More than three years after the COVID-19 pandemic began, many healthcare institutions continue to have difficulty fully staffing all their facilities.  In response, both the Oregon and Washington legislatures enacted new laws that will change how hospitals plan for and staff their facilities.  While both states will send shockwaves throughout their hospitals, the approaches differ…

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

High deductible health plan (“HDHP”) sponsors take note: the Continuing Appropriations Act, 2023 (“CAA23”) temporarily extends the flexibility for HDHPs to provide pre-deductible coverage of telehealth services without affecting the ability to contribute to a HDHP participant’s Health Savings Account (“HSA”).

As we discussed, due to relief first provided in the CARES Act and then extended in Consolidated Appropriations Act, 2022 (“CAA22”), HDHP participants were permitted to receive pre-deductible coverage of telehealth and remote care services during the COVID-19 pandemic without adversely affecting their ability to make or receive contributions to an HSA, except for a few months in the beginning of 2022. This relief was set to expire on December 31, 2022. CAA23 extends this relief through plan years that begin before January 1, 2025.…

Continue Reading Telehealth Safe Harbor Extended

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

Any provider who participates in the Medicaid program knows that it risks committing fraud if it bills twice for the same service.  Unfortunately, Certified Community Behavioral Health Clinics (CCBHCs) that are also Federally Qualified Health Centers (FQHCs) have been incorrectly advised by the Centers for Medicare & Medicaid & Services (CMS) to do just that. 

CCBHCs are entities that were created by a Substance Abuse and Mental Health Services Administration (SAMHSA) demonstration project to improve the availability and quality of services provided in community mental health centers.  Once certified, the CCBHC is required to offer a specific range of services and meet standards for service.  The model is intended to ensure access to coordinated comprehensive behavioral health care.  CCBHCs are paid similar to FQHCs using a Prospective Payment System (PPS) rate that is based on certain costs to provide CCBHC services. …

Continue Reading Certified Community Behavioral Health Clinics Beware! 

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

Stoel Rives recently continued its long-time sponsorship of the  Portland Business Journal Health Care of the Future awards. A special publication for the awards includes a collaboration by Stoel Rives’ attorneys Todd Hanchett, Tim Hatfield, Kelly Knivila and Sarah Oyer on an article addressing four current trends in health care.  Topics covered include behavioral health services, value-based purchasing, telehealth and employment-related issues.  Read the full article here.…

Continue Reading Stoel Rives’ Health Care Attorneys Contribute to PBJ ‘Health Care of the Future’ Special Publication

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

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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.