Biden Administration Partners with Pharmacies
to Deliver COVID Vaccines
This week, the Biden administration announced steps to complement the comprehensive National Strategy to combat the COVID-19 pandemic, including launching the first phase of the Federal Retail Pharmacy Program for COVID-19 Vaccination. Under this program, select retail pharmacies nationwide, including several independent pharmacy networks, will receive limited vaccine supply to vaccinate priority groups at no cost. In a statement, NCPA CEO Douglas Hoey said. “When independent pharmacies have access to the vaccine, they are able to quickly get the coronavirus shots in patients’ arms. We are encouraged by these efforts to accelerate vaccine distribution, and strongly encourage the administration and state policymakers to fully include small business pharmacies in their plans.”
Prior to the announcement, Reps. Abigail Spanberger (D-Va.) and David McKinley (R-W.Va.) sent a bipartisan letter to the administration urging it to implement lessons learned from states that have opted for a community pharmacist-led approach to reaching vulnerable populations.
More details on Biden’s plan are available in a fact sheet issued by the White House.
Pharmacy Organizations Urge HHS to Include
Retired Pharmacists and Techs in Vaccine Plan
This week, NCPA joined nine other pharmacy organizations on a letter to HHS, asking that HHS expand the fifth amendment to the PREP Act to include retired pharmacists (within five years) with an active license and pharmacy technicians as vaccinators.
NCPA Joins Coalition Letter Seeking Limited
Liability Protections in Next COVID Relief Bill
This week, NCPA joined over 580 organizations on a coalition letter to Congress urging members to include targeted and temporary liability protections in the next COVID relief package. The letter points out that as the Biden Administration strives to reopen schools, protect our nation’s health and strengthen our economy, liability protections will help safeguard educational institutions, healthcare providers, businesses and non-profit organizations from unfair lawsuits.
NCPA Comments to FDA on Fixed-Quantity
Unit-of-Use Blister Packaging
NCPA submitted comments to the Food and Drug Administration (FDA) on its notice to possibly require fixed-quantity unit-of-use blister packaging for certain immediate-release opioid analgesics under opioid analgesic Risk Evaluation and Mitigation Strategy (REMS). Based on available data, the agency suggested 5-, 10-, or 15-count blister package configurations for certain commonly prescribed immediate-related opioid analgesics for acute pain to "help prescribers to more carefully consider the amount of opioid pain medication they prescribe." NCPA asked the FDA to carefully consider the implications on the LTC community, as many LTC pharmacists conduct their own unique packaging of medications. NCPA also asked the FDA to clarify that any blister packaging requirements would not affect current manufacturer bulk packaging practices.
NCPA Comments to DEA on Partial Filling of Prescriptions
for Schedule II Controlled Substances
NCPA submitted comments to the Drug Enforcement Administration (DEA) on its proposed rule to implement the Comprehensive Addiction and Recovery Act of 2016 (CARA) provisions related to the partial filling of prescriptions for schedule II controlled substances (C-II). The proposed rule would allow pharmacists to partially fill a C-II prescription if requested by the patient or prescriber, and proposes to add requirements to ensure proper documentation of the partial fill on the prescription record. NCPA recommended that where C-II prescriptions have been modified following consultation between a pharmacist and prescriber, DEA should codify existing policy that aligns with state law and allow for updated prescriptions to be treated as valid authorization to the pharmacist to dispense a lesser quantity in keeping with any state law quantity limits. NCPA also asked that DEA work with NCPA to estimate the impact of the proposed rule on payments to pharmacies.
NCPA Helps Pa. County Controller
Find Money Wasted on PBMs
Over the past few months, NCPA has provided information to Lehigh County Controller Mark Pinsley pertaining to his audit of the county employees’ prescription drug benefit. In his final audit, Controller Pinsley determined proper oversight of its PBM, Express Scripts, could lead to potential savings of $1.4 million for the county. In discussions with NCPA, Controller Pinsley also expressed concerns that ESI was steering patients to out-of-state pharmacies, thus sending money out of the county and away from local, independent pharmacies.
NCPA, Others Notch Victory for Patients in D.C.
NCPA, along with the National Association of Chain Drug Stores, the National Grocers Association, and the Food Industry Association, submitted commentsto the District of Columbia Department of Health and its Board of Pharmacy in November highlighting the restrictive measures of the proposed ruling for COVID-19 testing by pharmacists. The letter asked for a broad standards-of-care approach, not limited to referencing the CDC’s national infection control guidelines for PPE requirements, allowing pharmacy flexibility on testing locations, and removing the requirement for scheduling appointments before testing. These recommendations were intended to positively impact patient access while maintaining the highest standard of care and we are pleased that DC Health amended their proposed rule to achieve just that.
CMS Delays Medicare Part D Electronic Prior Authorization
On January 29, CMS, in accordance with the memorandum “Regulatory Freeze Pending Review” from the Assistant to the President and the Chief of Staff, delayed the effective date of the final rule “Medicare Program; Secure Electronic Prior Authorization For Medicare Part D Program.” The final rule, which was published on December 30th, 2020, requires Part D plan sponsors to support a NCPDP SCRIPT standard version 2017071 for four electronic prior authorizations (ePA) and for prescribers to use the standard when performing ePA transactions for pharmaceuticals for Part D patients. The rule which was supposed to take effect on February 1, 2021 – with enforcement beginning on January 1, 2022 - is now delayed until March 30, 2021 for CMS to review and assess the policy. NCPA will continue to monitor any policy changes undertaken by the Administration which effect community pharmacy.
HRSA Finalizes Vaccine Table Rule
On January 21, HRSA finalized a rule implementing revisions to the National Vaccine Table for the National Vaccine Injury Compensation Program (VICP). The VICP is a no-fault alternative to the traditional legal system to resolve damages for injuries arising from vaccine administration. Under the rule, HRSA is removing Shoulder Injury Related to Vaccine Administration (SIRVA) and syncope from the eligible injuries for petitions for compensation for VICP. As stated in the rule, HRSA believes SIRVA and syncope are not intended to be covered and the liability for these injuries should lie with the vaccine administrators – which includes pharmacists - for causing these injuries. NCPA submitted comments which called into question the underlying premises of HRSA. NCPA raised issues on modifying the table and increasing potential liability during a period of time when vaccinations of the general public are so important. NCPA will continue monitoring the environment as the Biden Administration reviews not yet effective rules and as stakeholders explore legal options.
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.