NCPA Advocacy Update

Week ending December 18

Author: APCI Staff/Monday, December 21, 2020/Categories: Legislative Affairs

NCPA Hosts Rutledge v. PCMA Post-Decision Webinar

Last week, the Supreme Court upheld an Arkansas law reining in PBMs. It’s a win for community pharmacy, but what does it actually mean and how will it affect you and your business? That question was answered at a webinar hosted by NCPA this week where a panel of experts examined the decision. Arkansas Attorney General Leslie Rutledge, John Vinson, Executive Director, Arkansas Pharmacists Association and Howard Rubin and Rob Smith of Katten law joined NCPA to discuss the ramifications of the ruling.

If you missed the webinar – or if you’d like to see it again – you can watch it here.

Thank you to all those who contributed to the LDF which helped fund this legal battle and contributed greatly to this extremely positive outcome. If you have not done so, please consider contributing to the LDF to support NCPA’s continued efforts on behalf of community pharmacy.


Hoey Op-ed Highlights Pharmacy Win in Rutledge v. PCMA

This week, an op-ed by NCPA CEO Doug Hoey titled “SCOTUS Delivers a Win for Patients and Independent Pharmacies” was published by Morning Consult. In the piece, Hoey highlights the oversized role PBMs play in the prescription drug marketplace and how the Supreme Court decision opens the door for greater PBM oversite by states. NCPA hopes that the states build on this landmark decision and enact new rules protecting local pharmacies and their patients.


NCPA Leadership attends White House Reception
and Celebrates SCOTUS Victory

NCPA President Brian Caswell and Chairman Hugh Chancy represented NCPA at a White House holiday reception recognizing first responders and front-line personnel supporting the COVID-19 pandemic response. While in the nation’s capital they filmed this short video in celebration of the U.S. Supreme Court issuing its landmark ruling in Rutledge v. PCMA.


NCPA Meets with HHS Transition Team

This week NCPA staff met with members of President-Elect Joe Biden’s HHS transition team. NCPA was invited by the transition team to provide an overview of the independent pharmacy marketplace, NCPA’s views on COVID related pharmacy issues, an overview of CPESN and current challenges for pharmacies (including DIR fees).


Bipartisan Pharmacy Champions Tackle
Pharmacy DIR Fees in Op-ed

This week, Reps. Reps. Raja Krishnamoorthi (D-Ill.) and John Rose (R-Tenn.) authored an op-ed titled “Why Your Neighborhood Community Pharmacy May Close” that was published in The Hill. In the piece, the Reps. note how skyrocketing, retroactive DIR fees are hurting community pharmacies and forcing some out of business and highlight the urgent need for immediate Congressional action. NCPA appreciates the efforts of Reps. Krishnamoorthi and Rose and will continue to work with them to address this critical issue for community pharmacy.


Congress Reaches Tentative Deal on COVID Relief Package

Congressional leaders have struck a tentative deal on the broad outlines of a COVID relief package that would deliver $600 stimulus checks to many individuals, $325 billion for small businesses and a $300 weekly unemployment boost. However, the deal has not been finalized as disagreements remain over who is eligible for stimulus checks, how to spend money for health care, disaster relief funds and winding down the Federal Reserve’s emergency lending program. NCPA sent a letter to Congressional leaders urging them to complete their work on the package by including our Essential campaign priorities and issued a press release on the matter. Additionally, a coalition letterNCPA signed onto with over 700 signatories was resent to Congressional leadership highlighting the need for PPP loan forgiveness to be fully tax deductible. While the deal does contain many provisions that NCPA has been advocating for, leaders did not include liability protections that Democrats have objected to. Leaders hoped they could pass the relief package with a government funding bill before the last continuing resolution ends on Friday at midnight, so it now appears a government funding gap is likely to occur over the weekend until negotiations are concluded.


House Democrats Appoint New Members
to the Energy and Commerce Committee

This week, House Democrats appointed five new members to the Energy and Commerce (E&C) Committee. The committee has jurisdiction over many of community pharmacy’s policy priorities, including pharmacy DIR fees. NCPA congratulates Reps. Angie Craig (D-Minn.), Lizzie Fletcher (D-Texas), Kathleen Rice (D-N.Y.), Kim Schrier (D-Wash.), and Lori Trahan (D-Mass) on their appointments and looks forward to working with them in their new roles.


Webinar on Enrolling Pharmacies as Mass Immunizers

On December 15, NCPA and Centers for Medicare & Medicaid Services (CMS) held a webinar for NCPA members on Medicare supplier enrollment to bill for vaccines. The audio recording and transcript will be posted here once available. Refer to the CMS COVID-19 Toolkit to learn how to enroll in Medicare Part B and bill for the COVID-19 vaccine. For questions about enrollment, email providerenrollment@cms.hhs.gov.


Update: CMS’s Coverage and Reimbursement of Vaccines,
Vaccine Administration, and Cost Sharing
under Medicaid, CHIP, and BHP Toolkit

The Centers for Medicare & Medicaid Services’ (CMS) released an updated toolkit - Coverage and Reimbursement of Vaccines, Vaccine Administration, and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program. This update provides additional guidance on vaccine administration reimbursement and details the review process states can utilize to adjust vaccine administration reimbursement rates in their state plan. The toolkit also provides further clarification on the administration of all EUA approved COVID-10 vaccines and managed care network adequacy considerations and requirements. As for now, pediatric vaccines once approved, will go through the current COVID-19 program and not through the Vaccines for Children Program.


Pharmacy Organizations Welcome FDA Authorization
of COVID Vaccine: “We Stand Ready to Serve”

NCPA joined 17 pharmacy organizations in a statement welcoming the US Food and Drug Administration (FDA) to authorize the emergency use of the first COVID-19 vaccine, following the recommendation of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The statement underscored the importance of using pharmacists for increased access and to address vaccine hesitancy. “Pharmacists are the most accessible health care providers in the nation, with 90% of Americans living within 5 miles of pharmacy. Across the nation they stand ready, in all patient care settings, to administer the vaccine and counsel patients through this critical moment in our nation’s history. As trusted health professionals dedicated to serving the health care needs of our communities, we stand ready to serve.”


Summary of the Most Favored Nation Drug Pricing Initiative

Read NCPA’s summary of the Most Favored Nation (MFN) Model for Medicare Part B Drugs and Biologicals, announced on November 20 by the Centers for Medicare & Medicaid Services (CMS). The MFN Model will require participation of Medicare providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions, beginning January 1, 2021 and will operate for seven years until December 31, 2027. As of December 18, several industry groups have filed legal challenges against HHS, which increase the likelihood that President-elect Joe Biden’s administration may alter or suspend the rule. NCPA will be submitting comments to CMS on the MFN Model by the January 26, 2021 deadline.


NCPA Comments on HHS Draft HIV Plan for 2021-2025

NCPA submitted comments to the Office of Infectious Disease and HIV/AIDS Policy (OIDP) on the draft HIV National Strategic Plan (HIV Plan) for 2021-2025. Although pharmacies are recognized in the draft plan, NCPA emphasized that independent pharmacies stand ready to help confront the clinical barriers keeping patients from accessing and maintaining HIV care. NCPA will continue working with HHS to ensure that additional independent pharmacies will be involved in public/private partnerships for the Ready, Set, PrEP Program.


Summary of Florida Medicaid Report

NCPA has created a summary of the Florida Medicaid Managed Care report in which Milliman recommends greater PBM oversight after it found PBMs pocket almost $90 million in spread pricing, steer patients to PBM-owned pharmacies, and reimburse those PBM-owned pharmacies at greater rates for generic specialty drugs.


Pharmacy Groups Ask CMS to Finalize Disapproval
of Washington State’s Medicaid Reimbursement Plan

In November, an administrative law judge ruled that Washington State’s Medicaid reimbursement plan violates Medicaid rules. NCPA joined NACDS and the Washington State Pharmacy Association in a letter to CMS asking that CMS adopt this decision so Washington State is required to resubmit a state plan amendment that includes an appropriate dispensing fee. As background, in a win for community pharmacy, an administrative law judge issued a ruling recently confirming that Washington state’s pharmacy reimbursement plan violates Medicaid rules. The finding upholds CMS’ March 2019 decision to this effect, which was challenged by Washington State. The action arises from a 2017 lawsuit filed by NCPA, NACDS and WSPA against the state of Washington.


Long-term Care Pharmacists Concerned About Big-box Chains
Delivering COVID-19 Vaccines

A survey conducted by NCPA and the American Society of Consultant Pharmacists last week indicates that 82.5 percent of LTC pharmacists believe CVS and Walgreens personnel don’t have enough experience with nursing home patients to administer the COVID-19 vaccine safely and effectively. Additionally, 87.3 percent say the big chains don’t have enough staff to serve the facilities. Results of the survey were shared with CDC officials, and NCPA and ASCP have let federal officials know they are ready to assist. In a story by Bloomberg News, NCPA CEO Doug Hoey was cited as stating that the outreach to community pharmacies by CVS and Walgreens has surprised NCPA members because it suggests that the chains don’t have the personnel to run this effort. Read NCPA’s press release here.


USP Updates Operational Considerations to Reflect EUAs
for COVID-19 Vaccines

Earlier in December 2020, USP updated its guidance on <797> to recognize the possibility of vaccines and therapies being approved by the FDA by the Emergency Use Authorization (EUA) process. USP is encouraging any compounders, for any sterile products for COVID-19 treatments, an exception for preparation outside of ISO Class 5 air for conventionally manufactured products and therapies for single patients where the manufacturer has provided information regarding “the diluent, the resultant strength, the container closure system, and storage time” on the label. Additionally, for preparation of a conventionally manufactured COVID-19 vaccine approved through a EUA, the compounder should follow directions in the labeling.


HRSA Finalizes 340B Alternative Dispute Resolution Rule

On December 10th, 2020, HRSA finalized the 340B Administration Dispute Resolution (ADR) rule, as required by the Affordable Care Act, to settle claims between covered entities and manufacturers -but not the current dispute regarding shipments to contract pharmacies. The rule establishes a six person ADR Board consisting of members from HRSA, CMS, and the HHS Office of General Counsel. For each individual case, the HRSA Administrator will select three members to form an ADR Panel to hear the controversy. The disputes before the panel must meet certain requirements – damages in excess of $25,000, occur within three years of the date of filing, and claims are limited from the covered entities to overcharging and manufacturers to diversion or duplicate discounts, as well as specific pleading conditions. The rule will go into effect on January 13th, 2021.


Washington Attorney General Opinion
on Pharmacist Diagnosing Within a CDTA

After decades of pharmacists practicing under Collaborative Drug Therapy Agreements (CDTA) in Washington (WA) state, the WA State Medical Commission requested the opinion of the state’s attorney general on whether the practice of pharmacy under a CDTA includes the diagnosis of a patient’s condition. Attorney General Robert Ferguson’s opinion was that a pharmacist diagnosing patients pursuant to a CDTA with a physician or physician assistant does not commit an act of unlicensed practice of medicine if the pharmacist is practicing under the scope of guidelines within the agreed CDTA. Congratulations to WA pharmacists!


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.


Due to the holidays, there will not be an Advocacy Center Update on December 25 or January 1. It will resume on January 8, 2021.


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. The weekly update is intended exclusively for the recipient and is not for external distribution.

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