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New Jersey Health Law Bulletin
Spring 2014
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • Newly Enacted Health Care Laws in New Jersey
  • Pocket Vetoed Health Care Legislation
  • New Jersey Revised Uniform Limited Liability Act Becomes Effective
    for All LLCs
  • Appellate Court Limits Malpractice Insurer’s Ability to Rescind
  • Class Action Suit Filed Against Horizon Blue Cross Over Data Breach
  • New Jersey Supreme Court Rules on Nursing Home Collection Suit
  • New Jersey Joins in Global Settlement with Genzyme Corp.
  • Jury Awards Over $1.5 Million in Latest Accutane Suit

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • More Delays for Enforcement of the Medicare Two Midnight Rule
  • HHS and CMS Permit Patients Direct Access to Laboratory Test Results
  • Protections for Electronic Health Record Donations Extended
  • Rules Require That Providers Who Bill “Incident To” Must Comply with Applicable State Laws
  • IRS Notices Affecting Tax-Exempt Hospitals
  • OIG Issues Work Plan for 2014
  • OIG Approves Percentage-based Compensation for a Placement Agency’s Referrals to Senior Residential Communities
Winter 2014
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • Newly Enacted Health Care Laws in New Jersey
  • Proposed Legislation Affecting Health Care in New Jersey
  • Appellate Court Upholds Dismissal of Chiropractor’s Suit Against Horizon
  • Petition for Rulemaking on the Corporate and/or Unlicensed Practice of Dentistry
  • Settlement in Class Action Suit Against Horizon for Flawed Reimbursement Figures
  • Board of Medical Examiners Denies Petition to Amend Regulation Concerning Corporate Practice

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • Tuomey Judgment: $237.5 Million for Stark/FCA Violations
  • FDA Authority Over Compounding Pharmacies
  • Final Rules Published on Mental Health Parity
  • CMS Publishes Several Final Rules Affecting Medicare Policy and Payment for Calendar Year (CY) 2014
  • CMS Delays Enforcement of the 'Two-Midnight' Rule
  • Ordering and Referring Denial Edits Will Be Implemented on January 6, 2014
  • HHS Clarifies That Qualified Health Plans Under the Affordable Care Act Are Not Federal Health Care Programs
  • CMS Issues Two New Advisory Opinions Involving a Clinical Lab Providing Free Devices to Referring Physicians
  • OIG Publishes 2014–2018 Strategic Plan
  • OIG Advisory Opinion 13-15
  • HHS Issues Guidance on Disclosures to Law Enforcement and Marketing Practices
  • OCR Delays Enforcement of HIPAA Requirement for Certain CLIA and CLIA-Exempt Laboratories to Revise their Notices of Privacy Practices
Summer 2013
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • New Health Care Legislation
  • Proposed Bill of Rights for Continuing Care Retirement Community Residents
  • Proposed Bill to Impact Health Care Service Firms
  • Proposed Readoption of Rules by DOBI Regarding Third Party Administrators of Health Benefits and Third Party Billing Services
  • New Jersey Supreme Court Will Not Review Horizon Settlement
  • District Court Preliminarily Approves Aetna’s UCR Reimbursement Settlement
  • Statewide Health Information Network to Be Created

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • Enforcement of New HIPAA Rules Begins
  • Congressional Bill Introduced That Would Significantly Limit the Stark Exception for In-Office Ancillary Services
  • CMS Issues FY 2014 Inpatient Prospective Payment Final Rule
  • Other Regulatory Developments Regarding Fiscal Year 2014 Medicare Payment and Policy
  • CMS Issues Guidance On Policy Regarding Hospital Inpatient Admission Orders and Certifications
  • CMS Delays Enforcement of its DME Face-to-Face Requirement
  • New Regulation Requires Written Agreement Between Long Term Care Facilities and Hospice Providers
  • OIG Issues Report on Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries
  • OIG Issues Final Rule on Data Mining by State Medicaid Fraud Control Units
  • OIG Accepts Online Submissions of its Self-Disclosure Protocol
  • OIG Issues Negative Advisory Opinion on Proposed Agreement To Offer GPO Members an Equity Interest in GPO Parent Corporation
  • FDA Issues Several Guidance Documents
Spring 2013
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • Court Narrows Expert Testimony in Medical Malpractice Cases
  • Changes to Shareholder Rights Under the New Jersey Business Corporation Act
  • New POLST Form Unveiled by DOH
  • Proposed Bill to Limit Enforcement of Restrictive Covenants
  • Proposed Bill to Amend Physician Assistant Licensing Standards
  • Rule Proposal Concerning Medicaid ACO Demonstration Projects

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • Jury Finds Health System Violated the Stark Law and False Claims Act as a Result of Its Physician Employment Contracts
  • Congress Seeks to Overhaul Medicare Auditing
  • Medicare Issues Proposed Rule to Allow Part A to Part B Rebilling in Hospitals
  • Proposed Rules for Fiscal Year 2014 Medicare Payment and Policy
  • CMS and OIG Issue Proposed Changes to the Federal Stark Law Exception and Anti-Kickback Statute Safe Harbor for Electronic Health Records Donations
  • OIG Issues An Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs
  • OIG Updates Its Provider Self-Disclosure Protocol
  • U.S. Supreme Court Upholds Arbitration Decision in Oxford Health Case
  • Idaho State University Settles Alleged Violation of HIPAA Security Rule for $400,000
Winter 2013
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • Hospital Repurposing and Revitalization Tax Credit Act
  • Out-of-Network Reimbursement Settlement
  • Requirement for Presence of Anesthesiologists During Delivery of Anesthesia by Nurses in Hospitals
  • Governor Christie Rejects State-Run Health Insurance Exchange
  • Collaborative Practice Arrangements Between Pharmacists and Physicians
  • Amendments to State Board of Psychological Examiners' Rules
  • Office of the Insurance Fraud Prosecutor Recovers Approximately $45 Million in Settlements Involving False Claims Act Violations

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • OCR Publishes HIPAA/HITECH Omnibus Final Rule
  • CMS Publishes Final Sunshine Act Regulations
  • CMS Issues Proposed Rule Projected to Reduce Administrative Burdens and Save Providers $676 Million Annually
  • New FTC Clinical Integration Advisory Opinion - Norman PHO
  • OIG Okays Pre-Filled Rx Forms
  • OIG Permits Hospital to Provide Physicians With Free Access to Electronic Interface
  • OIG Allows FQHC to Offer Gift Cards to Encourage Visits to the Health Center
  • OIG Issues Favorable Opinion on Co-Management Agreements
Fall 2012
QUARTERLY SUMMARY OF STATE LAW DEVELOPMENTS
  • Changes Coming to New Jersey Limited Liability Company Act
  • Medication Disposal Protocols for Health Care Facilities
  • Increased Obligation to Report Suspected Child Abuse
  • Clarification of Independent Contractor vs. Employee
  • NJHA Petitions for Employment of Physicians By General Business Corporations
  • Scope of Confidentiality Under the Patient Safety Act
  • Electronic Prescriptions of Controlled Dangerous Substances
  • Permissibility of Medicated Contact Lenses

QUARTERLY SUMMARY OF FEDERAL LAW DEVELOPMENTS

  • OIG Finds Improvements Are Needed at the ALJ Level of Medicare Appeals
  • Proposed Settlement Will Expand Medicare's Coverage Rules for Chronic Conditions
  • DOJ and SEC Issue Long Awaited FCPA Guidance
  • FDA Issues Draft Guidance Regarding an IRB's Responsibility
  • OIG Okays Hospital's On-Call Coverage Compensation Arrangement
  • OIG Approves Radiology Group's Proposal to Offer Free Insurance Preauthorization Services
  • OIG Okays Waiver of Cost-Sharing Amount Based on Determinations of Financial Need
  • OIG Releases 2013 Work Plan

Summer 2012

  • New Stark Law Guidance on Personally Performed Medical Services in Hospitals
  • Health System Settles With Federal Government Over Allegations of Medicare Fraud
  • New Jersey Department of Health Reorganization
  • New Jersey Health Benefit Exchange Act Reintroduced in Legislature
  • Accountable Care Organizations Approved in New Jersey
  • CMS Relaxes Its Controversial Rule Regarding Ordering and Referring Providers
  • LEGISLATIVE & REGULATORY UPDATE

-  New Jersey Hospital Disclosure and Public Resource Protection Act
-  Provider Reporting to Motor Vehicle Commission
-  Healthcare Disclosure and Transparency Act Reintroduced
-  Suspension of Health Care Professional Licenses for Improper
   Medical Waste Disposal
-  Designation of Surrogate for Incapacitated Patients
-  In-Network Hospital Notification of Out-of-Network Providers

  • Office of Inspector General Advisory Opinion

Spring 2012

  • Medicinal Marijuana Program Final Implementing Regulations
  • Physician Order for Life-Sustaining Treatment Form
  • Hospitals Required to Notify Patients of Independent Health Care Appeals Program
  • General Durable Power of Attorney Act
  • LEGISLATIVE & REGULATORY UPDATE

-  44 N.J. Reg. 163(a) - Health Care Facility Infection Reporting
-  44 N.J. Reg. 151(a) - Registration Standards for Surgical Practices
-  44 N.J. Reg. 274(b) - Internal and External Health Care Appeals
   Amendments
-  S-958 - Pharmacy Sales of Syringes and Needles Without a
   Prescription
-  44 N.J. Reg. 276(a) - Proposed Amendments to Managed Care
   Regulations
-  A-2171 - New Jersey Health Benefit Exchange Act

  • Office of Inspector General Advisory Opinion

Winter 2012

  • Implementation of the New Jersey Medicaid Electronic Health Record Program
  • Accreditation Required for Advanced Diagnostic Imaging Suppliers
  • Hospital Political Activity May Not Affect Tax-Exempt Status
  • Revalidation of CMS Medicare Enrollment Form 855A
  • LEGISLATIVE & REGULATORY UPDATE

- Restrictions on Purchase of Individual Health Benefit Plans
- Enrollment as Medical Supply Provider in New Jersey Medicaid/
  FamilyCare
- Use of Advanced Physical Agent Modalities by Occupational Therapy
  Assistants
- Health Benefits Plans - Claim Disputes and Standard Forms
- Extension of Moratorium on Adult Day Health Services Facility
  Applications
- Patients' Rights in Ambulatory Surgical Centers

  • Office of Inspector General Advisory Opinions:  Online Referral Service Arrangement May Violate Anti-Kickback Statute

Fall 2011

  • Implementation of Medicaid Recovery Audit Contractor Program
  • Adoption of Patient Safe Handling and Violence Prevention Rules
  • Enactment of Medicaid ACO Demonstration Program
  • Implementation of Universal Transfer Form
  • LEGISLATIVE & REGULATORY UPDATE


    - Required Disclosures by Health Care Professionals
    - Provision of Influenza Vaccination of Health Care Workers
    - Reuse of Prescription Drugs
    - Practice of Respiratory Care
    - Infection Reporting for Ambulatory Surgery Facilities
    - MRSA Infection Prevention Programs
    - Proposed Amendments to health Maintenance Organizations and
      Health  Care Quality Act Rules
     

  • Office of Inspector General Advisory Opinion:  Arrangement Between Medical Equipment Supplier and Skilled Nursing Facility May Violate Anti-Kickback Statute

Summer 2011

  • Proposed Registration and Licensure Requirements for Single-Suite Surgical Centers
  • Designation of Surrogates and Decision Making Process for Patients Without Surrogates
  • Demonstration Project to Improve Care Coordination for Medicare Patients
  • Department of Health and Human Services Proposes Changes to HIPAA Privacy Rule
  • LEGISLATIVE & REGULATORY UPDATE

- Certificate of Need Required for Hospital-Based Obstetric and
  Pediatric Services
- Governor Signs Law Requiring Hospitals to Report Injuries to Police
- Advanced Practice Nurses Permitted to Determine Cause of Death
  and Execute Death Certificates
- Certain Licensed Psychologists Permitted to Prescribe Medications
- Governor Signs Law Requiring Distribution of Statement of Assisted
  Living Residents' Rights
- Requirements for Surgical Technologists
- Decrease of Minimum Corporation Business Tax on Certain New
  Jersey Subchapter S Corporations

  • Office of Inspector General Advisory Opinion:
    Referral Services Involving Certain Electronic Database Systems May Violate the Federal Anti-Kickback Statute

Spring 2011

  • Regulations Proposed to Regulate Accountable Care Organizations
  • Physician Assistants Are Entitled To Overtime Pay Mandated By The Fair Labor Standards Act
  • New Jersey Captive Insurance Companies to be Licensed by Department of Banking and Insurance
  • Proposed New Regulations to Extend Registration Requirements to Small Surgical Practices
  • LEGISLATIVE & REGULATORY UPDATE

    - Corporation Provided Right To Renounce Corporate Opportunity Doctrine
    - New Standards for Electronic Prescribing Systems
    - Restriction of Botulinum Toxin Injections For Minors
    - Professional Corporations Permitted to Use or Register Alternate Names
    - Nursing Home Reimbursement Adjustment for Cost of Energy Improvements
    - Corporate Directors Maintain Rights to Indemnification Under Certain
      Circumstances
    - Notice of Invitation for Certificate of Need Applications: Proposed New
      Hospital in Bergen County
  • Office of Inspector General Advisory Opinion:
    Certain Transportation Arrangements Between Hospitals and Physicians' Offices Do Not Violate Anti-Kickback Statue

Winter 2011

  • New Jersey Supreme Court Broadens Acceptable Affidavits of Merit in Medical Malpractice Lawsuits

  • New Jersey Appeals Court Rules That Physician Assistants Cannot Perform EMG Studies

  • Deadline for Physician-Owned Hospitals

  • Limit on Tax Exempt Status for Hospitals

  • Facility Fees Not Reimbursable

  • Medical Residents Not Exempt from Paying Taxes on Wages Earned

  • Healthcare Transparency and Disclosure Act Seeks to Regulate Out-of-Network Insurance Market

  • LEGISLATIVE & REGULATORY UPDATE:

-  New Regulations for Dentists

-  Amendments to Hospital Licensing Standards

-  No Coverage for Those Injured Due to Their Own

-  Loan Repayment for Physicians and Dentists

-  Additional Discussion Required for Hospital Discharge
   Procedures

-  Continuing Medical Education Credit Granted

   Office of Inspector General Advisory Opinions -
   Arrangements Between Sleep Testing Centers and
   Hospital-Owned Facilities Violate Anti-Kickback Statute
   When Marketing Fees are Paid on "Per-Test" Basis

 

~ 2008-2010 Bulletins

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