced so far this session in each of these categories. You can access the individual bill language and basic information on the bill by clicking on the individual bill number in the report that you can view by clicking here.


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.

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