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Health Law Diagnosis

Monitoring the Pulse of Health Care and Life Sciences

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2018 Connecticut Legislative Update

Connecticut Enacts Law Revising Various Department of Public Health StatutesConnecticut Enacts Legislation to Address Hospital-Insurer Network ConflictsConnecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

2019 Connecticut Legislative Update

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019Connecticut Expands Minors’ Confidential Access to Treatment for HIV and AIDS, Adds Reporting RequirementConnecticut Empowers DSS to Expand Medicaid Coverage of Telehealth Services

340B Drug Pricing Program

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court WinSupreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement MethodologyDelaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

Academic Medical Centers

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActFTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Enacts Legislation Making Various Changes to Public Health Laws

Accountable Care Organizations

Key Changes to the Medicare Shared Savings ProgramCMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee ScheduleCMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers

Accreditation

California Governor Signs Bill Further Increasing Oversight of Hospice AgenciesDepartment of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records ArrangementsRecent Joint Commission Guidance Recommends Steps for Health Care Organizations to Reduce Workplace Violence

Advisory Opinions

OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to Receive Data from a Digestible Medication SensorOIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory OpinionOIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities

Ambulance

Connecticut Enacts Legislation Making Various Changes to Public Health LawsConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicMassachusetts Issues COVID-19 Orders and Guidance for Providers

Ambulatory Surgical Centers (ASC)

Connecticut Repeals Tax on Ambulatory Surgical CentersCMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

Americans With Disabilities

CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility WorkersOCR Reaches Early Case Resolutions with the State of Connecticut and a Private Hospital Regarding Rights of Persons with Disabilities to Have Reasonable Access to Support Persons in Hospital Settings During COVID-19Connecticut Legislature Permits Facilities to Administer Emergency Medication to Defendants Without Consent in Limited Circumstances

Antitrust

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyONC Information Blocking Data Show Majority of Claims Against Health Care ProvidersConnecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers

Arbitration

CMS Issues Final Rule Restricting Arbitration Agreements with Long Term Care FacilitiesNinth Circuit Denies Arbitration in a False Claims Act CaseU.S. Supreme Court – the FAA Preempts State Court Ruling in Nursing Home Arbitration Case

CBD - Cannabis

CBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

Clinical Research

Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical TrialHHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information

Commercial Health Insurance

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Expands OHS AuthorityConnecticut Extends Expansion of Access to Telehealth Services

Connecticut Legislative Update 2017

Connecticut Enacts Legislation Intended to Curb Opioid Drug AbuseConnecticut Enacts Legislation Updating HIV Testing LawsConnecticut Legislature Expands Universe of Available Disciplinary Actions Against Licensed Practitioners

Contract Law

Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by ClinicNew Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

COVID-19

OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsA COVID-19 Laboratory Testing Conviction under EKRAOIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic

Department of Justice

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActDOJ Announces $13 Million Settlement Related to Improper Billing for Lab TestsThe DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth

Dialysis - ERSD

CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

Dietary Supplements

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

Employment Law

Recent NLRB Decision Requires Union Access to Parts of Asset Purchase AgreementNew Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

Employment/Labor

Recent NLRB Decision Requires Union Access to Parts of Asset Purchase AgreementNew Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

EMTALA

Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicHHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) EmergencyNew Connecticut Legislation Updates Laws Concerning Urgent Care Centers, Hospital-Based Facility Fees and Freestanding Hospital Emergency Departments

ERISA

Ninth Circuit Denies Health Care Providers’ ERISA Claims

False Claims Act

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActDOJ Announces $13 Million Settlement Related to Improper Billing for Lab TestsSupreme Court Denies Certiorari in Three FCA “Particularity” Cases

FDA

COVID-19 Vaccine Update – February 2022HHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information

Food and Beverage

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

FQHC

DOJ Settles Allegations of Fraudulent Loan Program Between Hospital System and FQHC

Fraud and Abuse

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActOIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsDOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests

Government Enforcement

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideCalifornia Governor Signs Bill Further Increasing Oversight of Hospice AgenciesNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

Health Information Exchanges and Electronic Medical Records (EMRs)

HHS Proposes Rule to Align Part 2 Records and HIPAAREMINDER: October 6 Deadline for Information Blocking Rules ApproachesONC Information Blocking Data Show Majority of Claims Against Health Care Providers

Health Information Technology

CMS Issues Calendar Year 2023 Home Health Final RuleREMINDER: October 6 Deadline for Information Blocking Rules ApproachesHHS Issues HIPAA Guidance to Support Audio-Only Telehealth Services

Health Plans

New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesDepartments of Labor, Health and Human Services, and the Treasury Issue FAQ guidance on the FFCRA, the CARES Act, and other health coverage issues related to COVID-19

Healthcare Technology

OIG Creates New Telehealth Resources WebpageOIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19Connecticut Extends Expansion of Access to Telehealth Services

Healthcare Transactions

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideRecent NLRB Decision Requires Union Access to Parts of Asset Purchase AgreementNew Jersey Governor Signs Act Concerning Changes in Control of Health Care Entities

HIPAA

HHS Proposes Rule to Align Part 2 Records and HIPAAREMINDER: October 6 Deadline for Information Blocking Rules ApproachesPrivacy Tip - Health Care Sector Continues to Be Hit with Ransomware

Home Health Agencies

Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 MillionConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency ContractsNew York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure Amendments

Home Health/ Home Care

California Governor Signs Bill Further Increasing Oversight of Hospice AgenciesNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActCMS Issues Calendar Year 2023 Home Health Final Rule

Hospice

New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit HospicesNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActNew York State Legislature Passes Act Enacting Moratorium on For-Profit Hospices

Hospitals and Health Systems

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActCMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee ScheduleDOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests

Laboratories

OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsDOJ Announces $13 Million Settlement Related to Improper Billing for Lab TestsThe DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth

Legislation

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideCalifornia Governor Signs Bill Further Increasing Oversight of Hospice AgenciesNew York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices

Life Sciences

Suspect Characteristics Identified under a Telehealth Special Fraud AlertAdvaMed Updates its Code of EthicsCOVID-19 Vaccine Update – February 2022

Long Term Care and Nursing Homes

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActNew Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

Long Term Care Facilities

CMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider WorkforceCMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

Managed Care

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider WorkforceConnecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers

Medical Devices

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvaMed Updates its Code of EthicsAdvisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

Medical Staff and Peer Review

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActMassachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower CaseConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic

Medicare Advantage

OIG Advisory Opinion Allows PHO Network Hospitals to Give 100% Discount on Medigap-Covered Inpatient Deductibles, with Savings Shared as a Premium Credit to Patients

Medicare and Medicaid

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActKey Changes to the Medicare Shared Savings ProgramCMS Issues Calendar Year 2023 Home Health Final Rule

Nursing Facilities

OSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care FacilitiesCMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

Office of Inspector General

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActOIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsTiming is Everything:  The Antitrust Division and OIG Sign Cross-Agency Agreement as Government Investigations Are Expected to Surge

OSHA

OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 StandardOSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care FacilitiesU.S. Supreme Court Upholds Health Care Worker Vaccine Mandate

Pharmaceuticals and Biologics

Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant SanctionsSecond Circuit Affirms HHS Rejection of Direct Copayment Assistance under Anti-kickback StatuteMarketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

Pharmacies

Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy ProfessionalsConnecticut Enacts Law to Increase Access to Epinephrine Auto InjectorsCBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

Pharmacy Law

Connecticut Makes Significant Changes to its Collaborative Drug Therapy LawsCOVID-19 Vaccine Update – February 2022New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

Physicians and Allied Health Professionals

CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee ScheduleSupreme Court Denies Certiorari in Three FCA “Particularity” CasesHome Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million

Privacy and Security

HHS Proposes Rule to Align Part 2 Records and HIPAAPrivacy Tip - Health Care Sector Continues to Be Hit with RansomwareHHS Issues HIPAA Guidance to Support Audio-Only Telehealth Services

Private Equity

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideNew York State Legislature Passes Act Enacting Moratorium on For-Profit HospicesDOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve FCA Allegations

Reimbursement

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActKey Changes to the Medicare Shared Savings ProgramCMS Issues Calendar Year 2023 Home Health Final Rule

Stark Law

Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 MillionCMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice StructureCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

Survey and Certification

CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

Telehealth

CMS Issues Calendar Year 2023 Home Health Final RuleThe DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and TelehealthSuspect Characteristics Identified under a Telehealth Special Fraud Alert

Telemedicine

CMS Issues Calendar Year 2023 Home Health Final RuleHome Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 MillionThe DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth

Uncategorized

HHS Proposes Rule to Align Part 2 Records and HIPAA340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court WinCMS issues Request for Information on the burdens the Stark Law may Impose on Care Coordination

Health Law Diagnosis

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