News & Analysis as of

Patient Access Medicare

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Benesch

Dialysis & Nephrology Digest - March 2025

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As Medicare physician reimbursement continues in 2025 to suffer from damaging shortfalls due to budget neutrality and lack of an inflation adjuster, steps are being taken in Congress to address the issue. On January 31, the...more

Seyfarth Shaw LLP

Executive Order on Health Care Access for Gender-Affirming Treatments for Minors

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Following through on a campaign theme focused on transgender issues and access to gender-affirming health care, on Friday, January 28, President Trump signed an Executive Order, titled “Protecting Children from Chemical and...more

Arnall Golden Gregory LLP

Fourth Circuit Upholds OIG’s Unfavorable Advisory Opinion on Patient Assistance Program

On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

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The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

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Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

Polsinelli

Medicare Changes to Make Drug Coverage More Manageable in 2025

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Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more

Whiteford

New CMS Guidance on Use of Algorithms and AI in Prior Authorizations and Utilization Management

Whiteford on

Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

King & Spalding

OIG Publishes Strategic Plan for Managed Care Oversight on New Featured Webpage

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On August 28, 2023, OIG released a new webpage on managed care oversight, which features the HHS-OIG Strategic Plan for Oversight of Managed Care for Medicare and Medicaid. OIG has designated oversight of managed care as a...more

Pullman & Comley - Connecticut Health Law

The Status of 10 Key CMS Waivers Affecting Health Care Practitioners Following the Expiration of the COVID Public Health Emergency...

The Centers for Medicare & Medicaid Services (CMS) used its emergency waiver authority to relax many aspects of health care delivery during the federal Public Health Emergency for COVID-19 (PHE) to allow health care...more

Bodman

The Expiration of the COVID-19 Public Health Emergency: Part II – Impact on the Provision of Medical Services via Telehealth

Bodman on

As announced by the White House on January 30, 2023, the public health emergency (PHE) is set to end on May 11, 2023. The end of the PHE also brings an end to several flexibilities that were implemented that impact telehealth...more

Fenwick & West Life Sciences Group

A Complex Regulatory Landscape Emerges for Telemedicine

Every year, Rock Health surveys the digital health landscape, noting the changing trends related to adoption by providers, patients and payers of these innovative new technologies....more

Burr & Forman

The DOJ Continues to Scrutinize Telemedicine

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Telemedicine saw a dramatic increase during the COVID-19 pandemic. A recent study from the U.S. Department of Health and Human Services (HHS), released in December 2021, showed an increase in Medicare telemedicine visits...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

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Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Nelson Mullins Riley & Scarborough LLP

ACO REACH – a Good Opportunity?

On February 24, CMS announced that effective January 1, 2023, the Direct Contracting, or DCE, Model would cease to exist. It is replacing DCE with a new form of ACO, the Realizing Equity, Access, and Community Health (REACH)...more

Jones Day

U.S. Federal Actions Support Continued Telehealth Services for Medicare Beneficiaries

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On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more

Polsinelli

Telehealth Policy Update

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There have been several significant developments with regard to Federal government telehealth policy. These include the recently enacted appropriations bill funding the Federal government for the balance of the fiscal year, a...more

Robinson+Cole Health Law Diagnosis

OIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19

The federal Office of Inspector General (OIG) recently published a report (OIG Report) as part of a series of analyses of the expansion and utilization of telehealth in response to the COVID-19 public health emergency.  In...more

Polsinelli

Congress Grants Five Month Extension for Telehealth Flexibilities

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On Tuesday, March 16, 2022, President Biden signed into law H.R. 2471, the Consolidated Appropriations Act, 2022 (“2022 CAA”). This new law includes several provisions that extend the Medicare telehealth waivers and...more

Polsinelli

CMS Greenlights Certain Telebehavioral Health Services Beyond the Public Health Emergency and Provides Important Incentives for...

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The COVID-19 Global Pandemic compelled the Centers for Medicare and Medicaid Services (“CMS”) to revamp its approach to regulating telehealth services and temporarily embrace the modality as a practical treatment option. In...more

Proskauer - Health Care Law Brief

Home Is Where the Health Care Is: New Study Shows Increase in Number of Homebound Older Adults While CMS Expands Home Health...

JAMA Internal Medicine recently published an article finding that the number of homebound adults aged 70 or older more than doubled during the last decade. In 2011, approximately 5% of adults aged 70 or older were homebound...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

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The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

Morgan Lewis - Health Law Scan

Tele-Tuesday: OIG Clarifies Stance on Telehealth Fraud Scrutiny

The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by...more

K&L Gates LLP

Information Blocking Considerations for Providers Under the CMS Interoperability and Patient Access Final Rule

K&L Gates LLP on

In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will...more

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