Healthcare Law

New
Jersey State: Selected Adopted Legislation

• P.L.2019, c.58  – A2031 – Approved – This statute, concerning health insurance coverage for mental health conditions and substance abuse disorders, passed both the Assembly and Senate and expands coverage for such conditions and disorders.
• P.L.2019, c.59 – A1504 – Approved – This statute, titled Medical Aid in Dying for the Terminally Ill Act, was passed by the Assembly and Senate and allows patients, under certain circumstances with appropriate safeguards, to self-administer medication in order to bring about a humane and dignified death.

New
Jersey State: Notice on Regulation

• 51 N.J.R. 509(a) – Notice – Division of Certificate of Need and Licensing cancelled its notice for new specialized long-term care beds for severe behavior management. The Department determined that there is not a need for new specialized long-term care beds for severe behavior management at this time.

Federal:
Selected Proposed and Enacted Legislation

• S. 801 – Introduced – To amend the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information.
• S. 913 – Introduced – To require group health plans and health insurance issuers offering health insurance coverage to disclose cost information to enrollees in such plans or coverage.
• S. 967 – Introduced – To amend the Public Health Service Act to establish limitations on cost-sharing for out-of-network services in the individual market and to prohibit balance billing for such services, and for other purposes.
• S. 1045 – Introduced – To amend the Public Health Service Act to expand the authority of the Secretary of Health and Human Services to permit nurses to practice in healthcare facilities with critical shortages of nurses through programs for loan repayment and scholarships for nurses.
• S. 1125 – Introduced – To amend the Health Insurance Portability and Accountability Act to preclude insurers from excluding pre-existing conditions and requiring insurers to accept every employer and individuals for coverage unless the insurer can prove certain hardships.
• H.R. 2035 – Introduced –  The Lifespan Respite Care Reauthorization Act of 2019 authorizes $200 million over five years for grants to states to carry out statewide coordinated systems of respite services, provide planned and emergency respite services, recruit and train respite workers and volunteers, and provide information to family caregivers to help them access respite services.
• H.R. 2113 – Introduced – To amend the Social Security Act to provide for drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain healthcare providers, and for other purposes.
• H.R. 2143 – Introduced –  The Promoting Integrity in Medicare Act (PIMA) is designed to address purported increased self-referral practices in advanced diagnostic imaging, anatomic pathology, physical therapy, and radiation therapy. Supporters suggest that by removing these four services from the in-office ancillary services exception (IOAS) under the Medicare self-referral law, the number of self-referrals covered would be reduced.

Federal: Selected Proposed and Adopted Regulations

• The US Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) announced the CMS Primary Cares Initiative, which includes a new set of payment models for primary care in the hopes of reducing costs while delivering better care.  HHS and CMS initiated these models based on empirical evidence that shows strengthening primary care is associated with higher quality and that primary care clinicians serve on the front lines of the healthcare delivery system. There are five payment model options: (1) Primary Care First (PCF); (2) Primary Care First – High Need Populations; (3) Direct Contracting – Global; (4) Direct Contracting – Professional; and (5) Direct Contracting – Geographic.  For more information, please view the following fact sheet:  Primary Cares Initiative.  For information regarding the timing of the models, please click here.
• 84 FR 15680 – Final Rule – This final rule increases plan choices and benefits, including allowing Medicare Advantage plans to include additional telehealth benefits. These additional telehealth benefits offer patients the option to receive healthcare services from places like their homes, rather than requiring them to go to a healthcare facility.  Up until now, seniors in Original Medicare could only receive certain telehealth services if they lived in rural areas. Starting this year, Original Medicare began paying for virtual check-ins when patients connect with their doctors by phone or video chat. Click here to see the Final Rule.  For a fact sheet on Final Rule (CMS-4185-F), please click here.
• 84 FR 17454-01 – Final Rule – The Department of Health and Human Services issued final rules setting forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal Platform (SBE-FPs). Click here to see the Final Rule.
• 84 FR 12130-01  – Interim Final Rule – This interim final rule revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018.  Click here to see interim final rule.
• 84 FR 13855-01 – Proposed –  The Department of Defense proposes an amendment to the TRICARE regulation to allow coverage of otherwise authorized physical therapy (PT), occupational therapy (OT), and speech therapy (ST) for TRICARE beneficiaries when such services are prescribed by an authorized TRICARE Allied Health Professional acting within the scope of their license. Click here to see proposed rule.
• 84 FR 16948-01 – Proposed – This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Click here to see proposed rule.
• 84 FR 17244-01 – Proposed – This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. Click here to see proposed rule.
• 84 FR 17620-01 – Proposed – CMS issued proposed rules to update the payment rates used for skilled nursing facilities (SNFs) for fiscal year (FY) 2020 and proposed to revise the definition of group therapy among other things. Click here to see proposed rule.
• 84 FR 17570-01 – Proposed – CMS issued proposed rules for payment rates for hospice care. Click here to see proposed rule.
• 84 FR 16617-01 – Notice – On December 30, 2015, CMS issued a final rule (80 FR 81674) titled “Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS),” which implemented section 1834(a)(15) of the Social Security Act by establishing an initial Master List of certain DMEPOS that was determined, on the basis of prior payment experience, to be frequently subject to unnecessary utilization and by establishing a prior authorization process for these items.  The Master List is updated annually.  This Notice adds four HCPCS codes to the Master List: E1390, E0466, E0784 and L0650. Click here for notice.
• 84 FR 16616-01 – Notice – This notice adds 12 HCPCS codes to the Required Prior Authorization List of DMEPOS that require prior authorization as a condition of payment:  K0857, K0858, K0859, K0860, K0862, K0863, K0864, E0193, E0277, E0371, E0372, and E0373.  Click here for notice.
• 84 FR 18151-01 – Notice – This notifies the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the HIPAA. Current HHS regulations apply the same cumulative annual CMP limit across four categories of violations based on the level of culpability. As a matter of enforcement discretion, and pending further rulemaking, HHS will apply a different cumulative annual CMP limit for each of the four penalties tiers in the HITECH Act. Click here for notice.

Federal
Guidance Documents

The Department of Labor’s Acting Administrator issued opinion letters regarding the use of the 8 and 80 overtime structure. Under this structure, institutions “primarily engaged in the care of the sick, the aged or the mentally ill”  pay workers extra when they work more than 8 hours in a day and over 80 hours in a two-week period, rather than when they exceed the typical 40-hour-per-week threshold.  According to DOL’s guidance document, three types of facilities can opt to use the 8 and 80 structure: (1) residential care institutions, such as nursing homes and convalescent homes, that make much of their money by providing noncritical care to patients who live on-premises; (2) facilities that care for “emotionally disturbed persons; and (3) facilities with a qualified physician who regularly provides therapy to more than 50 percent of residents.  Click here to review the opinion letter.

Federal Litigation

• A California federal judge declined to grant summary judgment to the U.S. Department of Justice in a whistleblower suit against UnitedHealth Group Inc. over alleged overpayments on medical claims, citing a previous decision by a D.C. federal court decision that struck down a rule that allowed the federal government to claw back funds paid out to private insurers who participate in Medicare Advantage if those payments were not fully supported by medical records or claimed to be exaggerated. For more information on the matter, see, U.S. ex rel. Poehling v. UnitedHealth Group Inc. et al., case number 2:16-cv-08697, in the U.S. District Court for the Central District of California.
• A North Carolina federal judge refused to certify two classes in an ERISA suit where the plaintiff claimed Aetna and OptumHealth Care Solutions disguised administrative fees as medical expenses.  The judge refused class certification because the plaintiff could not explain how she would identify class members. For more information on the matter, see, Peters v. Aetna Inc. et al., case number 1:15-cv-00109, in the U.S. District Court for the Western District of North Carolina.
• A Florida federal judge rejected CVS arguments against Sentry Data Systems, Inc.’s complaint, which alleges that CVS unlawfully forces healthcare providers to use its 340B Drug Pricing Program administrator Wellpartner LLC. For more information on the matter, see, Sentry Data Systems Inc. v. CVS Health et al., case number 0:18-cv-60257, in the U.S. District Court for the Southern District of Florida
• Seven individuals were found guilty in a Texas federal court for their roles in a scheme aimed at steering surgical patients to Forest Park Medical Center.  It was alleged that the hospital entered marketing agreements with certain physicians to market themselves, but the Court found that the agreements were kickbacks for referrals.  For more information on the matter, see, U.S. v. Beauchamp et al., case number 3:16-cr-00516, in the U.S. District Court for the Northern District of Texas.
• A Pennsylvania federal judge declined to permit University of Pittsburgh Medical Center (UPMC), Western Pennsylvania’s top hospital group, from intervening in a multidistrict litigation surrounding claims that Blue Cross Blue Shield (BCBS) is dominating regional health markets by dividing itself into regional healthcare markets in violation of the Sherman Act.   UPMC tried to intervene in the MDL to obtain a preliminary injunction preventing the national insurer from employing exclusive service areas, but the judge found that UPMC failed to demonstrate that the harm it would suffer is real.   For more information on the matter, see, Conway et al. v. Blue Cross and Blue Shield of Alabama et al., case number 2:12-cv-02532.

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.