| New Jersey State: Selected Proposed and Adopted Legislation |
- S. 2332 – Amended/Substituted – Entitled the “Healthcare industry Representative Certification Act,” this bill would establish requirements and qualifications for certification of healthcare industry representatives.
- P.L. 2017, c. 239 – Adopted – This law establishes minimum Medicaid reimbursement rates for personal care services
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| New Jersey State: Selected Proposed and Adopted Regulation |
- 49 N.J.R. 3294(a) – Proposed – This proposed rule would extend the expiration date of the Hospital Services Manual chapter 180 days from its current expiration date of December 6, 2017 to June 4, 2018.
- 49 N.J.R. 3360(b) – Adopted – This final rule provides amendments to N.J.A.C. 13:36-6A.2, 6A.3, 6A.4 and 6A.7, affecting definitions and standards for the declaration of brain death and the pronouncement of death.
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| Federal: Selected Adopted Regulations |
- 82 FR 46182-01 – Adopted – This regulation withdraws a proposed regulation published in the Federal Register on March 11, 2016, which would have implemented a new Medicare payment model for Part B drug payments under section 1115A of the Social Security Act.
- 82 FR 46181-01 – Adopted – This regulation withdraws a proposed rule published in the Federal Register on December 12, 2014. The proposed rule would have revised the applicable conditions of participation for certain providers, conditions for coverage for certain suppliers, and requirements for long-term care facilities, to ensure that the requirements are consistent with the Supreme Court decision in United States v. Windsor, 570 U.S. 12 (2013) and HHS policy.
- 82 FR 46181-02 – Adopted – This regulation withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule would have, among other things, specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics and specified accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics.
- 82 FR 46163-01 – Adopted – This regulation corrects technical errors in the final rule that appeared in the August 4, 2017 Federal Register, which will update the payment rates used under the prospective payment system for skilled nursing facilities for fiscal year 2018.
- 82 FR 48770-01 – Adopted – This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
- 82 FR 50080-01, 82 FR 50071-01, 82 FR 50080-02, 82 FR 50075-01, 82 FR 50077-01, 82 FR 50073-01, and 82 FR 45725-01 – Adopted – The FDA is classifying and/or reclassifying the following: (1) the FDA is correcting a final order entitled “Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss” that appeared in the Federal Register of July 28, 2017; (2) The FDA is classifying the acute kidney injury test system into class II (special controls); (3) The FDA is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls); (4) the FDA is classifying the Auoporin-4 autoantibody immunological test system into class II (special controls); (5) the FDA is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls); (6) the FDA is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls); and (7) the FDA is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls).
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| Federal: Selected Proposed Legislation |
- H.R. 3877 – Introduced – Amends Title XVIII of the Social Security Act to protect healthcare consumers from surprise billing practices.
- H.R. 3888 – Introduced – Amends the Public Health Service Act to provide grants for additional residency slots in children’s hospitals' graduate medical education programs.
- H.R. 3885 – Introduced – Directs the Attorney General to establish guidelines for a model elder abuse registry and provides grants to states for establishing and operating such a registry.
- H.R. 3928 – Introduced – Ensures that patients receive accurate healthcare information by prohibiting misleading and deceptive advertising or representation in the provision of Healthcare services and requires the identification of the license of the healthcare professionals to patients.
- H.R. 4116 – Introduced – Amends the Public Health Service Act to require reporting by drug manufacturers to increase transparency in drug pricing.
- H.R. 4129 – Introduced – Establishes a state public option through Medicaid to provide citizens with low-cost health insurance plan.
- S. 1879 – Introduced – Amends Title XVIII of the Social Security Act to provide for the coverage of marriage and family therapist services and mental health counselor services under Part B of the Medicare program.
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| New Jersey State Litigation |
- The New Jersey Appellate Division recently rejected the Burlington-based Our Lady of Lourdes Hospital’s long-running bid to recalculate its Medicaid reimbursement rate for the year 1995, ruling that the state properly applied a regulatory update imposing additional limitations on amounts medical providers could recoup for services. The appeal had focused on a 1993 regulation that applied an “economic factor” to account for inflation in setting reimbursement rates, which was subsequently amended in 1995. The hospital argued that the 1993 reimbursement rate instead of the 1995 reimbursement rate should have been the applicable reimbursement rate for its 1995 numbers. For more information, see, Our Lady Of Lourdes Hospital – Burlington v. Division Of Medical Assistance and Health Services, case no. A-2919-15t2, in the New Jersey Appellate Division.
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| Federal/Other State Litigation |
- The U.S. Supreme Court recently decided not to grant certiorari to a Florida Supreme Court ruling that voided two provider-patient medical malpractice arbitration agreements because they selectively included provisions from Florida’s Medical Malpractice Act favorable only to healthcare providers, which the Florida Supreme Court believed went against the legislative intent of the law. For information, see, Hernandez et al. v. Crespo et al., case number 16-1458, in the Supreme Court of the United States.
- A California federal judge recently decided to dismiss a False Claims Act suit against UnitedHealth Group Inc., which accused the entity of ignoring questionable diagnoses to boost its Medicare Advantage profits. The judge believed the suit was too vague, did not show intentional wrongdoing, and did not show that the government would have withheld payment if it had been aware of the alleged violations. For more information, see, U.S. ex rel. Swoben v. Scan Health Plan et al., case number 2:09-cv-05013, in the U.S. District Court for the Central District of California.
- The National Labor Relations Board recently ruled, reversing its original decision on orders of the First Circuit, that Southcoast Hospital Group Inc., a Massachusetts-based hospital group, can keep its hiring policy, which favors the hiring of nonunion workers for nonunion positions. The NLRB said, specifically, that the hiring policy was not motivated by a desire to weaken the union and is based on a legitimate business purpose. For more information, see, Southcoast Hospitals Group, Inc. and 1199 SEIU, United healthcare Workers East, case number 01–CA– 067303, before the National Labor Relations Board.
- A class action lawsuit was recently filed in Illinois circuit court by a group of nursing home employees who claim that compulsory daily biometric scans violate their privacy rights under state law. For more information, see, Martin Ragsdale v. Paramount of Oak Park Rehabilitation & Nursing Center LLC et al., case number 2017CH13911, in the Circuit Court of Cook County, Illinois, County Department, Chancery Division.
- A New Jersey federal jury recently convicted a New York doctor of accepting bribes in exchange for test referrals as part of Biodiagnostic Laboratory Services LLC. This conviction represents the 51st conviction, including 37 doctors, in connection with Biodiagnostic Laboratory Services LLC. For more information, see, U.S. v. Savino, case no. 2:16-cv-00582, in U.S. District Court for the District of New Jersey.
- A Florida judge recently ruled to block an emergency rule implemented following Hurricane Irma requiring nursing facilities to install backup generators, finding that the state failed to prove a qualified emergency situation and the remedies could not be implemented by the November 15 deadline. For more information on the consolidated cases involved, see, Florida Association of Homes and Services for the Aging Inc. v. Agency for healthcare Administration et al., case number 17-5388RE, Florida Assisted Living Association Inc. v. Florida Department of Elder Affairs, case number 17-5409RE, and Florida Argentum v. Florida Department of Elder Affairs, case number 17-5445RE, in the State of Florida Division of Administrative Hearings.
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| The list above does not include every proposed or adopted legislation, litigation or guidance document that may impact the healthcare industry. Instead, it includes only a select few chosen by the authors, and any information in this Update is not intended to provide legal advice. If you are concerned that a proposed or adopted legislation, litigation or guidance document may impact your practice, then you should seek legal advice. We send these Updates to our clients and friends to share our insights on new developments in the law. Nothing in this Update should be relied upon as legal advice in any particular matter. © 2017 Riker Danzig Scherer Hyland & Perretti LLP.
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