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OIG Issues Guidance for Ambulatory Surgery Center Safe Harbor’s “One-Third” Income Test

In March, OIG published a new frequently asked questions (FAQ) page, General Questions Regarding Certain Fraud and Abuse Authorities. The FAQ page, located here, includes new guidance for ambulatory surgery center (ASC)...more

Bill Averting Medicare Sequester Cuts Enacted

The House and Senate voted last week, and President Biden signed into law on December 10, 2021, a bill to delay looming reduction in Medicare rates set to take effect in 2022. The bill, the Protecting Medicare and American...more

President Biden Announces Healthcare Provisions in Build Back Better Framework

Last week, President Biden presented an outline of a $1.75 trillion Build Back Better (BBB) social spending reconciliation framework resulting from months of negotiations with House and Senate Democrats. Congressional...more

OIG Issues Advisory Opinion for Alzheimer’s Study to Subsidize PET Imaging Coinsurance Costs

On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more

CMS Proposes Cancelling Automatic Medicare Coverage for Breakthrough Devices

On September 15, 2021, CMS published a proposed rule to repeal a final rule that would have allowed Medicare to automatically cover certain medical devices as soon as they receive FDA approval (the Proposed Rule). The final...more

OIG Issues Advisory Opinion for Pharmaceutical Manufacturer’s Cost-Sharing Assistance Proposal

On September 18, 2020, OIG issued Advisory Opinion No. 20-05 analyzing a pharmaceutical manufacturer’s proposal to offer direct cost-sharing assistance to Medicare beneficiaries prescribed certain of the manufacturer’s new...more

Senate Finance Committee Leadership Makes Bipartisan Push to Increase HHS Transparency for COVID-19 Relief

In a letter dated June 11, 2020, Senate Finance Committee Chairman Charles Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) urged HHS Secretary Alex Azar to take measures to increase transparency around funds...more

District Court Rules that Supreme Court’s Allina Decision Requires Notice-and-Comment Rulemaking for CMS’s Long-Term Care Hospital...

On August 22, 2019, the United States District Court for the District of Columbia held that CMS had unlawfully changed its “must-bill” policy, without going through notice-and-comment rulemaking, when it denied bad-debt...more

HHS Argues It Cannot Be Sued by Patients for Hospitals’ Admission Decisions

n a motion filed last week in Alexander v. Azar, No. 3:11-cv-1703-MPS (D. Conn.), HHS argued that it cannot be sued by Medicare beneficiaries objecting to a hospital’s decision to admit them as inpatients instead of placing...more

CMS Releases Final Rule for Medicare Physician Fee Schedule and Quality Payment Program

On November 1, 2018, CMS issued a final rule (“Final Rule”) which finalizes numerous changes to the Medicare Physician Fee Schedule (“PFS”), the Quality Reporting Program, and the Medicare Shared Savings Program (“MSSP”). ...more

OIG Advisory Opinion Approves Ostomy Samples

OIG recently issued Advisory Opinion No. 18-02 addressing free samples provided by a company that distributes and sells ostomy products. The OIG Advisory Opinion found that, although the company’s practice of distributing...more

5/21/2018  /  Anti-Kickback Statute , Medicare , OIG

CMS Releases FY 2019 Medicare IPPS and LTCH PPS Proposed Rule, Proposes Significant Changes to Several Regulatory Requirements

On April 24, 2018, CMS issued the annual Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for FY 2019 (the Proposed Rule) which will...more

District Court Dismisses FCA Allegations Based Upon Difference of Medical Opinion

This month, the United States District Court for the District of Utah dismissed a relator’s allegations that a cardiac surgeon and two hospitals based in Utah violated the federal False Claims Act (FCA) by billing Medicare...more

HHS Claims it is Unable to Meet Court-Ordered Targets to Resolve Medicare Appeals Backlog

The U.S. District Court for the District of Columbia issued an order on December 5, 2016 compelling HHS to meet certain annual targets to resolve its backlog of hundreds of thousands of pending Medicare claim appeals. HHS...more

Republican Congressional Leader Promises Changes to ACA, Medicare in 2017

On November 17, 2016, House Budget Committee Chairman Rep. Tom Price (R-GA) provided some insights on the major changes Republicans plan to make to the Affordable Care Act and Medicare in 2017. The remarks come on the heels...more

CMS Releases Much Anticipated MACRA Final Rule

On October 14, 2016, CMS issued its Final Rule for the new physician payment system under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA replaced the Medicare Sustainable Growth Rate (SGR) with a new...more

HHS Wins Summary Judgment Against Hospitals Disputing CMS’s Treatment of Part C Days as Days “Entitled to Part A” for Purposes of...

On August 17, 2016 the United States District Court for the District of Columbia granted summary judgment in favor of HHS in a dispute over whether Part C days can be treated as “days entitled to benefits under Part A” for...more

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