Topics

ACA

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

Academic Medical Centers

Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at TrialPhysician Loses Rare Criminal E/M Fraud TrialGeorgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss

Accountable Care Organizations

Husch Blackwell at the NAACOS ConferenceThe “Pathways to Success” Final Rule is Here: ACO’s Face Big DecisionsPerformance 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-19From Slow Repeal to No Repeal to “Amended” Repeal

Antitrust

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

Behavioral Health Provider

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

Children's Hospitals and Pediatric Providers

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

Clinical Research & Trials

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Overturning of Chevron Deference: Implications for AI in Medical ResearchAnalysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic DrugsDOJ Continues to Eye Clinical Researchers (and the Universities and Hospitals Employing Them)

Compliance

New York State Department of Health Adopts Hospital Cybersecurity RegulationsMental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsDOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy Physicians

Data Privacy & Security/HIPAA/HITECH

New York State Department of Health Adopts Hospital Cybersecurity RegulationsHHS Changes HIPAA Privacy Rule to Restrict the Disclosure of Reproductive Health Care InformationConfidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 Rule

Employee Benefits

Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsRecent Case Law Regarding Health Plan Assignment of BenefitsEEOC’s targeting of wellness programs and what that means for your company

Fraud & Abuse

DOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy PhysiciansWhat to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances CaseShould Healthcare Providers Give Law Enforcement Protected Health Information When Informally Requested? Congress Says No.

Government Issues

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

Health Coverage

Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsFederal Judge Acquits Physician Following Criminal E/M Fraud Conviction at TrialIPSE DIXIT: Because My Patient Said So - How to Challenge Medical Experts Who Base an Opinion of Injury Causation Solely on a Patient’s Self-Report

Healthcare Litigation

Let’s Make a Deal with DOJ: The Impact of the DOJ’s New Whistleblower Reward Program on Corporate ComplianceArizona Physician Pleads Guilty to Healthcare Fraud over Improper “Incident To” BillingsHusch Blackwell Launches New FCA-Themed Podcast

Healthcare Providers

New York State Department of Health Adopts Hospital Cybersecurity RegulationsDOJ False Claims Act Suit Against Montana Oncologist Is a Warning Sign to Busy PhysiciansThe Overturning of Chevron Deference: Implications for AI in Medical Research

Healthcare Regulatory

New York State Department of Health Adopts Hospital Cybersecurity RegulationsMental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsLoper Bright Leads to Section 1557 Stay

Hospice & Palliative Care

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

Hospitals & Health Systems

New York State Department of Health Adopts Hospital Cybersecurity RegulationsIncreasing Colorado Hospital Reimbursement by Paying to the Upper Payment LimitFederal Judge Orders Whistleblower Who Filed a “Frivolous” Qui Tam to Pay Over $1 Million for Defendants’ Attorneys’ Fees

Immigration

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

Insurance

Mental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsMental Health Parity and Addiction Equity Act: Comprehensive Final Rule Expected in 2024Using Captive Insurance to Create Value for Your Company – Part VI

Intellectual Property

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

Labor & Employment

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

Litigation

Hospital Turns Tables on Whistleblower: Federal Judge Sends Hospital’s Case Against Whistleblower to TrialThe disposal of non-economic damage caps in the State of KansasOSHA, Workplace Violence, and the Healthcare Industry

M&A and Other Transactions

California Private Equity in Healthcare LegislationHow to Wear the Investor Hat When Physicians Are the Revenue GeneratorsHealthcare Founders Face New Exit Considerations

Medicare

Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial LossInflation Reduction Act Imposes Prescription Drug Pricing ReformsCMS 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 FacilitiesTexas hangs up on telephone prescribersStill no word from DOL on changes to FLSA regulations

Occupational Safety and Health Administration

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

Patient Health Data

Confidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 RuleNew Rules Promotes Patient Access to Personal Healthcare Information

Pharmaceuticals

340B Update: HRSA Notifies Six Manufacturers that They are in Violation of the 340B StatuteTax Court Rules in Favor of Generic Drug Manufacturer on Deductibility of Patent Litigation Expenses in Connection with ANDAsFDA 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 TRICARESlow Repeal of the ACA and Its Effect on the Pharmaceutical IndustryRevised Cuba rules allow medical collaboration, ease some pharmaceutical trade

Pharmacy

California Enacts First-in-Nation Pharmacy Medication Error Reporting LawSupreme Court Reaffirms Mens Rea Requirement in Controlled Substance Health Care Fraud Cases and Government Burden to Prove Subjective Bad Faith340B Update: HRSA Notifies Six Manufacturers that They are in Violation of the 340B Statute

Pharmacy Benefit Manager (PBM)

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

Physician Practices and Non-Physician Practitioners

Considerations Selling Physician PracticesBefore Buying or Selling Your Physician Practice, Listen To ThisPhysician 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 PhysiciansHow to Wear the Investor Hat When Physicians Are the Revenue GeneratorsSupreme 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 MissouriSignificant Change in Medicare Enrollment Risk Categories for SNFsCode Blue! — Violence in the Workplace

Private Equity

California Private Equity in Healthcare LegislationHealthcare Founders Face New Exit ConsiderationsTrial Lost, $400+ Million Liability Looming: Quick Takeaways From a Recent False Claims Act Jury Trial

Professional Compensation

OIG fraud alert regarding compensation agreements for physiciansPhysician compensation cautionStill no word from DOL on changes to FLSA regulations

Psychedelics & Emerging Therapies

Advancing Military Mental HealthPsychedelic Breakthroughs: Key Considerations for Clinical TrialsKetamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists

Reimbursement

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

Self-Disclosure

OIG updates policy regarding gifts of nominal valueUnique Considerations in Healthcare M&A Part 1 – Due DiligenceDeadline for HIPAA breach notification approaching

Specialty Pharmacy

COVID-19 - Legal Considerations for Pharmacists and PharmaciesLessons Learned from a Failed Private Equity-Specialty Pharmacy PartnershipUSP 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 PolicyTax Court Rules in Favor of Generic Drug Manufacturer on Deductibility of Patent Litigation Expenses in Connection with ANDAsReversal 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

New York State Department of Health Adopts Hospital Cybersecurity RegulationsTechnology Agreement Tug of WarSee You in Austin for 2020 SXSW

Telehealth

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

U.S. Department of Health & Human Services

New York State Department of Health Adopts Hospital Cybersecurity RegulationsMental Health Parity and Addiction Equity Act Final Rule: A Multi-Agency Effort to Strengthen Access to Mental and Substance Use Disorder Healthcare BenefitsHHS Changes HIPAA Privacy Rule to Restrict the Disclosure of Reproductive Health Care Information

Uncategorized

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