On Nov. 10, the Supreme Court is scheduled to hear arguments over whether Congress, in scuttling the Affordable Care Act’s (ACA) individual mandate to buy health insurance, rendered the entire health care reform law unconstitutional. The ACA extended 340B eligibility to rural and free-standing cancer hospitals. It also told the U.S. Health and Human Services (HHS) secretary to recertify providers’ 340B eligibility annually, develop guidance on avoiding duplicate 340B discounts and Medicaid rebates, create a 340B ceiling price database, impose fines on drug manufacturers and providers for 340B program violations, develop a formal 340B dispute resolution process and conduct selective audits of drug manufacturers for 340B program compliance. The ACA also required a Government Accountability Office study of 340B that led to 340B covered entity audits. It also said the newly eligible 340B hospitals could not get 340B pricing on orphan drugs. All the health care reform law’s 340B provisions would be wiped out if the Supreme Court strikes down the entire law. Ruth Bader Ginsburg’s replacement with a conservative justice by Nov. 10 could increase the odds that the court will declare all of the ACA unconstitutional.

HRSA’s Office of Pharmacy Affairs posted on its website a letter to Eli Lilly dated Sept. 21. While this letter does not state definitively that Lilly’s refusal to allow 340B-priced drugs to contract pharmacies is illegal, it states that HRSA has not yet made a final decision regarding its legality. Referring to Eli Lilly’s “unilateral policy” to “scrap 340B pricing to contract pharmacies,” the letter states that “although the Health Resources and Services Administration (“HRSA”) has significant initial concerns with Lilly’s new policy, it continues to review that policy and has yet to make a final determination as to any potential action…. Lilly’s decision to interpret HRSA’s responses as tantamount to definitive agency agreement with Lilly’s position is incorrect.” The letter lists four concerns about Lilly’s actions that are not directly related to the 340B statute. The letter also notes that “the timing of your pricing changes is, at the very least, insensitive to the recent state of the economy.” HRSA’s letter concludes by stating that a lawsuit by HRSA against Eli Lilly is “a potential consequence in the event that Lilly knowingly violates a material condition of the program that results in over-charges to grantees and contractors.” NACHC and PACHC will continue to monitor this situation closely.

Pennsylvania’s unemployment rate dropped by 2.2 percentage points in August, settling at 10.3 percent as the state continues to plot an economic recovery after the coronavirus ushered forth record-high unemployment earlier in the year. The economy added over 59,000 nonfarm jobs last month, with unemployment down by 144,000 and employment up by 86,000, according to the state Department of Labor and Industry.

The Pennsylvania Supreme Court handed down several voting-related decisions last week. The court extended the deadline for accepting mail ballots, will allow voters to submit their ballots through drop boxes and removed the Green Party’s candidate for president from the ballot. 2020 is the first year Pennsylvanians have the option to vote by mail without needing to specify a reason. The Pennsylvania Department of State says nearly 2 million people have already asked for mail ballots for the upcoming election–and that figure is expected to grow. PA voters must register to vote by Oct. 19 to be eligible to vote in the Nov. 3 election. PA residents may register to vote online.

Last week, the Centers for Medicare & Medicaid Services (CMS) finalized two new mandatory Medicare payment models.  The Radiation Oncology Model (RO Model) creates a bundled payment system that is the same for all providers of radiotherapy treatment, regardless of whether care occurs in an outpatient department or in a physician’s office. The End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model), part of the Federal Advancing Kidney Health Initiative, adjusts payments to ESRD facilities based on the availability of home dialysis programs and the reduction of kidney transplant wait times.  Each model begins January 1, 2021.  Read more here.

The Centers for Medicare & Medicaid Services (CMS) seek public input on the potential benefits and challenges of using a nationally available set of quality measures in the delivery of Medicaid-funded HCBS.  HCBS programs vary by state and serve a variety of targeted Medicaid enrollees, such as people with developmental disabilities, physical disabilities, and/or mental illness, and provide opportunities for Medicaid beneficiaries to receive services in their own homes and communities rather than in institutions.  Read more here.