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#WorkforceWednesday: AI Technology Regulations, Transparency in AI, OSHA's Permanent COVID-19 Standard - Employment Law This Week®
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More CBD Certainty: Clearing Confusion over Hemp in New York State
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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...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
Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more
The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...more
As promised, here is a summary of some key provisions in CMS’ proposed rule relating to the Medicare Advantage and Part D programs for contract years 2021 and 2022. CMS is soliciting comments on a number of issues and we urge...more
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more
On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more
Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more
On November 30, 2018, the Centers for Medicare & Medicaid Services (CMS) published 83 Fed. Reg. 62152, which proposes changes to Medicare Part D (prescription drug benefit) and drug plans offered by Medicare Advantage...more
This Week: Congress focuses on organizing for the next Congress and the continuing resolution; previews of drug pricing legislation for the next Congress; CMS issues controversial guidance concerning how states can use...more
On October 26, the Centers for Medicare and Medicaid Services (CMS) released a 362-page proposed regulation that makes changes to three expected areas: - New telehealth flexibilities for Medicare Advantage (MA) plans....more
Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more
The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service,...more
On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more
Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline....more
This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more
On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,...more
On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more
Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more
Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more
On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more
The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more
On July 3, 2014, CMS released the CY 2015 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. In its proposal, CMS seeks, among other things, to increase...more