NCPA Advocacy Update

Week ending September 25

Author: APCI Staff/Monday, September 28, 2020/Categories: Legislative Affairs

President Trump Proposes Discount Cards for Seniors

This week, President Trump announced his administration would be providing charge cards to seniors with $200 to spend on prescription drugs in the next few weeks. The President stated 33 million Medicare beneficiaries would soon be receiving the cards to cover prescription co-pays. At this time, details about funding and the timing of the mailing of the cards is not publicly known. NCPA will continue to monitor the details and the rollout of the program and what the potential impact on pharmacy might be.


Administration Announces Approval of Importation

This week, President Trump announced his administration had approved states to import pharmaceuticals from Canada. Previously, Congress had granted the authority to the President to permit state importation if the Secretary of HHS would certify such programs as safe and cost effective. Secretary Azar certified such plans would do just that on Wednesday, allowing Florida along with Colorado, Maine, New Hampshire, New Mexico, and Vermont, with enacted laws to create a state importation program (SIP). However, HHS retains final approval over the SIPs and has no timeline for deciding on the states’ submissions nor is it clear if states can submit plans before the effective date of 60 days after publication of the rule.

NCPA, as part of a coalition, previously provided comments expressing doubts to the Administration on the amount of the savings of any importation program and concerns with risks of intertwining drug supply chains with another country. NCPA also submitted our own comments previously highlighting NCPA’s Minimum Requirements Regarding Importation Policy Proposals. We will closely monitor to see if state plans that are submitted follow such minimum requirements.


HHS Publishes Requests for Proposals
from Private Sector on Drug Importation

The FDA requested proposals to create and operate new pathways for individuals to import prescription drugs through authorized State-licensed pharmacies, which would permit U.S. individuals who have obtained waivers from the Secretary to import certain FDA-approved prescription drugs from Australia, Canada, the European Union or a country in the European Economic Area, Israel, Japan, New Zealand, Switzerland, South Africa, or the United Kingdom. These pharmacies would be specified in authorized Individual Waiver Importation Plans (IWIPs). Waivers would be processed by HHS through an online portal, which is currently under development. It is important to note that imported drugs cannot be intermingled with domestically acquired pharmaceuticals and the IWIP would only cover prescribed drugs and not biologics or controlled substances.

In addition, the FDA requested proposals to develop new Insulin Reimportation Programs, in which insulin manufactured in the United States and exported to foreign countries can be reimported into the United States in a safe manner by a person other than the manufacturer of the insulin. 
Currently, there is no deadline to submit proposals to HHS.


2021 Medicare Open Enrollment Resources Now Available

Medicare Part D open enrollment starts Oct. 15, giving beneficiaries a chance to review coverage and make changes for 2021. Check out NCPA's list of helpful resources to help you answer patient questions about Part D, and don't forget to also use our Talk to Your Pharmacist First materials to get the conversation started. CMS makes changes to the program all the time, and our resource section lists important changes that community pharmacists should know. Medicare open enrollment ends Dec. 7.


Make Sure to Join Us: Rutledge v. PCMA
Webinar just days Away

Make sure you’re registered for Tuesday’s free webinar with Arkansas Attorney General Leslie Rutledge, the plaintiff in Rutledge v. PCMA. Rutledge will discuss the upcoming Supreme Court case and what every community pharmacist needs to know about this landmark case. During the webinar, you’ll have the opportunity to contribute to NCPA’s Legislative/Legal Defense Fund, which funds expenses related to Rutledge v. PCMA, which will be heard Oct. 6. Your donation to the LDF through this webinar is critical as our webinar sponsors, RxSafe, EHR Data, Liberty Software, Datarithm, Pharmacy Development Services, and Value Drug Company, will MATCH your individual contributions to the LDF dollar for dollar. Regardless of your ability to donate, we hope you will join us. You can register for the webinar here. Learn more about the case here.


Register Now for the NCPA 2020 Annual Convention

Registration for the NCPA 2020 Annual Convention is open! Sign up TODAY for this online live and virtual event where we’ll bring you all the innovative, business-focused programs you have come to expect from NCPA. And you can experience this convenient, affordable convention wherever you are! In some ways, this year’s event is no different than any other NCPA Convention: jam-packed with education for pharmacy teams inspired by pharmacy owners, a one-stop exhibition for products and services, and great programs, speakers, and networking opportunities. On the other hand, this year’s event spans two consecutive days instead of four, and attendees can check in from wherever they are. Look forward to “seeing” you Oct. 18 and 19.


NY Comptroller Finds Significant Overcharges
in MCO Program

The state of New York unnecessarily paid $605 million to the state’s Medicaid managed care organizations and their PBMs over a four-year period, according to a recently released audit. State Comptroller Thomas P. DiNapoli released the results which show that MCOs/PBMs made decisions to increase profits for themselves instead of working to save taxpayer dollars or increasing access to pharmacy services for beneficiaries. “MCOs typically work with their PBMs to conduct their own clinical reviews to identify drugs that provide the greatest value to THEM and therefore should be placed on the drug formulary," DiNapoli said. The legislature has already enacted a bill that will carve pharmacy benefits out of the Medicaid managed care program beginning in April 2021.


NCPA Attends NCOIL Meeting

Anne Cassity, VP of State and Federal Government Affairs, attended the National Council of Insurance Legislators (NCOIL) meeting in Alexandria this week. The healthcare focus of the meeting was on COVID-19 vaccination and testing and the importance of getting every provider engaged-including community pharmacists. Additionally, NCOIL Immediate Past President Sen. Jason Rapert (R-Ark.) took the opportunity to visit the NCPA offices while he was in town for the meeting.


Senate HELP Committee Examines Federal COVID-19 Response

This week, the Senate HELP Committee held a hearing titled, “COVID-19, An Update to the Federal Response,” to examine the Administration’s latest developments on vaccine progress and other components of the federal response to the COVID-19 pandemic. The panel of government witnesses from HHS and affiliated agencies presented information including COVID-19 infection levels, vaccine clinical trials and manufacturing status, and distribution plans. Critically, the officials confirmed that a vaccine could be available as early as October with broad availability for all by April. In regards to vaccine distribution, Sen. Enzi (R-Wyo.) asked about the impact on rural communities’ access given concerns about cold chain storage and whether pharmacies, hospitals, and other entities have the equipment needed to store the vaccine.


California Authorizes Pharmacists to Initiate
and Administer COVID-19 Vaccines

California (CA) Governor Gavin Newson (D) signed into law AB 1710, allowing pharmacists to independently initiate and administer any COVID-19 vaccine approved or authorized by the federal Food and Drug Administration (FDA). Recognizing the HHS authority granted to pharmacists to order and administer COVID-19 vaccines is a temporary, CA has ensured pharmacists will stay permanently engaged in the state’s efforts to overcome COVID-19.


NCPA PAC Hosts Meet and Greet for Montana
Congressional Candidate Matt Rosendale

This week, NCPA PAC hosted a pharmacy industry Meet and Greet for Montana Insurance Commissioner Matt Rosendale (R), who is running for Congress in Montana’s At-Large seat. Check out Rosendale’s websiteTwitter, and Facebookpages. You can learn more about Rosendale’s record holding PBMs accountable here.


NCPA Responds to NASEM Report
on Compounded Bioidentical Hormone Therapy

NCPA, in concert with NASPA and ACP, responded to the FDA on the NASEM report on compounded bioidentical hormone therapy (cBHT) to express concerns with the conclusions and recommendations included in the report. NCPA, along with its’ partners, believes if the FDA adopts the recommendations of the report, it will deprive or restrict millions of patients of much needed cBHT and deprive them of effective options in their treatment. NCPA believes the cBHT is an ill-suited fit for a one size fits all approach, and while seriously concerned with the outcome of the report, will continue to work with the FDA to resolve these issues.


HRSA Issues a Notice of Proposed Rulemaking for Insulin
and Injectable Epinephrine for 340B Grantees

This week, HRSA issued a notice of proposed rulemaking for insulin and injectable epinephrine for 340B programs as required by the President in his Executive Order on “Access to Affordable Lifesaving Medications,” which was issued on July 24, 2020. HRSA grantees which receive discounted drugs under the 340B program will be required to have written practices to provide the drugs to eligible low-income patients at or below the discounted price paid along with a minimal administration fee. HRSA defines a low-income patient for these specific drugs as an individual who has no health insurance, or has a high unmet deductible, or has a high cost sharing requirement for either of those two drugs. Comments will be due 30 days after the publication on September 28, 2020. NCPA will be seeking member input to inform our comments on the proposed rule.


HHS Responds to Lilly On 340B Contract Pharmacies

This week, the General Counsel at HHS responded to a letter from Eli Lilly & Co. telling the pharmaceutical manufacturer that they should not assume HRSA is backing the actions to end 340B shipments to contract pharmacies for not responding with the deadline provided by the company. In the response, HHS called the actions of Lilly a “unilateral price increase” and warned of a potential qui tam lawsuit under the False Claims Act in which an individual sues on behalf of the government, although it was left unclear what the exact factual basis for that lawsuit might be. NCPA will continue to monitor the actions taken by the pharmaceutical manufacturers, HRSA, and other stakeholders as this situation develops.


NCPA State Legislative Activity Update

NCPA tracks state legislation related to our top three state priorities: Medicaid reformscope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached 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.

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