Two more manufacturers have announced contract pharmacy restrictions (CPRs) on Community Health Centers and a third has tightened them:

·    Alkermes – who makes Vivitrol, an SUD treatment drug that CHCs often prescribe – announced CPRs that will go into effect on July 22. Due to varying payor rules about whether Vivitrol must be dispensed by a regular pharmacy or contract pharmacy, it will soon be impossible for most CHCs to obtain all their Vivitrol at the 340B price.

·    Sobi announced CPRs effective July 1, but they should have little impact on CHCs.

·    Effective July 1, Bristol Meyers Squibb will require CHCs with a single, designated contract pharmacy site to report data to ESP on that site. This data must be reported within 14 days of the drug being dispensed and include 16 elements for each claim. CHC experts say that meeting these requirements will be an extremely heavy lift, and possibly impossible.

·    Sanofi’s policy of treating free-standing CHC-owned pharmacies like contract pharmacies appears to have been adopted by Alkermes, Bausch & Lomb, and Sobi. More information will be forthcoming, but we’re told that health centers should prepare for most of their free-standing pharmacies to lose access to 340B-priced Sanofi, Bausch & Lomb, and Sobi drugs starting July 1, and Alkermes drugs starting July 22.

The Maternal and Child Health Stillbirth Prevention Act of 2024, HR 4581, passed through both the House and the Senate, and now awaits President Biden’s signature before it becomes law. The bipartisan bill amends the Maternal and Child Health Service Block Grant program to allow states to use those dollars for stillbirth prevention and research activities but does not include additional funding.

Senators Whitehouse and Cassidy introduced S. 4338, the Pay PCPs Act. The Pay PCPs Act would encourage the Centers for Medicare and Medicaid Services (CMS) to accelerate its existing efforts to support value-based primary care and improve the adequacy of pay for primary care providers in Medicare. This legislation serves as a marker for future primary care legislation and includes a request for information on hybrid payments for primary care providers, risk adjustment criteria, quality measures and services to be included in hybrid models, cost sharing and technical advisory committees. Please send any feedback on the RFI questions to federalpolicy@nachc.org by June 28.

State officials are taking another crack at finalizing proposed rules that would make it easier for Pennsylvania residents with criminal records to earn professional licenses in fields ranging from accounting and nursing to cosmetology and real estate. The PA Department of State (DOS), which oversees professional licensure, issued a revised version of the rules this month after an earlier draft was rejected in April by the Independent Regulatory Review Commission (IRRC). IRRC questioned whether the rules adequately protect public health and safety and was concerned, in part, that certain crimes were not listed as being “directly related” to certain professions, thus triggering a closer look from licensing boards. The rules, for example, did not make prior convictions for forgery or identity theft an automatic impediment for people seeking to become state-licensed CPAs. In its latest version, DOS added stronger language emphasizing that licensing boards have a responsibility to consider individual applications for licensure. The language also clarifies that boards can still consider offenses as part of a licensing decision even if they are not listed as “directly related.” The IRRC met this week and approved the updated version. The rules implement Act 53 of 2020, a state law enacted in 2020.

The 988 Suicide & Crisis Lifeline has created new social media shareables designed for use as social media posts, stories, and threads. Please be sure to utilize these free tools in your health centers to continue to spread the word about the 988 Suicide and Crisis Lifeline. The free partner toolkit can be found here.

The HHS Office of the National Coordinator (ONC) has updated FAQs on the Change Healthcare/UnitedHealth Group cyberattack, effective May 31, 2024. The FAQs address a variety of issues, including OCR’s investigation, breach report filing, ransomware guidance, HIPAA breach notifications by covered entities, and delegation of breach notifications. ONC indicates that under the HITECH Act, covered entities are ultimately responsible for ensuring that breach notifications occur. Of note, OCR says it understands that in this case, business associate notification to affected covered entities has not yet occurred and that UHG’s website states that they “are not announcing an official breach notification at this time. To help ease reporting obligations on other stakeholders whose data may have been compromised as part of this cyberattack, UHG has offered to make notifications and undertake related administrative requirements on behalf of any provider or customer.”¹ OCR says it will not consider the 60-calendar day period from discovery of a breach by a covered entity to start until affected covered entities have received the information needed from Change Healthcare or UHG. ONC recommends that covered entities coordinate with Change Healthcare and UHG who will be providing the breach notifications. Review the HHS FAQs on the cyberattack. OCR plans to update the page as needed.

Unfortunately, there’s more bad news to share on the contract pharmacy (CP) front. Last week, the drug maker Sanofi – a major manufacturer of insulin – significantly tightened its restrictions on Community Health Center use of CPs, including placing unprecedented restrictions on CHC-owned off-site pharmacies. Sanofi was one of the first three drugmakers to impose CP restrictions, starting in October 2020. Since then, Sanofi has allowed CHCs to use unlimited CPs if they submitted data to ESP. To date, CHCs have also been able to designate a single CP for each care delivery site without an in-house pharmacy. The new rules, effective July 1, 2024:

·    Sanofi is ending the option for FQHCs to receive 340B pricing at an unlimited number of CPs in exchange for submitting data to ESP. (This leaves Gilead and Novo Nordisk as the only manufacturers who still allow health centers to avoid CP restrictions by reporting data to ESP.)

·    FQHCs who own one (or more) of their own pharmacies are ineligible to receive 340B-priced Sanofi drugs at any contract pharmacy.

·    FQHCs who do not own a pharmacy that is co-located within a care delivery site registered on OPAIS can designate a single contract pharmacy to receive 340B-priced drugs. These health centers will not be required to submit data to ESP for this CP and must designate their single CP on ESP as soon as possible – even if they have already designated a CP. It appears that all current CP designations will soon be erased.

·    Sanofi distinguishes between two types of CHC-owned pharmacies: those that are co-located at an FQHC care delivery site registered on OPAIS (“CHC-owned on-site”), and those that are stand-alone (“CHC-owned off-site”). Sanofi effectively treats CHC-owned off-site pharmacies as CPs, making them ineligible to receive 340B-priced drugs unless the CHC has no on-site pharmacies and designates its CHC-owned off-site pharmacy as its single CP location. The new policy is very concerning as it marks the first time that any manufacturer (or other stakeholder) has sought to limit access to 340B drugs at CHC-owned pharmacies.

·    ·Going forward, Sanofi will consider all of a CHC’s care delivery sites together as constituting a single covered entity (CE.) This means that the strategy of registering one pharmacy (in-house or contract) for each delivery site will no longer work for Sanofi.

Questions? Contact Eric Kiehl, PACHC Director of Policy and Partnership.

The Pennsylvania Department of Human Services (DHS) is reminding consumers to protect their Supplemental Nutrition Assistance Program (SNAP) benefits from skimming at point-of-sale machines or ATMs. Card skimmer devices have been reported in Philadelphia and Southeastern Pennsylvania. DHS announced in 2023 that Pennsylvanians who have had their SNAP benefits stolen can have their cards replaced but must fill out a Benefit Theft Claim within 60 calendar days of the incident.

Reuters reported that the U.S. Supreme Court will hear a lawsuit alleging that Medicare underpays hospitals that serve low-income populations by an estimated $1.5 billion per year. The 200 hospitals across 32 states are requesting the court to overturn a U.S. Court of Appeals decision that upheld how the U.S. Department of Health and Human Services (HHS) calculates the Medicare disproportionate share hospital (DSH) funding. Hospitals argue that HHS only uses the number of Medicare patients who actually receive supplemental security income in their calculations and does not include those who are eligible but do not receive the benefit, when determining DSH funding. Read More.

The Pennsylvania Office of Mental Health & Substance Abuse Services (OMHSAS) has launched a web-based training platform – MyOMHSAS – designed as a one-stop for online training and resources for OMHSAS staff as well internal and external stakeholders. MyOMHSAS is a collaboration with the Office of Developmental Programs (MyODP), the University of Massachusetts Medical School (UMass), and OMHSAS. The initial launch of MyOMHSAS at the end of April 2024 included a limited number of inaugural course modules including Assisted Outpatient Treatment (AOT), the Children’s Hospital of Philadelphia (CHOP) transgender webinar series, Child and Adolescent Service System Program (CASSP)/System of Care (SoC), and Suicide Screening modules. Additional offerings are under development, they include a crisis worker certification curriculum, under development in partnership with Temple University Harrisburg (TUH), which will be launched later this year as a pathway for entry-level crisis workers to achieve accreditation. A dedicated MyOMHSAS resource account is available for questions, feedback, suggestions, and other communication related to the platform: RA-PWMYOMHSAS@pa.gov.