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On May 10, 2023, the Oregon Health Authority (“OHA”) announced that, effective May 11, it is suspending the statewide rule requiring that health care workers be fully vaccinated against COVID-19 unless they have an approved medical or religious exception. The news coincides with the end of the federal public health emergency on May 11, along with the anticipated end of the federal COVID-19 vaccination mandate for health care facilities certified by the Centers for Medicare and Medicaid Services (“CMS”).

The OHA stated that immediate suspension of the rule is necessary “to align with the end of the federal public health emergency and elimination of other COVID-19-related control measures, and because there is no longer a significant public health need for this rule.”

The OHA also stated:

The rationale for the rule when it was adopted was that COVID-19 was likely to be transmitted in these congregate settings, placing vulnerable persons at risk. [The Oregon mandate] is now being suspended, because immunity from the primary series is known to wane over time, such that 2 booster vaccinations have since been recommended for most persons. Moreover, the virus that causes COVID-19 has mutated such that the original series provides little longer-term protection against infection by currently circulating strains. Finally, at this point most people have been infected by the virus (94% by one estimate), giving survivors a degree of immunity at least equivalent to that provided by the original vaccination series for some period of time.…

Continue Reading Oregon Health Authority Suspends COVID-19 Vaccine Mandate for Health Care Workers

Long before enactment of HIPAA, substance use disorder (“SUD”) treatment records have enjoyed confidentiality protections under 42 C.F.R. Part 2 (“Part 2”). Since HIPAA/HITECH and related regulations went into effect, SUD treatment providers that are subject to Part 2 (“Part 2 programs”) have struggled to make sense of the inconsistencies between Part 2 and HIPAA. For example, Part 2 programs cannot rely on HIPPA’s treatment, payment or health care operations exception to the authorization requirement because Part 2 is more restrictive than HIPAA and only permits disclosure of Part 2 records without a consent under limited circumstances. These types of inconsistencies, historically, have created numerous operational burdens for Part 2 programs and impeded care coordination.

Part 2 plays an important role to help address concerns that discrimination and fear of prosecution would deter individuals from seeking SUD treatment. It has been challenging for regulators to balance the heightened need for confidentiality of SUD treatment records with the need for sufficient operational flexibility to allow for effective care coordination and treatment.

HHS issued a Notice of Proposed Rulemaking (“NPRM”) proposing rules that implement statutory amendments to section 290dd-2 of title 42 United States Code (42 U.S.C. § 290dd-2) enacted in section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Public comments on the NPRM were due by January 31, 2023. HHS is proposing to give providers 24 months to comply with the changes after the publication of the final rule, but it has welcomed comments on whether that compliance period is sufficient.[i]…

Continue Reading New Proposed Part 2 Rules Aim for Greater HIPAA Alignment

As a result of a new rule published on February 1, 2023, at 88 Fed. Reg. 6643, Medicare Advantage (MA) organizations soon will be facing enhanced exposure from Risk Adjustment Data Validation (RADV) audits. Under the new rule, effective for audits of payment years 2018 and after, Centers for Medicare & Medicaid Services (CMS) will use extrapolation to calculate MA organizations’ repayment obligations based on RADV audit findings. While CMS did not adopt any specific extrapolation methodology and plans to use methodologies appropriate to the specific audit, it will be focused on contracts identified as being high-risk for improper payments using statistical modeling, data analytics, or both. CMS does commit to disclosing the extrapolation methodology used in connection with any particular audit so that MA organizations will know how their repayment obligation was calculated. Notwithstanding its prior proposal to do so (https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/recovery-audit-program-parts-c-and-d/Other-Content-Types/RADV-Docs/RADV-Methodology.pdf), CMS did not adopt a Fee-For-Service Adjuster in RADV Audits.  Relying on a recent D.C. Circuit decision, CMS takes the position that the obligation to report and return overpayments is not subject to the “actuarial equivalence” provision of the statute (42 U.S.C. § 1395w-23(a)(1)(C)) that applies to the risk adjustment payment methodology. UnitedHealthcare Ins. Co. v. Becerra, 16 F.4th 867, 885-86 (D.C. Cir. 2021), cert denied, 142 S. Ct. 2851 (2022).…

Continue Reading CMS Issues Final Rule Authorizing Extrapolation as Part of RADV Audits

Though much of U.S. government-sponsored pandemic relief has expired as the country approaches it third new year since its first reported cases of COVID-19, pandemic-related law changes exist that continue to impact employee benefit plans, and it is important that plan sponsors and administrators pay close attention to these changes as the new year approaches.

Many health care entities took a “set it and forget it” approach to their CQIPs once the CQIPs were approved by DOH under regulations adopted in 2006.  Beginning tomorrow, such entities will need to reconsider their approach.  DOH has published significant changes to its regulations regarding approval of CQIPs that are operated by health care entities such as provider groups, health care facilities that are not hospitals, and health care plans.  In light of the revisions to WAC Chapter 246-50, health care entities should review the contents of their CQIPs regularly and establish new mechanisms for managing CQIPs.

The new regulations as adopted are available at: https://app.leg.wa.gov/wac/default.aspx?cite=246-50.

The final rule that shows the regulatory changes can be found at: http://lawfilesext.leg.wa.gov/law/wsr/2021/09/21-09-077.htm.

Requirements for Obtaining and Maintaining Approval for a CQIP…

Continue Reading Department of Health (“DOH”) Has Issued Material Updates to Rules Governing Coordinated Quality Improvement Program (“CQIP”) Approval

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 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

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.