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New Jersey Regulatory Update Part 5

New Jersey Regulatory Update Part 5

This fifth entry to our 2022 Regulatory Update further reviews regulatory changes published this year through the New Jersey Register (N.J.R.) including a new public notice on the amount of “modest meals” for prescribers, new prescribing authority for nurses and the revocation of certain COVID-19 related waivers. Although this is the final installment of this Update, we are certain that more regulations will be finalized before the end of this year.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

DCA Issues Public Notice on Modest Meal Rule for Prescribers

54 N.J.R. 1747(a): The New Jersey Division of Consumer Affairs ("DCA") has published a public notice defining the current dollar limits for “modest meals” accepted by prescribers from pharmaceutical manufacturers. This notice updates rules set by the New Jersey Attorney General, under the authority of N.J.S.A. 45:1-17(b), to regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers. Prescribers, who are not speaking or providing promotional activities, and who accept meals beyond the prescribed “modest” value limits from a pharmaceutical manufacturer, may be liable under N.J.A.C. § 13:45J-1 et seq. for the undue acceptance of a gift or compensation. The current dollar limits for “modest meals” may be found here.

Boards of Nursing and Optometry Amend Regulations to Permit Co-Prescribing of Narcan With Opiates

54 N.J.R. 1174(a): The New Jersey Board of Nursing amended rules regarding the prescription of opioid painkillers by advanced practice nurses ("APNs") to reflect new, limited circumstances, in which a patient may also be prescribed an opioid antidote, such as Narcan. The amended regulation provides an update for the term “opioid antidote,” and also defines the situations in which the simultaneous prescription of opioids and opioid antidotes are appropriate (e.g., a patient with a history of a substance abuse disorder). The updated definitions and amended prescribing standards may be found at N.J.A.C. § 13:37-7.9A.

54 N.J.R. 1175(a): Similarly, the New Jersey Board of Optometry amended rules regarding the prescription of opioid painkillers by optometrists to reflect new, limited circumstances, in which a patient may also be prescribed an opioid antidote, such as Narcan. The updated Board of Optometry regulations may be found at N.J.A.C. § 13:38-2.5.

Board of Polysomnography Adopts Telemedicine and Telehealth Rules

54 N.J.R. 1176(a): The New Jersey Board of Polysomnography has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-16 et seq.) by adopting telemedicine and telehealth rules for polysomnographic technologists, technicians, and trainees. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:44L-7 et seq.

Board of Nursing Readopts Rules Regarding Power of Attorney and Financial Misconduct

54 N.J.R. 1415(a): The New Jersey Board of Nursing readopted, without change, its regulations regarding powers of attorney and other prohibited forms of financial misconduct between licensees and their patients. These regulations specifically prohibit both nurses and homemaker-home health aides from having power of attorney over a patient or accepting financial loans from patients. Additionally, these regulations require licensees to specifically document any gift or money from a patient over $50 in value. The regulations may be found at N.J.A.C. § 13:37-5.4 for nurses and N.J.A.C. § 13:37-14.18 for homemaker-home health aides.

NJDOH Approves Revocation of Further COVID-19 Rule Waivers

54 N.J.R. 1573(a): The New Jersey Department of Health (“NJDOH”) announced that multiple rule waivers instituted in response to the COVID-19 Public Health Emergency would be revoked effective July 18, 2022. Pursuant to Executive Order 281 and its Appendix, certain rule waivers and regulatory relaxations were granted in order to address unique challenges presented by pandemic-related health challenges and administrative difficulties. Following the termination of the New Jersey COVID-19 Public Health Emergency, via revocation of Executive Order 103, multiple rule waivers were granted a grace period in recognition of ongoing challenges posed by the emergence of new COVID-19 variants. A full list of rule waivers terminated as of July 18, 2022 can be found here.

NJDOH Readopts Ambulatory Care Facility Annual Assessment Regulations

54 N.J.R. 1299(a): NJDOH readopted its regulations relating to its annual assessment reports and fees for ambulatory care facilities by the Division of Certificate of Need and Licensing. Although the provisions were readopted without change, ambulatory care facility administrators should be aware that the annual assessment fees must either be remitted electronically, via http://dohlicensing.nj.gov/, or via mail to: Ambulatory Care Facility Payment Unit, Accounting and Procurement, New Jersey Department of Health, 55 North Willow Street, 6th Floor, PO Box 360, Trenton, NJ 08625-0360. The telephone number for the Ambulatory Care Facility Payment Unit is (609) 376-8530. The readopted regulations may be found at N.J.A.C. § 8:31A-1.12.12.22.33.13.2, and 4.1.

New Jersey Regulatory Update: Part 4

Part 4 of our Regulatory Update focuses on vaccine administration, expanding who can prescribe Narcan, among others.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

Board of Pharmacy Updates Regulations for Pharmacy-Administered Vaccine

54 N.J.R. 449(a): Prompted by the COVID-19 pandemic, the New Jersey Board of Pharmacy ("NJ-BOP") amended regulations governing the administration of government-approved vaccines by pharmacists, pharmacy interns, and pharmacy externs. The updated regulations amend pharmacy permitting requirements under N.J.A.C. §13:39-4.21, setting training, documentation, and supervision requirements for pharmacy administration of government-approved vaccinations. Additionally, this rule update establishes specific criteria for the administration of influenza vaccines to minors, codified at N.J.A.C. § 13:39-4.21A.

Board of Nursing Ends Moratorium on Practical Nursing Program Applications

54 N.J.R. 500(a): Under this Public Notice, the New Jersey Board of Nursing ("NJ-BON") announced that it began accepting new applications for accreditation from New Jersey practical nursing programs. In 2009, the NJ-BON had ceased processing such applications due to concerns relating to the high volume of new applicants. As of February 4, 2022, the NJ-BON, having determined that the need for the moratorium no longer exists, will again begin processing accreditation applications for practical nursing programs.

DMAHS Updates Participation Standards for Non-Emergency Transport Providers

54 N.J.R. 620(b): The New Jersey Department of Human Services – Division of Medical Assistance and Human Services ("DMAHS") readopted and modified rules relating to independent transportation company participation for non-emergency transportation services under the NJ Medicaid/Family Care program. The rules establish participation standards, including credentialing and billing requirements, building upon DMAHS rules requiring all non-emergency medical transportation services to be provided by the transportation broker under contract with the Department of Human Services. This update modifies multiple subchapters under N.J.A.C. § 10:50-1 et seq. to reflect the updated participation standards.

Board of Dentistry Permits Limited Prescription of Narcan to Patients Receiving Opiates

54 N.J.R. 1170(b): The New Jersey Board of Dentistry ("NJ-BOD") amended rules regarding the prescription of opioid painkillers to reflect new, limited circumstances in which a patient may also be prescribed an opioid antidote, such as Narcan. The amended regulation provides an update for the term “opioid antidote,” and also defines the situations in which the simultaneous prescription of opioid and opioid antidote are appropriate (e.g., a patient with a history of a substance abuse disorder). The updated definitions and amended prescribing standards may be found at N.J.A.C. § 13:30-8.18.

Board of Medical Examiners Adopts Rules for Licensure of Electrologists

54 N.J.R. 1171(a): The New Jersey Board of Medical Examiners ("NJ-BOME") has adopted rules governing the licensure and practice of electrologists and electrology instructors within New Jersey. The newly established regulations, overseen in part by the Electrology Advisory Committee, establish standards for the education and licensure of electrologists within the state as well as standards of care for the practice of electrology. The new regulations, in their entirety, are available at N.J.A.C. § 13:35-12.1 et seq.

New Jersey Regulatory Update: Part 3

Part 3 of our New Jersey Regulatory Update continues to review regulatory changes published earlier this year through the New Jersey Register (N.J.R.). The following regulatory rule changes reflect rule relaxations and waivers related to the ongoing COVID-19 pandemic. Accordingly, each relaxation will expire when the COVID-19 New Jersey State of Emergency declared under Executive Order No. 103 (2020) is terminated.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

NJDOH Permits Residential SUD Facilities to Provide Counseling via Telemedicine

54 N.J.R. 301(a): The New Jersey Department of Health (“NJDOH”) has relaxed rules relating to the standards for licensure of residential substance use disorder (“SUD”) treatment facilities. The rule relaxation temporarily allows for substance abuse counseling services to be provided through telehealth/telemedicine modalities. The updates are reflected under N.J.A.C. § 10:161A-1.3, which defines telehealth and telemedicine per N.J.S.A. § 45:1-61 et seq., and N.J.A.C. § 161A-10.1, which provides for substance abuse counseling and supportive services. Interestingly, in December 2021, the NJDOH passed a regulation moving these regulations to N.J.A.C. 8:121 et seq. However, 54 N.J.R. 301(a) amended the old regulations, N.J.A.C. 10:161A-1.3, but not N.J.C.A. 8:12 1 et seq.

NJDOH Revises Rules for Outpatient SUD Treatment and OPT Programs

54 N.J.R. 301(b): The NJDOH relaxed multiple rules relating to the standards for licensure of outpatient SUD treatment facilities. The rule relaxation temporarily allows for substance abuse counseling services, buprenorphine physical examination, and comprehensive biopsychosocial assessments to be provided through telehealth/telemedicine modalities. Additionally, certain random or monthly drug screenings for clinic-based medical maintenance may instead be performed at least eight (8) times per year.

Opioid treatment providers ("OTPS") may follow newly released NJDOH Take-Home Dosing and Delivery Guidelines. Additionally, OTPS must include take-home dosing and service procedures being used in response to COVID-19 in their emergency plan or Continuity of Operations Plan ("COOP") and submit their COOPs to the IME COOP Activation email address at imecoop@ubhc.rutgers.edu with a copy to the State Opioid Treatment Authority, Mr. Adam Bucon, through email at adam.bucon@dhs.nj.gov.

The definitions of telehealth and telemedicine have been adopted per N.J.S.A. § 45:1-61 et seq. The regulations affected by this rule relaxation are N.J.A.C. § 10:161B-1.3, 6.3, 9.1, 10.1, 11.6, 11.9, 11.12, 11.13, 12.4, and 15.1.

NJDOH Expands Telehealth for Multiple Mental Health Service Providers

54 N.J.R. 305(a): The NJDOH has relaxed rules for the provision of community mental health services under the Community Mental Health Services Act. The update reflects an adoption of the terms “face to face,” “telehealth,” and “telemedicine,” as defined under N.J.S.A. § 45:1-61 et seq., to the direct service program elements codified at N.J.A.C. § 10:37-5.1.

54 N.J.R. 307(a): This regulation pertains to community support services for adults with serious mental illnesses.  (N.J.A.C. § 10:37B-1.2) They were updated to define the terms “face to face,” “telehealth,” and “telemedicine,” as provided under N.J.S.A. § 45:1-61 et seq. Additionally, the update reflects a technical change in the staff credentials and responsibilities regulation (N.J.A.C. § 10:37B-5.2) to reflect the reorganization of the crisis intervention training requirements now codified at N.J.A.C. 10:37B-4.4(b)(24).

54 N.J.R. 308(a): Similarly, the NJDOH has adopted the terms “face to face,” “telehealth,” and “telemedicine,” as defined under N.J.S.A. § 45:1-61 et seq. under the regulatory definitions for mental health partial care service providers (N.J.A.C. § 10:37F-1.3). Further, the definition of “signature” and “signed” were updated to include electronic marks, further supporting telehealth/telemedicine options.

54 N.J.R. 309(a): Regulations affecting Programs of Assertive Community Treatment ("PACT") providers were also relaxed to increase telehealth/telemedicine options. PACT services provide comprehensive, integrated rehabilitation, treatment and support services to individuals with serious and persistent mental illness, who have had repeated psychiatric hospitalizations, and who are at serious risk for psychiatric hospitalization. The amended regulations replace in-person meeting requirements with “face to face” and “interacting” language, permitting providers to utilize telehealth/telemedicine modalities to render services (N.J.A.C. § 10:37J-2.5). The regulatory definitions (N.J.A.C. § 10:37J-1.2) have further been amended to reflect the terms “face to face,” “telehealth,” and “telemedicine,” as provided under N.J.S.A. § 45:1-61 et seq.

No Discharge, New Problem: NJDEP Files Another Spill Act Suit Against Product Manufacturer Who Was Not a Discharger

NJDEP continues to assert a novel theory of Spill Act liability in a suit against the manufacturer of polychlorinated biphenyls (“PCBs”).  On August 4th, NJDEP filed a lawsuit in state court against the successors of “old Monsanto,” which had been the country’s sole producer of PCBs, the once widely used chemical that was banned under the Toxic Substances Control Act in the 1970’s.  The State seeks recovery of remediation costs and damages incurred by the Spill Fund, as well as natural resource damages (“NRD”), arising from a former Monsanto facility in Gloucester County and, significantly, from all discharges of PCBs that occurred throughout the entire state.  New Jersey joins several other states that, through plaintiff-side private firms engaged on a contingency basis, have sued Monsanto entities for statewide releases of PCBs.  In the last few months, Ohio and New Hampshire have obtained settlements of $80 million and $25 million, respectively, in such cases.  NJDEP’s new lawsuit has a New Jersey-specific twist—the use of the Spill Act to impose liability on a party that manufactured and sold, but did not actually discharge, a hazardous substance.  Both private plaintiffs and the State have had initial success pursuing this novel theory of Spill Act liability in per- and polyfluoroalkyl substances  (“PFAS”) litigation, and now NJDEP seeks to extend it to PCBs.   Favorable rulings for NJDEP in the new Monsanto case also may have significant repercussions for site remediation in New Jersey, as it could open the door for new contribution claims at any site impacted by PCBs.

Our May 4th article discussed two pending cases in which Spill Act claims survived motions to dismiss brought by 3M, which manufactured PFAS and sold them to New Jersey industrial facilities, but never discharged PFAS in New Jersey.  PCBs are a logical candidate for this novel extension of Spill Act liability to non-discharging manufacturers.  Both PCBs and PFAS were exclusively manufactured by one company—NJDEP’s complaint alleges that Monsanto manufactured 99% or more of all PCBs sold in the U.S., and 3M was the sole supplier of PFAS chemicals.  These unusual facts relieve plaintiffs of the difficult burden of having to establish which manufacturer long ago supplied the chemicals that eventually were discharged into the environment, a burden the plaintiff otherwise would bear in a Spill Act claim relating to chemicals that historically were manufactured by many different firms.

In NJDEP’s new case and any other Spill Act cases filed against Monsanto, it appears that New Jersey state courts, rather than federal courts, will decide the scope of Spill Act liability of non-discharging manufacturers.  This is because one of the defendants named in the State’s complaint—Pharmacia LLC—is alleged to have its principal place of business in New Jersey, which if true would destroy federal court diversity jurisdiction.  In contrast, because of its location outside of New Jersey, 3M is able to remove similar Spill Act claims against it for PFAS to federal court.

Absent a quick settlement with Monsanto, the New Jersey state appellate courts that have the ultimate authority to interpret the Spill Act under state law may decide in this case whether the Spill Act permits claims against manufacturers like Monsanto and 3M and, if it does, what a plaintiff must prove to succeed on such a claim.  If the courts recognize any Spill Act claim against a non-discharging manufacturer, perhaps the most significant issue in this new class of claims will be the level of culpability that could make a non-discharging manufacturer “in any way responsible” for a hazardous substance under the Spill Act.  Put another way, will a manufacturer and seller of a product be strictly liable under the Spill Act as long as the plaintiff can demonstrate that a subsequent purchaser of the product discharged it in New Jersey (i.e., the defendant’s product caused the remediation costs), or will some additional showing of fault be required on top of a showing of causation?   Although the text of the Spill Act explicitly imposes strict, joint, and several liability regardless of fault, see N.J.S.A. 58:10-23.11g.c.(1), NJDEP’s complaint against Monsanto suggests that some showing of fault should be required for a product manufacturer to be liable under the Spill Act.  Specifically, the Spill Act count of the recently-filed complaint alleges that (1) Monsanto knew that discharges of PCBs were “inevitabl[e]” during their “ordinary, intended use;” (2) Monsanto knew that PCBs were toxic; (3) Monsanto failed to warn its customers about the risk of contamination; and (4) Monsanto advised its customers to dispose of PCBs in ways that caused discharges to the environment.  If courts are willing to entertain at all a Spill Act claim against a manufacturer that is not the discharger, they may require the plaintiff to prove that the defendant was at fault (e.g., the defendant knew about and did not mitigate the risk of discharges to the environment) in addition to proving causation, which would be consistent with the theory espoused in the complaint.

Other private parties who have incurred remediation costs for PCBs could have Spill Act claims against the Monsanto entities if NJDEP’s claim in its new lawsuit succeeds.  Notably, there is no statute of limitations for Spill Act contribution claims following the New Jersey Supreme Court’s 2015 Morristown Associates decision, so there could be new claims for long ago remediation costs.  However, Monsanto would not be without defenses based on the passage of time.  Courts have held that laches may be a defense to a Spill Act claim.  If there was prior litigation over remediation costs at a site, Monsanto might also have a defense under the entire controversy doctrine if it was prejudiced by not being joined in the earlier litigation.  NJDEP’s new case against Monsanto, as well as the already pending cases against 3M regarding PFAS, may create a new frontier of Spill Act liability that all parties engaged in New Jersey site remediation should follow closely.

For more information, please contact the author Michael Kettler at mkettler@riker.com or any attorney in our Environmental Practice Group.

New Jersey Regulatory Update: Part 2

As we continue to focus on regulations, Part 2 of our New Jersey Regulatory Update focuses on the adoption of telemedicine rules and changes adopted by the Board of Pharmacy.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’NeillConnor BrezaWilliam R. Meiselas or Labinot Alexander Berlajolli.

Board of Dentistry Adopts Telemedicine and Telehealth Rules

54 N.J.R. 149(b): The New Jersey Board of Dentistry has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-16 et seq.) by adopting telemedicine and telehealth rules for dentists and dental hygienists. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:30-9 et seq.

Occupational Therapy Advisory Counsel Adopts Telemedicine and Telehealth Rules

54 N.J.R. 157(a): The New Jersey Occupational Therapy Advisory Counsel has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-16 et seq.) by adopting telemedicine and telehealth rules for occupational therapists, occupational therapy assistants, temporary occupational therapists, and temporary licensed occupational therapy assistants. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:44K-7 et seq.

Board of Pharmacy Amends Rules on Patient Counseling

54 N.J.R. 156(c): The New Jersey State Board of Pharmacy (“NJ-BOP”) amended N.J.A.C. § 13:39-7.21 with respect to patient counseling. In the context of pharmacists, “patient counseling” refers to pharmacists advising patients of pertinent information regarding their prescriptions, such as the name and description of the medication, the dosage and duration of the medication, proper administration and storage, etc. The latest amendment, N.J.A.C. § 13:39-7.21(e), requires pharmacists to document, at the time of dispensing, whether counseling was provided or refused.

Board of Pharmacy Changes Score Requirement for Reciprocal Licensure Applications

54 N.J.R. 156(b): The NJ-BOP amended N.J.A.C. § 13:39-2.2 and 2A.5 with respect to applicants seeking reciprocal licensure through the Multistate Pharmacy Jurisprudence Examination. Under the amended regulation, a passing score of not less than 75 must be attained. If an applicant fails the examination, he or she shall be required to repeat the examination.

New Jersey Regulatory Update: Part I

As we approach the fourth quarter of 2022, it is worth reviewing the regulatory rules that have become final in New Jersey over the approximately past twelve months. Part I of this multi-part series contains several regulatory changes published earlier this year through the New Jersey Register (N.J.R.) that have, or will soon become, active regulations.

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’NeillConnor BrezaWilliam R. Meiselas or Labinot Alexander Berlajolli.

Board of Respiratory Care Adopts Telemedicine and Telehealth Rules

53 N.J.R. 2050(a): The New Jersey State Board of Respiratory Care has implemented the New Jersey telehealth statutes (N.J.S.A. § 45:1-61 et seq.) by adopting telemedicine and telehealth rules for respiratory therapists. The new rules are identical to the telemedicine and telehealth rules already in place for other New Jersey healthcare providers. The rules have been codified at N.J.A.C. § 13:44F-11 et seq.

Board of Medical Examiners Revise Regulations on In-Office Surgical Procedures

53 N.J.R. 2013(a): The New Jersey State Board of Medical Examiners (“BME”) adopted and amended multiple regulations pertaining to surgery, special procedures, and anesthesia services performed in an office setting. Notably, the BME adopted N.J.A.C. § 13:35-4A.19, which states that nothing in the subchapter

shall be construed to preclude practitioners from authorizing advanced practice clinicians to perform minor procedures in the office consistent with their respective scopes of practice and as addressed within their individual collaborating agreements.

Additionally, multiple amendments were made throughout N.J.A.C. § 13:35-4A.1 through 4A.12 (See N.J.A.C § 13:35-4A et seq). Notably, the amendments revise multiple definitions under the regulation, including “moderate sedation,” “early aspiration abortion,” and “office.”

NJDOH Re-Codifies Mental Health Program Under New Section

53 N.J.R. 2008(a): The New Jersey Department of Health (“NJDOH”) has readopted and recodified the regulations relating to licensure standards for mental health programs. Such regulations were formerly codified at N.J.A.C. § 10:190 et seq. Per the new rulemaking, the regulations are now codified at N.J.A.C. § 8:121 et seq. Technical changes principally reflect that these regulations shall now be enforced by the NJDOH Division of Certificate of Need and Licensing.

NJDOH Re-Codifies Residential Substance Use Disorder Treatment Facilities Under New Section

53 N.J.R. 2208(a): The NJDOH readopted and recodified the regulations relating to licensure standards of residential substance use disorder treatment facilities. Such regulations were formerly codified at N.J.A.C. § 10:161A et seq. Per the new rulemaking, the regulations are now codified at N.J.A.C. § 8:111 et seq. Technical changes principally reflect that these regulations shall now be enforced by the NJDOH Division of Certificate of Need and Licensing, as well as updating resource-related information (e.g. references to the latest version of the DSM).

Board of Examiners of Ophthalmic Dispensers and Technicians Regarding Certificate Programs 

53 N.J.R. 2229(b): The New Jersey Board of Examiners of Ophthalmic Dispensers and Ophthalmic Technicians has adopted new rules and regulations regarding applications for an Ophthalmic Dispenser Apprentice Certificate and for an Ophthalmic Technician Apprentice Certificate. The rules establish new standards for applying for these certificates, though the new criteria do not apply to ophthalmic dispenser/technician apprentices or students who began their apprenticeships or coursework prior to 12/20/21. The new regulations may be found at N.J.A.C. § 13:33-1.1, 1.2, 2.1, 2.2, 8.9 and 1A.

Board of Dentistry Amends Scope of Practice for Dental Hygienists

54 N.J.R. 83(a): The New Jersey State Board of Dentistry ("BOD") adopted amendments to the scope of practice regulations for dental hygienists as well as the interval for inspection of permit holders who perform certain forms of sedation. Under the amendments, dental hygienists may now perform the removal of biofilm with prophy paste containing fluoride in a school setting under the general supervision of a licensed dentist. Moreover, the BOD has reduced the inspection interval from every six years to every five years for all dental offices in which parenteral conscious sedation or general anesthesia is conducted. The amended regulations may be found at N.J.A.C. § 13:30-1A.4, 8.2, and 8.3.

Board of Pharmacy Amends Labeling Requirements for Opioids

54 N.J.R. 88(a): The New Jersey State Board of Pharmacy adopted amendments to the labeling regulations regarding the color, font, and positioning of labels specifically affixed to prescriptions for opioid medications. Under the amendments, opioid medication labels must be (i) yellow, red or orange in color; printed in an easily and clearly readable, non-cursive font size of at least 10- point font; and, (iii) affixed to the side or cap of the prescription bottle or to the side of the box that contains the prescription label. The amended regulations may be found at N.J.A.C § 13:39-7.12(e).

A New Emphasis on MARPOL is a 2023 World Maritime Theme

A New Emphasis on MARPOL is a 2023 World Maritime Theme:

An example of its environmental impact closer to home

Maritime shipping emissions account for about 3% of the global carbon dioxide output, roughly the same as aviation and, according to the World Economic Forum, if shipping was a country, it would be the sixth-largest polluting country in the world. In an attempt to combat this impact, the International Maritime Organization ("IMO"), a specialized agency of the United Nations, has set a goal to decarbonize the industry as soon as possible before the end of the century. This priority is exemplified by the IMO’s decision to make “MARPOL at 50 – Our Commitment Goes On” its 2023 World Maritime Theme.  Under MARPOL the IMO already has begun to adopt measures to reduce emissions of greenhouse gases from international shipping.  The 2023 theme can be expected to promote further discussion around the next phase of work to reduce the environmental impacts of shipping.

Although ship decarbonization targets are a relatively new maritime endeavor, the enforcement mechanisms to combat marine pollution are not new. To address marine pollution, nearly 50 years ago, an international conference was held in 1973, which resulted in the creation of the International Convention for the Prevention of Pollution from Ships, known as MARPOL. Later amended by the 1978 Protocol, the two treaties are collectively known today as MARPOL 73/78. The United States’ enactment of MARPOL is known as the Act for the Prevention of Pollution from Ships ("APPS").

The United States government has increasingly pursued maritime violations of MARPOL 73/78 and APPS. Depending on the circumstances, civil or criminal actions may be brought against individuals, as well as the corporate entities that own, manage, or operate the vessels that violate environmental requirements. The investigative and prosecutorial methodology is fairly predictable. A potential violation typically starts with an investigation by the United States Coast Guard into the circumstances of any alleged marine pollution. The Coast Guard may refer certain matters to the Environmental Protection Agency (EPA) for enforcement.  In the most serious cases involving knowing violations, the Coast Guard may refer the matter to Department of Justice for prosecution under the applicable statute.

MARPOL Enforcement in the Delaware Bay - United States v. Vastardis

A recent example of typical enforcement of MARPOL 73/78 and APPS by the Department of Justice is United States v. Vastardis, No. 20-2040, 2021 U.S. App. LEXIS 36034 (3d Cir. Dec. 7, 2021).  The Third Circuit Court of Appeals joined the Second and Fifth Circuits in holding that Coast Guard rules requiring vessels to “maintain an Oil Record Book” also require that records must be substantively accurate when the ship docks in the United States.

        MARPOL 73/78 and APPS

MARPOL 73/78 and APPS require oil tankers weighing 150 gross tons or more and ships weighing 400 gross tons or more 1) to implement technology that regulates the amount of oil that can be discharged overboard during the regular operation of a vessel; and 2) to be equipped with oil-water separators ("OWS"), oil-content meters ("OCM"), and an Oil Record Book. See United States v. Anrogar, 459 F.3d 430, 432 (3d Cir. 2006).  OWSs separate oil particles from the wastewater to be discharged overboard. OCMs sound an alarm if the oil content of ship’s overboard discharge contains more than 15 parts per million (“ppm”) of oil.  Oil Record Books must document all treated and untreated discharges of oil-contaminated wastewater.

Under Coast Guard rules adopted to enforce MARPOL and APPS, entries are required in the Oil Record Book whenever certain machinery operations, such as using an OWS, occur and the master or “other person having charge of a ship” is responsible for the maintenance of the log. See 33 C.F.R. § 151.25. A person who knowingly violates this rule commits a felony subject to criminal penalties under APPS.

APPS provides at 33 U.S.C. § 1902 that it applies “to a ship of United States registry or nationality, or one operated under the authority of the United States, wherever located.”  Foreign-flagged vessels are subject to APPS in the navigable waters of the United States, the exclusive economic zone of the United States, and the ports or terminals in the United States.

        Factual Background, Procedural History and Trial

Nikolaos Vastardis was convicted and sentenced for crimes that allegedly occurred while he was the Chief Engineer onboard a Liberian-registered tanker, the M/V Evridiki. Vastardis, as Chief Engineer, was responsible for the Oil Record Book.  When the M/V Evridiki entered port in the Delaware Bay, the Coast Guard performed an inspection, and found that the OWS had a hidden valve that allowed the OWS to give a reading of 0 ppm. When the hidden valve was open, the OWS gave a reading of 40 ppm or higher, well over the 15 ppm limitation.

Vastardis was charged in a four-count indictment with violations including (1) knowingly causing the failure to maintain an accurate Oil Record Book (33 U.S.C. § 1908); (2) falsification of records under the Sarbanes-Oxley Act (18 U.S.C. § 1519); (3) obstruction of justice, in presenting false Oil Record Book entries and deceiving inspectors (18 U.S.C. § 1505); and (4) false statements in connection with a federal investigation (18 U.S.C. § 1001). Following a seven-day trial, a jury found Vastardis guilty on all counts and he was imposed a $7,500 fine, a $400 special assignment and three years’ probation. As a condition of the probation, Vastardis was barred from entering the United States.

        The Requirement to Maintain an Accurate Oil Record Book On Appeal

On appeal, Vastardis argued that the requirement to “maintain” an Oil Record Book only required a ship to physically possess an Oil Record Book, not that it be accurate. The Third Circuit disagreed, joining in the standard set forth by the Second and Fifth Circuit Courts of Appeal, finding that “[t]he recordkeeping provision would make little sense if, as Vastardis proposes, it required that ships only physically possess an Oil Record Book in any state of completeness or accuracy.” The Court affirmed the other charges as well, but vacated the condition that prohibited Vastardis from entering the United States, finding Vastardis’s career depends on travel in international waters and a condition of banishment impinges upon freedom of movement and could potentially interfere with the livelihood of a foreign national.

Conclusion

The IMO’s World Maritime Theme for 2023, “MARPOL at 50 – Our Commitment Goes On,” celebrates MARPOL’s legacy. The decision in United States v. Vastardis is only a recent example of its local impact. The 2023 emphasis on MARPOL forecasts new decarbonization initiatives and the potential adoption of further measures to enhance energy efficiency of ships. The shipping sector should prepare for new rules and initiatives in the United States arising from the emphasis on MARPOL.

For more information, please contact the author Holli Packer at HPacker@riker.com or any attorney in our Environmental Practice Group.

 

OIG Advisory Opinion on Specimen Collection and HIPAA Guidance

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

OIG Issues Advisory Opinion on Payments for Laboratory Specimen Collection

The Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued Advisory Opinion Number 22-09 which reaffirmed the OIG’s restrictions on arrangements involving payment for specimen collection fees. This Advisory Opinion assessed the regulatory implications under the federal Anti-Kickback Statute with respect to a proposed arrangement whereby the operator of a laboratory network (the "Requestor") sought to provide compensation to various hospitals (the "Contract Hospitals") for certain specimen collection services (the "Collection Services") in connection with tests provided by the Requestor (the "Proposed Arrangement").

Under the federal Anti-Kickback Statute, it is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, the referral of an individual to a person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable under a federal health care program (such as Medicare, Medicaid, or TriCare). Per the OIG, the statute has been interpreted to cover any arrangement where one purpose of the remuneration is to induce referrals for items or services reimbursable by a federal health care program.

Under the Proposed Arrangement:

  • Requestor would enter into contracts with the Contract Hospital, pursuant to which Requestor would pay the Contract Hospitals on a per-patient-encounter basis to collect, process, and handle specimens that are then sent to Requestor’s clinical laboratories for testing;
  • The Requestor would compensate Contract Hospitals for the Collection Services performed by the Contract Hospitals in connection with individuals who present with orders for testing and who are not currently inpatients or registered outpatients of the Contract Hospitals;
  • The Requestor would not compensate Contract Hospitals if the Collection Services are performed in connection with individuals who are currently inpatients or registered outpatients of the Contract Hospitals;
  • When individuals present to a Contract Hospital with laboratory testing orders that do not specify which laboratory will conduct the testing, the Contract Hospital would have the opportunity to choose to which laboratory it would send the specimens; and
  • The per-patient encounter compensation rate would be consistent with fair market value for the Services in an arm’s-length transaction.

In this Advisory Opinion, the OIG opined that the Proposed Arrangement would implicate the federal Anti-Kickback Statute because "it would involve remuneration from a laboratory to a party that is in a position to make referrals to the laboratory for, or otherwise arrange for the laboratory to furnish, items and services that may be paid for in whole or in part by a Federal health care program." The OIG elaborated that "[s]pecifically, where an individual—who may be a Federal health care program beneficiary—presents to a Contract Hospital without a laboratory specified on the order for laboratory services, the Contract Hospital could refer specimens from that individual to Requestor for reimbursable testing."

Furthermore, according to the OIG, the Proposed Arrangement would not satisfy the personal services and management contracts and outcomes-based payment arrangements safe harbor of the Anti-Kickback Statute because "the per-patient-encounter compensation methodology would take into account the volume or value of referrals or other business generated for which payment may be made in whole or in part under a Federal health care program."

Ultimately, based on the facts surrounding the Proposed Arrangement, because of the possibility that the per-patient-encounter fee would be used to induce or reward referrals to the Requestor and the corresponding risk of inappropriate steering to the Requestor, the OIG concluded that the Proposed Arrangement would pose more than a minimal risk of fraud and abuse under the federal Anti-Kickback Statute.

CMS Issues Guidance on Business Associates' HIPAA Requirements Compliance and on Virtual Credit Cards for EFT and ERA Transactions

Earlier this year, the National Standards Group ("NSG"), on behalf of HHS, issued two guidance documents providing guidance on (1) HIPAA Covered Entities’ responsibility for ensuring Business Associates’ compliance with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") regulations (GL-2022-03), as well as guidance on (2) health plans’ payment of health care claims using Virtual Credit Cards ("VCCs") and adopted HIPAA standards for Health Care Electronic Funds Transfers ("EFT") and Remittance Advice ("ERA") transactions. (GL-2022-04).

  1. GL-2022-03 clarifies covered entities’ obligation to ensure their business associates comply with HIPAA regulations (see 45 C.F.R. § 162.923(c)). Since NSG receives frequent complaints regarding business associates in connection with their relationship with covered entities, NSG makes clear that the HIPAA covered entity is responsible for the compliance of its business associates.
  2. GL-2022-04 provides guidance on the following three questions:
    • Do the adopted HIPAA EFT and ERA standards permit health plans to pay claims by VCCs?
    • If a health care provider requests that a health plan pay the provider’s claims using the adopted HIPAA EFT and ERA standards, must the health plan comply?
    • Can a health plan require a provider to agree to receive payment or reassociation services from a vendor of the health plan’s choosing as condition of receiving EFT or ERA using the adopted standards?

In sum, the NSG concluded as follows, respectively:

  • Yes, the adopted HIPAA EFT and ERA standards permit health plans to pay claims by VCC;
  • Yes, the health plan must comply under 45 C.F.R. § 162.925(a)(1) which dictates that if an entity requests that a health plan conduct a transaction as a standard transaction, the health plan must do so.
  • No, a health plan may not require that a provider agree to receive payment or reassociation services from its business associate (nor may the business associate otherwise require the provider to do so) as a condition of receiving health care payments using the adopted EFT and ERA standards.

CMS Suspends Prior Authorization for Certain DMEPOS and Skilled Nursing Home Update

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

CMS Issues Final Rule for the Suspension of Prior Authorization Requirements for Specified Orthoses Prescribed and Furnished Urgently or Under Special Circumstances

On August 10, 2022 the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (87 FR 48609) which was effective, retroactively, April 13, 2022. This rule further modifies the December 30, 2015 final rule, (80 FR 81674) titled, “Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies,” (“DMEPOS”) which established an initial Master List (called the Master List of Items Frequently Subject to Unnecessary Utilization) of certain DMEPOS that the federal government determined were frequently subject to unnecessary utilization and additionally established a prior authorization process for these items.

The final rule serves to announce the suspension of prior authorization for specified orthoses items on the Required Prior Authorization List that require prior authorization as a condition of payment under certain circumstances when reported with certain modifiers. Specifically, CMS is suspending prior authorization requirements indefinitely, under these limited circumstances:

  • Claims for Healthcare Common Procedure Coding System (“HCPCS”) codes L0648, L0650, L1832, L1833, and L1851 that are billed using modifier ST, indicating that the item was furnished urgently.
  • Claims for HCPCS codes L0648, L0650, L1833, and L1851 billed with modifiers KV, J5, or J4, by suppliers furnishing these items under a competitive bidding program exception (as described in 42 CFR 414.404(b)), to convey that the DMEPOS item is needed immediately either because it is being furnished by a physician or treating practitioner during an office visit where the physician or treating practitioner determines that the brace is needed immediately due to medical necessity or because it is being furnished by an occupational therapist or physical therapist who determines that the brace needs to be furnished as part of a therapy session(s).

Prior authorization will continue for these orthoses items (HCPCS L0648, L0650, L1832, L1833, and L1851) when furnished under circumstances not covered in this final rule, as well as all other items on the Required Prior Authorization List, available here.

CMS Issues Fiscal Year 2023 Skilled Nursing Facility Prospective Payment System Final Rule

On August 3, 2022, CMS issued a final rule that updates Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System ("SNF PPS") for fiscal year ("FY") 2023 which includes updates for the SNF Quality Reporting Program ("QRP") and the SNF Value-Based Purchasing ("VBP") Program for FY 2023 and future years. Among other things, the final rule reflects the following updates:

  • A 5.1% payment rate increase stemming from a 3.9% market basket increase, a 1.5 percentage point market basket forecast error adjustment, and a 0.3 percentage point reduction for productivity.
  • Recalibration of the Patient-Driven Payment Model ("PDPM") parity adjustment factor of 4.6% with a two-year phase-in period that would reduce SNF spending by 2.3%, or approximately $780 million, in FY 2023 and 2.3% in FY 2024.
  • Finalizing a permanent 5% cap on annual wage index decreases to smooth year-to-year changes in providers’ wage index payments.

Additionally, the final rule included a new quality measure for the FY 2024 SNF Quality Reporting Program ("QRP") that tracks influenza vaccination coverage among healthcare professionals in SNFs. CMS has issued a Fact Sheet summarizing the final rule.

New Jersey Legislature Approves Bill S2422 Aa (1R)

The New Jersey legislature approved a new bill updating the New Jersey Life and Health Insurance Guaranty Association Act on August 12, 2022. The bill expands the assessment base that is to cover the insolvencies of long-term care insurers and requires that all life and health insurers assist in covering these insolvencies. Additionally, this bill sets the cap at $500,000 on health insurance benefits issued by the guaranty association in cases of insurer impairment or insolvency and is proposed for adjustment based upon changes in the health care costs component of the consumer price index from January 1, 2022, to the date on which the member insurer, as defined in the bill, becomes an insolvent insurer.

Federal Legislation Addressing Burnout and Other Federal Updates

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

Federal Mental Protection Legislation for Health Care Providers Becomes Law

Federal legislation to improve mental and behavioral health among health care providers in the wake of the COVID-19 pandemic was recently signed into law. Public Health Law No. 117-105, also known as the Dr. Lorna Breen Health Care Provider Protection Act, establishes grants and requires other activities to improve mental and behavioral health among health care providers. Such grants will be made available for hospitals, medical professional associations and other health care entities.

Specifically, under the law, the United States Department of Health & Human Services ("HHS") must award grants for training health professional students, residents and other health care professionals to reduce and prevent suicide, burnout, mental health conditions and substance use disorders. The law further establishes a national education and awareness initiative regarding health care worker mental health, and studies on mental and behavioral health and burnout among health care workers.

The Dr. Lorna Breen Health Care Provider Protection Act is the latest in recent federal efforts to address health care worker mental health and burnout in the wake of the COVID-19 pandemic. The full text of the Dr. Lorna Breen Health Care Provider Protection Act can be read here.

HHS Repeals Final Rules Regarding Guidance, Enforcement, and Adjudication Procedures

In a recent final rule, 87 FR 44002, HHS announced that it would repeal regulations issued under two prior final rules: “Department of Health and Human Services Good Guidance Practices” (85 FR 78770); issued 12/7/2020) and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (86 FR 3010); issued 1/14/2021). The final rules had previously been codified as regulations, collectively, at 45 C.F.R. Part 1.

 

Both former final rules had been issued, and codified, pursuant to Executive Orders (E.O. 13891 and E.O. 13892). Both Executive Orders were subsequently repealed by the Biden Administration via E.O. 13992. The repeal of the HHS final rules removes multiple standards and requirements which heightened the administrative burdens of HHS when issuing guidance or pursuing civil enforcement actions.

The full text of 87 FR 44002 can be accessed here. HHS has not yet released a fact sheet summarizing this final rule.

CMS Announces New Quality Measure Targets for State Medicaid Home and Community-Based Services

The Centers for Medicare & Medicaid Service ("CMS") recently released a set of new Home and Community-Based Services ("HCBS") quality measures through a guidance letter issued directly to each State Medicaid Director (SMD# 22-003). Millions of Americans rely on Medicaid for HCBS, though coverage varies state by state. Accordingly, the HCBS Quality Measure is designed, at a national level, to provide insight into the quality of state Medicaid programs, enable states to measure and improve outcomes for Medicaid HCBS beneficiaries relying on long-term Medicaid services, and improve health equity.

The measures seek to address HCBS quality and outcomes in the following key priority areas:

  1. Access and awareness of eligible Medicaid beneficiaries to available HCBS resources.
  2. Opportunities for rebalancing of Medicaid spending and use of services and supports delivered in home and community-based settings relative to institutional settings.
  3. Community integration, which is focused on ensuring the self-determination, independence, empowerment, and full inclusion of eligible Medicaid beneficiaries.

CMS has stated that it will release additional technical details on each measure in future guidance. The CMS guidance letter outlining the new HCBS quality measure targets can be read here.

HHS Final Rule Regarding Notice of Benefit and Payment Parameters for 2023 Take Effect

An HHS final rule (87 FR 27208) regarding federal qualified health plans ("QHPs") recently went into effect, implementing new CMS standards and requirements for QHP issuers and related entities. The final rule seeks to strengthen the coverage options offered by QHPs listed on federal and state marketplaces that are hosted on the federal platform while also streamlining QHP review and comparison by consumers.

Under the final rule, QHP issuers face a host of new and updated standards. QHP issuers are now required to offer standardized plan options at every product network type, at every metal level (bronze, silver, gold, etc.), and throughout every service area in which they offer non-standardized options in plan year ("PY") 2023 and beyond. Additionally, CMS will conduct network adequacy reviews in all states with a Federally-Facilitated Marketplace ("FFM"), evaluating QHPs for compliance with quantitative network adequacy standards based on time and distance standards. Additionally, CMS has finalized multiple requirements designed to advance health equity in QHPS, including updating nondiscrimination policies affecting health plan designs and scaling back special enrollment period ("SEP") verification.

The full text of the final rule is available here. A fact sheet regarding the final rule may be read here.

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