The Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (collectively, “the departments”) recently confirmed that they will hold firm to the March 14, 2024 extended deadlines for initiating both new and previously initiated batched disputes or single disputes involving air ambulance services in the No Surprises Act Independent
On January 17, 2024, the Supreme Court of the United States heard oral argument in two cases—Relentless v. Dep’t of Commerce, and Loper Bright Enters. v. Raimondo—that could have far-reaching effects on administrative law jurisprudence and the authority of federal agencies in years to come.
At the core of both cases is the Supreme Court’s Chevron doctrine, which refers to how courts are to review an agency’s interpretation of a statute that it administers. Under the test of Chevron v. Natural Resources Def. Council, if an agency’s construction of an ambiguous statute is deemed to be reasonable, a court defers to the agency’s construction—even if the court believes the agency’s construction was not the best reading of the statute.
Over the last four decades, Chevron deference has faced criticism from those who argue that it is the role of courts, not federal agencies, to say what the law means. Arguing on Wednesday in support of overturning Chevron, counsel for Loper Bright argued that the Court should instead simply ask one question: “What is the best reading of the statute?”Continue Reading Supreme Court Tackles Chevron And Could Change How Agencies Regulate The Health Care Industry
The Department of Health and Human Services (HHS) released a final rule today governing federal protections for health care workers exercising their right to nondiscrimination on the basis of conscience objections.
The rule, entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes, is scheduled to be published in the Federal Register on Thursday, January 11 and will take effect on March 11, 2024. The rule effectively repeals the majority of a Trump-era rule that was blocked by federal court orders before it even went into effect.
The new rule reinstates provisions of an Obama-era rule that placed the Office for Civil Rights (OCR), the HHS office that handles nondiscrimination enforcement, in charge of coordinating complaints for violations of the conscience protections of various federal laws. The rule also implements a voluntary notice provision that establishes an industry best practice to alert employees to their rights under the laws.Continue Reading HHS Repeals Most of 2019 Health Care Conscience Protection Rule
Recent efforts by the federal government to develop a strategy for guiding (and regulating) the use of artificial intelligence (AI) have targeted multiple industry sectors, with healthcare at the forefront. For example, under the President’s recent executive order, in 2024 the Department of Health and Human Services is required to educate itself, publish guidance, and…
The Centers for Medicare & Medicaid Services (CMS) has published its final rule that requires nursing homes enrolled in Medicare and Medicaid to disclose additional ownership and management information to CMS and state Medicaid agencies. The rule finalizes CMS’s proposed rule from February, with just two differences, as we describe further below.
The rule implements Section 1124(c) of the Social Security Act, which was added by the Affordable Care Act to require the disclosure of additional information about ownership and oversight of nursing facilities. Medicare-enrolled skilled nursing facilities (SNFs) and Medicaid-enrolled nursing facilities (NFs) will soon be required to report many detailed aspects of their ownership and management structure, including both the executive leadership and any members of the facilities’ governing bodies.
CMS plans to gather the information in 2024, beginning when the revisions to the Form CMS-855A is completed, regardless of where a facility is on its current five-year revalidation schedule. The information will then be made publicly available within one year.
Of note in the final rule is that CMS declined to finalize a broad definition of “real estate investment trust” (also known an “REIT”) from its February proposed rule and instead has finalized a definition that it finds more consistent with current federal law and industry practice.Continue Reading CMS Finalizes Nursing Home Ownership Rule
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.”
This webinar comes about a month after FDA issued a proposed rule revising 21 C.F.R. Part 809 (specifically, 21 C.F.R, § 809.3) to state, explicitly, that in vitro diagnostics (IVDs) are medical devices, even if they are developed and manufactured in a laboratory setting.
This category of tests is generally referred to as “laboratory developed tests” (LDTs) and FDA has historically extended enforcement discretion, accepting the availability of certain LDTs outside of the FDA device clearance and approval pathway.
Of course this has not been a straightforward situation: we have seen decades of debate among FDA and industry stakeholders about the exact boundaries of FDA’s expressed enforcement discretion—where those boundaries should lie, and even interpretation (gleaned from enforcement action) of more precisely where they do, in FDA practice, actually lie.Continue Reading The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests
Good news for Medicare-eligible patients: the Centers for Medicare & Medicaid Services (CMS) is making it easier for individuals with limited income to apply and reenroll in Medicare Savings Programs (MSPs).
On Sept. 21, CMS issued a final rule that will streamline the enrollment and eligibility processes for the MSPs and align them with the requirements and processes for other public programs. The rule will also serve to reduce the complexity of the application and reenrollment process for eligible individuals. Continue Reading CMS Final Rule Streamlines Medicare Savings Program Eligibility and Enrollment
In a proposed rule sent to the federal register public inspection list on Sept. 1, the Centers for Medicare and Medicaid Services (CMS) announced a long-awaited minimum staffing requirement for Long Term Care (LTC) facilities that participate in the Medicare and Medicaid programs.
The proposed rule, set for publication in the Federal Register on Sept. 6, would create a floor for staffing in Medicare and Medicaid participating LTC facilities for both registered nurses (RN) and nurse aides (NA). Additionally, CMS is also seeking input on need to add on a minimum total nurse staffing requirement with the rule.
The staffing levels that the rule proposes exceed the current minimum staffing requirements of nearly every state. In the rule, CMS indicated that its proposed staffing requirement is merely a floor that could be adjusted upward based on acuity of resident need and that it may revisit the levels in later rulemaking with an eye toward increasing the staffing requirement even further.Continue Reading CMS Proposes National Minimum Nursing Staff Requirements for LTC Facilities
On August 28, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a final payment rule for inpatient and long-term care hospitals (“LTCH”) that builds on the Biden-Harris Administration’s priorities to provide support to historically underserved and under-resourced communities and to promote the highest quality outcomes and safest care for all individuals.
The fiscal year 2024 Inpatient Prospective Payment System (FY 2024 IPPS) and LTCH Prospective Payment System (LTCH PPS) final rule updates Medicare payments and policies for hospitals as required by statute. The rule adopts hospital quality measures to foster safety, equity, and reduce preventable harm in the hospital setting.
Under the rule, acute care hospitals and long-term care hospitals will see total payment increases of $2.2 billion and $6 million respectively. Additionally, the rule focuses on health equity and rural hospital access by recognizing higher costs to treat underserved populations.Continue Reading CMS Updates Medicare Rates and Policies for Inpatient and LTC Hospitals, Promoting Health Equity and Patient Safety
Three years after the Department of Health and Human Services’ (HHS) Office of the National Coordinator of Health Information Technology (ONC) issued a final rule that defined and clarified the scope of the information blocking provisions of the 21st Century Cures Act (the Information Blocking Rule), the HHS Office of Inspector General (OIG) has now published its own final rule implementing penalties for violations of the Information Blocking Rule by certain regulated actors (the OIG Final Rule).
The OIG Final Rule (i) implements OIG’s authority to impose civil money penalties (CMP) related to violations of the Information Blocking Rule; (ii) explains OIG’s approach to enforcement of its information blocking CMP authority; and (iii) codifies the CMP amounts at 42 C.F.R. part 1003, conforming with the Civil Monetary Penalties Law as amended by the Bipartisan Budget Act of 2018.
The OIG Final Rule is effective August 2, 2023, however, enforcement of the information blocking penalties will begin on September 1, 2023. Importantly, OIG will not impose information blocking CMPs for conduct occurring prior to September 1, 2023.Continue Reading OIG Finalizes Information Blocking Penalties
On June 6, 2023, the Center for Medicare and Medicaid Services (“CMS”) released a Quality Safety & Oversight memorandum (“QSO Memo”) reminding state survey agencies, accrediting organizations, and hospitals of the requirements for discharges and transfers to post-acute care (“PAC”) providers.
The standard for hospital discharge planning is set forth in 42 CFR 482.43, which requires a hospital to have “an effective discharge planning process that focuses on the patient’s goals and treatment preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge planning for post-discharge care.” Moreover, the hospital “must discharge the patient, and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient’s follow-up or ancillary care.” 42 C.F.R. 482.43(b). Continue Reading CMS Issues Requirements for Hospital Discharges to Post-Acute Care Providers
The Drug Enforcement Administration (DEA) has published a new final rule regarding reporting of theft or significant loss of controlled substances. Through the final rule, the DEA amended the existing regulations governing the form and timing used to formally report these thefts or losses.
The rule, which goes into effect on July 24, 2023, adds a follow-up requirement to the initial requirement of all registrants to report the theft or loss in writing to the DEA field office within one business day of discovery. Under the new rule, the formal follow-up notice must be electronically filed with DEA within 45 calendar days of the discovery.Continue Reading DEA Adds Second Step to Reporting Procedure for Controlled Substance Theft or Loss
Note: This is Part 2 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity. Part 1, covering the Digital Health Technologies framework is available here.
The Food and Drug Administration (FDA) has released draft guidance intended to help modernize the design and conduct of clinical trials by making them more efficient and enabling them to incorporate the newest technological and methodological advancements into their design.
FDA continues to issue guidance in the wake of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which in part requires FDA to provide further oversight and guidance on “Clinical Trial Diversity and Modernization.” Under Section 3607(c) of FDORA, consistent with its obligations modernize clinical trials, FDA is specifically required to “work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation” as it pertains to innovative approaches to clinical trial design and implementation.Continue Reading FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts
The Centers for Medicare and Medicaid Services (CMS) released a pair of proposed rules on April 27, 2023 that make substantial changes to the structure of Medicaid and the Children’s Health Insurance Program (CHIP), both in the traditional fee-for-service setting and for services provided through managed care organizations (MCOs), and incorporate feedback from stakeholders in…
In part I, we discussed whether federal district courts could exercise jurisdiction under the federal-question statute over legal challenges to overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data Validation (RADV) program for Medicare Advantage (MA) organizations. In part II, we discussed whether MA organizations must exhaust administrative remedies before filing suit under the federal-question statute.
In this final installment, we discuss a litigation nuance of potential significance in this unique context: namely, whether a district court may find that a MA organization can only challenge a RADV overpayment determination in the United States Court of Federal Claims.Continue Reading A Potential Route to RADV Judicial Review: Part III
Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity.
The Food and Drug Omnibus Reform Act of 2022 (FDORA) signed by President Biden on December 29, 2022, introduced significant changes to the way in which FDA will provide oversight for clinical trials as it pertains to “Clinical Trial Diversity and Modernization.” Under FDORA, among other things, FDA is required to issue guidance on decentralized clinical trials (which is a clinical trial in which some or all trial-related activities occur at a location separate from the investigator’s location) and to provide clarification on the use of digital health technologies (DHTs) in clinical trials.
Prior to the passage of FDORA, FDA set its sights on DHTs in the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, acknowledging the increased use of DHTs in drug development and the need for appropriate internal expertise and external guidance for their use and evaluation.Continue Reading New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development
In part I, we discussed whether federal district courts could exercise jurisdiction under the federal-question statute over legal challenges to overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data Validation (RADV) program for Medicare Advantage (MA) organizations. After concluding that existing Supreme Court precedent provided a substantial basis for arguing in favor of such jurisdiction, we left for another day the antecedent question whether MA organizations must exhaust administrative remedies before filing suit under the federal-question statute.
The seemingly straightforward exhaustion question presents a host of considerations that belie a one-size-fits-all answer. The practical answer likely depends on the nature of the specific overpayment determination at issue and the grounds upon which the MA organization wishes to challenge that determination.Continue Reading A Potential Route to RADV Judicial Review: Part II
The Medicare Act does not expressly provide for judicial review of overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data Validation (RADV) program for Medicare Advantage (MA) organizations. With the first wave of such overpayment determinations expected in the coming months, MA organizations impacted by RADV audits should begin considering a potential route to judicial review of such overpayment determinations and whether courts may deem exhaustion of administrative remedies a prerequisite to judicial review.Continue Reading A Potential Route to RADV Judicial Review: Part I
Health care and health care-adjacent organizations are seeing a steep increase in risk arising from the frequently utilized third-party analytics and advertising services on their websites, mobile applications, patient portals, and other Internet-connected services. Those organizations should pay attention to new regulatory guidance, published settlements with regulators, and an onslaught of class action filings stemming…
On March 27, 2023, two United States Senators, Bill Cassidy, MD (R-LA) and Jeff Merkley (D-OR) introduced the bipartisan No Unreasonable Payments, Coding, or Diagnoses for the Elderly (“No UPCODE”) Act to address perceived financial incentives inherent in the Medicare Advantage patient risk scoring reimbursement methodology. Senator Merkley alleges that the current reimbursement…