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

In a previous Health Law Insider blog post, Stoel Rives’ health care team discussed the prohibition on elective procedures promulgated by Oregon and Washington in an effort to conserve the states’ supply of Personal Protective Equipment (“PPE”) and manage provider treatment capacity to ensure adequate resources were available to combat COVID-19. Recently, Oregon and Washington issued guidance permitting providers to gradually restart the provision of elective and non-emergent procedures.[1] As discussed below, Washington also released interpretive guidance to help providers determine how to assess “harm” to the patient that would help determine which procedures are urgent such that they are permitted under the “critical care phase” described in Governor Inslee’s Proclamation 20-24.1.

Additionally, Minnesota recently eased its prohibitions on non-urgent and elective procedures. For information regarding Minnesota’s order, please refer to our earlier client alert.

Oregon

Oregon’s requirements for resumption of elective and non-emergent procedures are onerous and differ based on the provider type. Prior to resuming elective and non-emergent procedures, hospitals and ambulatory surgical centers (“ASC”), must:

  • Ensure that they have adequate bed and workforce capacity to “accommodate an increase in COVID-19 hospitalizations in addition to increased post-procedure hospitalizations.” Specifically, hospital bed (i.e., ICU, step-down, and medical/surgical beds) availability in the region must be maintained at or below 20% and providers must have sufficient capacity to treat all hospitalized patients “without resorting to crises standard of care”;
  • Attest that they are maintaining a 30-day PPE supply on hand (two-week supply and an “open supply chain” is sufficient for “small facilities”);[2]
  • Be able to obtain “sustained PPE supply” without the triggering PPE-conserving measures;
  • Hospitals must provide a daily PPE supplies report to the Oregon Health Authority’s hospital capacity web system;
  • Have adequate access to COVID-19 testing capacity that provides results within two days (four days for smaller facilities) and consider testing patients before performing non-emergent or elective procedures;
  • Have strict infection control and visitation policies in place; and
  • Have sufficient resources for peri-operative care (e.g., pre- and post-operative provider visits; lab, radiology, and pathology services; and other ancillary services).

Continue Reading Non-Urgent and Elective Procedures Update: Oregon and Washington Ease Prohibitions

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 a previous client alert, Stoel Rives’ health care team provided responses to certain frequently asked questions regarding the Federal Communications Commission’s (“FCC”) COVID-19 Telehealth Program (“Program”). At the time of that earlier client alert, FCC was awaiting the Office of Management & Budget’s approval of the Program application (“Application”) before beginning the application…

In a previous blog post, Stoel Rives’ health care team discussed orders issued by Washington and Oregon that banned elective procedures in an effort to preserve the states’ supply of certain medical equipment. Minnesota has issued similar orders to ensure its healthcare facilities have adequate capacity and medical equipment to treat COVID-19 patients.

After banning non-essential surgeries and procedures, Minnesota has compelled certain providers and businesses to prepare an inventory of personal protective equipment (“PPE”), ventilators, respirators, and anesthesia machines (collectively “Medical Equipment”) that are not being used to provide “critical health care services or essential services.”1 Providers were required to submit an inventory of their Medical Equipment online by March 25, 2020. Businesses who produced Medical Equipment for sale were excepted from this inventory submission requirement.

The chart below summarizes Minnesota’s ban on elective procedures and order preserving medical equipment:
Continue Reading COVID 19 Update: Minnesota’s Ban on Elective Procedures, Providers May Be Compelled to Donate or Sell Medical Equipment

On April 10, 2020, HHS announced the distribution of the first tranche of $30 Billion from the Provider Relief Funds authorized and appropriated under the CARES Act and deposited within HHS’s Public Health and Social Services Emergency Fund.  The funds released in this tranche are different from the previously announced Accelerated and Advanced Payment Program…

On April 2, 2020, the Federal Communications Commission (“FCC”) released its Report and Order 20-44 outlining how it plans to distribute $200 million appropriated to it by the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). The COVID-19 Telehealth Program (the “Program”) will allow eligible providers to be reimbursed for “telecommunication services, information services, and devices necessary to enable provision of telehealth services, on a temporary basis.”

The FCC will make the COVID-19 Telehealth Program Application and Request for Funding Form (the “Application”) publicly available as soon as the Office of Management and Budget (the “OMB”) approves the Program’s information collection requirements, and will begin accepting Applications immediately thereafter. Program funds will be distributed on a first-come, first-served basis and are capped at $200 million. Thus, early applicants will have a better chance of receiving the limited funding. Providers who are interested in seeking funding should familiarize themselves with the Program’s requirements and take steps to ensure they are prepared to submit their applications once the process is opened.

As discussed below, eligible providers will be able to use Program funds to purchase a range of eligible devices and services including internet connectivity services, smart phones or tablets, asynchronous audio/video platforms, and devices used for remote patient monitoring. The Program will terminate when the funding is exhausted or when the pandemic ends, whichever occurs earlier. While more guidance is needed to fully understand the reimbursement mechanics, it appears that an eligible provider will be awarded a certain amount of money based on projected costs of eligible services or devices described in the provider’s Application. After purchasing the eligible services or devices, the eligible provider will be required to submit an invoice supporting the costs of its purchases. The FCC will then reimburse the eligible provider an amount supported by the invoices.
Continue Reading FCC Releases $200M COVID-19 Telehealth Program Guidance: Your Questions Answered

In an effort to conserve the state’s medical supplies and equipment, specifically personal protective equipment (PPE), Washington and Oregon (among other states) have banned non-urgent, elective procedures.[1] A move that the states hope will help ensure adequate supply of PPE and other medical equipment (e.g., ventilators) to address the COVID-19 pandemic.

Here is a comparative chart summarizing the prohibitions promulgated by Washington and Oregon:
Continue Reading Desperate Times, Desperate Measures: Elective Medical Procedures Banned, PPEs at Risk of Confiscation

Several updates have made by the Oregon Health Authority (“OHA”) and the Health Evidence Review Commission (“HERC”) since this alert was first posted.  The following is updated as of March 31, 2020.

On March 16, 2020, the Oregon Health Authority (“OHA”) issued a new temporary emergency rule revising OAR 410-130-0610 – OHA’s Medicaid telehealth reimbursement…

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

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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.