News & Analysis as of

Department of Health and Human Services (HHS) Opioid Prescription Drugs

BakerHostetler

DOJ Announces Record-Breaking National Health Care Fraud Takedown Against 324 Defendants with Over $14.6 Billion in Alleged Fraud

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The DOJ announced on June 30 an unprecedented Health Care Fraud Takedown resulting in criminal charges against 324 defendants (including 96 doctors, nurse practitioners, pharmacists and other licensed providers), with an...more

Epstein Becker & Green

DEA Telemedicine Rules Further Delayed Until (Nearly) 2026

Epstein Becker & Green on

Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will...more

Bass, Berry & Sims PLC

The Future of Telemedicine Prescribing Comes Into Focus: New Final and Proposed Rules

On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...more

Holland & Knight LLP

DEA Extends Access to Telehealth Treatment with New Rules

Holland & Knight LLP on

The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules...more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

Lathrop GPM on

The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Goodwin

SAMHSA Final Rule Codifies Opioid Treatment Program Telehealth and Take-Home Medication Flexibilities

Goodwin on

On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more

Benesch

Health & Human Services Releases Final Rule for Opioid Treatment Programs

Benesch on

The U.S. Department of Health and Human Services (“HHS”) and the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published a final rule on Feb. 2, 2024, that cemented significant Pandemic-era flexibilities...more

Sheppard Mullin Richter & Hampton LLP

HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment...

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Foley & Lardner LLP

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends

Foley & Lardner LLP on

On February 24, 2023, the Drug Enforcement Agency announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The proposed rules are open for public...more

Dickinson Wright

Breaking Down Barriers: Expanded Access to Medication for Opioid Use Disorder

Dickinson Wright on

The Substance Abuse and Mental Health Services Administration (SAMHSA) 2021 National Survey on Drug Use and Health estimated that 9.2 million people ages 12 and older had misused opioids in the past year. Death by overdose...more

McGuireWoods Consulting

Washington Healthcare Update - August 2021

This week in Washington: Senate agrees on infrastructure compromise, budget resolution with reconciliation instructions to be voted on....more

Bricker Graydon LLP

2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changes

Bricker Graydon LLP on

On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...more

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

K&L Gates LLP

HHS Exemptions for Buprenorphine (but not Methadone) Prescribers

K&L Gates LLP on

For the year ending August 2020, provisional data from the Centers for Disease Control and Prevention shows that opioid overdose deaths increased 26.8 percent compared to the previous 12 months, with opioid overdoses...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Mintz - Health Care Viewpoints

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more

Epstein Becker & Green

Deadline Looms for Responding to DEA’s Proposed Aggregate Production Quotas for 2021

Epstein Becker & Green on

On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of...more

Holland & Hart LLP

Modernizing Part 2 Regulations: Improving Care Coordination

Holland & Hart LLP on

The U.S. Department of Health and Human Services (HHS) originally implemented 42 CFR Part 2 regulations in 1975 to ensure confidentiality of substance use disorder (SUD) records at a time when there were no broader healthcare...more

Mintz - Health Care Viewpoints

HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers

The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD)...more

BakerHostetler

Capitol Hill Healthcare Update - February 2020 #2

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SURPRISE BILLING PROGRESS DRIVES THE WEEK - Legislation to address surprise medical bills is moving forward this week, as two House committees mark up their own plans to protect patients....more

McGuireWoods Consulting

Washington Healthcare Update - February 2020 #2

This week in Washington: Senate to hold hearing on home healthcare in rural America, House to hold hearing on protecting women's access to reproductive healthcare....more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

McGuireWoods LLP

New HIPAA Change to Curb Opioid Abuse Requires Pharmacies to Note Partial-Fill Prescriptions

McGuireWoods LLP on

The U.S. Department of Health and Human Services finalized a rule last week that will require pharmacies to track when prescriptions are partially filled. This rule is part of an ongoing effort by HHS to stem the tide of...more

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