News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) Centers for Medicare & Medicaid Services (CMS) Medicare Part B

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Epstein Becker & Green

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

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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

Foley & Lardner LLP

Medicare Overpayments: CMS Proposes Regulation Establishing Six Month Suspended Deadline for 60-Day Refund Rule

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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

Lippes Mathias LLP

HHS Issues Final Rule to Expand Discrimination Prohibition in Health Care Services

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The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) and the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule on May 6, 2024 (the “Final Rule”) under Section 1557 of the...more

Wiley Rein LLP

Recent Developments in Pharmacy-Related Legislation and Regulations

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Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more

Stevens & Lee

U.S. Department of Health and Human Services Issues Final Rule Expanding Nondiscrimination Protections

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On April 26, 2024, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights and the Centers for Medicare & Medicaid Services issued a final rule under Section 1557 of the Affordable Care Act,...more

McDermott Will & Emery

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

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On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

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

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

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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

Holland & Knight LLP

With Inflation Reduction Act Signed, Other Health Policy Issues Ahead for Congress

Holland & Knight LLP on

Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

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​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2022 #2

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Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #2

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Sheppard Mullin Richter & Hampton LLP

CMS’s Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021 #2

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Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more

Foley & Lardner LLP

CMS Issues Final Rule Extending and Revising Comprehensive Care Joint Replacement Episode-Based Payment Model

Foley & Lardner LLP on

The Centers of Medicare and Medicaid Services (CMS) issued a Final Rule (the Rule) on April 29, 2021 extending and making various revisions to the Comprehensive Care for Joint Replacement Model (the CJR Model). The CJR Model...more

Polsinelli

The Fate of the Trump Administration’s Controversial Most Favored Nation Drug Pricing Model Is Unclear Given Mounting Legal...

Polsinelli on

On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Bricker Graydon LLP

A 60-Day Overpayment Refund Rule update

Bricker Graydon LLP on

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

McGuireWoods Consulting

Washington Healthcare Update

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Congress - House - Likely New Health Leadership - With the change in control of the House of Representatives in the next Congress, there will be “new” faces leading the health care agenda....more

Roetzel & Andress

Federal Court Overturns CMS Overpayment Rule

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A recent ruling by a federal district court could have a significant impact on how certain health insurers, specifically those providing coverage pursuant to Medicare Parts C (i.e., Medicare Advantage insurers) and D (i.e.,...more

Husch Blackwell LLP

Open Enrollment Update: CMS Releases Benefit And Market Data

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Anticipating open enrollment season for coverage in 2019, the Centers for Medicare and Medicaid Services (CMS) released coverage and premium information that will factor into consumer decisions about Medicare and individual...more

Arnall Golden Gregory LLP

Court Nixes CMS’s Negligence Standard for Applying False Claims Act Liability for Failure to Report and Return Overpayments

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

Baker Donelson

OIG June 2018 Work Plan Update

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The OIG added eight new items to its Work Plan in the June 2018 update. Among the items addressed are contingency planning for information technology systems, denials and appeals in Medicare Part D, review of certain home...more

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