News & Analysis as of

Comment Period Opioid

Perkins Coie

Regulatory Update: FDA Takes Action on Concentrated Kratom-Derivative Products

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On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA)....more

Holland & Knight LLP

CMS Releases CY 2023 Outpatient and ASC Payment System Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1772-P),...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

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The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Nossaman LLP

CDC Updates Guidance on Opioid Prescriptions

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In a shift from prior policy, the Centers for Disease Control and Prevention (CDC) proposed on February 22, 2022, new guidelines for prescribing opioid painkillers. The new guidance largely avoids figures on dosage strength...more

Holland & Knight LLP

CMS Issues 2022 MPFS and QPP Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) on July 13, 2021, released the calendar year (CY) 2022 Medicare Part B Physician Fee Schedule (MPFS) Proposed Rule, which also includes a number of provisions for the...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #1

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Food/Dietary Supplements - FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more

K&L Gates LLP

CMS Proposes Rules to Implement SUPPORT Act Coverage and Reimbursement of Opioid Treatment

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Recently, the Centers for Medicare & Medicaid Services (“CMS”) published its annual proposed rule outlining potential changes to the Medicare Physician Fee Schedule (“PFS”) for upcoming Calendar Year (“CY”) 2020 (“Proposed...more

McDermott Will & Schulte

SAMHSA Proposed Rule Would Reduce Barriers to Care Coordination

SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more

Proskauer Rose LLP

HHS and SAMHSA Issue a Proposed Rule to Ease Coordination of Care for Patients with Substance Use Disorders

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On August 26, 2019, the U.S. Department of Health and Human Services ("HHS") and the Substance Abuse and Mental Health Services Administration ("SAMHSA") issued a proposed rule amending the regulations governing the...more

Bass, Berry & Sims PLC

Proposed Changes Affect Privacy Protections of Patients Seeking Substance Use Disorder Treatment

On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

Baker Donelson

Most Restrictive Medicare Enrollment Rules Proposed for Opioid Treatment Programs

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Grounded in the bipartisan Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act designed to "alleviate the nationwide opioid crisis," CMS's proposed...more

Bradley Arant Boult Cummings LLP

HHS Proposes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records - Healthcare Alert

On August 26, 2019, the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services (HHS), published its much-anticipated notice of proposed rulemaking to revise 42...more

ArentFox Schiff

CMS Releases CY 2020 Proposed Physician Fee Schedule

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The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #3

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Food/Dietary Supplements - FDA Issues Information for Food Producers Affected by Tropical Storm Barry – The FDA encouraged food producers to utilize established FDA guidance on evaluating the safety of flood-affected food...more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

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Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

Burr & Forman

OCR Highlights - March 2019

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The U.S. Department of Health and Human Services Office of Civil Rights (“OCR”) was hard at work at the end of 2018—emphasizing the active efforts we have seen for the past few years from OCR. Below is a brief summary of some...more

McGuireWoods Consulting

Washington Healthcare Update February 2019 #3

Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more

Sheppard Mullin Richter & Hampton LLP

OCR Seeks Ideas on HIPAA Rule Changes to Promote Value-Based Care and Coordinated Care

The Office for Civil Rights (“OCR”) issued a request for information (“RFI”) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations (the...more

Robinson+Cole Health Law Diagnosis

CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 3: Part D Drug...

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Mintz - Health Care Viewpoints

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more

Stinson LLP

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

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In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

Foley & Lardner LLP

Additional Opioid Policy Changes Announced: What You Need to Know

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Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand...more

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