The Health Resources and Services Administration tells Inside Health Policy that drug makers that curb 340B discounts at contract pharmacies might prevent vulnerable people from getting affordable drugs and the agency is encouraging drug makers to continue the discounts — but it cautions the agency can only take enforcement action if there is a violation of the statute.

America’s Essential Hospitals is the latest group to call on HRSA and HHS to step in and stop recent moves by drug makers to require providers share claims data in order in order to access 340B discounts through contract pharmacies. Following related moves by a handful of other key drug makers, AstraZeneca recently told providers it plans to end 340B pricing for contract pharmacies, with few exceptions.

HRSA tells IHP it is looking into the manufacturer’s announcement, and that contract pharmacies are vital to 340B providers. The agency “strongly encourages all manufacturers to sell 340B priced drugs to covered entities through contract pharmacy arrangements,” HRSA says.

“Manufacturers that refuse to honor contract pharmacy orders may be significantly limiting access to 340B discounted drugs for many underserved and vulnerable populations. Many of these populations may reside in geographically isolated areas and rely on contract pharmacies as a critical point of access for obtaining their prescriptions,” HRSA says.

However, the agency notes that it has limited authority to enforce 340B guidance — unless there is a violation of statute.

“Without comprehensive regulatory authority, HRSA is unable to develop enforceable policy to ensure clarity in program requirements across all the interdependent aspects of the 340B Program, although HRSA is still considering this matter as raised by the actions of these manufacturers,” HRSA says.

Prior to AstraZeneca’s announcement, Sanofi told 340B providers they need to share claims data for 340B drugs dispensed through contract pharmacies or the drug manufacturer will stop shipping the discounted drugs to those pharmacies. Merck Sharpe & Dohme Corp. also told 340B providers it wants them to share contract pharmacy claims data for Merck products, or the drug maker may take other program integrity steps that are less collaborative with the providers and more burdensome to them. Also, as of July 1, Lilly limited the distribution of three formulations of the erectile disfunction drug Cialis at 340B prices to providers in the 340B program and their child sites — and will not extend the ceiling price to contract pharmacies.

HRSA previously told IHP it was working to understand Merck’s and Sanofi’s plans.

While HRSA did not explicitly tell IHP whether the drug makers’ actions violate the statute, Maureen Testoni, president and CEO of 340B Health, alleged they do. Testoni said 340B Health believes there is a strong, statutory basis for enforcement action from HRSA, but if agency doesn’t act then 340B Health would consider using the courts to compel HRSA to step in.

The statute says manufacturers have to offer 340B prices to covered entities; it doesn’t say manufacturers can avoid offering the discounts if they don’t like the way covered entities are obtaining them, such as though contract pharmacies, Testoni told IHP. The group, along with others in a 340B coalition, laid out reasoning behind why they want HRSA to step in to stop Lilly and Merck in a July 16 letter to HHS Secretary Alex Azar.

America’s Essential Hospitals on Tuesday (Aug. 18) increased the pressure on HHS.

“Recent actions by pharmaceutical manufacturers hinder access to affordable medications for millions of people who face financial hardships and defy clear statutory requirements that they provide drugs to 340B Drug Pricing Program covered entities,” said Bruce Siegel, president and CEO of America’s Essential Hospitals, in a statement.

Siegel alleged the data requests from manufacturers have no clear link to program integrity and “seem to be little more than a fishing expedition.” The federal government already has safeguard in place to avoid duplicate discounts, Siegel said.

CMS earlier this year said there was a need to avoid duplicate discounts between 340B and Medicaid. The agency suggested that states could use state plan amendments to keep some — or all — providers and contract pharmacies from using 340B drugs for Medicaid beneficiaries. However, there are no statutory prohibitions on Medicare or commercial duplicate discounts, and Siegel said data requests in those areas are particularly concerning.

“We call on the Department of Health and Human Services to intervene and put an end to these unwarranted manufacturer requests,” Siegel said. — Michelle M. Stein (mstein@iwpnews.com)

Becker’s Healthcare

Nearly one in five Americans live in rural areas and depend on their local hospital for care. Over the past 10 years, 131 of those hospitals have closed.

More than 30 states have seen at least one rural hospital shut down since 2010, and the closures are heavily clustered in the South, according to data from the Cecil G. Sheps Center for Health Services Research.

Listed below are the 14 rural hospitals that have closed this year, as tracked by the Sheps Center. For the purposes of its analysis, the Sheps Center defined a hospital closure as the cessation in the provision of inpatient services.

“We follow the convention of the Office of Inspector General that a closed hospital is ‘a facility that stopped providing general, short-term, acute inpatient care,'” reads a statement on the Sheps Center’s website. “We did not consider a hospital closed if it: merged with, or was sold to, another hospital but the physical plant continued to provide inpatient acute care, converted to critical access status, or both closed and reopened during the same calendar year and at the same physical location.”

As of August 21, all the facilities listed below had stopped providing inpatient care. However, some of them still offered other services, including outpatient care, emergency care, urgent care or primary care.

1. Bluefield (W.Va.) Regional Medical Center
   *Provides urgent or emergency care
2. Central Hospital of Bowie (Texas)
3. Cumberland River Hospital (Celina, Tenn.)
4. Decatur County General Hospital (Parsons, Tenn.)
5. Edward W. McCready Memorial Hospital (Crisfield, Md.)
   *Provides urgent or emergency care
6. Mayo Clinic Health System-Springfield (Minn.)
   *Provides outpatient/primary care
7. Mountain View Regional Hospital (Norton, Va.)
   *Operates as a nursing or rehabilitation facility
8. Pinnacle Regional Hospital (Boonville, Mo.)
9. Shands Live Oak (Fla.) Regional Medical Center
   *Provides urgent or emergency care
10. Shands Starke (Fla.) Regional Medical Center
    *Provides urgent or emergency care
11. St. Luke’s Cushing Hospital (Leavenworth, Kan.)
    *Provides urgent or emergency care
12. Sumner Community Hospital (Wellington, Kan.)
13. UPMC Susquehanna Sunbury (Pa.)
    *Provides outpatient/primary care
14. Williamson (W.Va.) Memorial Hospital

The Centers for Medicare and Medicaid Service (CMS) wants to make you aware of a recent Drug Safety Communication from the Food & Drug Administration (FDA). The FDA announced it now requires labeling for opioid pain medicine and medicine to treat OUD be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of the overdose reversal drug naloxone with patients and caregivers, both when beginning and renewing treatment.

Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients who are prescribed opioid pain medicines and who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose.  A naloxone prescription should also be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

The National Conference of State Legislatures (NCSL) wrote a blog post highlighting the importance of pharmacists in expanding access to care in rural areas.

The post also provides an overview of the new Pharmacist provider page which provides a state breakdown of scope of practice policy related to pharmacists’ ability to modify prescriptions, prescribe hormonal contraceptives, and prescribe tobacco cessation aids.

The blog post and the website are supported by HRSA through a cooperative agreement with the National Organizations of State and Local Officials (NOSLO).

In support of National Immunization Awareness Month, HRSA urges health centers and health care providers to “catch-up to get ahead” on childhood immunizations. The COVID-19 pandemic has led to alarming declines in well-child visits and routine immunization rates. This raises the risk for outbreaks and further strain on our nation’s health care system.

In support of National Immunization Awareness Month, HRSA urges health centers and health care providers to “catch-up to get ahead” on childhood immunizations. The COVID-19 pandemic has led to alarming declines in well-child visits and routine immunization rates. This raises the risk for outbreaks and further strain on our nation’s health care system.