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

The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule to allow Medicare Advantage plans to expand telehealth benefit coverage. (See alert for more detail) This proposed rule implements the statutory provisions in section 50323 the Bipartisan Budget Act of 2018. What you might not know, however, is that the Bipartisan Budget Act of 2018 is only one of many legislative vehicles by which advocates for telehealth expansion have been able to move the needle definitively in their favor during this session of Congress.

Over the past two years, Congress has shown its support for the utilization of telehealth by introducing forty-one bills that, if passed, would require Medicare to reimburse providers for their use of telehealth to treat numerous health conditions such as stroke diagnosis, mental health, chronic care management and opioid addiction treatment. Of note, the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 was the predecessor bill that passed out of the Senate in September of 2017 and became law on February 9, 2018 as a part of the Bipartisan Budget Act of 2018.
Continue Reading Government Affairs – The Progress of Telehealth Bills in Congress

This blog post has been prepared in collaboration with Nemours. Ms. Boyer is a Manager of Nemours Children’s HospitalMaya Upplauru is an associate in Crowell & Moring’s Health Care Group in Washington, D.C.

This Bulletin is brought to you by AHLA’s Children’s Health Affinity Group, which is part of the Academic Medical Centers and Teaching Hospitals and In-House Counsel Practice Groups.

One of the most fear-inducing experiences for new and first-time parents is the middle of the night illness of a young child. Many may head directly to the emergency department (ED) because they lack any means to communicate with their health care provider after-hours. Parents of children with chronic conditions or rare diseases are often forced to travel long distances to see specialists at regional centers of excellence and may struggle to check in or get questions answered once they are back at home. Teenagers managing chronic conditions may prematurely discontinue their treatment plan when they transition to college in a different state or when they enter the working world after college.
Continue Reading Delivering Virtual Pediatric Care Across State Lines: Regulatory Barriers and Opportunities

CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.

Virtual Check-Ins

CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”
Continue Reading Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

On April 17th, Crowell & Moring’s Government Affairs and Health Care Groups hosted speakers from Capitol Hill, federal agencies, and national trade groups during a thought-provoking half-day Long Term Care Policy Update forum (“LTC Forum”).  The LTC Forum was spearheaded by James Flood and Scott Douglas, who recently joined the firm from the Government Affairs division at Omnicare, a leader in the long-term pharmacy industry. 

The LTC Forum focused on overall policy affecting the long-term care industry, which the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), Congress, and other government agencies have consistently scrutinized.  Throughout the day, LTC Forum participants discussed the challenges and opportunities present in the long-term care industry that will only increase as payment reforms become the norm in Medicare. 

Of note, Sarah Johnson, the Legislative Assistant for U.S. Senator Rob Portman (R-OH) gave a timely overview of the negotiations that led up to the ultimate passage and signing of the Medicare Access and CHIP Reauthorization Act (MACRA).  MACRA repealed the Sustainable Growth Rate (SGR) formula for Medicare payments to physicians and phases in a new Merit-Based Incentive Payment System and other alternative payment models over the next ten years.  But MACRA partially funds these payment reforms with reductions to market basket updates for post-acute care providers, which creates increased concern from the industry about sustainability of long-term care providers under health reform initiatives.  According to one audience comment, there is concern that “in the long-term care industry, [stakeholders] are going to lose sight of overall health care industry shifts.”  Continue Reading Crowell’s Long-Term Care Policy Update—Recapping the Discussions and Debates

Once again, the Centers for Medicare & Medicaid Services (“CMS”) has delayed the enforcement of its controversial two-midnight rule.  On April 1st, the agency announced that it would postpone enforcement of the rule until April 30th, an additional month after the previous deadline, in order to give Congress additional time to

In a June 2014 opinion, the California Court of Appeals determined that reasonable & customary (R&C) charge valuations can consider actual payments accepted by a hospital for its services, not just the billed charges based on its charge master. This means that when determining the R&C values of services, California courts are required to consider the discounted amounts hospitals accept from governmental payers such as Medicare and Medi-Cal (Medicaid) and private plans. On the other hand, the Court also indicated that a provider’s cost may not be relevant to R&C valuations.

The case, Children’s Hospital Central California v. Blue Cross of California, 226 Cal.App.4th 1260 (Cal. Ct. App. 2014) which involved a dispute between an out-of-contract hospital and Blue Cross of California regarding amount of reimbursement owed to the hospital for post-stabilization services rendered to certain Medi-Cal beneficiaries enrolled in the plan.

California Department of Managed Health Care codified the so-called “Gould factors” in the Code of Regulations, title 28, section 1300.71, that are used to determine R&C value for reimbursement of claims. Under Gould v. Workers’ Comp. Appeals Bd. (1992) 4 Cal.App.4th 1059, R&C value of services rendered is to be based upon statistically credible information that is updated at least annually and takes into consideration:Continue Reading California Court of Appeal Revisits Litigation on Valuing Reasonable & Customary Charges

With enforcement of the Two-Midnight Rule delayed through September 30, 2014, providers should ensure that they are sufficiently documenting the basis for inpatient admissions. As a condition of payment for hospital inpatient services under Medicare Part A, section 1814(a) of the Social Security Act requires physicians to certify that it is medically necessary for such