Healthcare Law

New
Jersey State: Selected Proposed and Adopted Legislation

• A.2442 – Adopted – Establishes reciprocity requirements for out-of-state certified nurse aides to practice in New Jersey.
• S.466 – Adopted – Requires acceptance of universal dentist application for participation form by dental plan carriers.
• S.3075 – Amended/Substituted – Requires DOH to regulate and license embryo storage facilities.
• S.3202 – Amended – Prohibits managed care plans from preventing a healthcare provider from referring patients with breast cancer to an out-of-network plastic surgeon for reconstructive surgery under certain circumstances.
• S.3363 – Introduced – Requires DOH to establish maternity care evaluation protocols and maternity care evaluation database.
• S.3365 – Introduced – Establishes perinatal episode of care pilot program in Medicaid.
• S.3371 – Introduced – Directs DOH to develop standardized perinatal health curriculum for community health workers.
• S.3372 – Introduced – Requires DOH to develop inter-conception care resources to enhance postpartum care for women.
• S.3373 – Introduced – Establishes training protocols and treatment guidelines for general hospitals providing maternity care.
• S.3374 – Introduced – Provides Medicaid coverage to eligible pregnant women for a 365-day period beginning on last day of pregnancy.
• S.3375 – Introduced – Establishes maternal healthcare pilot program to evaluate shared decision-making tool developed by DOH and used by hospitals providing maternity services, and by birthing centers.
• S.3376 – Introduced – Requires DOH to establish "My Life, My Plan" program to support women of childbearing age in developing reproductive life plan.
• S.3404/A.4991 – Introduced – Requires DOH to create best practices manual for maternity care
• A.1597 – Amended – Enters New Jersey in multistate Nurse Licensure Compact.
• A.4988 – Amended/Substituted – Requires licensure of pain management clinics, establishes process to identify abnormal drug usage and prescribing practices, modifies requirements for opioid prescriptions and medication-assisted treatment, authorizes use of non-opioid advance directives, and addresses liability.

New Jersey State: Selected Proposed and Adopted Regulations

• 51 N.J.R. 102(c) – The Department of Human Services is soliciting applications from eligible entities to become Programs of All-Inclusive Care for the Elderly (PACE) organizations. Proposals are due on April 30, 2019.
• 51 N.J.R. 178(a) – Notice of Certificate of Need Call for Intermediate and Intensive Bassinets in Certain Counties: On February 4, 2019, the Commissioner of the Department of Health invited applications on a full review basis to establish intermediate and intensive neonatal bassinets in certain counties. The applications are due on June 3, 2019.

Federal:
Selected Proposed and Enacted Legislation

• PL 115-320, 2018 HR 315 – Approved – Improving Access To Maternity Care Act. Amends the Public Health Service Act to distribute maternity care health professionals to health professional shortage areas identified as in need of maternity care health services.
• H.R. 506 – Introduced – Amends the Social Security Act. Appropriates $160,000,000 to the Federal Trade Commission to hire staff to investigate, as consistent with the Sherman Antitrust Act and other relevant federal laws, anti-competitive mergers and practices under such laws to the extent such mergers and practices relate to providers of inpatient and outpatient healthcare services.
• H.R. 1035 – Introduced – To amend the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes.
• H.R. 1034/S.377 – Introduced – To amend the Social Security Act to require pharmacy-negotiated price concessions to be included in negotiated prices at the point-of-sale under part D of the Medicare program, and for other purposes.
• 2019 S. 221 – Introduced – Requires the Under Secretary of Health to report major adverse personnel actions involving certain healthcare employees to the National Practitioner Data Bank and to applicable State licensing boards.

Federal:
Selected Proposed and Adopted Regulations

• 83 FR 67816-01 – Adopted – Under the Medicare Shared Savings Program, providers of services and suppliers that participate in an Accountable Care Organization (ACO) receive traditional Medicare fee-for-service (FFS) payments under Parts A and B and are eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this final rule provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage the formation of additional ACOs.
• 84 FR 1536-01 – Proposed – This proposed rule updates the proficiency testing (PT) regulations under CLIA to address current analytes, and also makes additional technical changes to PT referral regulations to more closely align them with the CLIA statute.
• 84 FR 2340-01 – Proposed – This proposed rule eliminates the safe harbor protection for rebates involving prescription pharmaceuticals and the creation of a new safe harbor protection for certain point-of-sale reductions in price on prescription pharmaceuticals and certain pharmacy benefit manager service fees.

Federal/State
Litigation

• A New Jersey Appellate Division reversed arbitration awards requiring insurers to pay for medical procedures not recognized by New Jersey regulators. The Appellate Division held that the awards were unjustified, see New Jersey Manufacturers Insurance Co. v. Specialty Surgical Center et al., Case Numbers A-0319-17T1 and A-0388-17T1
• The Eighth Circuit recently ruled that UnitedHealth Group Inc. cannot offset overpayments to providers from certain health plans by withholding payments to those providers from other health plans. For more information, see Louis J. Peterson, D.C., et al. v. UnitedHealth Group Inc., et al., Case Number 17-1744
• The 11th U.S. Circuit Court of Appeals upheld a federal district judge's April Ruling that the combination of the Blues plans' exclusive territories, in which they agreed not to compete, and the agreement to limit competition on non-Blues branded products is a per se violation of the Sherman Antitrust Act. For more information, see Oscar Insurance Company of Florida v. Blue Cross and Blue Shield of Florida Inc. et al, Case Number 6:18-cv-01944

In the News

• In January 2019, CMS launched eMedicare, which allows recipients of Original Medicare as well as caregivers and others to determine, using their mobile phones, whether Medicare covers a specific medical item.
• In January 2019, the United States Department of Health and Human Services issued voluntary healthcare cybersecurity standards. The guidance document can be downloaded from the following link: https://www.phe.gov/Preparedness/planning/405d/Pages/default.aspx.
• On February 14, 2019, the HHS and CMS announced a new payment model for emergency ambulance services that aims to allow Medicare beneficiaries to receive the most appropriate level of care for lower out-of-pocket costs. Instead of always going to the hospital, ambulance service providers, under the new model – Emergency Triage, Treat and Transport (ET3) – will make it possible for participating ambulance service providers to partner with qualified healthcare practitioners to deliver treatment on-the-scene, through telehealth, at the doctor’s office or urgent-care clinic. The ET3 model will have a five-year performance period, with an anticipated start date in early 2020. Under the ET3 model, participating ambulance service providers can earn up to a 5% payment adjustment in later years of the model based on their achievement of key quality measures. CMS anticipates releasing a Request for Applications in Summer 2019 to solicit Medicare-enrolled ambulance service providers.

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.