Tag Archives: cms

Final rules modernizing Anti-Kickback Statute and Stark Law under review by OMB: anticipating the future of value-based care

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, FDA Establishing Interagency Task Force on LDT Quality Oversight

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

Final Rules Issued Extending Protections of Electronic Health Record Donations

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

Marilyn Tavenner to Replace CMS Administrator Donald Berwick

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

Summary and Analysis of Medicare’s Shared Savings Program for Accountable Care Organizations

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

CMS Withdraws 2007 Medicaid Financing Rule

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

CMS Launches Center for Medicare and Medicaid Innovation

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

Upcoming Congressional Hearings, Markups

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

CMS Hospital Value-Based Purchasing Program Special Forum (Oct. 26)

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

Dr. Gilfillan Selected to Head CMS Innovation Center

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

Amount in Controversy Thresholds for 2011

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

CMS Reporting to the Healthcare Integrity and Protection Data Bank (HIPDB)

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

CMS Forum on ESRD Quality Incentive Program (Aug. 24, 2010)

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

Memorandum of Understanding Between FDA and CMS

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

CMS Delays PECOS Enrollment Requirement for Ordering Physicians

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

CMS Updates on Part D Coverage Gap Rebates/Discount Program

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 Alerts on MSP Mandatory Reporting Requirements

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

Q&As on ACA Medicare “Accountable Care Organization” Shared Savings Program

CMS’s Office of Legislation has released preliminary questions and answers on the ACA’s provisions to encourage the development of Accountable Care Organizations (ACOs) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare beneficiaries and reduce unnecessary costs. Participating ACOs that meet specified quality performance standards will be eligible to receive … Continue Reading

Advance Primary Care (Medical Home) Demonstration

CMS is soliciting state applications for the “Multi-payer Advanced Primary Care Practice Demonstration,” under which Medicare and Medicaid, along with private insurers, will join together in state-based efforts to improve the delivery of primary care and lower health care costs. HHS describes an Advanced Primary Care (APC) practice, also referred to as a patient-centered medical … Continue Reading
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