Topics

ACA

Nondiscrimination in Healthcare: HHS’s New Final Rule Under Section 1557 of the Affordable Care Act Guidance for Hospice Providers to Address the Visitors Ban Imposed by Nursing Facilities to Reduce the Spread of COVID-19 Medicare for All, Part 2: Cost, Financing and Impact on Provider Payment

Academic Medical Centers

What Medical Schools and Hospitals Should Know About HHS OCR’s Newly Announced DEI-Targeted Investigations Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at Trial Physician Loses Rare Criminal E/M Fraud Trial

Accountable Care Organizations

Husch Blackwell at the NAACOS Conference The “Pathways to Success” Final Rule is Here: ACO’s Face Big Decisions Performance Report: “Pathways” Rules Help CMS Advance Two-Sided Risk Sharing

Antitrust

Healthcare Industry Faces Heightened Antitrust Scrutiny Under New Merger Guidelines, HSR Rules U.S. DOJ sues to stop health plan mergers Unique Considerations in Healthcare M&A Part 3 – Closing/Post-Closing

Behavioral Health Provider

New California Transparency Requirements for Substance Abuse Treatment Centers Husch Blackwell Represents Talkspace in SPAC Combination New Mental Health and Substance Use Disorder Parity FAQs

Children's Hospitals and Pediatric Providers

Decoding Legalese of Value-Based Contracts American Health Law Association New Publication on Emerging Issues in Health Equity in the U.S.: Legal, Legislative, and Policy Perspectives Two Strikes for DOJ: Health Care Executives Not Guilty of Antitrust Conspiracies

Clinical Research & Trials

DEA’s Pending Telemedicine Rule: What Ketamine Clinics Need to Know Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Compliance

Clinic to Cap Table: Building Companies and Advisory Roles the Right Way DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Data Privacy & Security/HIPAA/HITECH

Big News in AI Policy: Proposed 10-Year Moratorium on State AI Regulation OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations

Employee Benefits

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare Benefits

Fraud & Abuse

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

Government Issues

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center False Claims Act Update: A Mid-Year Review (2023)The Sword Becomes a Shield

Health Coverage

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare Benefits

Healthcare Litigation

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case

Healthcare Providers

Wisconsin Governor Signs Pelvic Exam Informed Consent Bill, Vetoes Direct Primary Care Agreement Bill DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Healthcare Regulatory

California Enhances Regulation of Private Equity Investments in Healthcare Wisconsin Governor Signs Pelvic Exam Informed Consent Bill, Vetoes Direct Primary Care Agreement Bill OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Hospice & Palliative Care

CMS Proposes to Expand 36-Month Rule to Hospice Agencies Code Blue! — Violence in the Workplace Hospice Audit Series: It’s That Time of Year Again: Quality Data Reporting Determinations Raise New and Recurring Issues

Hospitals & Health Systems

Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers Forget the False Claims Act—How a Virginia Hospital Got Criminally Charged New York State Department of Health Adopts Hospital Cybersecurity Regulations

Immigration

Slow Repeal of the ACA and Its Effect on Healthcare Technology Congress extends immigrant investor and physician programs without change Spouses of certain H-1B workers may obtain employment authorization

Insurance

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare Benefits

Intellectual Property

IP Essentials for HLTH and Beyond: Safeguard and Maximize the Value of Your Life Sciences and MedTech Business Licensing Software and Intellectual Property: A Guide for Startup Healthcare Companies Gearing Up for HLTH USA 2025

Labor & Employment

Colorado Eliminates Noncompete Agreements for Healthcare Workers Wyoming Restricts Employer Use of Noncompete Agreements: How Will This Impact Physicians?Physician Organizing: Trends and Takeways

Life Sciences

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers

Litigation

Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case Justice Department Files False Claims Act Complaint Against Home Health Agency Over PPP Loans

M&A and Other Transactions

IP Essentials for HLTH and Beyond: Safeguard and Maximize the Value of Your Life Sciences and MedTech Business Licensing Software and Intellectual Property: A Guide for Startup Healthcare Companies Clinic to Cap Table: Building Companies and Advisory Roles the Right Way

Medicare

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss Inflation Reduction Act Imposes Prescription Drug Pricing Reforms

Nursing and Allied Health Schools

National Institutes of Health COVID-19 Support/Research at Academic Medical Centers and Other Facilities Texas hangs up on telephone prescribers Still no word from DOL on changes to FLSA regulations

Occupational Safety and Health Administration

OSHA Pursues Healthcare Workplace Violence Rule Update on Possible OSHA Prevention of Violence in Healthcare and Social Assistance Rule Compliance Guidance for Healthcare: OSHA Directive for COVID-19 ETS

Pharmaceuticals

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know 340B Update: HRSA Notifies Six Manufacturers that They are in Violation of the 340B Statute Tax Court Rules in Favor of Generic Drug Manufacturer on Deductibility of Patent Litigation Expenses in Connection with ANDAs

Pharmacy

California Board of Pharmacy Proposes Amended Regulation Governing Pharmacy Business Discontinuations California Enacts First-in-Nation Pharmacy Medication Error Reporting Law Supreme Court Reaffirms Mens Rea Requirement in Controlled Substance Health Care Fraud Cases and Government Burden to Prove Subjective Bad Faith

Pharmacy Benefit Manager (PBM)

HHS Targets PBMs But May Exceed Its Legal Authority in Proposed Rule Eliminating AKS Protection for Drug Rebates Pharmacy Benefit Managers 101: Who They Are and What They Do CVS Health – Aetna Transaction: Understanding the Business and Legal Issues

Physician Practices and Non-Physician Practitioners

Colorado Eliminates Noncompete Agreements for Healthcare Workers Considerations Selling Physician Practices Before Buying or Selling Your Physician Practice, Listen To This

Physicians

Colorado Eliminates Noncompete Agreements for Healthcare Workers Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers DOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy Physicians

Post-Acute Care & Nursing Facilities

Avoiding the Pitfalls of Involuntary Nursing Home Discharges/Transfers in Missouri Significant Change in Medicare Enrollment Risk Categories for SNFs Code Blue! — Violence in the Workplace

Private Equity

California Legislature Takes Another Swing at Private Equity Participation in Healthcare California Private Equity in Healthcare Legislation Healthcare Founders Face New Exit Considerations

Professional Compensation

OIG fraud alert regarding compensation agreements for physicians Physician compensation caution Still no word from DOL on changes to FLSA regulations

Psychedelics & Emerging Therapies

Advancing Military Mental Health Psychedelic Breakthroughs: Key Considerations for Clinical Trials Ketamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists

Reimbursement

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests Increasing Colorado Hospital Reimbursement by Paying to the Upper Payment Limit Telehealth News Alert: New Coronavirus (COVID-19) Considerations for Telehealth Providers

Self-Disclosure

OIG updates policy regarding gifts of nominal value Unique Considerations in Healthcare M&A Part 1 – Due Diligence Deadline for HIPAA breach notification approaching

Specialty Pharmacy

COVID-19 - Legal Considerations for Pharmacists and Pharmacies Lessons Learned from a Failed Private Equity-Specialty Pharmacy Partnership USP Finalizes Revisions to Sterile Compounding Standards

Tax

IRS Cutbacks May Impact Healthcare M&A Transactions 2021 Texas Legislature Amends Texas Tax Code to Define Medical and Dental Billing Service and Address Texas Comptroller Policy Tax Court Rules in Favor of Generic Drug Manufacturer on Deductibility of Patent Litigation Expenses in Connection with ANDAs

Technology & Information Systems

Big News in AI Policy: Proposed 10-Year Moratorium on State AI Regulation OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations

Telehealth

DEA’s Pending Telemedicine Rule: What Ketamine Clinics Need to Know DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

U.S. Department of Health & Human Services

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Uncategorized

Colorado Eliminates Noncompete Agreements for Healthcare Workers Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI ESG Due Diligence Considerations in the Healthcare Industry