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U.S. House of Representatives Passes Drug-Pricing Bill

On December 12, 2019, the U.S. House of Representatives passed a major Democratic drug-pricing bill, H.R. 3, or the “Elijah E. Cummings Lower Drug Costs Now Act.” If enacted, HHS would be allowed to negotiate the prices of...more

Georgia Officials Announce Section 1115 Waiver Application to Expand Medicaid Eligibility

On November 4, 2019, Georgia officials announced a proposed Section 1115 demonstration waiver, referred to as the “Georgia Pathways Health Waiver,” to expand Georgia’s Medicaid program eligibility for non-disabled adults. If...more

False Claims Act Case Based on Stark Law Violations to Continue After the Third Circuit Revives Whistleblowers’ Claims

On September 17, 2019, the U.S. Court of Appeals for the Third Circuit revived three whistleblowers’ claims alleging that the University of Pittsburgh Medical Center (UPMC) and neurosurgeons employed by three subsidiary...more

Medicare Changes Coverage Restrictions to Allow Lower Volume Facilities to Perform Aortic Valve Procedure

On June 21, 2019, CMS finalized a decision memo updating the national coverage policy for Transcatheter Aortic Valve Replacement (TAVR), a procedure used to address aortic stenosis. The decision changes the volume...more

CMS Announces New Opportunities to Test Integrated Care Models for Dually Eligible Individuals

On April 26, 2019, CMS issued a letter to State Medicaid Directors (2019 Letter) inviting states to partner with CMS in one of three new opportunities to test state-driven approaches to integrating care for individuals who...more

CMS Seeks Public Comments on Proposed Changes to Hospital Quality Star Ratings

On February 28, 2019, CMS issued a 48-page request for public comment (the Request) on several potential updates to and future considerations for the methodology used in the Overall Hospital Quality Star Rating. As explained...more

Coalition of Senators Voice Concerns Over Liver Distribution Policy Changes

On January 22, 2019, twenty-two (22) Senators sent a bipartisan letter to HHS (the Letter) to voice their concerns over a change in the national liver distribution policy adopted on December 3, 2018 (Revised Policy), by the...more

CMS Launches New Procedure Price Lookup Tool

On November 30, 2018, CMS launched the Procedure Price Lookup tool that enables consumers to search the tool by type of procedure to compare the national average cost for procedures performed in both ambulatory surgery...more

Fifth Circuit Declares Stalemate in Aetna Out-of-Network Payment Dispute

On July 31, 2018, the U.S. Court of Appeals for the Fifth Circuit weighed in on a five-year out-of-network payment dispute between Aetna Life Insurance Co. (Aetna) and North Cypress Medical Center (NCMC), a physician-owned...more

D.C. District Court Judge Strikes Down Kentucky’s Medicaid Work Requirement

Days before the Medicaid work requirement for Medicaid patients in Kentucky was to take effect, U.S. District Court Judge James Boasberg struck down the requirement in a decision issued June 29, 2018....more

Advocacy Group Files Suit against HHS to Stop 2% Sequestration Cut to Medicare Part B Drug Reimbursement

On May 30, 2018, the Community Oncology Alliance, Inc. (Alliance), a non-profit organization that advocates for community oncology practices, sued HHS, HHS Secretary Azar, the Office of Management and Budget (OMB) and OMB...more

Senate Passes Bill Authorizing Electronic Health Record Incentive Payments to Behavioral Health Providers

On May 8, 2018, the Senate passed S. 1732, a bipartisan bill giving CMS the authority to offer incentive payments to “behavioral health providers” who implement certified electronic health records. The bill, titled,...more

Fifth Circuit Says Federal Court has Jurisdiction to Grant Injunction Against Recoupment of Alleged Overpayment until ALJ Hearing

A March 27, 2018 decision by the United States Court of Appeals for the Fifth Circuit, Family Rehabilitation Incorporated v. Azar, II, No. 17-11337 (“Family Rehab”), potentially paves the way for Medicare providers to seek...more

Escobar Pleading Standard Narrows Scope of FCA Allegations Against UnitedHealth Group

The U.S. Department of Justice elected not to file a second amended complaint-in-intervention in U.S. ex rel. Poehling v. UnitedHealth Group Inc., 2:16-cv-08697, a Federal False Claims Act (FCA) case pending in the U.S....more

OIG Issued a No-Sanctions Letter to PhRMA Following Rescission of OIG Advisory Opinion Regarding a Patient Assistance Charity...

On January 4, 2018, OIG issued a letter to Pharmaceutical Research and Manufacturers of America (PhRMA) addressing OIG’s Final Notice of Rescission of OIG Advisory Opinion No. 06-04 dated November 28, 2017. The OIG’s 2018...more

1/25/2018  /  Health Care Providers , OIG , PHRMA

CMS Updates the Medicare Program Integrity Manual Provisions Addressing ALJ Hearings

On October 13, 2017, HHS issued a transmittal change request to update Section 3.9 of the Medicare Program Integrity Manual (MPIM), stating that only one entity (CMS or a CMS contractor) may attend an ALJ hearing as a party,...more

Six Home Health Providers Agree to Pay $1.8 Million to Settle False Claims Act Liability

On September 5, 2017, the Department of Justice (DOJ) announced that six Tennessee-based home health entities agreed to pay the United States $1.8 million to settle potential violations of the Stark Law and/or Anti-Kickback...more

CMS Clarifies the Application Processes for the Mid-Build Exception under the 21st Century Cures Act and for Relocation Exception...

CMS has issued guidance documents addressing how hospitals can (1) qualify an off-campus provider-based department (PBD) for the “mid-build” exception set forth in the 21st Century Cures Act and (2) request from their CMS...more

House Passes 21st Century Cures Act

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more

Optometrists Who Leased Space at Texas Wal-Mart Stores Cannot Recover Damages for Technical Violation of State Licensing Law Under...

The United States Court of Appeals for the Fifth Circuit, in a per curium decision issued October 27, 2016 in Forte v. Wal-Mart Stores, Inc., vacated approximately $1.4 million in statutory civil penalties awarded by the...more

CMS Issues Final Rule Addressing Improvements in Care, Safety and Consumer Protections for Nursing Home Residents

On September 28, 2016, CMS issued a final rule to improve the care and safety of nursing home residents in long-term care facilities. The new rules are intended to reduce unnecessary hospital readmissions and infections,...more

Senate Finance Committee Chairman Releases White Paper Examining Potential Reforms to the Stark Law

On June 30, 2016, Senate Finance Committee Chairman Orrin Hatch released a white paper examining potential reforms to the Federal Stark law. The white paper, entitled “Why Stark, Why Now? Suggestions to Improve the Stark...more

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