We recently released the 2021 U.S. Health Care Outlook digital white paper, an industry trends report written by numerous lawyers on our health care team. The Health Care Outlook gives an in-depth look at the major regulatory issues that life science and health care companies can expect to face throughout the rest of this year … Continue Reading
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 final … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 between … Continue Reading
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
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 currently … Continue Reading
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 … Continue Reading
On January 26, 2011, President Obama again submitted to the Senate his nomination of Dr. Donald M. Berwick to be Administrator of CMS. Dr. Berwick has been serving as Administrator since July 2010 through a recess appointment, which bypassed the Senate confirmation process.… Continue Reading
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 financing arrangements. CMS … Continue Reading
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 named … Continue Reading
On November 17, 2010, the Senate Finance Committee is holding a hearing on "Strengthening Medicare and Medicaid: Taking Steps to Modernize America’s Health Care System," at which CMS Administrator Donald Berwick, M.D. is scheduled to testify. Also on November 17, the Senate Health, Education, Labor and Pensions Committee is scheduled to consider a number of … Continue Reading
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 discharges occurring on … Continue Reading
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.… Continue Reading
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 and judicial review … Continue Reading
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 types, … Continue Reading
On August 24, 2010, CMS is hosting a listening session regarding the recent trend of Medicare beneficiaries receiving extended observation care as a hospital outpatient. Pre-registration is required.… Continue Reading
On August 24, 2010, CMS is hosting a Special Open Door Forum on the Medicare End Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for payment year 2012. The call, which is designed for ESRD facilities and provider, supplier, and laboratory groups, will focus on CMS’s August 12 proposed rule that would establish performance standards … Continue Reading
This post was written by Paul Sheives and Areta Kupchyk. The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy, utilization, coverage, payment, … Continue Reading
On July 13, 2010, CMS issued a letter to state Medicaid directors on implementation of Section 6506 of the ACA, which gives states up to one year from the date of discovery of an overpayment for Medicaid services to recover, or to attempt to recover, the overpayment before making an adjustment to refund the federal … Continue Reading
On July 7, 2010, President Obama announced the recess appointment of Dr. Donald Berwick to be CMS Administrator, bypassing the Senate confirmation process.… Continue Reading
CMS has announced that it is not implementing at this time changes that would have automatically rejected certain Medicare claims based on orders, certifications, and referrals made by providers that have not had their PECOS enrollment applications approved by July 6, 2010. Nevertheless, the Affordable Care Act provides that only a Medicare enrolled physician or … Continue Reading
The ACA provides a tax-free, one-time $250 check for beneficiaries who reach the Part D coverage gap during 2010 and are not eligible for low-income subsidies. A June 10, 2010 CMS memo to Part D plan sponsors provides additional information on implementation of coverage gap rebate. The memo notes that prompt submission of prescription drug … Continue Reading
CMS has issued a series of guidance documents on the Medicare Secondary Payer (MSP) mandatory reporting provisions in section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA). The new guidance documents address: risk management write-offs by providers, physicians, suppliers, and non-provider/supplier entities; reporting health reimbursement arrangements; what entities are MMSEA Section … Continue Reading
