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August 1, 2016 Regulatory Developments

August 24, 2016 | Comments Off on August 1, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on August 1, 2016:

  • On August 1, 2016 at 48 NJR 1485, the Department of Health published notice of its proposal of amendments to its rules governing the newborn screening program. The proposed regulations will update the fee schedule for the newborn screening program and will add 8 tests to the list of newborn screening tests that are already being performed.
  • On August 1, 2016 at 48 NJR 1487, the Department of Human Services published notice of its proposed readoption with amendments to its rules governing adult mental health rehabilitation services provided in/by community residence programs.
  • On August 1, 2016 at 48 NJR 1490, the Department of Human Services published notice of its proposed readoption with amendments to the rules governing children’s programs under New Jersey FamilyCare.

July 18, 2016 Regulatory Developments

July 19, 2016 | Comments Off on July 18, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on July 18, 2016:

  • On July 18, 2016 at 48 NJR 1412, the Department of Human Services published notice of its proposal of amendments to its rules governing the Pharmaceutical Services Manual, which regulates the provision of pharmaceutical services under New Jersey Medicaid and the New Jersey FamilyCare fee-for-service program.
  • On July 18, 2016 at 48 NJR 1421, the Department of Human Services published notice of its proposal of amendments to its rules governing psychiatric residential treatment facility services for individuals under age 21.
  • On July 18, 2016 at 42 NJR 1428, the State Board of Nursing published notice of proposed amendments to its rules governing the recognition of certain additional entities as meeting the Board requirements for advanced practice nursing certification bodies.
  • On July 18, 2016 at 48 NJR 1445, the Department of Health published notice of its readoption with amendments to its rules governing the licensure of home health agencies. Among other things, the amendments extend the period for notification of the Department of Health of an anticipated change in ownership of a home health agency from the current 30 day time period to a 90 day notification time period. In addition, the amendments revise employee health requirements, require the governing body of the home health agency to develop and implement a written conflict of interest policy, and revise the description of the roles and the responsibilities of the agency director of nursing.
  • On July 18, 2016 at 48 NJR 1462, the Board of Dentistry published notice of its adoption of amendments to its rules as well as the adoption of new rules governing the scope of practice for dental hygienists. The amendments also require each dental office, facility, dental clinic or institution at which there is patient contact to have a written protocol for managing medical and dental emergencies; have equipment to maintain adult and pediatric airways; maintain an ambu bag on site and ensure that all staff are trained upon hire and, at least annually thereafter, to implement the emergency protocol.
  • On July 18, 2016 at 48 NJR 1468, the Department of Health published notice of its rescheduling of a certificate of need call for applications for mobile intensive care units.

 

July 5, 2016 Regulatory Developments

July 18, 2016 | Comments Off on July 5, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on July 5, 2016:

  • On July 5, 2016 at 48 NJR 1350, the Department of Human Services published notice of its proposed readoption of its rules governing the licensure of outpatient substance treatment facilities.
  • On July 5, 2016 at 48 NJR 1352, the Board of Medical Examiners published notice of its proposal of amendments to its rules and the proposal of new rules governing continuing education requirements for the renewal of an athletic trainer license.
  • On July 5, 2016 at 48 NJR 1354, the State Board of Respiratory Care published notice of its proposed amendments to its rules as well as the proposal of new rules governing license reinstatement and reactivation requirements for professional licenses. The amendments would also update the language of the regulations to correct certain of the terminology used and codify current standards of practice and licensure, including, but not limited to, continuing education requirements.
  • On July 5, 2016 at 48 NJR 1366, the Department of Human Services published notice of its readoption with amendments to its rules governing the Pharmaceutical Assistance to the Aged and Disabled eligibility manual.
  • On July 5, 2016 at 48 NJR 1371, the Department of Banking and Insurance published notice of its readoption of its rules governing organized delivery systems.
  • On July 5, 2016 at 48 NJR 1371, the Board of Marriage and Family Therapy Examiners and the Professional Counsellor Examiners Committee jointly proposed amendments to their rules governing educational requirements and licensure by endorsement.

U.S. Supreme Court Issues Important Decision Regarding False Claims Act Liability

June 30, 2016 | Comments Off on U.S. Supreme Court Issues Important Decision Regarding False Claims Act Liability
Posted by Beth Christian

On June 16, 2016, the United States Supreme Court issued a unanimous decision which held that an implied false certification made for the purpose of claiming payment from the government can serve as a basis for False Claims Act liability. The court held that when an individual or entity submits a claim to the government making specific representations about goods or services provided, but fails to disclose noncompliance with material statutory, regulatory or contractual requirements that result in those representations being misleading, that individual or entity may be subject to liability under the False Claims Act.

The case involved claims for payment for mental health services provided to a teenage beneficiary of the Massachusetts Medicaid program. The patient received counseling services from Arbour Counseling Services, a mental health facility owned and operated by a subsidiary of Universal Health Services, Inc. (“Universal”). The patient had an adverse reaction to a medication that an Arbour employee had prescribed. The patient’s condition worsened and she eventually died of a seizure. Read more

June 20, 2016 Regulatory Developments

June 23, 2016 | Comments Off on June 20, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 20, 2016:

  • On June 20, 2016 at 48 NJR 1049, the Department of Banking and Insurance published notice of its proposed readoption with amendments to its rules governing New Jersey Workers Compensation managed care organizations.
  • On June 20, 2016 at 48 NJR 1059, the Board of Nursing published notice of its proposal of amendments to its rules governing the dispensing of pharmaceutical samples to patients by advanced practice nurses. The proposed amendment would require advance practice nurses who dispense pharmaceutical samples to label the samples with the complete name of the medication dispensed, the strength, and quantity of the medication dispensed, instructions as to the frequency of use, special precautions if appropriate and the expiration date of the medication.

Read more

June 6, 2016 Regulatory Developments

June 7, 2016 | Comments Off on June 6, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 6, 2016:

  • On June 6, 2016 at 48 NJR 878, the Department of Health published notice of its proposed readoption with amendments to the standards for licensure of pediatric community transitional homes.
  • On June 6, 2016 at 48 NJR 911, the Department of Human Services published notice of its proposed readoption with amendments to its rules governing family support services offered through the Division of Mental Health and Addiction Services.
  • On June 6, 2016 at 48 NJR 945, the Board of Nursing published notice of its proposal of amendments to its rules governing license renewal and the educational requirements for certification of advanced practice nurses.

Read more

May 16, 2016 Regulatory Developments

May 24, 2016 | Comments Off on May 16, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on May 16, 2016:

  • On May 16, 2016 at 48 NJR 804, the Department of Banking and Insurance published notice of its readoption of its rules regarding managed care plans.
  • On May 16, 2016 at 48 NJR 822, the Division of Taxation published notice of its adoption of new rules governing business registration and tax clearance requirements for professional license holders. Under the new rules, the Director of the Division of Taxation may suspend the professional license of an individual with regard to the failure to satisfy a state tax indebtedness. If the individual does not pay the state tax liability in full within 60 days from the date of the demand letter, the Director of the Division of Taxation may suspend the professional license of the individual.

Appellate Division Accords Absolute Privilege To Patient Safety Act Materials

May 6, 2016 | Comments Off on Appellate Division Accords Absolute Privilege To Patient Safety Act Materials
Posted by Beth Christian

On May 4, 2016, the Superior Court of New Jersey, Appellate Division, issued a decision in Conn vs. Rebustillo which held that the  materials provided  to the Department of Health in the contact of a Patient Safety Act report and submission,  including  the root cause analysis prepared by the hospital in the context of an internal Patient Safety Act investigation, are subject to an absolute privilege and are not subject to disclosure in discovery.  The case was a medical malpractice action involving an inpatient at Newton Medical Center who fell out of bed while hospitalized, suffered a brain hemorrhage, and later died.  The hospital conducted an internal root cause analysis (which was submitted to the Department of Health)  and also submitted a Patient Safety Act report.  The wife of the hospital inpatient who died filed a medical malpractice lawsuit, and her attorneys sought to compel disclosure in discovery of the root cause analysis.  The plaintiff contended that disclosure of the documents in discovery was permitted because the hospital had not shown that it complied with all of the process requirements of the Patient Safety Act.  The trial court held that the underlying facts of the root cause analysis had to be disclosed, as well as any and all other documents withheld by the hospital on the basis that the documents were protected as a root cause analysis. The Appellate Division reversed the decision of the trial court, finding that the privilege set forth in the Patient Safety Act is an absolute privilege and protects all documents submitted to the Department of Health, including the root cause analysis.  Internal documents  prepared by the hospital as part of its Patient Safety Act investigation which are not submitted to the Department of Health are also subject to protection from disclosure if the hospital can show that the documents were developed as part of a Patient Safety Act plan which complies with the requirements of the Patient Safety Act.  The court concluded that the protection accorded to documents submitted to the Department of health is absolute, and that the privilege is not subject to review to determine whether or not the hospital complied with the process requirements of the Patient Safety Act.

May 2, 2016 Regulatory Developments

May 3, 2016 | Comments Off on May 2, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on May 2, 2016:

  • On May 2, 2016 at 48 NJR 673, the Department of Human Services published notice of its readoption with amendments to its rules governing patient supervision at state psychiatric hospitals.
  • On May 2, 2016 at 48 NJR 714, the State Board of Dentistry published notice of its adoption of new rules governing credit toward licensure as a dental hygienist and as a dental assistant for education, training and experience received while serving as a member of the Armed Forces.

April 18, 2016 Regulatory Developments

April 26, 2016 | Comments Off on April 18, 2016 Regulatory Developments
Posted by Beth Christian

Here are the most recent health care related regulatory developments as published in the New Jersey Register on April 18, 2016:

  • On April 18, 2016 at 48 NJR 619, the Department of Health published notice of its proposal of new rules implementing the Health Care Professional Responsibility and Reporting Enhancement Act. The proposed rules will establish reporting requirements, as well as penalties that may be imposed by the Department to ensure compliance.       The proposed rules would also establish a procedure for health care providers to request, and respond to requests for information from, other health care providers care professional regarding a health care professional’s conduct as it relates to patient safety during a period of previous employment.
  • On April 18, 2016 at 48 NJR 626, the Department of Health published notice of its proposal of a new rule which would require hospitals to post information regarding the Independent Health Care Appeals program in conspicuous places in each of their waiting rooms.
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