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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…

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

On May 3, 2021, the Centers for Medicare & Medicaid Services (CMS) published an 81-page final rule to both extend and change the Comprehensive Care for Joint Replacement (CJR) model. We previously reported on the proposed rule here. The CJR model was initially implemented by way of notice-and-comment rulemaking in April 2016; the recent…

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

The much-anticipated final rules modernizing the safe harbors under the Anti-Kickback Statute (AKS) and the physician self-referral exceptions under the Stark Law are officially under review by the Office of Management and Budget (OMB). The Department of Health and Human Services (HHS) anticipates publishing the final rules in August 2020, although that target date is…

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include: (1) identifying areas of similarity…

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the “sunset” provisions).
Continue Reading Final Rules Issued Extending Protections of Electronic Health Record Donations

CMS Administrator Donald Berwick is resigning as CMS Administrator, effective December 2, 2011 (under his recess appointment, Dr. Berwick could only serve until December 31, 2011 without Senate confirmation, which Senate Republicans pledged to block). President Obama has announced his intention to nominate Marilyn B. Tavenner to fill the CMS Administrator’s position. Ms. Tavenner…

The Patient Protection and Affordable Care Act (“PPACA”), enacted in March 2010, requires that the Secretary (“Secretary”) of the Department of Health & Human Services (“HHS”) establish a Medicare “Shared Savings Program” by January 1, 2012.  The Shared Savings Program is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to…

On November 30, 2010, CMS formally withdrew its controversial May 29, 2007 final rule entitled “Medicaid Program; Cost Limit for Providers Operated by Units of Government and Provisions To Ensure the Integrity of Federal-State Financial Partnership,” which sought to limit federal Medicaid payments to government health care providers and restrict certain state Medicaid …

On November 16, 2010, CMS formally established a new Center for Medicare and Medicaid Innovation (Innovation Center). Created by the ACA, the Innovation Center will examine new ways of delivering health care and paying health care providers that can save money for Medicare and Medicaid while improving the quality of care. Richard Gilfillan, MD, has been …

On October 26, 2010, CMS is hosting a “Special Forum” on development of the Medicare hospital value-based purchasing (VBP) program, as required by Section 3001 of the ACA.  Under Section 3001, an inpatient hospital quality incentive payment program must be established effective with the FY 2013 inpatient prospective payment system (IPPS) payment determination for Medicare…

Richard Gilfillan, MD, has been named Acting Director of a new Center for Medicare and Medicaid Innovation (CMI) within CMS. The Affordable Care Act established the CMI to research, develop, test, and expand innovative delivery arrangements to reduce program expenditures under federal health care programs while enhancing the quality of care furnished to beneficiaries.

CMS has announced its annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The 2011 AIC threshold amounts are $130 for ALJ hearings and $1,300 for judicial review. The new threshold amounts are effective for requests for ALJ hearings…

According to a recent OIG report, CMS does not always comply with the statutory requirement to report adverse actions against providers to the HIPDB, a national data bank administered by the Health Resources and Services Administration (HRSA) that contains reports of adverse actions against health care practitioners, providers, and suppliers. With regard to specific provider …