News & Analysis as of

Proposed Regulation Comment Period Department of Health and Human Services (HHS)

McDermott Will & Emery

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

McDermott Will & Emery on

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

McDermott Will & Emery

The Proposed MHPAEA Regulations: A Comment on the Comments

McDermott Will & Emery on

In our last post, we considered some of the comment letters submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and...more

McDermott Will & Emery

Discerning Congressional Purpose from the Proposed MHPAEA Regulations Comment Letters

McDermott Will & Emery on

We continue our investigation of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and Human Services and the Treasury (the Departments)...more

Bass, Berry & Sims PLC

First Installment of Surprise Billing Regulations Released

On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more

Mintz - Health Care Viewpoints

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...more

Foley & Lardner LLP

CMS Proposes Revisions to Stark Law

Foley & Lardner LLP on

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician...more

Polsinelli

HHS Office for Civil Rights Proposes Changes to Section 1557 Rules: What Health Care Providers Need to Know

Polsinelli on

On May 24, 2019, the Department of Health and Human Services (“HHS”) announced its proposed changes to the regulations issued under Section 1557 of the Affordable Act Care (“ACA”). Section 1557 is the primary...more

Proskauer - Employee Benefits & Executive...

HHS Proposes to Narrow Scope of Nondiscrimination Regulations under Affordable Care Act

The U.S. Department of Health and Human Services (HHS) recently proposed regulations that scale back nondiscrimination protections under Section 1557 of the Affordable Care Act (ACA). The new regulations, proposed on May 24,...more

Foley & Lardner LLP

CMS Proposes to Ever-So-Slightly Expand Stark Law Exceptions for Compensation Arrangements

Foley & Lardner LLP on

The Centers for Medicaid & Medicare Services (CMS) proposes to revise regulations issued pursuant to the Federal physician self-referrals Statute (Stark Law) to harmonize the regulations with the newly enacted Bipartisan...more

Tucker Arensberg, P.C.

Temporary Regulations Issued by the PA Department of Health for Medical Marijuana Laboratories

Tucker Arensberg, P.C. on

The Pennsylvania Department of Health has posted suggested temporary regulations for Laboratories that will be testing medical marijuana under the Medical Marijuana Act. There is an open comment period on these proposed...more

Tucker Arensberg, P.C.

PA Department of Health Issues Temporary Regulations for Medical Marijuana Growers/Processors and Draft Temporary Regulations for...

Tucker Arensberg, P.C. on

The Pennsylvania Department of Health has posted suggested temporary regulations for Dispensaries under the Medical Marijuana Act. There is an open comment period on these proposed regulations until November 4, 2016. After...more

Foley & Lardner LLP

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

Balch & Bingham LLP

Nondiscrimination in Health Programs and Activities: Proposed Rules from HHS

Balch & Bingham LLP on

...So, why did HHS need over five years to propose the set of rules published September 8? Here are a few highlights. For brevity’s sake, we omit foreign language service requirements, disability accommodation, compliance...more

Manatt, Phelps & Phillips, LLP

Manatt on Health Reform: Weekly Highlights - September 2015 #2

Colorado’s uninsured rate is down 9 percentage points in four years; Michigan requests increased cost-sharing for its Medicaid expansion population above the federal poverty line; and, HHS’s proposed guidance strengthens...more

King & Spalding

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

King & Spalding on

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Mintz - Health Care Viewpoints

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

McDermott Will & Emery

CMS Proposes Value-Based Purchasing Model, Other Updates to the 2016 Home Health Prospective Payment System

McDermott Will & Emery on

The U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) published its proposed update to the home health prospective payment system (HHPPS) for calendar year (CY) 2016 in the July...more

K&L Gates LLP

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

K&L Gates LLP on

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

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