News & Analysis as of

Comment Period Public Comment Health Care Providers

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

Tucker Arensberg, P.C. on

On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

Fisher Phillips on

The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Affordable Care Act Proposed Rule Would Broaden Access to Over-the-Counter Contraception Without Cost Sharing

Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more

McDermott Will & Schulte

CMS Revives, Expands Proposed Changes to Medicare Overpayment Rule

In response to comments on the 2022 proposed changes to the overpayments regulation, the Centers for Medicare & Medicaid Services (CMS) proposed additional changes to the overpayment rule to clarify that the obligation to...more

Pullman & Comley - Connecticut Health Law

OHS Issues 2024 Statewide Health Care Facilities and Services Plan

The Connecticut Office of Health Strategy (OHS) has released the 2024 Statewide Health Care Facilities and Services Plan, along with a biennial inventory of all Connecticut health care facilities and services (the Plan)....more

McDermott+

Top 10 Comments on Proposed Mandatory Episode-Based Payment Model, TEAM

McDermott+ on

Time’s up and pencils down! Public comments on the Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation were due this past Monday, June 10, 2024. CMS...more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper Locke on

The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...more

BakerHostetler

Navigating the FDA’s SIUU Guidance: Key Insights for Pharma and MedTech

BakerHostetler on

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

Nossaman LLP

CMS Attempts to Reduce Appointment Times for Medicaid and CHIP Patients - How Will This Impact Your Managed Care Plan?

Nossaman LLP on

A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017.  Timely access to health care providers has long been an...more

K&L Gates LLP

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

Bass, Berry & Sims PLC on

On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more

Burr & Forman

Proposed Rules Could Impact How Health Care Providers Handle Medical Waste

Burr & Forman on

In August 2022, the Alabama Department of Environmental Management (“ADEM”) published proposed changes to its rules for public comment. Specifically, the rules affect how a healthcare provider stores medical waste. If the...more

Barnea Jaffa Lande & Co.

How to Maintain Patient Privacy when Digitally Transferring Medical Information

Barnea Jaffa Lande & Co. on

The Israeli Privacy Protection Authority (PPA) recently published a document for public comments entitled, “Protecting Patients’ Privacy When Transferring Medical Information via Digital Devices and Undesignated Software.”...more

McDermott Will & Schulte

CMS Seeks Provider and Stakeholder Feedback on First National Directory of Healthcare Providers and Services

McDermott Will & Schulte on

The US Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) seeking comments on the creation of a national directory of healthcare providers and services that would become a “centralized...more

Polsinelli

Telehealth: CMS Proposes to Discontinue Audio-Only E/M Services and Virtual Direct Supervision in 2023 Proposed Rule

Polsinelli on

On July 07, 2022 the Centers for Medicare and Medicaid Services (“CMS”) released the 2023 Physician Fee Schedule (“PFS”) Proposed Rule, which proposes several significant changes to Medicare telehealth services....more

Fisher Phillips

Top 10 Takeaways as OSHA Sets Sights on Permanent COVID-19 Standard for Healthcare Settings

Fisher Phillips on

Federal workplace safety authorities just announced that they are accepting additional comments regarding a final permanent standard that will address COVID-19 exposure in healthcare settings. According to the March 22...more

Bowditch & Dewey

New CMS Regulations Mandating Vaccination of Health Care Facility Staff

Bowditch & Dewey on

On November 5, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule requiring that a wide variety of providers and suppliers participating in the Medicare program ensure their staff are...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Goodwin

CMS Proposes Important New Updates to the Sunshine Act’s Open Payments Program

Goodwin on

The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 20, Number 6. Privacy Briefs: June 2020

Report on Patient Privacy 20, no. 6 (June 2020): A divided Indiana Court of Appeals has reinstated a patient’s claim that a hospital is vicariously liable for the actions of a medical assistant who accessed the patient’s...more

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