Photo of James Segroves

Supreme Court review of Rule 9(b)’s application in False Claims Act cases may finally be coming whether the Executive Branch likes it or not.

In January, the Supreme Court, which is considering a certiorari petition in Johnson v. Bethany Hospice and Palliative Care, LLC, asked the Solicitor General to weigh in on whether the Court should accept the case. The case presents the question of what Rule 9(b) requires in cases arising under the False Claims Act, which is an important threshold question in many False Claims Act cases resulting in significant motions practice.

As past Solicitors General have done before her, the current Solicitor General’s brief filed late on May 24 argued that the Supreme Court should not grant plenary review because there really isn’t a meaningful circuit split on the issue. The brief also argues that the case is not a good vehicle for Supreme Court review because the district court dismissed the relator’s case on the alternative ground that the relator had not adequately pleaded violations of the federal anti-kickback statute, an issue the U.S. Court of Appeals for the Eleventh Circuit did not reach on appeal.

Continue Reading SCOTUS Review of Rule 9(b) in False Claims Act cases may be on the way

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new final rule that further delays until December 15, 2021, the effective date of the final rule titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (the January 2021 Rule), which was published in the

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute.

As we wrote when the proposed rules were released last autumn (see client alerts here and here),

Earlier this month and with little fanfare, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would invoke CMS’s rarely used retroactive-rulemaking authority to essentially ensure that, despite the Supreme Court’s adverse rulemaking decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), CMS will apply the same Medicare payment methodology found procedurally improper in Allina. CMS’s invocation of its retroactive-rulemaking authority to effectively circumvent Allina sets a potentially dangerous precedent that should not go unnoticed by all Medicare stakeholders.
Continue Reading “Contrary to the Public Interest”: CMS invokes retroactive-rulemaking authority to escape consequences of Allina

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

The Centers for Medicare & Medicaid Services (CMS) has announced a controversial plan to allow states to apply to participate in a new Medicaid “Healthy Adult Opportunity” (HAO) Demonstration.  In short, the HAO Demonstration will give participating states greater flexibility in the scope and administration of Medicaid benefits for certain beneficiary populations (i.e., the Affordable

The Centers for Medicare & Medicaid Services (CMS) has proposed rescinding current procedural standards that must be met for states to demonstrate that Medicaid fee-for-service (FFS) payments are sufficient to assure beneficiary access to covered services.

As we previously reported, regulations adopted in 2015 require states to establish and periodically update access monitoring review

The Centers for Medicare & Medicaid Services (CMS) recently released its 232-page proposed rule to update the Medicare skilled nursing facility (SNF) prospective payment system (PPS) for federal fiscal year (FY) 2020, which begins on October 1, 2019. Overall, CMS projects that SNF PPS payments would rise by $887 million under the proposed rule. Specifically,

As we reported on April 20, 2018, the Senate recently approved a joint resolution of disapproval under the Congressional Review Act (CRA) invalidating a five-year-old guidance document issued by the Consumer Financial Protection Bureau. It marked the first time in which a House of Congress invoked the CRA to invalidate something other than a formal

The Congressional Review Act (CRA) was long viewed as something of a paper tiger, and for good reason. The CRA requires agencies to submit certain rules to Congress before they go into effect. The CRA also creates a streamlined process for Congress to rescind such rules through the passage of a “joint resolution of disapproval”

The Centers for Medicare & Medicaid Services (CMS) is proposing to exempt states with high rates of Medicaid managed care enrollment from current requirements to analyze and monitor access in fee-for-service (FFS) delivery systems. The proposed rule also would loosen current state access analysis requirements when states make what CMS contends are “nominal” reductions in