Topics

ACA

Nondiscrimination in Healthcare: HHS’s New Final Rule Under Section 1557 of the Affordable Care Act Medicare for All, Part 2: Cost, Financing and Impact on Provider Payment Health Care Drives Voters at the Polls, but Will Health Care Drive Policymaking?

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

American Health Care Act (AHCA)

Guidance for Hospice Providers to Address the Visitors Ban Imposed by Nursing Facilities to Reduce the Spread of COVID-19 From Slow Repeal to No Repeal to “Amended” Repeal

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

The Overturning of Chevron Deference: Implications for AI in Medical Research Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs DOJ Continues to Eye Clinical Researchers (and the Universities and Hospitals Employing Them)

Compliance

What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity Forget the False Claims Act—How a Virginia Hospital Got Criminally Charged

Data Privacy & Security/HIPAA/HITECH

OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations HHS Changes HIPAA Privacy Rule to Restrict the Disclosure of Reproductive Health Care Information

Employee Benefits

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 Recent Case Law Regarding Health Plan Assignment of Benefits

Fraud & Abuse

Justice Department Files False Claims Act Complaint Against Home Health Agency Over PPP Loans DOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy Physicians What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

Government Issues

False Claims Act Update: A Mid-Year Review (2023)The Sword Becomes a Shield Unintended Consequences? Amendment to Colorado's Non-compete Statute for Physicians

Health Coverage

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 Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at Trial

Healthcare Litigation

Justice Department Files False Claims Act Complaint Against Home Health Agency Over PPP Loans Forget the False Claims Act—How a Virginia Hospital Got Criminally Charged Let’s Make a Deal with DOJ: The Impact of the DOJ’s New Whistleblower Reward Program on Corporate Compliance

Healthcare Providers

What Medical Schools and Hospitals Should Know About HHS OCR’s Newly Announced DEI-Targeted Investigations OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations

Healthcare Regulatory

What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations

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

Forget the False Claims Act—How a Virginia Hospital Got Criminally Charged New York State Department of Health Adopts Hospital Cybersecurity Regulations Increasing Colorado Hospital Reimbursement by Paying to the Upper Payment Limit

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

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 Mental Health Parity and Addiction Equity Act: Comprehensive Final Rule Expected in 2024

Intellectual Property

Patent Office Guidance Improves Personalized Medicine’s Long-Term Prognosis Personalized Medicine Patents: Federal Circuit Gives Personalized Medicine Patents a Shot In The Arm Husch Blackwell attorneys celebrate Nobel Prize winner

Labor & Employment

Physician Organizing: Trends and Takeways Diagnosing the Future: Considering DEIA as a Treatment Plan for Healthcare Employers to Improve Patient Outcomes The Future of Affirmative Action in Medical School Admissions

Life Sciences

Understanding and Protecting Your IP: Key Considerations for Life Sciences Businesses Raising Capital in a Highly Regulated Market Structuring the Right Deals for Growth in Life Sciences

Litigation

Justice Department Files False Claims Act Complaint Against Home Health Agency Over PPP Loans Hospital Turns Tables on Whistleblower: Federal Judge Sends Hospital’s Case Against Whistleblower to Trial The disposal of non-economic damage caps in the State of Kansas

M&A and Other Transactions

California Legislature Takes Another Swing at Private Equity Participation in Healthcare California Board of Pharmacy Proposes Amended Regulation Governing Pharmacy Business Discontinuations California Private Equity in Healthcare Legislation

Medicare

Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss Inflation Reduction Act Imposes Prescription Drug Pricing Reforms CMS Looks Beyond COVID-19 for Telehealth Expansion

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

Patient Health Data

OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity Confidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 Rule New Rules Promotes Patient Access to Personal Healthcare Information

Pharmaceuticals

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 FDA Complete Response Letters: The design v. reality of FDA’s responses to drug applications

Pharmaceuticals and PBMs

2017 NDAA brings privatization and cost-savings incentives to TRICARE Slow Repeal of the ACA and Its Effect on the Pharmaceutical Industry Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade

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

Considerations Selling Physician Practices Before Buying or Selling Your Physician Practice, Listen To This Physician Compensation Under the New Physician Fee Schedule: Major Changes to wRVUs, Conversion Factor, and More

Physicians

DOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy Physicians How to Wear the Investor Hat When Physicians Are the Revenue Generators Supreme Court Reaffirms Mens Rea Requirement in Controlled Substance Health Care Fraud Cases and Government Burden to Prove Subjective Bad Faith

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

Increasing Colorado Hospital Reimbursement by Paying to the Upper Payment Limit Telehealth News Alert: New Coronavirus (COVID-19) Considerations for Telehealth Providers Recent State Laws Restrict Payer-to-Provider Reimbursement via Virtual Credit Cards

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

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 Reversal of Texas Sales Tax Policy on Medical Billing Services to Cause Potential Texas Sales Tax Increases for Healthcare Clients Effective in 2020

Technology & Information Systems

OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity New York State Department of Health Adopts Hospital Cybersecurity Regulations Technology Agreement Tug of War

Telehealth

What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy Two Weeks’ Notice for the Public Health Emergency: What’s Next for Telehealth

U.S. Department of Health & Human Services

What Medical Schools and Hospitals Should Know About HHS OCR’s Newly Announced DEI-Targeted Investigations What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity

Uncategorized

Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI ESG Due Diligence Considerations in the Healthcare Industry New York District Court: The Choice of Medical Necessity Criteria is a Fiduciary Act