Please Hold Off on Comments to the CMS Proposed Rule
NCPA is requesting all membership to hold off on submitting comments to the proposed rule as we continue to refine our position. While NCPA appreciates the willingness of our membership to be proactive on this important proposal, we will be providing a uniform template for members to personalize and submit in the coming days as we did for the FTC commenting period. More information to follow.
NCPA Requests CMS Action
on Dismal Antivirals Reimbursements
This week, NCPA CEO Douglas Hoey sent a letter to CMS Administrator Chiquita Brooks-LaSure, asking for immediate intervention before independent pharmacies are forced to stop dispensing the oral antiviral drugs because they can’t justify the cost to their business. In the letter, Hoey told the administration that fees paid to pharmacies range from $10.50 on the high end, still far below the pharmacists’ cost of dispensing, all the way down to $1. One dollar is what Blue Cross Blue Shield’s Prime Therapeutics thinks pharmacies should be paid for a process that takes nearly one hour and includes dozens of additional procedures and considerations. “It is unconscionable that Medicare Part D plan sponsors and/or their pharmacy benefit managers (PBMs) are reimbursing pharmacies at these dismal rates, especially when these therapies can avoid costly hospitalizations,” Hoey wrote in part.
CVS Caremark will pay $4.8 million to Oklahoma
over ERISA, Part D fees
On Thursday, the Oklahoma Insurance Department (OID) announced a $4.8 million settlement agreement with CVS Caremark regarding the collection of transaction fees from pharmacies for Medicare Part D and ERISA plan claims. The amount of the settlement includes $2.3 million for Oklahoma pharmacies and $2.5 million in penalties. OID began investigating the PBM in September 2020, over what the state believes are violations of the Patient’s Right to Pharmacy Choice Act. PCMA v. Mulready, a case that will determine whether Oklahoma law is preempted by the federal regulations governing Medicare and ERISA plans, is pending before the U.S. District Court in the Western District of Oklahoma. Distribution of restitution and penalties included in the CVS Caremark settlement is dependent upon the outcome of the PCMA v. Mulready litigation and whether or not the court finds the Patient’s Right to Pharmacy Choice Act is preempted by federal law. NCPA has supported the Mulready case, and we will provide updates when they are available.
Update on CMS Mandate Compliance for Retail Pharmacy
Retail pharmacies are not included in the list of providers and suppliers in the CMS vaccine mandate interim final rule (IFR). Therefore, the rule does not directly affect retail pharmacies that do not work with facilities that participate in Medicare or Medicaid programs. However, the interim rule could potentially affect pharmacies that provide services under a contract or arrangement with a listed facility that does participate in Medicare or Medicaid programs.
For those who do fall within this rule, employees now have until Feb. 14 to get their first (or only) COVID -19 vaccine dose, and March 15 to get the second dose. Note: CMS says a facility with more than 80 percent of staff vaccinated and a plan to achieve 100 percent staff vaccination rate within 60 days of Feb. 14 will not be subject to enforcement actions. NCPA will continue to monitor any further action for employees of health care facilities and the impact on community pharmacy.
CMS Extends Part D COVID-19 Permissive Actions
for Contract Year 2022
On January 14, 2022, CMS informed Medicare Advantage Organizations, PDPs, and Medicare-Medicaid Plans that CMS will extend flexibilities currently in place regarding actions for ensuring enrollee and employee safety for the 2022 contract year. Part D sponsors can implement strategies they deem reasonable and necessary in order to continue to provide prescription drug coverage and prevent the spread of COVID-19. This includes waiving delivery documentation and signature log requirements, relaxing prior authorization requirements to the greatest extent possible, and suspending plan-coordinated pharmacy audits. This is a positive development for NCPA members as PDPs can continue to relax those certain requirements for pharmacies throughout 2022.
NCPA Survey Results: Pharmacies Scrambling
for At-Home Tests
NCPA released the results of a survey of roughly 8,000 pharmacy owners and managers to get a fix on what news headlines have suggested for weeks about the surging demand for at-home COVID-19 tests. The results show that 92.7 percent say they are having a tough time sourcing enough at-home COVID-19 tests to meet the demand. This result comes at the same time as the announcement of the federal government that Americans can order tests through a government website and have them delivered by USPS. The surging demand for tests is sky high due to protocols established by both public and private employers, schools and colleges, and even restaurants and bars in some cities that require some patrons to present a negative test.
NCPA Provides Comments to DEA on Telepharmacy
NCPA submitted comments to the Drug Enforcement Administration in response to its proposed rule on the “Regulation of Telepharmacy Practice.” NCPA provided detailed comments from NCPA members on issues like the telepharmacy medication verification process, how controlled substances are accounted for, employee training, whether automated machines are registered with the DEA, and the number of remote sites one pharmacist oversees. NCPA detailed the security measures that telepharmacies currently have that ensure that the patient who was prescribed the drug receives it. NCPA also confirmed that telepharmacy has proven essential to patients in rural areas because telepharmacies often work in underserved, remote areas where pharmacies could not otherwise afford to operate. NCPA will continue to represent independent, community pharmacists’ telepharmacy issues to the DEA.
NCPA Comments on DEA’s Proposed EPCS Transfer Rule
NCPA submitted comments to the Drug Enforcement Administration in response to its proposed rule on the “Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling.” The DEA proposed rule would allow for a pharmacy to transfer an electronic prescription for a controlled substance (EPCS), including schedule II-V controlled substances, between registered retail pharmacies for initial filling on a one-time basis. In the comments, NCPA indicated that the proposed rule would help prevent potential duplication of prescriptions and reduce the burden on the patient. NCPA will continue to work with DEA on EPCS initiatives to ensure independent, community pharmacists’ issues are represented.
Colorado State Agencies Approve Rules
to Implement Provider Status
The Colorado Medical Services Board approved emergency rules that revise their Medicaid program for pharmacists to be eligible to receive reimbursement for services within their scope of practice. The approval comes after the passage of HB 21-1275, which requires Medicaid to reimburse pharmacists for delivery of medically necessary services. The rules include permitting pharmacists to dispense, administer and be reimbursed for long acting injectables for both mental illness and substance use disorders even if the product is given by a physician’s office. There are plans by the Colorado Pharmacists Society and the state’s Department of Health Care Policy and Financing to hold a town hall in February to assist pharmacists in implementing the new billing and payment eligibility.
NCPA Presents to Virginia Pharmacists Association
This week, Adam Harbison, NCPA’s Director of Congressional Affairs, joined the Virginia Pharmacists Association’s Virtual Pharmacy Legislative Day to provide a Federal Advocacy Update. His presentation focused on the work that NCPA is doing with Congress and the Biden Administration to advance community pharmacy priorities, including the recent 2023 proposed rule from CMS to address DIR fees.
NCPA Submits Comments to FDA
on OTC Hearing Aids Proposal
This week, NCPA submitted comments to the FDA on the proposed rule for Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids, which would establish a regulatory framework for Over-the Counter (OTC) hearing aids. The FDA is required by the FDA Reauthorization Act of 2017 to undertake rulemaking to implement the parameters for OTC hearing aids. NCPA supported the proposed changes to permit devices for mild-to-moderate hearing loss to be able to be sold over the counter at pharmacies. NCPA will continue to work with other stakeholders as the FDA moves forward in the rulemaking process to ensure OTC hearing aids can be obtained at community pharmacies.
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.