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The Department of Labor (DOL) recently modified its guidance regarding leave under the Families First Coronavirus Response Act (FFCRA). These changes pertain to the applicability of FFCRA leave to employees of health care providers. The changes – which take effect on September 16, 2020 – are a response, in part, to a recent New York federal district court opinion invalidating some of the DOL’s prior guidance. (See here.)

The DOL narrowed the applicability of the FFCRA exemption for health care providers. Under the new guidance, not all employees of health care providers are exempt from FFCRA. Only the following employees may be excluded: (1) licensed doctors of medicine, nurse practitioners, chiropractors, dentists, and others permitted to issue FMLA certifications under 29 C.F.R. 825.125; and (2) employees who provide diagnostic, preventive, or treatment services, or “other services that are integrated with and necessary to the provision of patient care and, if not provided, would adversely impact patient care.” This exemption includes, among others, nurses, medical technicians, and laboratory technicians. We recommend that health care providers seeking to exempt some employees from FFCRA talk to their legal counsel about whether the exemption applies.

The DOL encourages health care providers to minimize use of the exemption to the extent possible in order to prevent the spread of COVID-19. Employers may choose to allow some types of FFCRA leave (e.g., leave for employees with COVID-19 symptoms) and not others (e.g., childcare leave).Continue Reading Department of Labor Narrows FFCRA Exemption for Health Care Providers

On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) made substantial changes to the permitted uses and disclosures of substance use disorder (SUD) records for programs covered by 42 C.F.R. Part 2. The stated intent of the final rule is to facilitate the provision of well-coordinated SUD care. The rules do indeed appear to remove regulatory barriers that have made it difficult for SUD providers to engage in the type of care coordination activities that are increasingly common outside the substance abuse context.

Perhaps the most significant change to the rules is the expansion and clarification of the permitted uses and disclosures for the purposes of “health care operations.”  A Part 2 program has long been able to obtain patient consent for the use and disclosure of substance abuse information for “payment and/or health care operations.” Previously, however, the relevant rules explicitly stated that “health care operations” cannot include disclosures “to carry out other purposes such as substance use disorder patient diagnosis, treatment, or referral for treatment.” 83 Fed. Reg. 239-01, 243 (Jan. 3, 2018). SAMHSA specifically advised that this language meant that the term “health care operations” is “not intended to cover care coordination or case management.” Id.

Through these recent rule changes, SAMHSA effectively has reversed this guidance and now defines the term “health care operations” to include any “payment/health care operation activities not expressly prohibited,” including “care coordination and/or case management services.” This more closely aligns with the definition of “health care operations” found in HIPAA and will allow the disclosure of SUD records to entities that perform care coordination services. It also will allow such entities to disclose such records to its contractors or legal representatives for health care operations. We note, however, that any disclosure for health care operations still will require specific patient authorization. 42 C.F.R. § 2.31.
Continue Reading Part 2 Amendments Facilitate Care Coordination Activities of Substance Use Disorder Treatment Programs

The Employee Benefits Security Administration (EBSA) of the Department of Labor (DOL) and the Department of Treasury and Internal Revenue Service (IRS) issued a notification of relief, effective immediately, that extends certain critical deadlines in health, disability, and other welfare plans (Deadline Relief).[1] This Deadline Relief requires that these plans extend certain deadlines that affect plan participants, beneficiaries, claimants and Consolidated Omnibus Budget Reconciliation Act (COBRA) qualified beneficiaries, by disregarding days during the COVID-19 “Outbreak Period” from counting toward statutory and regulatory timeframes.

The Outbreak Period began on March 1, 2020 and lasts until 60 days after the announced end of the “National Emergency” period for COVID-19 that was declared by the President.

These deadline extensions will impact employer plan sponsors, administrators and insurers.
Continue Reading Important Deadlines Delayed for Health and Welfare Plans due to COVID-19 Emergency: Impacts for Employer Plan Sponsors, Administrators, and Insurers

In light of the COVID-19 pandemic, the Drug Enforcement Agency (“DEA”) recently issued guidance permitting the use of telemedicine to prescribe controlled substances (schedule II to V) for the duration of the public health emergency declared by the Secretary of Health and Human Services.

Specifically, if (a) the prescription “is issued for a legitimate medical purpose” in the usual course of professional practice; (b) “audio-video, real-time, two-way interactive communication system” is used for the telemedicine encounter; and (c) the practitioner complies with applicable state and federal laws, then controlled substances may be prescribed via telemedicine without first conducting an in-person medical evaluation. DEA FAQ. Nonetheless, if the practitioner has previously conducted an in-person examination, then telemedicine may be used to prescribe controlled substances regardless of whether a public health emergency has been declared as long as the prescription is made in compliance with state law and within the usual course of the provider’s professional practice. Id.
Continue Reading COVID-19 Leads to Liberalization of e-Prescribing of Controlled Substances, May Presage Permanent Rulemaking

On March 13, 2020, President Donald Trump issued a proclamation declaring a national emergency concerning the novel coronavirus disease (the “Emergency Declaration”).  The president framed the emergency declaration as empowering the Secretary of Health and Human Services (“HHS”) to waive “laws to enable telehealth,” which gave providers hope that the administration would remove some of the primary regulatory barriers to the broad implementation of telehealth services. In the days since the declaration, the administration has taken increasingly significant steps to do just that.

The Emergency Declaration authorized the Secretary of HHS to exercise his waiver authority under Section 1135 of the Social Security Act (42 U.S.C. § 1320b–5). Section 1135 empowers the Secretary to waive or modify only certain provisions under Medicare, Medicaid, the Children’s Health Insurance Program (“CHIP”), and the Health Insurance Portability and Accountability Act (“HIPAA”) during a national emergency.  Congress broadened these waiver authorities in the emergency supplemental appropriations bill, signed into law on March 6, which gave the Secretary additional authority under Section 1135 to loosen Medicare’s telehealth billing standards. It also specifically allowed the Secretary to waive the requirement that the beneficiary live in a rural area and receive the services at an approved remote site, such as a rural hospital.Continue Reading CMS Takes Significant Action to Spur Use of Telehealth Services for Duration of COVID-19 Emergency

The National Labor Relations Board (the “Board”) recently issued a decision in UPMC Presbyterian Shadyside that reverses longstanding Board precedent and holds that employers no longer have to allow nonemployee union representatives access to public areas of their property unless (1) the union has no other means of communicating with employees or (2) the employer discriminates against the union by allowing access to similar groups.

The UPMC case arose after the employer, a hospital, ejected two union representatives from its cafeteria, where they had been discussing organizational campaign matters with and providing union literature and pins to employees.  Previously and for many years, the Board had held that an employer could not restrict nonemployee union representatives from engaging in promotional or organizational activity in its public spaces, including cafeterias, so long as the union representatives were not “disruptive.”  In UPMC, the Board returned to a more common-sense approach and held that the National Labor Relations Act “does not require that the employer permit the use of its facility for organization when other means are readily available.”
Continue Reading NLRB Gives Employers Greater Discretion to Limit Union Activity on Their Premises

In late January, the U.S. Department of Health and Human Services’ Healthcare & Public Health Sector Coordinating Council issued a new cybersecurity guidance document for healthcare businesses of all sizes. The guidance document, entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” available at https://www.phe.gov/Preparedness/planning/405d/Pages/hic-practices.aspx, provides concrete and practical guidance for addressing what the Council has identified as the “most impactful threats . . . within the industry” and serves as a renewed call to action for implementation of appropriate cybersecurity practices. This document is critical reading for healthcare business managers faced with ever-increasing cybersecurity risks and the attending risks to patient safety and operational continuity, business reputation, financial stability, and regulatory compliance.
Continue Reading HHS Issues Practical New Cybersecurity Guidance for Healthcare Businesses of all Sizes

Late last year, Congress passed the Tax Cuts and Jobs Act, which included a provision  effectively repealing the requirement for most Americans to have health insurance.  This “individual mandate” was originally imposed by the Affordable Care Act (“ACA”). Beginning in 2019, the tax penalty individuals face if they do not enroll in health coverage considered minimum essential coverage (“MEC”) will drop to zero.

For many Americans, the individual mandate was satisfied by the health coverage provided by employers. From an employer perspective, the repeal of the individual mandate penalty might first appear to have little effect. The ACA’s employer shared responsibility provisions (also known as the “pay-or-play penalties”) remain intact, and applicable large employers (“ALEs”)  will likely continue to provide group health coverage to employees and their dependents even though the individual mandate is no longer in effect. And though the Congressional Budget Office projected that an additional 4 million individuals will go uninsured when the federal penalty disappears, most of these individuals were previously insured in the individual market, not the group market.

But the repeal of the federal penalty has spurred activity at the state level that will require employer attention. Many states are concerned that the resulting increase in uninsured individuals will further strain state safety nets, resulting in accelerated efforts to strengthen state insurance markets by imposing state-law individual mandates to reduce the rate of uninsured individuals.
Continue Reading Effects of State Individual Mandates on Employer Group Health Plans

On August 1, 2018, the Centers for Medicare & Medicaid Services issued a final rule that allows individuals to purchase short-term limited-duration health plans. Under the rule, short-term health plans can span an initial period of less than 12 months, with renewals and extensions capped at 36 months. Under the Affordable Care Act (“ACA”), lower-grade…

Touted as a major step in its efforts toward Medicare modernization, CMS issued a proposed Physician Fee Schedule rule on July 12, 2018 that would, in part, gut the current five-tier structure for Evaluation and Management (“E/M”) codes and collapse levels 2 through 5 down to one payment rate. The proposed payment overhaul, coupled with changes in the documentation required to support certain claims for reimbursement, is geared toward simplifying the Medicare billing rules and reducing the administrative burden for physicians so that they can focus on patient care.

E/M services comprise about 40% of the charges approved by Medicare under the physician fee schedule, with office visits representing half of that amount. Currently, documentation for these visits must comply with rigorous Documentation Guidelines that require a record of all clinically relevant information, as well as justification for medical necessity and appropriateness. There are five visit levels in each new patient and established patient E/M code family, and documentation must justify the code level being billed. Each visit level is tied to a different reimbursement rate reflecting different levels of service complexity and time spent.

The proposed rule would retain the existing CPT coding structure, but provide for a single, blended reimbursement rate for both new and established patients for outpatient E/M level 2 through 5 office visits. Add-on codes will be available to reflect additional resources involved in providing complex primary care and non-procedural services. The documentation standards for more complex office visits would be reduced to the amount required for a level 2 visit. While many providers would continue to document justification for higher levels of care, in part because of non-Medicare payers, CMS asserts that the change would provide immediate relief from the need to “audit against the visit levels.” The single work RVU for the collapsed office visit category would fall somewhere between the current level 2 and level 5 amounts. The following example is provided in the proposed rule:

Preliminary Comparison of Payment Rates for Office Visits, New Patients

HCPCS Code CY 2018 Non-facility
Payment Rate		 CY 2018 Non-facility
Payment Rate under the
proposed methodology
99201 $45 $44
99202 $76 $135
99203 $110
99204 $167
99205 $211

Continue Reading Proposed Medicare E/M Payment Overhaul Draws Mixed Reviews

Ten Republican Senators have introduced a bill that they say will require health insurers to cover pre-existing conditions if the Affordable Care Act (“ACA”) is invalidated. Critics counter that the bill offers little actual protection. Like the ACA, it would prohibit insurers from denying enrollment based on pre-existing conditions, but unlike the ACA, it would not require insurers to cover the conditions themselves.

The bill is the latest volley in an ongoing battle over the fate of the ACA. Here are some key steps that set the stage:

  • The 2017 tax bill eliminated the ACA tax penalty on individuals who do not have health insurance, effective as of 2019. This is one of two elements that has brought more healthy people into the individual market; the other is subsidized plans for those in lower income brackets.
  • In April 2018, CMS and HHS issued a rule permitting states to establish the levels of coverage insurers must offer in their health plans. Federal law no longer requires insurers to cover all of the ACA’s “essential health benefits.”
  • This month, hearings in Texas v. United States begin. A group of 20 states will argue that the tax penalty is a constitutional linchpin of the ACA, without which the law is invalid. The states also are asking for a preliminary injunction to halt operation of the ACA while the case is litigated. Seventeen states have filed an opposing motion.
  • The Justice Department is not defending the ACA in the Texas case. It has suggested that without the tax penalty, some parts of the ACA may still be valid, but the individual mandate, the pre-existing condition coverage requirement, and the prohibition on charging higher premiums based on medical history are not.

Continue Reading ACA Debate Intensifies Ahead of Midterm Elections

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The Health Law Insider blog provides insights about health care-related laws and regulations from Stoel Rives’ dedicated team of health care lawyers and industry experts. This blog covers the full spectrum of regulatory and compliance issues faced by the health care industry, including data privacy and security, fraud and abuse, reimbursement, health care transactions, antitrust, taxation, and insurance regulation.