New Jersey State: Selected Proposed and Adopted Regulations

  • 49 N.J.R. 3481(b) – Proposed – This proposed amendment to N.J.A.C. 13:35-6.4 would change the training time required to become a certified medical assistant and to perform subcutaneous and intramuscular injections and venipuncture.
  • 49 N.J.R. 3549(b) – Adopted – The American Board of Dental Specialties sought to allow dentists to advertise certain specialties not specifically recognized by the American Dental Association. The Board of Dentistry determined that it needs more time to consider this issue, but has placed a moratorium, as of October 4, 2017, on the enforcement of the specialty advertising rules set forth at N.J.A.C. 13:30-6.1. However, the Board will continue to enforce its professional advertising rules, other than those specifically related to specialty advertising.

Federal: Selected Proposed and Adopted Regulations

  • 82 FR 56336-01 – Proposed – This proposed rule revises the Medicare Advantage program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act.
  • 82 FR 50738-01 – Adopted – This final rule updates and makes revisions to the end-stage renal disease prospective payment system for calendar year 2018, including renal dialysis services furnished by an ESRD.
  • 82 FR 51676-01 – Adopted – This final rule updates the home health prospective payment system rates for 2018.
  • 82 FR 52356-01 – Adopted – This final rule updates the hospital outpatient prospective payment system and ambulatory surgical center payment system rates for 2018.
  • 82 FR 52976-01 – Adopted – This final rule updates the physician fee schedule and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program.
  • 82 FR 52568-01 – Adopted – The Medicare Access and CHIP Reauthorization Act of 2015 established the Quality Payment Program for eligible clinicians, which allows eligible clinicians to participate via one of two tracks: Advanced Alternative Payment Models or the Merit-based Incentive Payment System. CMS began implementing the Quality Payment Program in 2017. This final rule provides updates for the second and future years of the program.
  • 82 FR 53374-01 – Adopted – This final rule notes that, as the Health Education Assistance Loan program (“HEAL”) was transferred from HHS to the Department of Education, the regulations pertaining to HEAL have also been transferred to the Department of Education.
  • 82 FR 54289-01 – Adopted – The FDA recently announced the availability of a document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” This guidance document provides health care professionals with FDA’s current thinking on the scope of this exception set forth in the human cells, tissues, and cellular and tissue-based products regulations.

Federal: Selected Proposed and Adopted Legislation

  • H.R. 4138/S. 2011 – Introduced – Amends Title XVIII of the Social Security Act to provide for the negotiation of lower covered Part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of HHS under Medicare Part D.
  • S. 2027 – Introduced – Amends Title XIX of the Social Security Act to provide clarification with respect to the liability of third party payers for medical assistance paid under the Medicaid program.
  • S. 2057 – Introduced – This bill aims to prevent conflicts of interest that allegedly stem from the revolving door that raises concerns about the independence of pharmaceutical regulators.
  • S. 2059 – Introduced – Amends Title XVIII of the Social Security Act to provide for a 90-day period for the determination of whether a Merit-Based Incentive Payment System (MIPS) eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use.
  • H.R. 4392 – Introduced – Provides that the regulation regarding cuts to the 340B drug discount program shall have no force or effect and that payment for such drugs or biologicals covered under the 340B drug discount program shall be calculated as if the regulation did not apply.
  • S. 2157 – Introduced – Requires drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug.
  • P.L. 115-83 – Adopted – “Protecting Patient Access to Emergency Medications Act of 2017” identifies a procedure for allowing EMS professionals to administer controlled substances in Schedule II, III, IV or V to ultimate users receiving emergency medical services, including registration requirements with the Attorney General.

New Jersey State Litigation

  • The New Jersey Appellate Division recently found that Deborah Heart & Lung Center and its officials abided by the rules of the New Jersey Health Care Professional Responsibility and Reporting Act by informing the New Jersey Board of Medical Examiners and other facilities that one of its physicians resigned while under review for allegedly performing unnecessary procedures. For more information on the suit, see, Christine Gasperetti M.D. v. Deborah Heart And Lung Center et. al., case no. A-0244-13T2, in the Superior Court of New Jersey, Appellate Division.

Federal and Other State Litigation

  • The Third Circuit, in upholding a lower court’s dismissal of a former University of Pittsburgh Medical Center’s suit seeking entitlement to the protection of ERISA for his “top-hat” plan, clarified that ERISA does not protect “top-hat” plans regardless of whether or not the employee in question had bargaining power to influence the design or operation of their deferred compensation plan. For more information on the suit, see, Paul F. Sikora v. UPMC et. al., case no. 17-1288, in the U.S. Court of Appeals for the Third Circuit.
  • The Florida Supreme Court recently ruled that citizens have a right to privacy even after death under the Florida Constitution and also struck down part of the state’s pre-filing requirements for medical malpractice claims. The requirement allowed prospective medical malpractice defendants to conduct meetings with treating doctors while the plaintiff’s lawyers were not present. Plaintiff argued that this provision threatened privacy. For more information on the case, see, Emma Gayle Weaver v. Stephen C. Myer et al., case number SC15-1538, in the Supreme Court of Florida.
  • The American Hospital Association and two other hospital groups recently filed suit in federal court against the Department of Health and Human Services over the recent final rule that would reduce reimbursement by nearly 30 percent for drugs purchased under the 340B drug. This rule is expected to slash $1.6 billion in reimbursements. For more information on the suit, see, The American Hospital Association et al. v. Eric D. Hargan et al., case number 1:17-cv-02447, in the U.S. District Court for the District of Columbia.
  • A class of nurses recently has sought the approval of the District Court for the District of Oregon to its agreement to a $9.5 million settlement between the class and St. Charles Health System, Inc. Specifically, the nurses alleged that the health care provider forced the nurses to study and take tests, without compensation, for certifications not necessary to maintain a nursing license in Oregon. For more information on the suit, see, Giles v. St. Charles Health System Inc., case number 6:13-cv-00019, in the U.S. District Court for the District of Oregon.
  • The Ninth Circuit recently ruled to revive a suit against Blue Cross Blue Shield and the Office of Personnel Management claiming their health plan information was far too vague to allow potential enrollees to project their costs. Specifically, the plaintiffs alleged that the provider’s failure to define what is inpatient hospital care and what is outpatient hospital care prevents enrollees from assessing what plan is best for them. For more information on the suit, see, Bruce Norvell v. Blue Cross and Blue Shield Association, case number 17-35239, in the U.S. Court of Appeals for the Ninth Circuit.

In the News

  • The State Health Planning Board recently voted unanimously to approve the sale of Meadowlands Hospital Medical Center to Yan Moshe, a Long Island-based developer who already owns two surgery centers in Bergen County, for $12.2 million. The Acting state Department of Health Commissioner, Christopher Rinn, has to make a final decision to approve or deny the sale.
  • OIG recently decided to revoke an advisory opinion it first issued in 2006 and modified in 2015, finding that a patient-assistance charity’s recent actions made it a potential conduit for drug industry dollars. Specifically, the OIG found that the charity in question breached two commitments that were the bedrock of the advisory opinion shielding it from kickback liability. Namely, the charity gave patient-specific data to one or more donors, enabling them to “correlate the amount and frequency of their donations with the number of subsidized prescriptions or orders for their products,” and the charity “allowed donors to directly or indirectly influence the identification or delineation of [its] disease categories.”
  • Nursing home chain operator Preferred Care Partners recently filed for Chapter 11 bankruptcy protection in Texas, saying that it and its affiliated nursing homes are facing an “overwhelming” number of personal injury suits (more than 160), which does not include liability on a $28.5 million verdict against it in Kentucky State Court. At the time of its filing, the chain operator had 74 affiliated nursing facilities in Texas, Florida, Kansas, Iowa, Arizona, Mississippi, Nevada, Louisiana, Colorado and Oklahoma.