Midterm elections just days away

The midterm elections are just days away where every pharmacy champion in the House and several in the Senate will be on the ballot, with many in competitive races which could go either way. As with every election, it is vital that everyone take time to vote. For those who consider a candidate’s position on pharmacy issues in their decision making process, a list of NCPA PAC supported candidates and a matrix of cosponsors of federal pharmacy legislation are available.

Regardless of the outcomes of the midterms, there will be significant changes in the 116th Congress. Read NCPA’s election preview for U.S. Senate and U.S. House races and keep your eyes open for our post-election analysis coming in mid-November.

Proposed rule on lowering drug prices is pending at OMB

Another Part D proposed rule is pending at Office of Management and Budget (OMB) as of late last week. OMB is the body responsible for reviewing whether proposed and final rules will be economically significant to the federal government. Only the name of the proposed rule ("Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Costs (CMS-4180-P)," not its contents, is known at this point. The public, including NCPA, will not know if or how this new proposed rule might address pharmacy DIR until it is released. OMB typically completes its review before release within 90 calendar days, although an extension of up to 30 days is possible. NCPA will continue to monitor this proposed rule closely.

CMS clarifies provider preclusion list requirements
in proposed rule

Late last Friday, CMS released a proposed rule titled Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021 (CMS-4185-P), RIN 0938-AT59, a proposed rule that outlines several changes to MA and Part D plans structure. Much of the proposed rule does not address changes to the pharmacy space, but the following are proposals found in the proposed rule that are worth noting:

• Provide clarity on the preclusion list: CMS seeks to clarify that providers cannot be placed on the Medicare preclusion list until the provider has exhausted their first level of appeal. By way of background, the 2019 Part D Final Rule created the provider preclusion list that replaces the current provider enrollment requirements in the Medicare program. This proposal is a welcomed clarification that ensures providers (including pharmacists) cannot be unfairly placed on the preclusion list without remedy.
• Update to measures for 2022 and 2023 Star Ratings: CMS states these measure changes are routine and “do not have a significant impact on the ratings of contracts.” Notably, however, CMS seeks comment on the implementation of a “hold harmless provision” for new Star Ratings when plan sponsor contracts are impacted by extreme and uncontrollable circumstances (such as enrollees are located in a FEMA-designated area). NCPA is evaluating this provision for potential impact to community pharmacies.
• Offer MA plans flexibility to cover telehealth benefits: CMS seeks to give Medicare Advantage plans broader flexibility in how coverage of telehealth benefits is paid to meet the needs of their enrollees. NCPA continues to advocate that pharmacists should be a key provider utilized in conjunction with any telehealth benefit offered.

CMS is accepting comments on this proposed rule through December 31, 2018

NCPA talks opioids at HHS meeting

NCPA's senior vice president of government affairs Karry La Violette offered input on industry efforts to combat the opioid epidemic at a recent meeting at the U. S. Department of Health and Human Services. La Violette and representatives of the National Conference of Pharmaceutical Organizations met with Assistant Secretary of Health Admiral Brett Giroir, M.D., to discuss ways the NCPO can assist the administration. NCPA is a member of NCPO, a coalition of organizations and associations that represent more than 300,000 pharmacy practitioners and pharmaceutical scientists, and companies engaged in health care delivery, as well as pharmacy regulators and educators.

CMS’ additional guidance on 2019 opioid edits in Medicare

CMS recently released the attached guidance regarding the implementation of opioid edits that were announced in the 2019 Final Call Letter this spring. The guidance is not a formal regulation but is an explanation of CMS’ current thinking on the opioid edits. In the document, CMS emphasizes that the care coordination safety edit contemplated in the 2019 Final Call Letter was “not intended to overburden the pharmacist” and committed to working with the National Council for Prescription Drug Programs (NCPDP) to “develop coding and messaging to improve efficiency of pharmacy workflow.” Of note, the guidance outlines situations when a pharmacist does not have to conduct a care coordination edit and can use an override code provided by a plan sponsor. The document also outlines important information for the soft and hard edits discussed in the 2019 Call Letter.

On Wednesday, Nov. 28th at 2 p.m., NCPA's regulatory and policy team will discuss this change and other regulatory changes to the Part D space that you and your patients should know for contract year 2019. NCPA's policy and regulatory team will also review other regulatory and legislative actions that have happened over the past year that impact the pharmacy space, including the recent passage of gag clause and opioid abuse legislation. Finally, this webinar will review regulatory initiatives on the horizon and what those actions may mean for community pharmacists. Registration is required if you plan to participate.

Congressional white paper cites
PBM role in higher insulin prices

This week, Reps. Diana DeGette (D-Colo.) and Tom Reed (R-N.Y.), co-chairs of the Congressional Diabetes Caucus, issued a whitepaper on insulin pricing. This report was the culmination of a yearlong bipartisan insulin inquiry. According to the American Diabetes Association, the average list price for insulin nearly tripled between 2002 and 2013. In the whitepaper, the Diabetes Caucus lays out a number of potential legislative actions to lower prices including: expedited FDA approval of biosimilar insulins, a patient-centric appeals process for changes to insurance formularies, requiring drug manufacturers to disclose how they set their prices and to prove the effectiveness of new versions of insulin over old ones. NCPA and several members engaged with Reps. DeGette and Reed during the inquiry and drafting process and were able to influence the final whitepaper, which highlights many opaque and questionable PBM practices.

NCPA teams up with consumer, patient, provider,
and consumer groups to develop
a new patient affordability platform

CMS recently proposed a rule which would require prescription drug manufacturers to post the Wholesale Acquisition Cost (WAC) for drugs covered in Medicare or Medicaid in direct-to-consumer television advertisements. Specifically, drug manufacturers would be required to post prices for a routine acute medication (like an antibiotic), or a 30 day supply of medication for a chronic condition that is taken every month. CMS has signaled implementing an exception to this proposal which would exclude prescription drugs with the list price of less than $35 per month. In light of this proposal, NCPA has joined up with PhRMA and patient, provider, and consumer groups – including CancerCare, the National Alliance on Mental Illness, the National Consumers League, the National Hispanic Council on Aging, and the National Medical Association – to develop a new patient affordability platform that will launch in early 2019. The new platform will include resources like an enhanced search tool that would provide medicine-specific public cost and affordability information. NCPA will play a key role in deciding which of these tools are most helpful to patients at the pharmacy counter.

CMS is accepting comments on this proposed rule through December 31, 2018.

CMS finalizes changes to the
home health payment system

On Wednesday, CMS finalized significant changes to the Home Health Prospective Payment System. CMS specifically made changes to improve access to solutions via remote patient monitoring technology, updated payments for home health care with a new case-mix system, begin the new home infusion therapy benefit, and reduce burden. The new case-mix system model, the Patient-Driven Groupings Model (PDGM), will begin with calendar year 2020 and relies on patient characteristics to pay for home health services. The final rule can be downloaded from the Federal Register.

NCPA’s recent efforts in the compounding space

NCPA has been actively engaged in the compounding space to ensure that the recent FDA and USP compounding revisions are reasonable and not overly burdensome on compounding pharmacists. NCPA is currently preparing to comment on three key documents: (1) FDA’s Revised Memorandum of Understanding (“MOU”); (2) FDA’s Revised Draft Guidance on Insanitary Conditions; and (3) revisions to USP General Chapter <797>.

In addition to analyzing the FDA’s revised MOU, NCPA, along with the International Academy of Compounding Pharmacists (IACP) and the American Pharmacists Association (APhA) have sent a joint letter and a survey to all State Boards of Pharmacy expressing concerns about the MOU addressing the interstate shipment of inordinate quantities of compounded medications. Through this survey, we hope to develop data on the positions of the State Boards of Pharmacy that will help inform our comments and benefit our advocacy efforts on the MOU.

The FDA’s revised draft guidance on insanitary conditions affects compounding facilities classified under sections 503A and 503B and aims to aid these facilities in identifying and correcting insanitary conditions that could lead to potential harm. NCPA will be commenting on the revisions that apply to 503A compounding facilities as they affect pharmacy.

Lastly, the proposed revisions to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations revises classifications of compounded sterile preparations and Beyond Use Dates (BUDs). These revisions modify simplified compounded sterile preparation (CSP) microbial risk levels from three (low, medium, and high) to two—Category 1 CSPs and Category 2 CSPs. Category 1 and 2 CSPs are distinguished primarily by the facility in which they are made and the BUD. NCPA is thoroughly reviewing these revisions and will be submitting comments.

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.