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

340B Program

Supreme 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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsHHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAA

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

CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health EmergencyCalifornia Governor Signs Bill Further Increasing Oversight of Hospice AgenciesDepartment of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements

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)

Pending Illinois Legislation Could Heighten Merger Requirements for Health Care FacilitiesConnecticut Repeals Tax on Ambulatory Surgical CentersCMS Finalizes Guidance on Hospital Co-Location

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

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

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

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsCompliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?Addressing COVID-Related Staffing Shortages: Strategies To Recruit And Retain Employees

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

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareAddressing COVID-Related Staffing Shortages: Strategies To Recruit And Retain EmployeesKentucky Governor Signs Bill Aimed at Mitigating Healthcare Workforce Shortages: Beginning of a Trend?

Employment/Labor

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareAddressing COVID-Related Staffing Shortages: Strategies To Recruit And Retain EmployeesKentucky Governor Signs Bill Aimed at Mitigating Healthcare Workforce Shortages: Beginning of a Trend?

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityStark Settlement Targeting Hospital and Physicians a Reminder for Health Care OrganizationsNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityCompliance Corner—The End of the Public Health Emergency: What’s Next for Telehealth?OIG Compliance Updates

Government Enforcement

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

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

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

Health Policy

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsCMS Proposes New Rule that Would Require 80 Percent of Payment to Go Toward Home Care Worker Compensation

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

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CarePending Illinois Legislation Could Heighten Merger Requirements for Health Care FacilitiesNew York Proposes Regulatory Overhaul for HealthCare Transactions with a Focus on Investor-Backed Healthcare Transactions

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

Eighteen 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 MillionConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsNew York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityCMS 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 Care

Licensure

CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health EmergencyCalifornia Governor Signs Bill Further Increasing Oversight of Hospice AgenciesNew York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure Amendments

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

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityCMS 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 Care

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

OIG Compliance UpdatesStark Settlement Targeting Hospital and Physicians a Reminder for Health Care OrganizationsNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

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

New 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 SubstancesAdvisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 MonthsPending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities

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

Unanimous Supreme Court Endorses Subjective Belief Standard for False Claims LiabilityOIG Compliance UpdatesStark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations

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