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Public Comment Opioid

Venable LLP

FDA Announces Plan to Restrict 7-OH Opioid Products

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On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Holland & Knight LLP

CMS Issues 2020 MPFS and QPP Final Rule

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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2019, published the Calendar Year (CY) 2020 Final Rule for the Medicare Physician Fee Schedule (MPFS). The MPFS dictates Medicare rates and policies under Part B,...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

Bass, Berry & Sims PLC

CMS Proposal Vastly Expands Medicare Coverage for Opioid Treatment

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On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder...more

Mintz - Health Care Viewpoints

Open Payments Program Expansion

On July 30, 2019, the Centers for Medicare & Medicaid Services ("CMS") announced more proposed changes to the Open Payments Program. The Open Payments reporting requirements, otherwise known as the Sunshine Act, require...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

Bricker Graydon LLP

Ohio Board of Pharmacy releases proposed rules on pain management and office-based opioid treatment clinics

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The State of Ohio Board of Pharmacy recently issued a number of proposed rule sets for public comment. Notably included were new rules on the operation of office-based opioid treatment (OBOT) clinics and rules governing the...more

Mintz - Health Care Viewpoints

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to...more

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