NCPA Advocacy Center Update – Week Ending December 1, 2017

HHS nominee Azar passes first confirmation test: Alex Azar, President Trump’s nominee to be HHS Secretary, outlined four priority issues during a three-hour Senate HELP Committee hearing: 1) address prescription drug prices; 2) advance affordable, consumer-focused health care; 3) enhance Medicare value-based reimbursement; and 4) tackle the opioid epidemic. (For more, detailed summary below.) 

Dec. 6 is “DIR Day” – ask Members of Congress to cosponsor key bill: Spread the word! This upcoming Wed., Dec. 6 is “DIR Day.” NCPA encourages community pharmacy supporters to contact Congress. Share how much you have paid in retroactive DIR fees this year and how the uncertainty affects your ability to manage pharmacy operations and impacts patient care. Urge your legislators to cosponsor S. 413 / H.R. 1038 (or thank them for sponsoring it already). 

What Does 2018 Hold for Community Pharmacy? Find out during an NCPA Members Forum on the Community Pharmacy 2018 Checklist Dec. 7 at 2 p.m. ET. NCPA Advocacy Center staff will make sure you are up-to-date on the new Administration’s impact on small business community pharmacy, NCPA’s federal and state legislative priorities, and topics such as Medicare, Medicaid, Tricare, regulatory compliance deadlines, compounding, and track & trace, among others. This webinar is open to NCPA members only. Register here.

Senate appears poised to pass tax reform after securing a 50th vote for passage: Sen. Jeff Flake (R-Ariz.) agreed to support the package after securing concessions. Senators Bob Corker (R-Tenn.) and Susan Collins (R-Maine) have yet to announce their position on the bill, but Sen. Collins has also won inclusion of her amendments to strengthen deductions for medical expenses, which may move her to a yes. It appears the Senate will move forward with or without the vote of Corker, who had been pushing to get a guarantee that the bill won’t increase the deficit. The full details of what the Senate will be voting on remain to be seen as they have engaged in intense negotiations over the past 24 hours. However, the House of Representatives is prepared to come back into session early on Monday and will vote to go to conference to begin the process of hammering out differences between the two chambers’ bills. 

As CMS leaders re-direct Innovation Center, NCPA shares feedback: Our comments concerning the future mission of the Center for Medicare and Medicaid Innovation articulated that community pharmacists are a ready ally. Namely, that: 1) NCPA is at the forefront of promoting CMMI’s provider choice and incentives principle, such as robust pharmacy choice in Part D preferred networks; 2) CMMI’s benefit design and price transparency principle is aligned with our recommendation for reforming pharmacy DIR; and 3) NCPA supports realizing CMMI’s principle of patient-centered care through greater pharmacist utilization in MTM, med sync, diabetes prevention, Mental Health First Aid and other models.

CMS urged to keep essential health benefits in ACA plans: CMS officials should, at minimum, maintain requirements that health plans in state exchanges include prescription drug benefits, NCPA argued recently in comments to the agency. To that end, NCPA also signed on to a letter to CMS organized by the I Am Essential coalition. Notably, many health plans pushed back against loosening coverage requirements as well, saying they could trigger higher costs.

CMS proposed Part D rule triggers additional reaction: Activity continues to buzz in response to CMS’ recently released Part D proposed regulation that, among many other provisions, announced the agency is considering a requirement to account for all pharmacy DIR at point-of-sale, as NCPA has recommended. NCPA issued a statement with its initial reaction and hosted a call this week to discuss the proposal with stakeholders that signed on to an earlier letter to Congress urging a ban on such retroactive fees. Stay tuned for additional updates on how NCPA members and partners can support the CMS proposal. In addition, advocates for PBMs criticized portions of the rule, while health plans were more measured and NACDS also weighed in. For more read NCPA’s Executive Update from earlier today. 

Opioid epidemic activity roundup:

  • Several Congressional hearings and roundtables examined various aspects of the opioid epidemic, further underscoring lawmakers’ appetite to consider additional legislation in this area.
  • Attorney General Sessions announced $12 million in new grants and the establishment of a DEA field office in Louisville, Ky. to bolster the agency’s work in the hard-hit Appalachian region. In addition, White House advisor Kellyanne Conway was designated point person on the opioid epidemic response. At a related news conference, Sessions also expressed support for legislation expanding DEA enforcement authority, amid a debate concerning a 2016 law enacted by Congress unanimously.
  • CMS announced an updated opioid prescribing mapping tool with additional detail on regional variation in prescribing rates. Among the changes, the data presented by CMS now includes additional information about prescriptions for extended-release drugs.
  • President Trump donated his quarterly salary to support efforts to combat the epidemic.

FDA Compounding Advisory Committee Votes to Add Two Substances to “Positive List”: During the recent FDA PCAC meeting, the advisory committee voted in line with the FDA against adding certain bulk drug substance to the 503A “positive list” except pregnenolone. In sum, two substances were recommended to be added to the list and therefore to remain available for compounding, l-citrulline and pregnenolone. Substances voted against include Astragalus, 7-keto dehydroepiandrosterone, epigallocatechin gallate, and resveratrol. Even though all substances except l-citrulline and pregnenolone were voted against there is still an opportunity to respond via the formal rulemaking process. NCPA will continue to fight for the use of these substances in compounding and in the meantime FDA will use enforcement discretion concerning all of these substances.

NCPA urges changes to Massachusetts proposed compounding regulation: NCPA comments argued that it is critical to balance the standards and expectations of safety and quality with patient care needs and access to medications, and that the fiscal effect of proposed new regulation 247 CMR 17.00 would not pass that test. NCPA described how closer alignment of proposed new regulation 247 CMR 17.00 with current U.S. Pharmacopeial Convention (USP) guidelines, especially USP <797>, would provide that balance. 

Tell Your Patients: Talk to Your Pharmacist First: NCPA has created new marketing materials for you to use in your pharmacy to encourage patient-pharmacist conversations — about medication, health plan options and more – and they’re free for members. We included a “Talk to Your Pharmacist First” poster in the November issue of America’s Pharmacist® magazine to you to display in your pharmacy. Need another one? We have a limited supply left; contact NCPA if you need one. Or you can download differently sized versions of the poster, as well as bag stuffers, on the NCPA website (member login required). 

PhRMA report highlights how practices of PBMs contribute to higher patient drug costs: The “Follow the Dollar” white paper criticizes higher cost-sharing for patients when they may not directly realize the benefits of growing rebates paid to PBM intermediaries. It also notes, “Although PBMs say they prefer lower list prices, as this paper shows, in many cases, the system creates incentives for PBMs to prefer medicines with higher list prices and higher rebates.”

CMS Releases Memo to State Survey Agency Directors Regarding F-Tags: CMS’ Office of Survey & Certification at the Centers for Medicare & Medicaid Services has released a new memo, “Temporary Enforcement Delays for Certain Phase 2 F-tags and Changes to Nursing Home Compare.” Phase 2 of the Conditions for Participation will be implemented as planned on Nov. 28, 2017, but there is a moratorium on enforcement of some F-tags. CMS will provide an 18-month moratorium that includes civil money penalties, discretionary denials of payment for new admissions, and discretionary termination whether the remedy is based on one of the F-tags listed below. Deficiency findings for all other F-tags will not be included in the moratorium. Note that facilities are expected to comply with Phase 2 regulations and can be cited for noncompliance on all F-tags.

Following the implementation of the new LTC survey process on Nov. 28, 2017, CMS will hold constant the current health inspection star ratings on the Nursing Home Compare website for any surveys occurring between Nov. 28, 2017 and Nov. 27, 2018. The survey findings of facilities surveyed under the new LTC survey process will be published on NHC, but will not be incorporated into calculations for the Five-Star Quality Rating System for 12 months. 

F-tags included the moratorium are:

  • F655 (Baseline Care Plan); §483.21(a)(1)-(a)(3)
  • F740 (Behavioral Health Services); §483.40
  • F741 (Sufficient/Competent Direct Care/Access Staff-Behavioral Health); §483.40(a)(1)- (a)(2)
  • F758 (Psychotropic Medications) related to PRN Limitations §483.45(e)(3)-(e)(5)
  • F838 (Facility Assessment); §483.70(e)
  • F881 (Antibiotic Stewardship Program); §483.80(a)(3)
  • F865 (QAPI Program and Plan) related to the development of the QAPI Plan; §483.75(a)(2) and,
  • F926 (Smoking Policies). §483.90(i)(5)

Questions for CMS should be directed to

HHS nominee Azar passes first confirmation test: Alex Azar, President Trump’s nominee to be HHS Secretary, outlined four priority issues during a three-hour Senate HELP Committee hearing: 1) address prescription drug prices; 2) advance affordable, consumer-focused health care; 3) enhance Medicare value-based reimbursement; and 4) tackle the opioid epidemic.

During his opening statement, Azar declared drug prices too high, which became the hearing’s predominant theme. He emphasized his previous experience leading Eli Lilly and supply-chain familiarity as assets to address this and pledged to accelerate generics; fight brand manufacturer “patent games” and to narrow the gap between U.S. and global prices.

Citing the input of frustrated Maine pharmacists and an NCPA-supported NBC News report, Sen. Susan Collins expressed outrage about “co-pay clawbacks” that can inflate out-of-pocket costs for insured consumers above cash prices, and asked Azar whether they should be prohibited. He described them as jaw-dropping, frightening and an example of the systemic issues in prescription distribution and payment that he wants to address.

Other drug topics raised include importation; reforming Part B drug payments; generic drug price spikes; and alleged manipulation of the FDA’s REMS process. Azar also agreed to Sen. Isakson’s request to provide recommendations within six months of confirmation on how to address abuses and “gaming” of the system. In concluding the hearing, Chairman Lamar Alexander called drug prices a focus for the committee and announced a subsequent Dec. 12 hearing on the subject (which reportedly may focus on a new National Academies report).