Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Todd Rosenberg and Samuel Krause to discuss ERISA preemption of state regulation of pharmacy

Potentially overlooked between the enactment of the Families First Coronavirus Response Act (the FFCRA) on March 18 and the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) on March 27, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument via teleconference on March 20 in Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury, No. 19-05212 (D.C. Cir. July 30, 2019). At issue in that case is the fate of a Trump Administration rulemaking expanding the scope of non-ACA compliant short-term limited duration insurance (STLDI) plans. Already controversial—with some arguing that STLDI plans increase access to health care, while others decry them as misleading consumers and destabilizing the individual insurance market—STLDI plans are of particular import given the COVID-19 pandemic.

As millions face unemployment, lose access to employer-sponsored health insurance coverage, and qualify to seek coverage via a special enrollment period, others may look to STLDI policies to obtain at least some coverage in the wake of COVID-19. But, as with ACA requirements such as essential health benefits and community rating, STLDI plans are not subject to the recently enacted zero-dollar cost-sharing and other coverage requirements for COVID-19 diagnostic testing.


Continue Reading Appeals Court Hears Argument on Short-term, Limited Duration Insurance Plan Rule; STLDI Plans are not Required to Provide $0 Cost-share of COVID-19 Diagnostic Testing

On February 11, the U.S. Court of Appeals for the Seventh Circuit ruled that consultants who provide services to nursing homes and long-term care facilities lack standing to sue the state Medicaid agency and its contracted Managed Care Organizations on behalf of patients.

In Bria Health Servs., LLC v. Eagleson, No. 18-3076 (7th Cir.

On December 31, 2019, in New Mexico Health Connections v. U.S. Dep’t of Health and Human Services, the U.S. Court of Appeals for the Tenth Circuit upheld the methodology adopted by the U.S. Department of Health and Human Services (“HHS”) to administer the Risk Adjustment Program under the Affordable Care Act (“ACA”). In doing

The U.S. Court of Appeals for the Fifth Circuit could strike down the Affordable Care Act (ACA) as unconstitutional any moment. Several states are preparing for the impact.

In April 2018, Texas, 19 other states, and two individual plaintiffs filed a complaint in the U.S. District Court for the Northern District of Texas, arguing that the ACA, as amended by more recent legislation, is unconstitutional. They won—the district court held in Texas v. U.S. that the individual mandate is unconstitutional, and that the rest of the law cannot be severed from that provision, so it also must fall. The Fifth Circuit heard oral arguments in July of 2019 and may hand down a decision at any time. Rather than waiting for the possible results of that decision, many states are acting now to soften the blow.

As discussed below, if the district court’s decision is upheld and ACA is struck down, the effects likely would be widespread and dramatic. Nearly 20 million people with insurance under the ACA would be at risk of losing such coverage, markets would be disrupted, and popular consumer protections would be ineffective, including those for persons with preexisting conditions and coverage of dependent children up to age 26. As we have discussed in this space before, the sudden absence of some less-talked-about provisions of the ACA could have serious impacts on the authority behind innovative payment models, several of which have states as direct participants. In addition, billions of dollars in federal Medicaid funding would be removed from states’ budgets.


Continue Reading States Take Action in Anticipation of Possible ACA Unconstitutional Ruling

In a long-awaited opinion, on September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit in United States v. Aseracare, Inc., et al, unanimously vacated AseraCare’s False Claims Act (FCA) victory and remanded the case for further proceedings.[1] While this might seem a victory only for the Government at first blush, the opinion contains key takeaways for defendants that will likely reach far beyond just this case.

Importantly, even though the Eleventh Circuit vacated the district court’s grant of summary judgment to AseraCare, it affirmed the district court’s conclusion that a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for purposes of the FCA, when there is only a reasonable disagreement between medical experts as to the accuracy of that conclusion, with no other evidence to prove the falsity of the assessment. The Eleventh Circuit also concluded, however, that the Government should have been allowed to rely on the entire record, not just the trial record, to prove otherwise. The Government was precluded from doing so, the Court found, due to an earlier decision by the district court to bifurcate proceedings into two phases: one on falsity, and the other on the remaining elements of the FCA.

In affirming the district court’s holding regarding clinical judgment, the Eleventh Circuit remarked that it appears to be the “first circuit court to consider the precise question at issue here,”[2] and is an extraordinary move that provides hospice facilities, hospitals, and providers more generally with a degree of assurance that a reasonable disagreement between clinicians in a courtroom, without other evidence of objective falsehood, does not create a jury question and cannot serve as the basis for an action under the FCA: “While there is no question that clinical judgments must be tethered to a patient’s valid medical records, it is equally clear that the law is designed to give physicians meaningful latitude to make informed judgments without fear that those judgments will be second-guessed after the fact by laymen in a liability proceeding.”[3]


Continue Reading 11th Circuit Issues Long-Awaited Opinion in AseraCare Affirming that Mere Differences in Reasonable Clinical Judgement Cannot Be False Under the FCA and Remanding for New Trial and Consideration of Full Record

In the latest episode of Payers, Providers, and Patients – Oh My!, Troy Barsky and Alice Hall-Partyka talk with Joe Records and Payal Nanavati about how recent litigation challenging the constitutionality of the Affordable Care Act may impact providers and payers. The discussion focuses on the authority for innovative health care models and