2019 Physician Fee Schedule Rule Review: Use of Telehealth Expanded

Telehealth for Treatment of Substance Use Disorders

As part of the CY 2019 Medicare Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period to expand the use of telehealth for the treatment of substance use disorders and co-occurring mental health disorders. Existing law provides for reimbursement of telehealth services only if the originating site is located in a rural health professional shortage area, is not in a metropolitan statistical area or is an entity that participates in a federal telemedicine demonstration project. The originating site must also be one of a specific type of facility, such as a hospital, physician’s office or skilled nursing facility. With respect to telehealth services used to treat a substance use disorder or co-occurring mental health disorders, the interim final rule removes the originating site geographic restrictions and permits a patient’s home to be an originating site. When the patient’s home is used as the originating site for telehealth services, Medicare will pay no facility fee. The interim final rule is effective for telehealth services performed on or after July 1, 2019. CMS is requesting comments on the interim final rule, and the comment period closes January 22, 2019. Continue Reading

2019 Physician Fee Schedule Rule Review: Option to Extend MSSP Agreements for Currently-Expiring ACOs Finalized

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Physician Fee Schedule Final Rule (PFS Rule), which contains a number of significant substantive changes to Medicare payment practices and policies. The PFS Rule will be officially published in the Federal Register on November 23, 2018. The PFS Rule also includes an interim final rule implementing amendments to federal telehealth regulations to maintain consistency with recent changes to the Social Security Act to address the opioid crisis enacted in October 2018 through the SUPPORT for Patients and Communities Act. Continue Reading

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the University’s foundation, under substantially identical terms. Continue Reading

OIG Issues Favorable Advisory Opinion Regarding Health Plan’s Incentive Payment Program

On October 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a Medicaid managed care organization’s (Requestor) proposal to pay incentives to its network providers who meet benchmarks for increasing the amount of early and periodic screening, diagnostic, and treatment (EPSDT) services provided to Medicaid beneficiaries (Proposed Arrangement).

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OSHA Clarifies Position On Anti-Retaliation Rule

On October 11, 2018, the Occupational Health and Safety Administration (OSHA) issued a memorandum to clarify its position regarding whether drug testing policies and safety incentive programs would be considered violations of OSHA’s regulations. Employers may recall that, in May 2016, OSHA published a final rule that, among other requirements, prohibited employers from retaliating against employees for reporting work-related injuries or illnesses. That portion of the final rule became known as the Anti-Retaliation Rule. Almost immediately, there was confusion over which workplace safety incentive programs and post-incident drug testing policies, if any, were permissible under the final rule. OSHA originally took the position that certain programs and policies could deter employees form reporting work-related injuries and illnesses, thus violating the Anti-Retaliation Rule. OSHA has now clarified that the Anti-Retaliation Rule does not prohibit workplace safety incentive programs and post-incident drug testing. Continue Reading

Laws Affecting Health Care Entities in Connecticut Take Effect October 1, 2018

On October 1, 2018, a number of new laws affecting health care entities in Connecticut became effective. Below please find a brief description of some of the newly-effective provisions, as well as links to our analyses of the changes. Continue Reading

Congress Considering Legislation Aimed at Curbing Surprise Medical Bills

The United States Senate is currently considering bipartisan legislation that would establish statutory limits on the financial exposure of certain patients to so-called “surprise” medical bills. The proposed legislation would amend the federal Public Health Service Act (at 42 U.S.C. § 300gg-19a) to prohibit surprise balance billing of patients receiving health care services in the following three situations: (1) Emergency services provided by a nonparticipating (i.e., out of network) provider in a nonparticipating facility; (2) Non-Emergency services following an emergency service at a nonparticipating facility; and (3) Non-Emergency services performed by a nonparticipating provider at a participating (in-network) facility. The proposed legislation would take effect during health plan years that begin on or after January 1, 2020. Continue Reading

CMS Revises Hospital Inpatient Admission Order Documentation Requirements

On August 17, 2018, the Centers for Medicare & Medicaid Services (CMS) published its Hospital Inpatient Prospective Payment Systems final rule for Fiscal Year 2019 (Final Rule). The Final Rule contains a number of important updates to Medicare Part A that take effect October 1, 2018.

Among other provisions  in the Final Rule, CMS finalized its proposed update of the regulations that govern hospital admissions under Medicare Part A (42 C.F.R. § 412.3). Specifically, the Final Rule revises language in 42 C.F.R. § 412.3(a) to remove the current requirement that an inpatient admission order “must be present in the medical record and be supported by the physician admission and progress notes, in order for the hospital to be paid for hospital inpatient services under Medicare Part A.” As a result, starting October 1, 2018, CMS will “no longer require a written inpatient admission order to be present in the medical record as a specific condition of Medicare Part A payment.” Continue Reading

Ninth Circuit Issues Long-Awaited Interpretation of Escobar Two-Part Test

In late August, the U.S. Court of Appeals for the Ninth Circuit issued a long-awaited decision in U.S. ex rel. Rose v. Stephens Institute that interprets key aspects of the implied false certification theory of False Claims Act (FCA) liability under the Supreme Court’s 2016 Escobar decision. As the Ninth Circuit explains in its decision, Escobar “unsettled” Ninth Circuit law related to the standard for proving falsity and materiality in an FCA case. The Ninth Circuit therefore sought to reconcile its precedents with Escobar in Rose, which was before it on an interlocutory appeal from a denial of summary judgment sought by the defendant. Continue Reading

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a warranty program to hospital customers covering three joint replacement products (“Proposed Arrangement”).

Under the Proposed Arrangement, the manufacturer would refund hospitals for the combined purchase price of three of its products if a patient who received them as part of a joint replacement surgery was readmitted to the hospital within 90 days following the surgery, due to a failure of any of the products to perform as expected (“Warranty Program”). The products include: (1) a total knee or hip implant, (2) a wound therapy system, and (3) an antimicrobial dressing (collectively, the “Product Suite”). Continue Reading

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