Certified Community Behavioral Health Clinics Beware!

By Kelly Knivila on January 18, 2023 Posted in Fraud and Abuse, Medicaid

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.

In 2016, CMS issued detailed guidance to CCBHCs concerning the PPS rate that unfortunately included some incorrect guidance directed to those CCBHCs that were also FQHCs. In that guidance (which can still be found on SAMHSA’s website here), CMS strongly implied that CCBHCs could bill the same encounter twice – once using its CCBHC rate and once using its FQHC rate. The guidance stated as follows:

3.0a FQHCs
A clinic that participates in the Medicaid program as both a FQHC and CCBHC should receive the CCBHC PPS rate whenever it provides any of the services covered by this demonstration, even if there is an overlap with services included in the clinic’s FQHC PPS rate. The state should continue to pay the health center its established FQHC PPS rate and does not need to modify the payment amount. If a clinic user received a CCBHC service and FQHC service during one encounter/visit the provider is eligible to receive both the CCBHC PPS and the FQHC PPS.

This gave the wrong impression that a CCBHC could get paid twice for the same service if it was also an FQHC. At the very least, it is unclear because it seems to assume without stating that a “CCBHC service” will never overlap with an “FQHC service,” which is simply not the case. Many FQHCs provide services that are included in the costs used to establish their PPS rates that are also services that would be used to establish their PPS rate if they were certified as a CCBHC.

Fortunately, in 2021, the federal Government Accountability Office (GAO) issued a report highlighting this problem. When GAO sought comment from CMS, CMS indicated that it intended to state that CCBHCs are only eligible for both payments if nonoverlapping services are provided. See page 30 of Medicaid Behavioral Health CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication (Sept. 2021). CMS explained, for example, that “a CCBHC also certified as an FQHC may provide mental health counseling and a dental cleaning for the same client on the same day” and two payments would be appropriate. But “a client with mental health counseling and a primary care screening service on the same day should not trigger both types of payments, because both of these services are already included in CCBHC prospective payment rates. In this case, CMS officials told us states should pay only the CCBHC rate.” Id.

CCBHCs relying on the 2016 guidance and billing twice for the same encounter should consider whether they have identified an overpayment that must be reported and returned to the state Medicaid agency. 42 C.F.R. § 401.305. Failure to report and return an overpayment within sixty (60) days of identification can result in an ordinary overpayment being treated as a false claim potentially subject to penalties of up to triple the amount of the overpayment plus $12,000 to $25,000 per claim. One would hope that under these circumstances the state Medicaid agency would take into account the unclear CMS guidance provided when determining how to resolve such a self-report.

Is Any Pandemic Relief Still Available for Employee Benefit Plans?

By Bethany Bacci and Gabby Hansen on November 18, 2022 Posted in Employee Benefits, Health Plans, Legal Updates

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. In a recent article for the Daily Journal of Commerce, we discuss several special relief provisions that directly or indirectly affect group health plans. You can read the full article here.

Originally published as an Op-Ed by the Oregon Daily Journal of Commerce on November 4, 2022.

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

By Ronak Chokhani and Terri Rambosek on May 20, 2021 Posted in Legal Updates

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

The new rule becomes effective May 21, 2021, and requires health care entities to:

Apply for renewed approval of their current CQIPs by December 31, 2021, and pay a $75 renewal fee;
Request renewed DOH approval for their CQIPs every five years thereafter;
Notify DOH within 30 days if there is a change in the entity’s “authorized representative” who submitted the application for new or renewed approval; and
Modify their CQIPs within six months to comply with any future changes to CQIP requirements adopted by DOH or the Washington legislature and to seek DOH approval for the modifications.

If a health care entity does not apply for renewed approval on a timely basis, the existing approval for the CQIP lapses, and the entity must submit a new application for approval. This scenario may be a trap for unwary organizations that overlook the renewal date. Quality improvement and peer review records created during the interim period between the expiration of approval and a new application may not be considered privileged and confidential in the same way they would be while the CQIP approval is in effect. During that interim period, individuals who provide information or participate in peer review and quality improvement activities may not enjoy the immunity protections provided for under the statute that authorized the DOH approval process, RCW 43.70.510.

Health care entities should consider adopting measures to mitigate the effects of lapsed approvals such as participating in a patient safety organization (“PSO”), that offers additional protection under the Health Care Quality Improvement Act of 1986, and requiring contractors to represent that their CQIPs are in good standing with DOH.

Although all health care entities must apply for renewed approval for their CQIPs by the end of the year, they need not worry about the consequences of any delay caused by the volume of renewal requests. Current CQIP approval remains in place while a renewal application is under DOH review. However, a health care entity that intends to seek new approval for a CQIP should apply as soon as possible to avoid delays caused by a potential backlog of renewal applications. Continue Reading

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

By Todd Hanchett, Timothy Hatfield, Kelly Knivila and Sarah Oyer on October 8, 2020 Posted in News, Oregon

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.

Department of Labor Narrows FFCRA Exemption for Health Care Providers

By Karin Jones and Laura Rosenbaum on September 16, 2020 Posted in COVID-19, Employment Law, National

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).

Part 2 Amendments Facilitate Care Coordination Activities of Substance Use Disorder Treatment Programs

By Timothy Hatfield and Reilley Keating on July 23, 2020 Posted in Legal Updates, National

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

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

By Kelly Knivila and Ronak Chokhani on May 26, 2020 Posted in COVID-19, Oregon, Washington

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).

Important Deadlines Delayed for Health and Welfare Plans due to COVID-19 Emergency: Impacts for Employer Plan Sponsors, Administrators, and Insurers

By Howard Bye-Torre, Bethany Bacci and Abbey Hendricks on May 13, 2020 Posted in COVID-19, Employee Benefits, Health Plans, HIPAA, Insurance Law, National

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

COVID-19 Update: FCC Accepting Applications for Its $200M Telehealth Program; Red Light Rule Waived

By Ronak Chokhani and Timothy Hatfield on April 23, 2020 Posted in COVID-19, Reimbursement, Telehealth

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 process.

The Application is now available via the FCC’s online portal, which can also be used to submit the Application. Funding decisions are being made on a rolling basis, and the FCC will stop accepting applications once the funding is exhausted or the COVID-19 pandemic ends. As of April 16, 2020, the FCC has approved six applications worth $3.23 million. See FCC News Release. As discussed in the previous client alert, applicants must (a) obtain an eligibility determination from the Universal Service Administrative Company (“USAC”) by submitting Form 460; (b) obtain a FCC Registration Number using the COmmission REgistration System (CORES); and (c) register with the System for Award Management. Note that providers can submit an Application while their USAC eligibility determination is pending.

Only “nonprofit and public eligible health care providers” may qualify to receive Program funding, which substantially limits the number of providers that can benefit from the Program and likely hinders the effectiveness of the Program. Providers who qualify for Program funds will not receive a cash award or grant to purchase eligible services or devices. Instead, Program recipients must first purchase the eligible services or devices, and subsequently submit invoices to the FCC for reimbursement. Thus, providers must have funds available to initially purchase the eligible services or devices.

Awardees must submit invoices on a monthly basis using the U.S. Department of Treasury’s Bureau of the Fiscal Service Invoice Processing Platform (“IPP”). Using the IPP, providers must submit the Request for Reimbursement Form and supporting documentation (e.g., invoices). For more information regarding the invoicing process, please refer to Wireline Competition Bureau and Office of Managing Director’s invoicing guidance.

On April 21, 2020, FCC announced that it is waiving the “red light” rule that would otherwise empower the FCC to withhold Program funds from applicants who were delinquent in their debts owed to the FCC until the debt was paid in full or other resolution was reached. Interested applicants can review Application Filing Instruction to learn more about the application process and the information and documentation needed to complete the Application. FCC FAQs and Guidance provide additional information regarding the Program.

COVID 19 Update: Minnesota’s Ban on Elective Procedures, Providers May Be Compelled to Donate or Sell Medical Equipment

By Ronak Chokhani and Laurie Huotari on April 20, 2020 Posted in COVID-19, Minnesota

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