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The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA) approval of mifepristone. Throughout the questioning, the Justices focused on both the standing of the plaintiffs to bring the cases and on the suitability of the remedy sought.

The Court is expected to rule on the case in late June or early July. Although the Court has a 6-3 majority of justices appointed by Republican presidents, the questioning by the justices and the areas that they focused on seemed to indicate that any judicially-imposed limitations on both the FDA’s approval of the drug and the FDA’s current restrictions on the dispensing of mifepristone may be narrow.

At different times during the argument, both liberal and conservative Justices mixed together in the thrust of their questions in a way that could result in this case being a close decision with many different opinions or even resulting in a majority decision that would allow continued dispensation of the drug due to standing considerations.Continue Reading SCOTUS Arguments on Mifepristone Cases Focus on Standing and Remedy

As promised back in April in an announcement of its plans to modernize compliance program guidance, the Department of Health and Human Services Office of Inspector General (OIG) issued the first of its new guidance documents for the health care industry on November 6, 2023. The first release is a general compliance program guidance (GCPG) designed to serve as a resource to all segments of the health care industry, regardless of the particular items or services offered.

In its newest release, OIG reiterates its view that the GCPG is by its very nature a voluntary guidebook that can act as a roadmap for a compliance program to follow, but that it is not binding on any individual or entity in the health care industry. This updated GCPG includes the following information for health care compliance programs, which we summarize further below: (1) key Federal authorities for entities engaged in health care business; (2) the seven elements of a compliance program; (3) adaptations for small and large entities; (4) other compliance considerations; and (6) OIG processes and resources.

Additional industry specific compliance guidance documents will be forthcoming, according to OIG, with its first updated guidance setting the stage for those to follow.Continue Reading HHS OIG Issues General Guidance as First Step in Effort to Modernize Compliance Guidance

On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key medication for women seeking an abortion. Both rulings faulted the FDA’s handling of the approval and its subsequent restrictions on the dispensing of mifepristone, but the two rulings came to very different conclusions as to what the availability of the drug should be.

Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a 67-page opinion ordering that the FDA’s initial approval of the drug, which was approved in 2000, should be stayed pending the court’s full review of the merits of the case. The court then stayed its own order for seven days to allow the FDA to appeal to the U.S. Court of Appeals for the Fifth Circuit.

Just minutes later, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a 31-page opinion ordering FDA and HHS not to make any changes to the availability of mifepristone under the current operative Risk Evaluation and Mitigation Strategy (REMS) program, which requires the drug to be prescribed and dispensed only by certified providers, among other requirements. Unlike Judge Kacsmaryk, whose injunction has nationwide effect, Judge Rice limited the effect of his order to only the 17 states and the District of Columbia who brought the challenge in his court. The 17 plaintiff states in this lawsuit are: Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington and the District of Columbia.

The most difficult-to-reconcile aspect of the two orders is the fact that Judge Kacsmaryk’s order is a nationwide stay of the drug’s approval, while Judge Rice’s order to maintain the status quo availability only applies to the specific plaintiffs.  Notably absent from the Washington order’s applicability would be California, Massachusetts, New Jersey, New York, North Carolina, New Hampshire, and Virginia.Continue Reading Mifepristone Cases – Our Thoughts

The U.S. Supreme Court on July 26 issued its judgment in the case of Dobbs v. Jackson Women’s Health, officially setting in motion abortion bans in at least four states.

A “judgment” is distinct from the opinion and typically follows issuance of the opinion by about a month. This certified document from the clerk of The Supreme Court is usually simply a formality to allow the Court of Appeals from which the case originated to either close its docket or begin the process of implementing what was ordered on remand.

In the Dobbs case, the Supreme Court issued its opinion (142 S. Ct. 2228) on June 28, but the judgment issued from the clerk’s office to the Fifth Circuit about 30 days later.

Because of the way the trigger bans in at least four states were worded, the issuance of the judgment on July 26 also started the clock on the enforcement of those states’ laws. The trigger laws in Texas, Tennessee, Idaho, and North Dakota will each take effect 30 days after the judgment was issued, i.e., on August 25, 2022.Continue Reading Supreme Court judgment triggers abortion bans in states, legislative action in others

In an opinion authored by Justice Samuel Alito and joined by four of the other conservatives, The Supreme Court in Dobbs v. Jackson Women’s Health Organization held that there is no federal constitutional right to an abortion, and that the decision to regulate abortion should be governed exclusively by state law. In doing so, the decision overruled The Supreme Court’s previous decisions of Roe v. Wade decided in 1973 and Planned Parenthood of Southeastern PA v. Casey decided in 1992.

The Dobbs opinion tracks closely with the previous leaked draft opinion from The Supreme Court and includes concurring opinions from Justice Thomas, Justice Kavanaugh, and Chief Justice Roberts, as well as a dissent by Justices Breyer, Sotomayor and Kagan.

The Chief Justice concurred in the judgment but wrote separately to indicate that he would have only upheld the Mississippi law, and stopped short of overturning the precedents of Roe and Casey.

Decision changes landscape of reproductive health care rights

The Court’s decision, which was effectively 6-3 given the Chief Justice’s concurrence in the judgment, changes the landscape of reproductive health care rights throughout the country.Continue Reading Supreme Court Overturns Roe and Casey

Includes proposed changes to the OPPS and ASC payment rates and Stark Law exemptions.

On August 4, 2020, CMS posted for inspection the Proposed Outpatient Prospective Payment System (“OPPS”) Rule for 2021.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 12, 2020 and would revise the Medicare hospital OPPS…

Academic medical centers and other health care entities operating within institutes of higher education need to be aware of the compliance risks surrounding the recent release of higher education grants under the CARES Act. On April 21, 2020, the U.S. Department of Education (Department of Education) announced the release of $6.2 billion in connection with…

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak.

CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical…