New Jersey State: Selected Proposed and Adopted Legislation
- Proposed: Assembly Bill No. 4444: The Out-of-Network Consumer Protection, Transparency, Cost Containment, and Accountability Act, among other things, is meant to ensure that patients are informed about costs before they schedule a service with an out-of-network provider, and establishes binding arbitration to resolve disputes between providers and insurers and patients. The Act would also place limitations on out-of-network billing for medically necessary services provided in an emergency setting. In addition, a separately proposed bill will provide a price index so that patients can compare potential costs between out-of-network and in-network services.
- Proposed: Senate Bill No. 864 and Assembly Bill No. 1935: Amends NJSA 26:2H-12(g) so that all surgical practices must be licensed by DOH as ambulatory care facilities, but shall not be required to meet the physical plant and functional requirements of multi-room centers.
- Proposed: Assembly Bill No. 4476: Amends NJSA 26:2H-12(i)(6). The exception to the moratorium allowing new registrations for surgical practices and new licenses to ambulatory care facilities to hospitals and medical schools will be limited to hospitals and medical schools located in New Jersey.
- Proposed: Senate Bill No. 3246: Amends New Jersey’s self-referral rules to include an exception for medically-necessary intraoperative monitoring services rendered during a surgical procedure that is performed as an inpatient hospital service.
- Adopted: Assembly Bill No. 2477: Establishes requirements for pharmacists to dispense biological products.
- Adopted: Assembly Bill No. 1102: Requires licensure of dementia care homes by DOH.
New Jersey State: Selected Proposed and Adopted Regulations
- Proposed: N.J.A.C. 13:39A: Amended to, among other things, revise the scope of practice for physical therapist assistants.
- Proposed: N.J.A.C. 13:44L: Amendments by Board of Polysomnography to, among other things, application for a temporary license as a Polysomnographic Technician, application for license as a Polysomnographic Technologist, scope of practice for licensed Polysomnographic Technician, scope of practice for Licensed Polysomnographic Trainee.
- Adopted: N.J.A.C. 13:35-2.4: Establishes standards for the administration of hyperbaric oxygen therapy by licensed podiatrists.
- Adopted: N.J.A.C. 13:37-5.6 has been repealed with the expected effect that it will eliminate barriers that prevent hospitals from employing nurses in roles outside of traditional nursing positions.
Federal: Selected Proposed Legislation
Proposed: Senate Bill No. 2256: Establishes programs for healthcare provider training in federal healthcare and medical facilities, to establish federal co-prescribing guidelines, to establish a grant program with respect to naloxone, and for other purposes.
State Litigation
Horizon’s Omnia challenged: The Middlesex County Superior Court, on Monday, November 9, 2015, denied St. Peter’s University Hospital’s request for an injunction against the Omnia Health Alliance policies that will go into effect January 1, 2016. St. Peter’s argued that its designation of Tier 2 will lead to irreparable harm. The Court, however, did grant a hearing to determine if St. Peter’s was wrongfully excluded from Tier 1 status. Since this case, on November 19, 2015, about a dozen other hospitals designated Tier 2 have joined together to challenge the Department of Banking and Insurance’s approval of the plan in the first place. Capital Health Regional Medical Center et. al. v. The NJ Division of Banking & Insurance in the Appellate Division.
Federal Litigation
ERISA:
The Seventh Circuit turned down a request from a group of Pennsylvania chiropractors to reconsider a decision that disputes between healthcare providers and insurers over in-network rates are not covered under ERISA. Instead, the chiropractors must now pursue claims in state court on breach of contract claims. Pennsylvania Chiropractic Association et al v. Independence Hospital Indemnity Plan, Inc., Case Number 14-2322 in the 7th Circuit. The 5th Circuit ruled in a similar manner in that disputes involving in-network contracts are not pre-empted by ERISA. Kelsey-Seybold Med. Group P.A. v. Great-West healthcare of Texas Inc., Case Number 14-20506 in the 5th Circuit.
On October 13, 2015, the United States Supreme Court declined to hear UnitedHealth’s question regarding the split in authority among the Circuit Courts on whether a health insurance third party plan administrator may be sued under ERISA. United healthcare of Arizona Inc. et al. v. Spinedex Physical Therapy USA Inc. et al., Case Number 14-1286 in US Supreme Court.
Debt Forgiveness:
The Southern District of Texas ruled in United States of America ex rel. Susan Ruscher, et al. v. Omnicare, Inc., Case Number 4:08-cv-3396, that there was insufficient evidence to support a finding that Omnicare willfully forgave any skilled nursing facility debt to induce future referrals. The District Court ruled that the debt forgiveness was similar to the way other businesses forgive debt from delinquent clients.
Trial Splitting and Statistical Sampling:
A federal court in Alabama recently allowed defendants to bifurcate trial in an insurance fraud matter. The bifurcation will require the Department of Justice (DOJ) to first prove that the claims were objectively false and, if so, the second phase will require the DOJ to establish that the defendant knew of the falsity. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al, Case Number 2:12-cv-00245 in the Northern District of Alabama. At the same time, however, the federal court allowed the DOJ to use statistical sampling to extrapolate the number of fraud claims thereby making it easier for the DOJ to increase the number of claims that are alleged to be fraudulent. Another federal court in South Carolina, however, denied the DOJ’s request to use statistical sampling and allowed the question to be reviewed by the 4th Circuit, potentially making it the first case on statistical sampling to be decided by a Circuit Court. U.S. ex rel Michaels et al. v. Agape Senior Community, Inc. et al, Case Number 0:12-cv-03466 in the District of South Carolina.
On October 30, the federal court in Georgia ruled that Fresenius did not violate the False Claims Act by billing for drugs that it obtained without charge because, among other things, there was no evidence showing that the company knew it should not bill for free extras and that Medicare was aware of the issues for years. United States of America ex rel. Chester Saldivar v. Fresenius Medical Care Holdings Inc., Case Number 1:10-cv-01614, in the Northern District of Georgia.
Selected Guidance Documents
OIG Advisory Opinion 06-10
On November 2, 2015, the Office of the Inspector General (OIG) issued a modification to advisory opinion 06-10. This modification relates to a nonprofit, tax-exempt, charitable organization’s practice of providing certain therapy management services and assistance with Medicare cost-sharing obligations to financially needy Medicare beneficiaries undergoing medical treatment for certain metastasized cancers.
OIG Advisory Opinion 07-18
On November 2, 2015, OIG issued a modification of advisory opinion 07-18. As with the other opinion modified, this one addressed anti-kickback concerns. This opinion, however, deals with concerns about the management by a healthcare industry consultancy of a charitable organization’s arrangements to subsidize patient cost-sharing and premium obligations.
Free Outpatient Drugs Not Kickbacks
On October 31, 2015, the OIG issued a policy statement that hospitals can apply discounts or waive fees on self-administered drugs that are not covered by Medicare but that Medicare patients are given in outpatient facilities without violating federal laws. The hospitals, however, must uniformly apply their policies regarding discounts and waivers.
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. © 2015 Riker Danzig Scherer Hyland & Perretti LLP.
