Pharmacy DIR provisions not included
in CMS’ final drug pricing rule
This week, CMS released its final drug pricing rule in which the agency declined to move forward with the pharmacy DIR provisions that were included when the rule was proposed in November. While CMS may have declined to act, the fight for pharmacy DIR relief continues. NCPA is working on the next steps in the process and will provide an update on our strategy going forward in the very near future. For more on this, please reference NCPA’s joint statement with NACDS or this issue of qAM.
CMS issues guidance addressing
PBM spread pricing in Medicaid and CHIP
This week, CMS issued guidance for Medicaid and CHIP managed care plans clarifying that the amount retained from a pharmacy benefit manager under “spread pricing” must be excluded from the amount of actual claims used in calculating Medicaid and CHIP managed care plans’ Medical Loss Ratio. NCPA CEO Douglas Hoey said the guidance shows that CMS and the Trump administration recognize that PBM practices have led to increased costs for states and taxpayers. NCPA had several meetings with CMS on this issue and submitted comments in support of this action to expose PBMs spread pricing tactics at the expense of taxpayers. Read NCPA’s statement here.
NCPA President Bill Osborn visits
with community pharmacy champions on Capitol Hill
This week, NCPA President Bill Osborn met with several community pharmacy champions on Capitol Hill. Along with Anne Cassity, NCPA’s vice president for federal and state government affairs, Osborn thanked pharmacy friends such as Sens. Shelly Moore Capito (R-W.Va.), Jim Inhofe (R-Okla.), James Lankford (R-Okla.), and Jon Tester (D-Mont.) and Reps. Peter Welch (D-Vt.) and Morgan Griffin (R-Va.). These members of the House and Senate are among those legislators who consistently support measures to address the issues facing community pharmacy.
Memorial Day Congressional recess is one week away,
invite your legislator for a visit
The Memorial Day in-district work period is only one week away. Congress will be away from Washington from May 24-June 23. Schedules are coming together so if you have not done so, extend an invitation to your legislator to visit your pharmacy or schedule a group meeting with multiple community pharmacists with legislators and discuss priority issues. These carry extra value if your legislator is new to Congress so you can familiarize them with community pharmacy and our issues or if they are a member of the Energy and Commerce or Ways and Means health subcommittees, the starting points for much of community pharmacy’s legislation in the House.
Pharmacy visits and face-to-face meetings are tremendously effective ways to communicate with legislators and to establish yourself as a resource to them as issues arise. Visit NCPA’s pharmacy visits webpage or contact Michael Rule at michael.rule@ncpanet.org for tips on arranging a visit with your legislator.
NCPA presents at GeriMed conference
This week, NCPA senior vice president, government affairs and director of the Advocacy Center Karry La Violette and vice president, pharmacy policy and regulatory affairs, Ronna Hauser, PharmD presented at the GeriMed 2019 Conference about LTC pharmacy advocacy issues. We appreciate the partnership and their support for NCPA’s LTC division.
New opioid measures adopted by PQA
This week, the Pharmacy Quality Alliance endorsed three new performance measures at its annual meeting that evaluate initial opioid prescriptions: at high dosage, for long duration, or for long-acting or extended-release opioids. The measures retrospectively evaluate health plan performance for these prescriptions, however, NCPA did not support the measures as presented for various reasons, including patients with legitimate pain needs being adversely impacted.
CMS revises FAQs on opioid point-of-sale safety edits
On October 23, 2018, CMS issued Frequently Asked Questions (FAQs) related to formulary-level opioid point-of-sale safety (POS) edits. The FAQs have been revised to include additional information and new FAQs to assist Part D plan sponsors in operationalizing these edits. One of the revisions include an exemption from the opioid safety edits for beneficiaries with sickle cell disease. The FAQs also further explain situations in which pharmacists must provide enrollees with a written copy of the standardized CMS pharmacy notice. In addition, the revisions expand upon when a pharmacist may override a care coordination edit at POS.
NCPA represents community pharmacies
on track-and-trace at FDA
This Wednesday, NCPA staff along with NCPA board member, Michael Kim, represented community pharmacies’ interest in front of the FDA at a listening session on upcoming requirements under the Drug Supply Chain Security Act (aka the track-and-trace law). Kim discussed the challenges community pharmacies may face with the upcoming (Nov. 27, 2019) saleable return verification requirement and gave specific examples of how the requirement, if not implemented smoothly, could have resounding negative impact on community pharmacies’ inventory management and financial viability.
HHS signals potential
for pharmacies to be paid for crucial services.
In last week’s HHS direct-to-consumer final rule, which requires drug manufacturers to publish the wholesale acquisition cost, or list price, for any medication featured in direct-to-consumer television advertisements the agency signaled the potential for pharmacies to be paid for educational services related to finding lower cost alternative drugs. In comments to the agency, NCPA suggested that community pharmacists play a key role in reducing patients’ out-of-pocket costs at the pharmacy counter by informing patients of lower cost alternatives, checking for drug interactions, providing product information, or informing the patient about manufacturer coupons available for a medication. NCPA argued that these crucial patient services are time consuming, complex, and burdensome. Thus, NCPA stressed a larger role for pharmacists in drug pricing counseling, including the need for payment to pharmacists for such crucial services. NCPA will continue to work with the administration to explore payment for such services.
ONDCP furthers its National Drug Control Strategy
The Office of National Drug Control Policy (ONDCP) released its 2019 Performance Reporting System (PRS) Report on the Administration’s National Drug Control Strategy. The Strategy aims to combat the effects of the opioid crisis by preventing drug use, treating those with substance use disorders and maintaining long-term recovery, and addressing drug trafficking across U.S. borders. The PRS describes the Strategy’s 2-year and 5-year performance measures and targets for each strategy goal and objective established for reducing drug use, availability, and the consequences of drug use.
FDA finalizes guidance to push interchangeable biosimilars
FDA finalized guidance to assist plan sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product. FDA stated the guidance will be particularly important to the development of interchangeable insulin, bringing the first real generic competition to the product. Acting FDA Commissioner Ned Sharpless stated that "there are currently no approved insulin products that can be substituted at the pharmacy level. But, under the BPCI Act, on March 23, 2020, insulin and other biological products that were approved as drugs under the Federal Food, Drug, and Cosmetic Act will be deemed biological products licensed and regulated under the PHS Act. After this transition, the FDA will be able to license biosimilar and interchangeable insulin products that meet the requirements of the PHS Act, and today’s guidance will, among other things, help developers seek licensure for such products."
NCPA attending NABP Annual Meeting
NCPA staff is currently attending the 2019 NABP Annual Meeting in Minneapolis, Minn. this week. NCPA hosted a breakfast at the meeting with our members serving on state boards of pharmacy to discuss issues such as compounding, electronic prescriptions, PBM reform, and scope of practice. We will continue to engage with NABP and the state boards of pharmacy on issues relevant to community pharmacists and the patients they serve.
South Carolina governor signs PBM regulation bill
South Carolina Gov. Henry McMaster (R) signed S. 359, which requires PBM licensure, increases reimbursement transparency, and controls anti-competitive PBM practices.
NCPA urges Oklahoma governor to sign PBM regulation bill
For the second time this legislative session, the Oklahoma State Legislature has unanimously passed a bill that would protect patient access to community pharmacies. The first bill was vetoed by Gov. Kevin Stitt (R) to avoid potential lawsuits by the PBMs. HB 2632, however, contains changes to address those concerns while maintaining robust protections for patients and community pharmacies. NCPA sent a letter to Gov. Stitt urging him to sign HB 2632 into law.
Texas Medicaid pharmacy reimbursement reform bill
heads to the Senate floor
HB 3388, a bill that establishes a reimbursement floor of NADAC plus a dispensing fee in Medicaid managed care plans, was voted out of the Texas Senate Health Committee this week. It’s likely to be heard on the Senate floor in the very near future.
NCPA state legislative activity update
Click the links to view a report of bills that have been introduced so far this session specifically dealing with NCPA’s top three state priorities: Medicaid managed care payment reform, scope of practice and compensation for services, and PBM reform and regulation. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the report. Bills that have moved this week are listed at the top in the “Recently Updated” section.
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.