Riker Danzig Health Care Update June 17, 2019
New Jersey State: Selected Proposed and Adopted Legislation
S.1784 – Adopted – This statute provides Medicaid coverage for doula care. For the complete statute, click here.
S. 3365 – Adopted – This statute establishes a perinatal episode of care pilot program in Medicaid that establishes a provider reimbursement model based on target total cost of care for services provided within a perinatal episode of care. For the complete statute, click here.
S. 3378 – Adopted – This statue prohibits health benefits coverage for certain non-medically indicated early elective deliveries under Medicaid program, SHBP, and SEHBP. For the complete statute, click here.
S.3406 – Adopted – This statute requires obstetrical providers to complete the Perinatal Risk Assessment form, as used by the Department of Human Services, for each pregnant Medicaid recipient and for each individual eligible for Emergency Medical Services for Non-Qualified Aliens who receives prenatal care from the provider. For the complete statute, click here.
A. 2810 – Adopted – This statute directs a regulatory officer to implement a protocol for the review and approval of regulations, actions and decisions proposed by a professional board to determine whether the proposed regulation, action, or decision has the potential to displace competition. The bill is intended to maintain antitrust immunity after the United States Supreme Court in North Carolina State Board of Dental Examiners v. Federal Trade Commission where the Supreme Court held that if a controlling number of a board’s members are active market participants in the profession the board regulates, then the board may invoke state-action antitrust immunity only if it is subject to active supervision by the state. For the complete statute, click here.
S. 10/A. 10 – Proposed – Revises requirements to authorize and access medical cannabis. For the complete statute, click here.
S. 3116 – Proposed – Requires certain facilities, such as dementia care facilities, nursing homes, hospitals, and long-term care facilities to undertake end-of-life planning and training as condition of licensure. For the complete statute, click here.
S.3641 – Proposed – This statute requires drug manufacturers to establish drug take back programs, which will accept the return of covered drugs for disposal or destruction, and requires certain pharmacies to become authorized collection sites for covered drugs. For the complete statute, click here.
S. 3746 – Proposed – The bill prevents health insurance carriers limiting, reducing, or denying coverage for any drugs currently in use by a person covered under a plan, except in certain situations. To the extent a switch occurs, the bill requires a switch communication to be provided, which must contain certain disclosures, including the right of a covered person to file an appeal. For the complete statute, click here.
A.5254 – Proposed – This statute permits a physician, who practices cardiology, upon application to and approval of the Department of Health, to refer a patient of the physician to an ambulatory care facility and permit the physician to bear full legal and medical responsibility for the medical treatment of the patient within the ambulatory care facility. For the complete statute, click here.
A. 5369/S.3816 – Proposed – The “Patient Protection Act” requires health care professionals, prior to obtaining consent to transfer a patient to a health care facility located outside the State, to provide the patient and the patient’s insurance carrier, with certain information. For the complete statute, click here.
A. 5371 – Proposed –The bill makes it clear that economic loss, as defined in the “New Jersey Automobile Reparation Reform Act,” otherwise known as the “no-fault law,” may include economic loss for any uncompensated medical expenses, notwithstanding the longstanding interpretation of that definition in the statute to the contrary. In so doing, the bill codifies the holding of the Appellate Division in the consolidated case of Haines v. Taft and Little v. Nishimura, 450 N.J. Super. 295 (App. Div. 2017). For the complete statute, click here.
A. 5406 – Proposed – This bill enters New Jersey into Interstate Medical Licensure Compact, which would reduce the burdens required under telemedicine. For the complete statute, click here.
New Jersey State: Selected Proposed and Adopted Regulation
- 51 N.J.R. 624(a) – Final – With this rule, additional types of providers including dental assistants gain access to the Prescription Monitoring Program, requires pharmacies to provide certain information to the Program when dispensing controlled substances, and requires providers to look up certain information within the Program before prescribing controlled substances in certain circumstances. For the complete rule, click here.
- 51 N.J.R. 626(a) – Final – This final rule imposes additional limitations and obligations on prescribers before accepting compensation from pharmaceutical manufacturers. For the complete rule, click here.
- 51 N.J.R. 561(a) – Proposed – This proposal modifies the rules on telemedicine and telehealth under N.J.S.A. 45:1-16 et seq. including how a licensee will create a licensee-patient relationship. For the complete rule, click here.
- 51 N.J.R. 713(a) – Proposed – This provides the Board of Medical Examiners the authority to recognize volunteer medical services as satisfying up to 10 percent of the continuing education hours required in order to renew a license. For the complete rule, click here.
- 51 N.J.R. 714(a) – Proposed – The Hearing Aid Dispensers Examining Committee proposed these rules for allowing licensed hearing aid dispensers to engage in telemedicine. For the complete rule, click here.
Federal: Selected Proposed and Enacted Legislation
- S. 1266 – Proposed – This amends ERISA to allegedly protect patients from surprise medical bills. For a complete review of the proposal, click here.
- S. 1357/HR 2581 – Proposed – This bill amends the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals, and for other purposes. For a complete review of the proposal, click here.
- S. 1384 – Proposed – A bill to reform prescription drug pricing and reduce out-of-pocket costs by ensuring consumers benefit from negotiated rebates by requiring coinsurance obligations to be based on the net price of the drug as opposed to a percentage of the list price of the drug. For a complete review of the proposal, click here.
- S. 1437 – Proposed – A bill to amend Title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information. For a complete review of the proposal, click here.
- HR 1499 – Proposed – This proposed statute would prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products. For a complete review of the proposal, click here.
- HR 1503 – Proposed – This proposed statute, which passed the House, amends the Federal Food, Drug, and Cosmetic Act regarding brand drugs and requires the FDA to publish certain information about such drugs including patent information. For a complete review of the proposal, click here.
- HR 1520 – Proposed – This proposed bill, which passed the House, amends the Public Health Service Act to provide for the publication of a list of licensed biological products and to include other information such as date of marketing material approval and patent information. For a complete review of the proposal, click here.
- HR 2580 – Proposed – This amends the Controlled Substances Act to deem drugs or other substances that act as mu opioid receptor agonists to be in schedule I, subject to exceptions for substances intended for legitimate medical or research use. For a complete review of the proposal, click here.
Federal: Selected Proposed and Adopted Regulations
- 84 FR 19718 – Final – This removes the regulatory text that allows a state to make Medicaid payments to third parties on behalf of an individual provider. It becomes effective July 5, 2019. For the file rule, click here.
- 84 FR 19855 – Final – This revises the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. It becomes effective July 8, 2019. For the final rule, click here.
- 84 FR 20732 – Final – This amends regulations for the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products to include the Wholesale Acquisition Cost (WAC or list price) of that drug or biological product. It becomes effective July 9, 2019. For the final rule, click here.
- 84 FR 23170-01 – Final – This revises existing regulations that provide protections in health care for individuals and entities on the basis of religious beliefs or moral convictions to, among other things, ensure enforcement of these rules and to delegate overall enforcement and compliance responsibility to the Department's Office for Civil Rights. It further clarifies OCR's authority to conduct investigations, supervise and coordinate compliance by the Department, and use enforcement tools otherwise available in existing regulations to address violations and resolve complaints. Several states have already filed suits challenging this final rule. It becomes effective July 22, 2019. For the final rule, click here.
- 84 FR 23832 – Final – This final rule amends the Medicare Advantage program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans' negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees. It becomes effective January 1, 2020. For the final rule, click here.
- 84 FR 18748-01 – Proposed Rule – This proposed rule would add requirements and a specified process to address changes of ownership as they relate to the sale, transfer, and/or purchase of assets of Accrediting Organizations. For the complete rule, click here.
- 84 FR 19158 – Proposed Rule – This proposed rule would update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year 2020 and advances two key CMS priorities by proposing historic changes to the way Medicare pays hospitals. Since one in five Americans live in rural areas, this payment policy changes the way CMS reimburses hospitals so that rural hospitals receive higher payments. Under the old system, hospitals located in areas with wages less than the national average receive a lower Medicare payment rate than hospitals located in areas with wages higher than the national average. Since wages tend to be lower in rural areas, CMP payments to hospitals in rural areas are lower. To address these disparities, CMS is proposing to increase the wage index of low wage index hospitals.
- In addition, to address concerns raised by hospitals in encouraging new technologies, CMS is proposing to increase the new technology add-on payment, which provides hospitals with additional payments for cases with high costs involving new technologies. CMS is also proposing to modernize payment policies for medical devices that meet FDA’s Breakthrough Devices designation. For devices granted this expedited FDA approval, real-world data regarding outcomes for the devices in different patient populations is often limited. At the time of approval, it can be challenging for innovators to meet the requirement for evidence demonstrating “substantial clinical improvement” in order to qualify for new technology add-on payments. Therefore, CMS is proposing to waive for two years the requirement for evidence that these devices represent a “substantial clinical improvement.
- CMS is also considering several changes to payment policies for CAR-T for 2020, including additional changes to new technology add-on payments for CAR-T and changes to the formula that is used to calculate payments to hospitals for CAR-T. CAR-T is the first-ever gene therapy and is used to treat certain forms of cancer for which no other treatment options exist.
- For a fact sheet on the rule, click here. For the complete rule, click here.
- 84 FR 19000-01 – RFI – This request for information solicits public comment on ideas for innovative programs and waiver concepts that states could consider in developing a 1332 waiver plan. The overarching goal of section 1332 waivers is to give all Americans the opportunity to gain high value and affordable health coverage regardless of income, geography, age, gender, or health status while empowering states to develop health coverage strategies that best meet the needs of their residents. This RFI seeks to understand how states can innovate in ways that will strengthen their health insurance markets, expand choices of coverage, target public resources to those most in need, and meet the unique circumstances of each state. For the RFI, click here.
- 84 FR 24027-01 – Notification of availability – The FDA announced the availability of guidance for the “Section 503A Bulks List Final Rule Questions and Answers—Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the FDA Act. Entities may provide comments to the new guidance. For the complete notice, click here and click here for the guidance document.
The list above does not include every proposed or adopted legislation, litigation or guidance document that may impact the health care 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.