Secretary Becerra Extends PHE 90 Days
On January 14, 2022, HHS Secretary Becerra extended the public health emergency for an additional 90 days. The determination is effective from January 16, 2022 until April 16, 2022. This applies to pharmacists’ ability to provide COVID-19 testing, immunity from liability claims under the Public Readiness and Emergency Preparedness (PREP) Act, the ability to administer childhood vaccines, and other flexibilities that have been implemented by HHS. Be sure to visit NCPA’s Coronavirus Advocacy page for more information on federal, state, and local developments related to the PHE that affect pharmacists.
Judge Grants Stay in DIR Lawsuit
Today, NCPA joined APhA on a statement in response to the US District Court for the District of Columbia granting a stay in NCPA v. Becerra, which challenges the legality of pharmacy DIR fees. The statement commended the Court for granting the stay until after the proposed Part D Rule, which includes provisions that address pharmacy DIR fees is finalized. NCPA and APhA are joined in the case by the Coalition of State Rheumatology Organizations, Fruth Pharmacy of West Virginia, Hi-School Pharmacy Services LLC of Washington, Kare Drug of New Mexico, and Tyson Drug Co. of Mississippi.
Supreme Court Blocks OSHA Vaccination Mandate
for Large Employers
This week, the U.S. Supreme Court blocked the implementation of the OSHA emergency testing standard (ETS) which would have covered employers with more than 100 employees. The ETS would have required approximately 80 million workers to receive vaccinations or submit to testing. The court is letting a separate rule issued by CMS requiring shots for workers in nursing homes, hospitals and other facilities, such as long term care facilities and skilled nursing homes, which receive Medicare and Medicaid payments from the federal government to take effect. NCPA members who physically enter or are in close proximity to LTC or SNF staff or patients, including pharmacy staff, must have received their first dose of a two-dose or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by Jan. 27 2022, with full vaccination by Feb. 28, 2022.
Sen. Wyden Voices Support for CMS’ DIR Proposal
Senate Finance Committee Chair Ron Wyden (D-Ore.) issued a press release after the Centers for Medicare & Medicaid Services (CMS) proposed a new rule to address pharmacy DIR fees. Wyden said, “This proposed rule is an important step towards easing the financial strain on thousands of independent pharmacies and millions of Medicare beneficiaries across the nation,” Wyden said. “By constraining these out-of-control fees and requiring additional transparency, this action will help communities that count on these businesses for access to medicine and quality local service.” NCPA will be working with Sen. Wyden and other champions to ensure the intent of the rule is followed and that a strong final rule ensures transparent and predictable pharmacy reimbursement.
The Coalition for PBM Reform
Releases Statement on Part D Rule
Last week, NCPA joined other members of the Coalition for PBM reform to release a statement which “thanks the Centers for Medicare & Medicaid Services for taking the first steps to address so-called pharmacy direct and indirect remuneration (DIR) fees charged by Pharmacy Benefit Managers (PBMs).” NCPA and other members of the Coalition are committed to working with CMS and Members of Congress to ensure a strong final Part D rule and to find ways to further curb PBM abuses across the pharmacy landscape.
Biden: Health Plans Will Cover OTC COVID-19 Tests
Starting January 15, 2022, most OTC COVID-19 tests are to be covered by health insurance plans. The Administration is incentivizing insurers and group health plans to set up programs that allow people to get the tests directly through preferred pharmacies with no upfront costs. In-network community pharmacies will be able to submit reimbursement claims on behalf of patients. If the pharmacy is out of network, they will provide a receipt to the patient which they can use to claim reimbursement directly from their health plan. How networks for tests will be determined is not yet known.
At this time, those who are on Medicare will not be able to get their at-home COVID-19 tests reimbursed through the program, according to CMS. However, those who have Medicare Advantage may be covered and should check with their plan for more details. Currently, Medicaid and Children's Health Insurance Program plans are required to fully cover the cost of at-home tests.
For more information, please see this FAQ provided by CMS.
NCPA Joins Joint Pharmacy Statement Condemning
FDA Decision on COVID Oral Antivirals
In December, NCPA joined the American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, and the National Alliance of State Pharmacy Associations on a joint statement condemning FDA’s decision to prevent pharmacists from writing prescriptions for COVID-19 oral antiviral medications.
In part the statement notes, “Pharmacists have ordered and administered nearly 200 million doses of the COVID-19 vaccines and vast numbers of COVID-19 tests. They have immunized more Americans than any other category of health care provider, and they have been instrumental in the success of the COVID vaccine program. It makes absolutely no sense to restrict their ability to help patients rapidly mitigate the severity of COVID-19 symptoms just as the most aggressive strains of the virus to date are driving up hospitalizations and fatalities across the country.”
Maryland Report Says PBM Laws not Preempted by ERISA
The Maryland Insurance Administration (MIA) released a report concluding that, if the state were to apply its PBM laws to PBMs serving ERISA plans, enforcement of those laws would not be preempted by the federal ERISA law. In the wake of the U.S. Supreme Court’s Rutledge decision, the Maryland General Assembly asked the insurance administration to weigh in on the impact of the decision on the state’s laws. Relying on Rutledge and the subsequent Wehbi decision from the 8th Circuit, the MIA concluded “should the legislature elect to make all of the current [PBM laws] applicable to PBMs when contracted with an ERISA plan, the enforcement of those laws by the MIA would not be preempted by ERISA.”
MIA’s report continues the trend of state insurance officials analyzing the scope of ERISA preemption as it pertains to PBM regulations. NCPA is in frequent contact with the National Association of Insurance Commissioners, which is working on multiple projects to address that very issue.
NCPA Joins More than 80 Business Organizations
in Opposing Proposed Tax Increases
This week, NCPA joined more than 80 other business organizations on a letter to House and Senate leadership urging them to end efforts to pass massive tax increases in the Build Back Better Act. Instead, the signatories urge leadership to focus on alleviating current challenges, including inflation, labor shortages, and supply chain constraints.
USP Grants NCPA Request For Deadline Extension
for <795> and <797> Comments
On January 14, 2021, USP announced the deadline for comments on proposed revisions to USP Compounding General Chapters <795> and <797> is being extended from January 31, 2022 to March 17, 2022. NCPA had joined with APC and APhA to request an extension as the comment period fell over the holidays and the ongoing issues combatting COVID-19. NCPA will be providing comments to USP on the potential impact on community pharmacies. NCPA will continue to engage the Compounding Expert Committee, along with our partner stakeholders, to develop the best possible regulatory framework for compounding pharmacies.
NCPA’s Ronna Hauser Presents
to Montana Pharmacy Association
Last week, Ronna Hauser, NCPA’s Senior Vice President for Policy and Pharmacy Affairs, presented to the Montana Pharmacy Association at their Winter Virtual CE Conference. Hauser provided a law and policy update, including an update on the NCPA v. Becerra case and strategies to change the pharmacy payment model, including advocacy surrounding pharmacy DIR reform.
NCPA and APC Briefing for Prescribers
on upcoming BUD Changes
In response to proposed changes by the USP to beyond use dates for compounded medications, NCPA and APC are hosting a briefing focused on prescribers to explain the changes and the impact on patient care. NCPA is requesting all compounding pharmacies to share the following registration link with their prescribers: http://A4PC.org/budbriefing. The 30 minute briefing will take place on Thursday, January 20, 2022 at 5PM EST.
NCPA State Legislative Activity Update
NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope 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. The weekly update is intended exclusively for the recipient and is not for external distribution.