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

Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court WinSupreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology

Academic Medical Centers

Connecticut Governor’s Health Care Bill Makes Important Changes to the Certificate of Need ProcessUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

Accountable Care Organizations

Pending Illinois Legislation Could Heighten Merger Requirements for Health Care FacilitiesCMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health EmergencyKey Changes to the Medicare Shared Savings Program

Accreditation

Connecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing AvenuesConnecticut Governor Signs Bill Introducing Programs to Improve Maternal HealthCMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

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 Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need AppealsConnecticut Governor’s Health Care Bill Makes Important Changes to the Certificate of Need ProcessPending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities

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

Pending Illinois Legislation Could Heighten Merger Requirements for Health Care FacilitiesFTC Takes Action to Block Hospital Transactions in Utah and New JerseyONC Information Blocking Data Show Majority of Claims Against Health Care Providers

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

Certificate of Need

Connecticut Governor’s Health Care Bill Makes Important Changes to the Certificate of Need Process

Clinical

New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesDOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound

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

Connecticut Governor Signs Health Care Bill Revising Connecticut’s Facility Fee LawConnecticut Health Care Bill Revises Provider-Payor Contracting Requirements to Address Competitive ConcernsFTC Takes Action to Block Hospital Transactions in Utah and New Jersey

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

Connecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete AgreementsAdvisory 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 Entities

COVID-19

Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7VDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsCompliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?

Department of Justice

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsStark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations

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

Education

Kentucky Governor Signs Bill Aimed at Mitigating Healthcare Workforce Shortages: Beginning of a Trend?OIG Issues Favorable Advisory Opinion Regarding Home Health Agency’s Proposal to Pay Tuition Costs for New Employees

Employment Law

Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete AgreementsNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

Employment/Labor

Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete AgreementsNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

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

Connecticut Expands Applicability of State False Claims ActUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityStark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations

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

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint VentureConnecticut Expands Applicability of State False Claims ActUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims Liability

Government Enforcement

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint VentureConnecticut Expands Applicability of State False Claims ActUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims Liability

Health Information Exchanges and Electronic Medical Records (EMRs)

HHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAAHHS Proposes Rule to Align Part 2 Records and HIPAAREMINDER: October 6 Deadline for Information Blocking Rules Approaches

Health Information Technology

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareOCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023CMS Issues Calendar Year 2023 Home Health Final Rule

Health Plans

Two Pathways for Medicaid Self-Disclosures Announced by OMIGNew 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

Health Policy

Connecticut Governor Signs Bill Introducing Programs to Improve Maternal HealthUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

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

Two Pathways for Medicaid Self-Disclosures Announced by OMIGNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CarePending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities

HIPAA

Compliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?HHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAAOCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023

Home Health Agencies

Connecticut Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need AppealsEighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million

Home Health/ Home Care

CMS Proposes New Rule that Would Require 80 Percent of Payment to Go Toward Home Care Worker CompensationNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareKentucky Governor Signs Bill Aimed at Mitigating Healthcare Workforce Shortages: Beginning of a Trend?

Hospice

Eighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information 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 Act

Hospitals and Health Systems

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint VentureConnecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7VConnecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and Overtime

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

Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeConnecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing AvenuesConnecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home Facilities

Licensure

Connecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing AvenuesConnecticut Governor Signs Bill Introducing Programs to Improve Maternal HealthCMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

Life Sciences

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareSuspect Characteristics Identified under a Telehealth Special Fraud AlertAdvaMed Updates its Code of Ethics

Long Term Care and Nursing Homes

Eighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information 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 Entities

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

Connecticut Places Checks on PBM Contracts in Support of 340B Covered EntitiesFTC Takes Action to Block Hospital Transactions in Utah and New JerseyMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

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

Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeCOVID-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 Case

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

Two Pathways for Medicaid Self-Disclosures Announced by OMIGConnecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home FacilitiesUnanimous Supreme Court Endorses Subjective Belief Standard for False Claims Liability

Nursing Facilities

Connecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home FacilitiesOSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care FacilitiesCMS Finalizes Guidance on Hospital Co-Location

Office of Inspector General

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint VentureOIG Compliance UpdatesStark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations

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

Connecticut Places Checks on PBM Contracts in Support of 340B Covered EntitiesNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareAs COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsConnecticut Makes Significant Changes to its Collaborative Drug Therapy Laws

Physicians and Allied Health Professionals

Connecticut Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need AppealsConnecticut Governor Signs Bill Introducing Programs to Improve Maternal HealthConnecticut Expands Applicability of State False Claims Act

Privacy and Security

HHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAAOCR Reminder: Pandemic-Era HIPAA Flexibilities Will End May 11, 2023Annual Breach Notification Deadline to OCR Looming

Private Equity

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareCalifornia Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideNew York State Legislature Passes Act Enacting Moratorium on For-Profit Hospices

Reimbursement

Connecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home FacilitiesConnecticut Expands Applicability of State False Claims ActConnecticut Governor Signs Health Care Bill Revising Connecticut’s Facility Fee Law

Stark Law

Stark Settlement Targeting Hospital and Physicians a Reminder for Health Care OrganizationsHome 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 Structure

Survey and Certification

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

Telehealth

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsCompliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?OIG Compliance Updates

Telemedicine

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsCompliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?OIG Compliance Updates

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