Healthcare Law

New Jersey State: Selected Adopted and Proposed Legislation

• A. 312 – Approved – The bill establishes the “Palliative Care and Hospice Care Consumer and Professional Information and Education Program” in the Department of Health.  The program is designed to provide comprehensive and accurate information and education about palliative care and hospice care to the public, to healthcare providers, and to healthcare facilities.  For the complete statute, click here.
• A.3717 – Vetoed –  We recently reported that this bill passed both houses and prohibits a pharmacy benefits manager from retroactively reducing payment on a properly-filed claim for payment by a pharmacy.  These retroactive reductions in payment are often referred to as direct and indirect remuneration fees.  Despite passing both the Assembly and Senate, it was vetoed with recommendations from the Governor.  For the veto, click here.
• A. 4938  – Approved – This bill establishes a “My Life, My Plan” program in the DOH to promote and support reproductive life planning for all women of childbearing age and their families.  For the complete statute, click here.
• A. 5021– Approved – The bill provides for an expansion of the State Medicaid program to include coverage for group prenatal care services.  The new model is a healthcare redesign that changes the traditional model of the patient and healthcare provider in an exam room to a group setting which allows for care based on clinical and peer support.  For the complete statute, click here.
• A. 5363 – Vetoed –  We previously reported that this bill passed both houses and requires carriers that offer health benefits plans to provide new or existing subscribers with notification of certain hospital and health system contract expirations. Despite passing both the Assembly and Senate, it was vetoed with recommendations from the Governor.  For the veto, click here.
• S.3075 – Vetoed – We previously reported that this bill passed both houses and requires DOH to regulate and license embryo storage facilities. Despite passing both the Assembly and Senate, it was vetoed with recommendations from the Governor.  Since the veto, the Senate has passed the bill with the Governor’s recommendations. For the veto, click here.
• S. 499 – Approved – This bill provides for an improved system for eligibility determination for the Medicaid and NJ FamilyCare programs.  It requires the Commissioner of Human Services to develop an information technology platform for the intake, processing, and tracking of applications for benefits under the Medicaid and NJ FamilyCare programs.  The goals of the system are, among other things,  to simplify the applications and eligibility determination processes for both applicants and eligibility determination staff and to standardize application of eligibility policy across the various agencies responsible for eligibility determination.  For the complete statute, click here.
• S. 1109 – Approved – This bill  renames "Physician Orders for Life-Sustaining Treatment Act" as "Practitioner Orders for Life-Sustaining Treatment Act" and its purpose is to allow physician assistants to sign, modify, or revoke Physician Orders for Life-Sustaining Treatment forms, in the same manner as physicians and advanced practice nurses. Further, physician assistants would be required to complete two credits of continuing medical education on topics related to end-of-life care as a condition of continued licensure. For the complete statute, click here.
• S. 2507 – Approved – This bill prevents the sale or leasing of dental provider network contracts.  For the complete statute, click here.
• S. 2690 – Approved – This bill addresses “clawback schemes” by prohibiting a pharmacy benefits manager from charging a covered person a copayment for a prescription drug benefit in an amount that exceeds the cost of the prescription drug that the pharmacy would charge to persons who do not purchase the drug through their health insurance coverage.  It also addresses “gag clauses” by requiring a pharmacy benefits manager to not prohibit a network pharmacy from disclosing to a covered person lower cost prescription drug options, including those that are available to the covered person if the covered person purchases the prescription drug without using health insurance coverage.  It also requires the pharmacy to disclose certain pricing information.  For the complete statute, click here.
• S. 3312 – Approved – This bill provides that any hospital in the state, which provides services in a municipality that has a disproportionately high rate of firearm violence or homicides, may not be designated as a Level One or Level Two trauma center unless the hospital operates or contracts with a hospital-based or hospital-linked violence intervention program that provides appropriate counseling to patients who have been injured as a result of violence, assuming that funding is available. For the complete statute, click here.
• S.3301 – Approved – This bill requires the Commissioner of Health to establish a "Hospital-Based Violence Intervention Program Initiative." The Commissioner is required to implement a comprehensive plan to create hospital-based violence intervention programs, in which people recovering from violent injuries are counseled by trained intervention specialists.  The bill provides that, in addition to any moneys appropriated by the Legislature, the Commissioner may seek money from other sources like private foundations.  For the complete statute, click here.
• S. 3334 –  Approved – Surgical technologists employed at a surgery practice were not required to meet certain training and certification requirements that apply to surgical technologists employed at licensed healthcare facilities, as surgical practices were not licensed.  This changed with a 2017 enactment, section 1 of P.L.2017, c.283, which required surgical practices to be licensed.  One effect of this enactment has been that surgical technologists employed at a surgical practice are now required to demonstrate certain training and certification requirements.  This bill provides that surgical technologists employed at a surgical practice on the effective date of P.L.2017, c.283 are not required to meet these training and certification requirements. For the complete statute, click here.
• S. 3963 – Approved – This revises the law to allow recovery of unreimbursed medical expenses as economic loss in civil action for damages arising from an automobile accident. For the complete statute, click here.
• S. 4062 – Proposed – This bill requires insurance carriers to pass prescription drug savings on to consumers.  For the complete statute, click here.

New
Jersey State: Selected Adopted and Proposed Regulations

• 51 N.J.R. 1359 (a) – Adopted – The new rules set forth the manner in which the New Jersey Medicaid/NJ FamilyCare programs will provide covered health services to eligible persons through the Managed Care program, by means of managed care organizations (MCOs).  The new rule also affects Medicaid/NJ FamilyCare providers, including managed care entities and those providers who will continue to provide certain services on a fee-for-service basis to beneficiaries who are also enrolled in managed care.  For the complete adopted rule, click here.
• 51 N.J.R. 1249(a) – Proposed – This rule amends the curriculum requirements for licensure and continuing education requirements for electrologists.  Comments are due by October 5, 2019.  For the complete proposed rule, click here.
• 51 N.J.R. 1312 (a) – Proposed – This establishes standards to which hospices that elect to accept and dispose of surrendered prescription medications must adhere.  Comments are due by October 18, 2019.  For the complete proposed rule, click here.

Federal:
Selected Proposed Legislation

• S. 2244 – Proposed – This amends the Controlled Substances Act to allow community addiction treatment facilities and community mental health facilities to register to dispense controlled substances through the practice of telemedicine.  For the complete proposed rule, click here.
• S. 2247 – Proposed – This is another proposed statute that seeks to provide greater transparency of discounts provided by drug manufacturers, to establish requirements relating to pharmacy-negotiated price concessions. For the complete proposed rule, click here.
• S. 2408 – Proposed –  This bill establishes a national telehealth program, and for other purposes. For the complete statute, click here.
• S. 2412 – Proposed –  This bill provides coverage of addiction counselor services under part B of the Medicare program. For the complete statute, click here.
• H.R. 3910 – Proposed – This statute intends to improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation.  For a complete review of the proposal, click here.
• H.R. 3925 – Proposed – This statute prohibits states receiving federal medical assistance for medication-assisted substance abuse treatment under Medicaid from imposing utilization control policies or procedures with respect to such treatment. For a complete review of the proposal, click here.
• H.R. 3947 – Proposed – This bill provides somewhat of a comprehensive approach to addressing drug pricing by eliminating delays of generic drugs and biosimilar products, increasing access to drugs and increasing drug price competition, requiring certain patient disclosures, and appointing a Chief Pharmaceutical Negotiator to conduct trade negotiations and to enforce trade agreements overseas relating to United States pharmaceutical products.  For the complete statute, click here.
• H.R. 4106 – Proposed – This bill restricts direct-to-consumer drug advertising. For a complete review of the proposal, click here.
• H.R. 4126 – Proposed – This credits individuals serving as caregivers of dependent relatives with deemed wages for up to five years of such service.  For a complete review of the proposal, click here.
• H.R. 4158 – Proposed – This proposal intends to prohibit price gouging in the sale of drugs by finding that a manufacturer will have engaged in price gouging if prices increase a certain percentage within a certain period of time. For the complete statute, click here.

Federal:
Selected Adopted and Proposed Regulations

• 84 FR 38384 – Final – This proposed rule updates the hospice wage index, payment rates, and cap amount for fiscal year 2020. Significantly, the rule rebases the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care and changes to the Hospice Quality Reporting Program.  This rule becomes effective on October 1, 2019.  For the complete rule, click here.
• 84 FR 38424 – Final – This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), revises and rebases the IPF market basket to reflect a 2016 base year and removes the IPF Prospective Payment System (PPS) 1-year lag of the wage index data and updates the Inpatient Psychiatric Facilities Quality Reporting Program. This rule becomes effective October 1, 2019.  For the complete rule, click here.
• 84 FR 38728 – Final – This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020, makes minor revisions to the regulation text to reflect the revised assessment schedule under the Patient Driven Payment Model (PDPM), revises the definition of group therapy under the SNF PPS, implements a subregulatory process for updating the ICD-10 codes used under PDPM, and updates requirements for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program.  This final rule becomes effective October 1, 2019.  For the complete rule, click here.
• 84 FR 39054 – Final – This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020.  Importantly, this rule, among other things, rebases and revises the IRF market basket to reflect a 2016 base year rather than the current 2012 base year, and revises the case mix groups and updates the case mix group relative weights and average length of stay (LOS) values beginning with FY 2020.  It also clarifies the regulations for determining whether a physician qualifies as a rehabilitation physician.  This final rule becomes effective October 1, 2019.  For the complete rule, click here.
• 84 FR 42044-01 – Final – CMS revised the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes and implement certain recent legislation.   The final rule also (1) updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020.  Importantly, the final rule addresses the wage index disparities impacting low wage index hospitals and provides for an alternative IPPS new technology add-on payment pathway for certain transformative new devices and qualified infectious disease products; (2) establishes  new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs); (3) establishes  new requirements and revising existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs; and (4) updates policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.   The Final Rule is effective October 1, 2019.  For the complete rule, click here.
• 84 FR 38330 – Proposed – This rule updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2020, updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI), updates the requirements for the ESRD Quality Incentive Program (QIP), and proposes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services and revises existing regulations related to the competitive bidding program for DMEPOS. This proposed rule also would streamline the requirements for ordering DMEPOS items, and develop a new list of DMEPOS items potentially subject to a face-to-face encounter, written orders prior to delivery and/or prior authorization requirements.   Comments are due by September 27, 2019.  For the complete proposed rule, click here.
• 84 FR 39398 – Proposed – This revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2020, updates the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, establishes requirements for all hospitals for making hospital standard charges available to the public, establishes a process for prior authorization for certain covered outpatient department services, revises the regulations to allow grandfathered children's hospitals-within-hospitals to increase the number of beds without resulting in the loss of grandfathered status, and solicits comments on an appropriate remedy in litigation involving the OPPS payment policy for 340B-acquired drugs. Comments are due by September 27, 2019.  For the complete proposed rule, click here.
• 84 FR 40482-01 – Proposed – This rule modifies the physician fee schedule based on national uniform RVUs to ensure that CMS’s payment systems are updated to reflect changes in medical practice and the relative value of services. The proposed rule also includes other Medicare Part B payment policies, Medicare Shared Savings Program quality reporting requirements, Medicaid Promoting Interoperability Program requirements for eligible professionals, telehealth services, home infusion therapy benefits, the establishment of an ambulance data collection system, updates to the Quality Payment Program, Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm, and amendments to Physician Self-Referral Law advisory opinion regulations. In terms of the Anti-Kickback statute, CMS is proposing a change that allows parties, who did not submit the advisory opinion request, to rely on CMS’s advisory opinions. In addition, even though a favorable advisory opinion with respect to one arrangement would not legally preclude CMS from pursuing violations against parties to a different arrangement, CMS would no longer consider using enforcement resources for purposes of imposing sanctions on parties, who are in an arrangement that CMS believes is materially indistinguishable from an arrangement that has received a favorable advisory opinion.   Comments are due by September 27, 2019.  For the complete rule, click here.
• 84 FR 44566 and 68 – Proposed – This regulation proposes to amend its Confidentiality of Substance Use Disorder Patient Records regulations as proposed by the Substance Abuse and Mental Health Services Administration (“SAMHSA”) including to clarify one of the conditions under which a court may authorize disclosure of confidential communications made by a patient to a part 2 program as defined in this regulation. Specifically, courts may authorize disclosure of confidential communications when the disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, even if the extremely serious crime was not allegedly committed by the patient. Comments to 44568 are due by October 25, 2019 and comments to 44566 are due on September 25, 2019.  For the complete proposed rules, click 44568 and 44566.

Guidance
and Decisions

• CMS Guidance on Tackling Medicaid Opioid Use:   On 8/5/19, CMS issued new guidance to states concerning implementation of the new Medicaid Drug Utilization Review (DUR) provisions that were included in Section 1004 of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, which are designed to reduce opioid related fraud, misuse and abuse. This guidance addresses the required implementation of these provisions, including requirements regarding opioid prescription claim reviews at the point of sale (POS) and retrospective reviews. The guidance also describes the components of the State Plan Amendment (SPA) that each state must submit by December 31, 2019, in order to comply with these new requirements. For a complete review of the guidance, click here.
• In August 2019, CMS finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell” therapy, which is a form of cancer treatment that uses a patient’s own genetically-modified immune cells to fight disease.  For a complete review of the decision, click here.

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. © 2019 Riker Danzig Scherer Hyland
& Perretti LLP.