Healthcare Law

New Jersey State: Selected Proposed Legislation  

• S. 1288 – Introduced – Establishes a process for county colleges to offer baccalaureate degree nursing programs.
• S. 1260 – Introduced – Extends Medical Malpractice Liability Insurance Premium Assistance Fund and collection of annual surcharges for five years.
• S. 1291 – Introduced – Requires certain healthcare facilities to offer, and healthcare workers to receive, an annual influenza vaccination.
• S. 1344 – Introduced – Individual’s status as minor may not disqualify him from bone marrow donation if medical criteria and informed consent requirements are met.
• S. 1292 – Introduced – Prohibits substitution of prescribed epilepsy drugs by pharmacists without prior notification to and written consent of physician and patient.
• S. 1073 – Introduced – Permits pharmacists to prescribe self-administered hormonal contraceptives under certain circumstances; clarifies certain health insurance coverage requirements for contraceptive prescriptions.
• S. 1041 – Introduced – Requires DHS to develop a timeline for use by individuals with developmental disabilities to gain benefit of State and federal programs; requires posting this timeline on DHS, DCF, and DOE websites.
• S. 1183 – Introduced – Requires DHSS to post on their website information concerning hospital emergency department staffing and services for pediatric patients.
• S. 1272 – Introduced – Requires newly licensed registered professional nurses to attain a baccalaureate degree in nursing within 10 years of initial licensure.
• S. 1296 – Introduced – “Reproductive Donation Safety Act.”
• S. 1171 – Introduced – Requires audits of managed care plan provider networks.
• S. 1035 – Introduced – Requires for-profit hospitals to report certain information to DOH.
• S. 1380 – Introduced – Clarifies that first aid, ambulance or rescue squads, as entities, have immunity from civil damages in certain circumstances.
• S. 1349 – Introduced – Requires narcotic and drug abuse treatment centers to offer Hepatitis C testing to clients.
• S. 1390 – Introduced – Requires health benefits coverage for orthotic and prosthetic appliances from licensed podiatrists.
• S. 1398 – Introduced – Expands infertility coverage under certain health insurance plans.
• S. 1576 – Introduced – Requires certain disclosures in advertisements by healthcare professionals.
• S. 1575 – Introduced – Establishes “Right to Try Act” permitting terminally ill patients to access investigational drugs and treatment.
• S. 1819 – Introduced – “Compounding Pharmacy Quality Assurance Act.” This act requires accreditation by the Pharmacy Compounding Accreditation Board of pharmacies that create customized versions of prescription medications that are not available through pharmaceutical manufacturers, so called “compounding pharmacies,” as a prerequisite to operation in the State of New Jersey.
• S. 1799 – Introduced – Prohibits bio-analytical laboratories from charging patients more than 115% of the applicable Medicare rate.
• S. 1695 – Introduced – Requires a carrier which offers a managed care plan that provides benefits for diagnostic radiologic services to offer the same fee schedule, including any additional compensation in addition to the fee schedule, for those diagnostic radiologic services to all participating providers.
• S. 1031/A. 3001 – Introduced – Restricts health insurers from limiting access to pain medication.
• S. 1694/A. 2876 – Introduced – Limits upfront costs for oral anticancer medications for persons covered under certain health benefits plans.
• A. 3441 – Introduced – Eliminates use of vaccines containing mercury.
• A. 2711 – Introduced – Requires SHBP and SEHBP to provide coverage for expenses incurred in screening for prostate cancer.
• A. 3007 – Introduced – Deletes prior authorization requirements by certain insurers for accessing certain healthcare services.
• A. 3023 – Introduced – Provides alternate standard for involuntary commitment to treatment in outpatient setting.
• A. 3138 – Introduced – Requires psychiatrists to complete screening certificates no later than 12 hours after completion of screening documents.
• A. 3427 – Introduced – Requires DOBI to provide notification of suspension or revocation of license or registration of third party administrators.
• A. 3423 – Introduced – Provides for designation of acute stroke-ready hospitals; requires development of emergency services stroke care protocols; and mandates insurance coverage for telemedicine for stroke care.

Federal: Selected Proposed Legislation

• H.R. 4553 – Introduced – Amends Title XVIII of the Social Security Act to clarify reasonable costs for critical access hospital payments under the Medicare program, and for other purposes.
• H.R. 4565 – Introduced – Amends the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.
• H.R. 4589 – Introduced – Amends Title XVIII of the Social Security Act to repeal the cap on the Medicare Advantage star rating bonuses, and for other purposes.
• H.R. 4695 – Introduced – Amends Title XI of the Social Security Act to improve the quality, health outcomes, and value of maternity care under the Medicaid and CHIP programs by developing maternity care quality measures and supporting maternity care quality collaboratives.
• H.R. 4632 – Introduced – Amends Title XVIII of the Social Security Act to cover screening computed tomography colonography as a colorectal cancer screening test under the Medicare program.
• H.R. 4627 – Introduced – Amends Title XIX of the Social Security Act to provide parity among states in the timing of higher federal Medicaid matching rates for the ACA-expansion population.
• S. 2618 – Introduced – Amends Title XIX of the Social Security Act to require states to publish a Medicaid fee-for-service provider directory.

Federal: Selected Proposed Regulations

• 81 FR 13230 – Introduced – This proposed rule would implement a new Medicare payment model under §1115A of the Social Security Act as it relates to the Part B Drug Payment Model.  Specifically, the rule would create a two-phase model whereby the first phase would change the 6 percent add-on to Average Sales Price to a 2.5 percent plus flat fee.  Then the second phase would implement value-based purchasing tools similar to those employed by commercial health plans, PBMs, hospitals, and other entities that manage health benefits and drug utilization.

Federal Litigation

• The Sixth Circuit held that where two hospital patients had provided express consent to be contacted by a debt collection agency’s automated calls by providing their cell phone numbers to the hospital, that express consent was enough to negate any claim related to a violation of the Telephone Consumer Protection Act.  For more information on the case, see, Zachary Baisden et al. v. Credit Adjustments Inc., case number 15-3411, in the U.S. Court of Appeals for the Sixth Circuit.
• The Department of Health and Human Services and the State of Georgia recently reached a settlement over whether the federal government must refund the state $75 million in mistaken Medicaid payments.  HHS has decided to end its challenge of a District Court allowing the refund even though HHS argued that the statute of limitations for Georgia to ask for a refund had passed.  For more information, see, Georgia Department of Community Health v. U.S. Department of Health and Human Services et al., case numbers 15-5236 and 15-5254, in the U.S. Court of Appeals for the District of Columbia.
• The Pennsylvania Supreme Court recently gave State Farm the go-ahead to use its own formula for calculating payments for medical devices and services in response to a medical supplier’s proposed class action against State Farm over allegedly underpaid bills.  For more information on the case, see, Freedom Medical Supply Inc. v. State Farm Fire and Casualty Co. et al., case number 8 EAP 2015, in the Supreme Court of the State of Pennsylvania.
• A plumbing company, which enrolls employees in a health insurance plan offered by Blue Cross Blue Shield of Alabama, filed an antitrust action against Blue Cross with claims that they have limited competition and facilitated price increases by dividing markets up geographically.  For more information on the class action, see, Pettus Plumbing & Piping Inc. v. Blue Cross Blue Shield of Alabama et al., case number 3:16-cv-00297, in U.S. District Court for the Northern District of Alabama.
• The U.S. Supreme Court ruled in favor of Liberty Mutual Insurance, upholding the Second Circuit’s ruling in their favor, that ERISA’s reporting requirements preempt a Vermont state law reporting requirement for self-insured employee health plans.  Writing for the majority, Justice Kennedy wrote that ERISA’s reporting requirement was crafted to prevent insurance companies from having to navigate a “hodgepodge” of different state regulations.  For more information on the case, see, Gobeille v. Liberty Mutual Insurance Co., case number 14-181, before the Supreme Court of the United States.
• The U.S. Supreme Court declined to hear the appeal of a Connecticut-based teeth-whitening clinic, effectively ending its challenge to a Connecticut law that limited the services that they could provide.  For more information on the case, see, Sensational Smiles LLC, et al., v. Mullen, et al., case number 15-507, in the Supreme Court of the United States.

In the News

• The West Virginia House of Delegates approved a bill that would exempt hospitals and providers under their state’s healthcare Authority’s jurisdiction from state and federal antitrust scrutiny.  The reason for this bill appears to be to avoid the FTC’s opposition to a proposed merger between Cabell Huntington Hospital and St. Mary’s Medical Center.  The bill now heads to the Senate.  For more information, see, West Virginia Senate Bill 597.
• While no formal case has been filed yet the New York attorney general has subpoenaed 16 major health insurers, including Empire Blue Cross Blue Shield, Aetna, and CareConnect, to determine whether they have cheated policyholders by denying coverage for hepatitis C drugs.

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. Nothing in this Update should be relied upon as legal advice in any particular matter. © 2016 Riker Danzig Scherer Hyland & Perretti LLP.