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

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! 

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

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

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

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