Midweek Update

SCOTUS

Midweek Update

David Ermer–Rx coverage, SCOTUS–

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Has any law generated more litigation in a short period of time than the Affordable Care Act??? Katie Keith in the Health Affairs blog provides a lengthy status report on the major ACA cases pending in the U.S. Supreme Court and the U.S. Court of Appeals.

In other judicial news, the U.S. District Court for the District of Columbia ruled yesterday that the Department of Health and Human Services failed to follow the Administrative Procedure Act in certain respects with respect to its 2013 and 2016 rule makings on access to medical records by patients and third parties such as lawyers and insurers. The details are explained in this Health Security IT article. Due to the importance of this issue to HHS, the FEHBlog expects the agency to take remedial administrative action quickly.

In good prescription drug news:

  • Healthcare Dive reports that pharmaceutical manufactures finally are rolling out biosimilar drugs which action will lower the cost of expensive specialty drugs over time.
  • CVS Health announced today “a new solution eliminating member out-of-pocket costs associated with all diabetes prescription medications, including insulin. Offered through the company’s pharmacy benefit manager (PBM), CVS Caremark, RxZERO enables employers and health plan sponsors to leverage formulary and plan design approaches to offer all categories of diabetes medications at zero dollar out of pocket for their members without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.”

Tuesday Tidbits

David Ermer–ACA, CDC, SCOTUS–

This morning without comment, the Supreme Court denied the motion of the petitioners defending the Affordable Care Act to expedite the Court’s review of the Fifth Circuit Court of Appeal’s decision on the ACA’s constitutionality (Nos. 19-840, 841). The FEHBlog has long given up on trying to predict Supreme Court decisions. Now. the respondents seeking to take down the law will have until shortly after the Super Bowl to submit their briefs. The petitioners will have an opportunity to reply, and then the Supreme Court can consider the petitioner in due course, perhaps late March or April. If the Court decides to review the Fifth Circuit opinion, which the FEHBlog assumes is unlikely, the case would be argued next fall. As yet, Federal District Judge Reed O’Connor has not begun the process of reconsidering his vacated decision holding the entire remainder of the ACA inseparable from the unconstitutional ACA individual mandate at least according to the docket sheet available on PACER. The stay order that the Judge Reed entered in December 2018 states in pertinent part that “The parties are directed to notify the Court upon the conclusion of the appeal of the partial judgment within 14 days of any decision.” As the Court is busy, it’s likely that the Judge will tend to other matters until the Supreme Court decides what to do at this stage at least in the FEHBlog’s view.

The Centers for Disease Control (“CDC”) announced today that the agency

is closely monitoring developments around a novel (new) coronavirus first identified in Wuhan, Hubei Province, China. Chinese authorities identified the new coronavirus, which has resulted in close to 300 confirmed cases in China, including cases outside Wuhan City, with additional cases being identified in a growing number of countries internationally. The first case in the United States was announced on January 21, 2020. There are ongoing investigations to learn more.

The Wall Street Journal reported over the weekend that

Nancy Messonnier, the CDC’s director for the National Center for Immunization and Respiratory Diseases, said that as health officials develop diagnostic tests and start testing people with symptoms who have traveled to Wuhan, more cases are likely to be identified around the world, including in the U.S. 

“As we start testing more, I expect that we’re going to see more cases,” she said. 

“I think it’s highly plausible there will be at least a case in the United States.” 

She called the spread a “serious issue,” but added that the CDC has “faced this challenge before.”

“Based on the info CDC has today, we believe the current risk from the virus to the general public is low,” Dr. Messonnier said in a telephonic press conference.

FYI, the Government Accountability Office (GAO) has issued a report on Artificial Intelligence in Healthcare: Benefits and Challenges of Machine Learning in Drug Development. Here’s a link to the GAO’s version of Cliff Notes on the report.

Supreme Court scheduling action

David Ermer–ACA, SCOTUS, Uncategorized–

Healthcare Dive reports that “The Supreme Court on Monday set a Friday [January 10] afternoon deadline for challengers of the ACA to respond to the blue state coalition’s motion to expedite the case.” The lead coalition member State of California has requested that the Court calendar to case for oral argument this Spring so that a Supreme Court decision may be issued before the end of the current term in late June / early July. This scheduling order allows the Supreme Court to consider the motion to expedite at its Friday January 17, 2020, conference. Approval of the motion would require the support of at least five justices. If the Court decides the motion on January 17, the decision would be announced that Friday afternoon or the following Tuesday morning. Stay tuned.