HRSA Tells Manufacturers to Immediately Resume
Offering 340B Drugs to Contract Pharmacies

This week, HRSA publicly released a letter to each of the six pharmaceutical manufacturers – Eli Lilly, AstraZeneca, Novo Nordisk, Novartis, Sanofi, United Therapeutics - who have placed restrictions on deliveries to contract pharmacies stating those restrictions in violation of the 340B statute. Utilizing the same interpretation of the 340B statute as the earlier advisory opinion, HRSA orders the manufactures to immediately resume offering 340B drugs to contract pharmacies – failure to do so could result in a fine up to $5,000 per instance – along with a refund of any overcharge. HRSA requested the manufacturers provide an update by June 1, 2021 on their status of compliance. Currently, many of the manufacturers, along with PhRMA, are engaged in litigation with HHS on the enforcement. NCPA will continue to pursue and advocate for polices which protect independent pharmacies participating in the 340B program.

NCPA Provides Comments to CMS
on Part D Reporting Requirements

This week, NCPA provided comments to CMS in response to their information collection request in conjunction with the Part D rule issued on January 15, 2021, which requires Part D Plans to submit pharmacy performance measures to CMS, starting January 1, 2022. NCPA builds upon this regulatory requirement to encourage CMS to maximize the reporting requirements of the plans/PBMs and provide as much specifics as possible on the measures used in determining DIR fees. NCPA will continue to work with CMS on uniform pharmacy performance measures and to bring transparency and fairness to the metrics plans use to reimburse pharmacies in the Part D program. NCPA’s press release on our comments is available here.

Tennessee PBM Bill Headed to Governor for Signature

Tennessee SB1617/HB1398 sponsored by Senator Shane Reeves (R) and Representative Esther Helton (R) recently passed the Tennessee house and senate and is now headed to Gov. Bill Lee (R) for his signature. This legislation is a win for patients and pharmacies! The bill (among other things):

• Prohibits PBMs from reimbursing pharmacies below their acquisition costs – this provision would apply to ERISA plan claims due to the Supreme Court’s decision in Rutledge
• Addresses PBM conflicts of interests by prohibiting patient steering practices through means such as coercive copays
• Prohibits spread pricing in the commercial market
• Prohibits discriminatory payments/reimbursements fir the dispensing of 340B prescriptions

NCPA Urges Support for New York Medicaid
Managed Care Reform

This week, NCPA sent a letter to members of the New York State Senate Committee on Health, asking them to support SB 6603. Introduced by Sen. James Skoufis (D), the bill would require reimbursements to be no lower than the Medicaid fee-for-service program. Passing the legislation is critical because it’s important that taxpayer-funded programs be transparent, and this legislation would bring transparency and fairness to pharmacy reimbursements in the state’s Medicaid managed care program. On Wednesday, the bill was voted out of committee without opposition, and is now headed to the Senate Finance Committee. Assemblyman Richard Gottfried (D), chairman of the Assembly Health Committee, has introduced a companion bill, A7598.

US Attorney’s Office and HHS OIG Advise COVID-19 Providers
Not to Charge Patients

This week, an Acting US Attorney, the HHS-OIG, and the California Department of Justice issued an advisory to inform the public they should not be asked to pay to receive any of the COVID-19 vaccines. According to the agreement with the CDC in the COVID-19 Vaccination Program, providers – including any participating pharmacies - must administer the vaccines to a patient. Providers may seek reimbursement from the appropriate private insurance or public program – but providers are prohibited from seeking any payment from the vaccine recipient. Providers who do bill a patient directly or deny a patient because of the inability to pay for a vaccine face suspension or termination from the program and potential criminal and civil liability. If you need assistance for reimbursement from HRSA for uninsured or underinsured individuals, please contact NCPA at covid@ncpa.org.

SBA Still Accepting Certain PPP Applications Until May 31

The Small Business Administration (SBA) has stopped accepting new Paycheck Protection Program (PPP) applications from most lenders before the program’s scheduled deadline of May 31. Although the PPP general fund has been expended, SBA continues to offer PPP loans originated by participating community financial institutions which typically work with businesses in underserved communities, including Certified Development Companies (CDCs), SBA microlenders, Community Development Financial Institutions (CDFIs), and Minority Depository Institutions (MDIs) until May 31 or until remaining funds are exhausted. Check the SBA website for eligibility and additional information on First Draw and Second Draw PPP loans. If you are ineligible for a PPP loan or are unable to originate one from a participating community financial institution, SBA is still offering Economic Injury Disaster Loans (EIDLs).

FDA Delays UDI Labeling Compliance Deadline Until 2023

The Food and Drug Administration (FDA) announced in guidance released on May 21, 2021 that it will delay enforcement of its rule requiring medical devices to use unique device identifiers (UDI) rather than National Health Related Item Codes (NHRICs) or National Drug Codes (NDCs) for two years until September 23, 2023. Many stakeholders have indicated that they have had to shift resources to respond to COVID-19 and are not ready to shift away from using NHRICs or NDCs in their systems; NCPA welcomes this delay, which will allow pharmacies to continue prioritizing COVID-19 response efforts without shifting resources to modify technological and operational systems, and will prevent any disruption to existing reimbursement, supply chain, procurement processes, or healthcare delivery systems.

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.