Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
Kim Brandt on the Latest Washington Healthcare News
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more
The Centers for Medicare & Medicaid Services issued its long-anticipated final rule clarifying the 60-day overpayment refund obligation (the 60-Day Rule) first established in a 2016 regulation for Medicare Part A and B...more
In the Calendar Year 2025 Medicare Physician Fee Schedule, the Centers for Medicare & Medicaid Services (CMS) finalized changes to the Medicare Parts A and B Overpayment Rule that were proposed in two prior rulemakings. This...more
Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more
Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more
On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning...more
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
With the May 11, 2023 expiration of the federal public health emergency (PHE) for COVID-19, many operational flexibilities healthcare providers used during the PHE will now sunset. Some flexibilities end immediately while...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
Report on Medicare Compliance 30, no. 11 (March 22, 2021) - A cancer center has won its appeal of $2 million in Medicare claim denials in a case about modifier 25 and the extrapolation of an overpayment. Problems with the...more
California physician Donald Woo Lee was found guilty Oct. 17 for his role in providing medically unnecessary procedures to Medicare beneficiaries, upcoding, and repackaging single-use catheters for re-use, the Department of...more
The 60-Day Overpayment Refund Rule (60-Day Rule) was enacted as Section 6402 of the Affordable Care Act (ACA) on March 23, 2010. ...more
In what has become widely known as the “60-day rule,” the Affordable Care Act (ACA) requires that Medicare and Medicaid overpayments be reported and returned within the later of the date which is 60 days after the date on...more
Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs? ...The Medicare Advantage...more
Providers, plans, and vendors that provide services under the Medicare Advantage program, should be aware that the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) is once again...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more
Overpayments to healthcare providers receiving Medicare reimbursements are at risk of civil and criminal enforcement action if not attuned to a particular reimbursement rule and diligent in compliance with the rule’s...more
DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE - On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more
In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to...more
NATIONAL - Medicare Proposes New Part B Payment System - The Center for Medicare and Medicaid Services (CMS) on April 27 proposed a new rule that would transform Medicare Part B reimbursement to practitioners into...more
The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification. Although this requirement has...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more