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Healthcare Proposed Rules

McDermott+

McDermott+ Check-Up: November 8, 2024

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Republicans Win Control of White House and Senate, Seem Poised to Maintain Control of House. Former President Donald Trump will return to the White House, and Republicans also gained control of the Senate. Some toss-up House...more

Manatt, Phelps & Phillips, LLP

CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation...more

Bradley Arant Boult Cummings LLP

Update: Federal and State Agencies Release Telehealth-Related Updates

Following the telehealth boom initiated by the COVID-19 pandemic, agencies continue to contend with competing interests in the telehealth space. Current legislation on both state and federal levels indicates that while these...more

Foley & Lardner LLP

New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

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After considerable pressure from both Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on October...more

McCarter & English, LLP

CMS Proposes Further Changes to Medicare Overpayment Rule

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The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule, 89 FR 61596, that revives portions of a 2022 proposal to amend the Medicare Overpayment Rule. The 2024 proposed rule comes after...more

Troutman Pepper

CFPB Intensifies Scrutiny on Medical Debt Collection Practices

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On October 1, the Consumer Financial Protection Bureau (CFPB or Bureau) issued an advisory opinion aimed at debt collectors and emphasizing their obligations under the Fair Debt Collection Practices Act (FDCPA) and Regulation...more

Seyfarth Shaw LLP

Final Rules Related to the Mental Health Parity and Addiction Equity Act May Drive You Wild

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Seyfarth Synopsis: On September 9, 2024, the Departments of the Treasury, Labor, and Health and Human Services (the “Departments”) released highly anticipated Final Rules under the Mental Health Parity and Addiction Equity...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Seyfarth Shaw LLP

Agencies Release Final Mental Health Parity Rule

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On Monday, September 9, 2024, the Departments of Health and Human Services, Labor and Treasury (the “Departments”) issued their final rule regarding the nonquantitative treatment limitation (NQTL) comparative analysis...more

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

Ballard Spahr LLP

Chopra Defends CFPB’s Medical Debt Proposed Rule

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CFPB Director Rohit Chopra on Thursday defended his agency’s proposed rule to prohibit the listing of medical debt on credit reports, contending that such debts are not a fair indication of a person’s financial health....more

McDermott Will & Emery

ASTP Proposes Certification Criteria for Patient, Payer and Provider APIs

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Baker Donelson

CMS Proposes Extending COVID-Era Telehealth and Supervision Flexibilities through CY 2025

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The Centers for Medicare & Medicaid Services (CMS) proposed to extend a number of COVID-era regulatory flexibilities related to telehealth, remote services, and supervision in the CY 2025 Medicare Physician Fee Schedule (PFS)...more

Troutman Pepper

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

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In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

Ballard Spahr LLP

Final Section 1557 Rules: Highlights for Health Plan Sponsors

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The U.S. Department of Health and Human Services (HHS) has issued final regulations on the nondiscrimination rules set forth in Section 1557 of the Affordable Care Act. The new rules apply to certain group health plans, as...more

Ballard Spahr LLP

CFPB issues proposal to prohibit use of medical debt information in credit decisions

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The steady drumbeat of steps during Rohit Chopra’s tenure as CFPB Director to call into question the reliability and predictability of medical debt information in credit underwriting reached a crescendo last week with the...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

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On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

Troutman Pepper

New Staffing Mandates for Long-Term Care Facilities

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Last month, on April 22, the Centers for Medicare & Medicaid Services (CMS) issued its Minimum Staffing Standards for Long-Term Care Facilities final rule, which will apply to any long-term care (LTC) facilities that receive...more

McDermott Will & Emery

Heard at the 2024 Antitrust Law Section Spring Meeting: Part I

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The American Bar Association Antitrust Law Section’s annual Spring Meeting is underway in Washington, DC. The annual Spring Meeting features updates from federal, state and international antitrust enforcers and extensive...more

King & Spalding

CMS Issues Hospice Proposed Payment Rule

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Last week, CMS issued a proposed rule (Proposed Rule) for fiscal year (FY) 2025 aiming to update Medicare hospice payments and aggregate cap amount in accordance with existing statutory and regulatory requirements. The...more

McDermott Will & Emery

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Health Care Compliance Association (HCCA)

News Briefs: September 11, 2023

The HHS Office for Civil Rights (OCR) on Sept. 7 announced a proposed rule to bar discrimination based on disability.[1] “The rule, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal...more

Sheppard Mullin Richter & Hampton LLP

CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes

On December 13, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, titled Advancing Interoperability and Improving Prior Authorization Processes (“Proposed Rule”), to improve patient and...more

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