National Policy: 340b Drug Pricing, Price Transparency Rule, Public Charge Rule

Last week, President Joe Biden announced that he would roll back a controversial Trump-era rule that would have required green card applicants and other immigrants to demonstrate that they would have health insurance upon arrival to the U.S. The so-called “public charge” rule would have allowed the government to deny visa applications if they sought public assistance of any kind, including Medicaid.

From the president’s proclamation, via BenefitsPro:

My administration is committed to expanding access to quality, affordable health care. We can achieve that objective, however, without barring the entry of noncitizens who seek to immigrate lawfully to this country but who lack significant financial means or have not purchased health insurance coverage from a restrictive list of qualifying plans.

President Biden has not made any gestures towards rolling back the Centers for Medicare and Medicaid Services’s Hospital Price Transparency Rule, which went into effect in January. According to the National Law Review, the rule, which requires hospitals to post their prices for procedures on their websites in a machine readable format and/or include a user-friendly list of shoppable services for price comparison, is not finding the most ubiquitous compliance. An analysis of hospitals from March found that 65 of 100 hospitals surveyed were “unambiguously noncompliant”.

A study published in the JAMA Network Open last week found again that most hospitals are failing to comply with the price transparency requirements. Researchers looked at 5,288 hospitals and determined that only 48.5% of them had chargemaster data on their pages, Becker’s Hospital Review reports. 305 hospitals had broken links or incorrectly linked files and 138 hospitals only had online cost estimators.

Last Thursday, the Biden Department of Justice defended the Trump-era CMS Medicare Part B reimbursement cuts for 340b drugs and pay cuts for outpatient clinics, saying the Supreme Court would not need to take up the lawsuits. The briefs called back the Trump administration’s arguments that neither pay provision should be reviewed since they were included in annual Medicare rules, Inside Health Policy reports.

The American Hospital Association said the cases are necessary and that the appellate court gave too much weight to the Department of Health and Human Services when interpreting the statutes. From AHA’s Rick Pollack, President and CEO:

These concerns led us to file a lawsuit late last year to require HHS to stop these illegal actions from drug companies and protect vulnerable patients and communities and to participate in other cases challenging the program. We continue to urge HRSA to ensure that the drug companies that denied appropriate discounts since these illegal practices began last year make the impacted hospitals whole for the benefit of the vulnerable communities they serve.

The Health Resources and Services Administration (HRSA) Acting Administrator Diana Espinoza sent six letters to pharmaceutical manufacturers to let them know that their policies that place restrictions on 340b Program pricing to covered entities resulted in overcharges since July 2020.

[The drug manufacturer] must immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements… [The drug manufacturer] must comply with its 340B statutory obligations and the 340B Program’s CMP final rule and credit or refund all covered entities for overcharges that have resulted from [this] policy. . . . Continued failure to provide the 340B price to covered entities utilizing contract pharmacies, and the resultant charges to covered entities of more than the 340B ceiling price, may result in CMPs as described in the CMP final rule.