States Scrutinize PBMs

According to The Wall Street Journal, states including Ohio, Oklahoma, Georgia, New Mexico, Kansas, Arkansas, and Mississippi, as well as the District of Columbia, are investigating PBM practices. The paper bases its reporting on interviews with offices of state attorneys general and auditors, as well as public documents including state contracts and securities filings. WSJ reports that several states, including Ohio, Mississippi, Arkansas and Kansas, have hired the same law firm, Liston & Deas, to investigate PBMs. From the story: “Lawrence Deas, a partner with the firm, said it was also working with Georgia and New Mexico. The number of states working with the firm is ‘certainly growing,’ he said.” While these ongoing investigations are important, the discoveries being made are consistent with NCPA’s goal of changing the pharmacy payment model and echo concerns NCPA raised for years. Here’s a link to the full story. (Note: The site requires a subscription.)

Supreme Court Kicks North Dakota Case back to 8th Circuit

Last summer, the Eighth Circuit Court of Appeals threw out a North Dakota law regulating PBMs citing ERISA and Part D preemption concerns. After the Rutledge decision, the Supreme Court kicked the case, Wilke v. PCMA, back to the Eight Circuit for reconsideration. Among other things, the law in question prohibits most fees after the claim has been adjudicated, as well as prohibits gag clauses and bars PBMs (subject to exceptions) from having an ownership interest in mail order specialty pharmacies and patient assistance programs. PCMA recently submitted their brief to the court, and the state of North Dakota will be submitting their brief in response at the end of June. This is another opportunity to expand a state’s authority to rein in abusive PBM practices . NCPA is analyzing PCMA's brief and will report out on any further actions in the case.

NCPA Continues Dialogue with SBA Office of the Ombudsman

NCPA staff recently met with a representative from the Small Business Administration (SBA) Office of the National Ombudsman, which works with small businesses to assist with excessive federal regulatory issues. The Office refers comments submitted by small businesses to the appropriate federal agency for high-level fairness review, a service which is provided free of charge through their case management system. NCPA staff plans to meet with the new National Ombudsman once appointed to discuss, among other issues, DIR fees, as well as to set up an informational webinar for NCPA members.

As a reminder, please be sure to check the SBA website for updates to the Paycheck Protection Program (PPP) and Economic Injury Disaster Loan (EIDL) programs, as well as resources from the SBA Office of Advocacy, which NCPA has worked with on various issues over the years, including DIR reform. A list of SBA regional advocates can be found here, and you can search for the nearest District Office here.

NABP Requests Delay in MOU Enforcement

On April 27, 2021, NABP sent a letter to the FDA requesting a delay in the enforcement of the MOU governing interstate shipments of compounded drugs. NABP, in response to multiple states contacting them regarding the upcoming October 2021 deadline, believes there is insufficient time for states to take action on the MOU. NABP reiterates many of the concerns NCPA, in conjunction with other stakeholders raised in our own letter to the FDA, namely that state boards might not have adequate time to engage in regulatory changes, have significant backlog of COVID-19 issues, or have the state legislature act. If the state boards fail to act by the deadline, there could be significant implications for patient access to compounded drugs. NCPA will continue to work with our partners in the compounding community to advocate for an extension of the deadline by the FDA.

NCPA Releases Easy Reference Guide on 340B
Covered Entity Drug Shipment Restrictions

NCPA, in conjunction with assistance from members of the NCPA 340B Task Force, is releasing a one-page reference guide for members participating as contract pharmacies. As the covered entities you might work with have questions regarding specific restrictions on 340B drug shipments from manufacturers, members can utilize this document to determine which manufacturers might be limiting delivery of the pharmaceuticals and potential avenues for any exceptions for certain products or pharmacies granted by those manufacturers. Additionally, it provides a point of contact or website for each manufacturer for those pre-determined exceptions processes. However, members should not construe the guide to be an alternative for legal counsel and encourage their covered entity partners to utilize their legal representative.

New Nursing Home Requirements, Resources
to Meet Facility Needs

CMS has released a new interim final rule that puts new requirements on long-term care (LTC) facilities around COVID-19 vaccines: educating staff and residents on the risks and benefits, offering the vaccine to all staff and residents, and reporting vaccination status to the Centers for Disease Control and Prevention (CDC). These new requirements will go into effect on Friday, May 21, 2021. The NCPA LTC Division suggests reaching out to your LTC facility clients to see how your pharmacy might be able to alleviate some of their challenges. NCPA has a variety of resources to assist you with educating your communities, including this great in-service ready presentation (click here) from CPESN on vaccine hesitancy.

Texas PBM Reform Bill Headed to Governor

Texas HB 1763, which unanimously passed the state House and Senate, is now headed to Governor Greg Abbott (R) for his signature. It was authored by Reps. Tom Oliverson (R), Cole Hefner (R), Eddie Lucio III (D), Cecil Bell (R), and Richard Peña Raymond (D) with Sen. Bryan Hughes (R) ushering it through the Senate. It was also supported by the Texas community pharmacy advocates. Great job Texas!

Among other things, this comprehensive PBM reform bill:

• Prohibits PBM clawbacks that reduce the amount paid to a pharmacy for a prescription weeks or months after a prescription is filled.
• Ensures patient choice by allowing local pharmacies to mail and deliver prescriptions if requested by the patient.
• Prevents self-dealing by prohibiting PBMs from steering patients to PBM-owned specialty pharmacies by requiring accreditations or certifications above those required by state and federal law.
• Prohibits PBMs from paying affiliated retail or mail-order pharmacies more than they pay other pharmacies in a network.
• Allows pharmacists access to their PSAO contract.
• Provides legal protections for pharmacies against retaliatory actions by PBMs for lodging appeals or complaints against PBMs.

Alabama PBM Bill Signed into Law

SB 227, introduced by Sen. Tom Butler (R), is a pro-local pharmacy bill that will help put an end to PBM conflicts of interests that raise costs for patients and payers and that limit access to pharmacies was signed into law by Governor Kay Ivery (R). It requires PBMs to become licensed with the state, prohibits patient steering, prohibits a PBM from reimbursing its pharmacies at higher rates than non-affiliated pharmacies, and contains other pro-patient limits on PBM conflicts of interest. Congratulations to the Alabama Pharmacy Association, the American Pharmacy Cooperative, Inc., and other pharmacy advocates in the state! NCPA was proud to work with these groups to further PBM reform in Alabama.

Multiple Bills Pass in Oklahoma

Multiple bills have seen gubernatorial action recently in Oklahoma. Gov. Stitt (R) signed three pro-pharmacy bills into law: SB 2677, SB 392, and HB 2123. SB 2677 strengthens existing fair pharmacy audit laws and helps keep PBMs accountable for reimbursement amounts. SB 392 requires insurers to reimburse pharmacies for providing covered services. HB 2123 creates the Patient’s Right to Pharmacy Choice Commission. Unfortunately, Gov. Stitt vetoed SB 821, which would have given patients greater authority to utilize the in-network pharmacy of their choice. However, efforts are underway to potentially override the veto.

NCPA Voices Concerns Over Duplicative Maine Legislation

NCPA submitted a letter to the Committee on Health Coverage, Insurance and Financial Services expressing concern over Maine LD 673, which would create the Insulin Safety Net Program. The bill would duplicate existing patient assistance programs and would create additional administrative burdens both for patients seeking affordable insulin and the pharmacists working to provide those patients access to the lifesaving drugs.

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.