Medicare

Subscribe to Medicare

In February 1971, at the tail end of Richard Nixon’s first term, his Secretary of Health, Education and Welfare, Elliot Richardson, approved a directive that was printed in the Federal Register as a Statement of Policy on “Public Participation in Rulemaking”.

The statement asserted that the Department of Health Education and Welfare (the precursor to the current Department of Health and Human Services [HHS]) would NOT exempt from full notice and comment rulemaking any rules relating to public property, loans, grants, benefits or contracts. The Department made this decision even though it was permitted to exempt these rules by the text of the Administrative Procedure Act (APA). Additionally, the policy statement urged the agency to only sparingly use a “good cause” exemption from notice and comment that was also included in the text of the APA.Continue Reading Elimination of the Richardson Waiver Means Changes . . . But To What End?

At the Federal Bar Association’s (FBA) Annual Qui Tam Conference on February 20, 2025, Department of Justice (DOJ) representatives Michael Granston (Deputy Assistant Attorney General for Commercial Litigation) and Jamie Yavelberg (Director of the Fraud Section in the Civil Division) discussed enforcement priorities for the False Claims Act (FCA), including Medicare Advantage, cybersecurity, and pandemic…

In the final 2025 Medicare Physician Fee Schedule, which is set to be published in the Federal Register on December 9, the Centers for Medicare and Medicaid Services (CMS) included substantive changes to the regulations governing when a provider must report and return a Medicare overpayment in order to avoid liability under the False Claims…

This month, the Centers for Medicare & Medicaid Services (CMS) has begun an off-cycle revalidation process directed at all Medicare-participating skilled nursing facilities (SNFs). The process is designed to implement provisions of the Affordable Care Act (ACA) that require facilities to detail their ownership structures and key managerial personnel.

CMS is seeking information about ownership of SNFs by private equity firms and real estate investment trusts (REITs). In September, CMS revised Form 855A to require a SNF to report those types of ownership interests. The agency has also released a guidance document detailing the requirements and how a SNF should go about filling out the form.

CMS indicated that it would seek this off-cycle revalidation process as part of its effort to implement the disclosure requirements of Section 1124(c) of the Social Security Act (42 U.S.C. § 1320a-3(c)) in a Final Rule issued in November 2023 (88 Fed. Reg. 80,141).Continue Reading CMS Ramps up Process for Identifying Private-Equity Ownership of SNFs

In its recently released 2025 proposed Medicare Physician Fee Schedule (“MPFS”), the Centers for Medicare & Medicaid Services (“CMS”) proposed two important modifications to the Medicare 60-day overpayment refund rule—a new “identified overpayment” standard and codification of a 6-month timeframe to investigate and quantify an overpayment.

A product of the Affordable Care Act, the 60-day rule requires a person to report and return Part A and B overpayments within 60 days of identification. In 2016, CMS clarified that an overpayment is “identified” when a person, “through the exercise of reasonable diligence,” should have identified and quantified an overpayment. In the preamble to the 2016 rule, CMS established that “reasonable diligence” is demonstrated through a timely, good faith investigation, which is, at most, 6 months from the receipt of credible information of a potential overpayment.Continue Reading CMS Revisits Medicare Overpayment Standards in 2025 Physician Fee Schedule

The Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have released a final rule establishing “disincentives” (i.e., penalties) for health care providers that participate in certain Medicare payment programs who have engaged in information blocking, as determined by the HHS Office of Inspector General…

On March 9, 2024, in response to the cyberattack on UnitedHealth Group’s subsidiary, Change Healthcare/Optum, in late February 2024, the Centers for Medicare & Medicaid Services (“CMS”) made available Change Healthcare/Optum Payment Disruption (“CHOPD”) accelerated payments to Medicare Part A providers and advance payments to Medicare Part B suppliers experiencing claims disruptions as a result of the cyberattack.

CMS, through the Medicare Administrative Contractors (“MACs”), may grant CHOPD accelerated and advance payments in amounts representative of up to thirty days’ worth of Part A or Part B claims to eligible Medicare providers and suppliers, which is calculated by taking the total claims paid to the provider/supplier between August 1, 2023 through October 31, 2023 and dividing that number by three.

In this post, we will detail eligibility requirements and terms of the payments. We note that these are not loans or grants. They are advanced and accelerated payments and CMS will immediately begin to recoup the payments. For more details, CMS has issued a Fact Sheet and Frequently Asked Questions.Continue Reading CMS Offers Change Healthcare/Optum Payment Disruption Payments to Medicare Providers and Suppliers

Not a question that we thought we would be asking more than a year after the large omnibus package was signed into law by President Biden. But here we are, with a federal judge in Texas ruling on Feb. 27 that the House’s passage of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (CAA, 2023) violated the “quorum clause” of Article I, Section 5 of the U.S. Constitution.

The court’s ruling puts in jeopardy a number of substantive health policy provisions if it is allowed to stand. Many of the provisions of the act that could be overturned were designed to sunset at the end of 2024 and some have since been reauthorized. But some, like the FDA’s new cosmetic regulatory regime that was included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are more permanent and are now under threat.

The court’s decision limited its impact to only one aspect of the law and enjoined that provision only as applied to public employees in Texas, but the court’s analysis of the way that the law was passed calls into question the entire appropriations act. The Department of Justice (DOJ) has 60 days from the court’s decision to appeal to the U.S. Court of Appeals for the Fifth Circuit. The agency has filed a notice of compliance with the court indicating that neither the DOJ or Equal Employment Opportunity Commission will enforce the law against the state or its agencies.Continue Reading Was the Consolidated Appropriations Act, 2023 Legitimately Passed by the House?

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

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

On February 28, 2023, six of the seven Medicare Administrative Contractors (MACs), who administer Medicare reimbursement on behalf of the Centers for Medicare and Medicaid Services (CMS), came together for a multijurisdictional contractor advisory committee (CAC) meeting. The purpose of the CAC meeting was to discuss remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) for non-implantable devices. Specifically, the MACs were looking to determine whether a local coverage determination (LCD) should be developed to guide those performing remote patient monitoring and utilizing these billing codes.  

The public was permitted to submit written comments and responses to a set of specific discussion questions through March 10, 2023. The questions covered a range of issues including the advantages of RPM/RTM in a clinical setting and the use of third-party vendors in the provision of RPM/RTM services.

Importantly, if any MAC decides to develop an LCD after the CAC, the LCD will be published both on the MAC’s webpage and on the Medicare Coverage Database. The LCD will then go through a public comment period and other administrative hurdles before it can be finalized as policy. To date, there have been no established Medicare coverage policies for remote monitoring services. Continue Reading MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization

Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule on February 15, 2023 that would require Medicare-enrolled skilled nursing facilities (“SNFs”) and Medicaid-enrolled nursing facilities (“NFs”) to disclose additional ownership and management information to CMS and state Medicaid agencies.

The proposed rule would implement Section 1124(c) of the Social Security Act, which was created by the Affordable Care Act to require the disclosure of information about ownership and oversight of SNFs and NFs. CMS first published a proposed rule in 2011 to implement the provision; after receiving public comments, that rule was not finalized. Twelve years later, CMS is trying again, citing concerns about the standard of care that residents receive in these facilities, including those owned by private equity companies and real estate investment trusts (“REITs”).Continue Reading CMS Wants to Know Who Owns Nursing Facilities

The Centers for Medicare & Medicaid Services (CMS) recently issued a Medicare-related final rule invoking the agency’s statutory authority to promulgate retroactive rules after finding that failure to apply the final rule retroactively would be “contrary to the public interest.” The final rule is expected to face vigorous legal challenges in the coming years.

Of note, such challenges may ultimately provide the Supreme Court of the United States with an opportunity to reexamine a constitutional question whose importance goes beyond just the Medicare program: namely, whether a “public interest” statutory standard—whereby Congress directs an agency to regulate according to what the agency determines to be in the public interest—complies with the constitutional prohibition against Congress delegating its legislative power to agencies.Continue Reading “Contrary to the Public Interest” Part II: CMS Again Invokes Retroactive-Rulemaking Authority

On January 26, 2023, the Centers for Medicare and Medicaid Services (CMS) issued guidance for Rural Emergency Hospitals (REHs), through which CMS outlined requirements on eligibility, the conversion process for eligible facilities, and other related information. The guidance clarifies the final rule CMS issued in November that established REHs as a new Medicare provider type, effective January 1, 2023.

This provider type was established to address the concern over closures of rural hospitals, which was particularly problematic during the COVID-19 pandemic. The final rule set forth the Conditions of Participation (CoPs) that REHs must meet in order to participate in the Medicare and Medicaid programs. The standards for REHs closely align with the current CoPs for Critical Access Hospitals (CAHs), available here.

This article provides a brief overview of CMS’s recent eligibility guidance.Continue Reading CMS issues guidance for rural emergency hospital eligibility requirements

On December 28, 2022, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal by a drug manufacturer to enter into an arrangement with certain hospitals to provide up to a specified number of free samples of a long-acting antipsychotic drug for inpatient use.

The OIG indicated it would not impose administrative sanctions, despite the fact that there is no safe harbor available under the federal Anti-Kickback Statute (AKS) to protect the proposed arrangement.Continue Reading OIG approves arrangement involving free drug samples for inpatient hospital use

The Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA) runs more than 1,600 pages long in the official PDF version, so you would be excused if you missed a few key substantive health provisions that were included in the law.

Many of the substantive provisions of the law had been proposed as parts of other packages throughout the year, including the Infrastructure law, the FDA User Fee legislation and the Inflation Reduction Act. However, for one reason or another, these provisions were eliminated from the final versions of the laws that were passed.

The 2023 CAA included, among other aspects, changes to the Medicare payment program and sequestration requirements, additions to the accelerated approval process for drugs, a regulatory regime for cosmetics, and changes related to pre-approval communication of health care economic information to payors, formularies and similar entities.

This is the first in a series of posts exploring some of the more important policy aspects of the law. With part 1, we will explore the changes to Medicare payment rules.Continue Reading Health Provisions of the Consolidated Appropriations Act, 2023: Part 1 Medicare Payments

The Centers for Medicare and Medicaid Services (CMS) is proposing significant and important modifications to its National Coverage Determination (NCD): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). Medicare pays for lung cancer screening, counseling, and shared decision-making visits, and for an annual screening for lung cancer with low dose computed tomography as a preventive service benefit under the Medicare program. CMS issued its NCD in 2015 initiating this screening benefit, but stakeholders have observed that many of the features of the initial NCD served as a barrier to the effectiveness of this screening program. The proposed NCD makes numerous improvements to this program and eliminates many of the barriers to qualified patients’ ability to gain access to important LDCT lung cancer screenings.

Last year, a formal joint request to reconsider the NCD was submitted to CMS by the GO2 Foundation for Lung Cancer, The Society of Thoracic Surgeons, and American College of Radiology (ACR), and CMS received numerous comments from various stakeholders, including from the Association for Quality Imaging. This new proposed NCD is in response to that request and the comments from stakeholders.Continue Reading New and improved proposed national coverage determination on screening for lung cancer with low dose CT

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.

Rebate for Discarded Amounts of Medicare Part B Single-Dose Container or Single-Use Package Drugs

First, the legislation requires manufacturers of single-dose container or single-use package drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of that drug.  The rebates will be charged each quarter, beginning with the first quarter of 2023, and must be paid in regular intervals, as determined appropriate by the Secretary of the U.S. Department of Health and Human Services (“HHS”).  The legislation provides that, in order to enforce this provision, HHS will conduct periodic audits of both drug manufacturers and providers who submit claims.  For violations of this provision, HHS will impose Civil Monetary Penalties in amounts equal to the sum of the amount that the manufacturer would have paid and twenty-five percent of such amount.Continue Reading Health Care Provisions in the Infrastructure Investment and Jobs Act