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

HHS Distributes $30 Billion from CARES Act Public Health Emergency Funds

By Kelly Knivila and Anthony Miles on April 11, 2020 Posted in COVID-19, Reimbursement

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 and are being pushed out to all providers enrolled in the Medicare Fee-for-Service program. Medicare-enrolled providers should look for an ACH payment advice from Optum Bank (an affiliate of the UnitedHealth Group) labeled “HHSPAYMENT”.

Providers regularly paid by check can expect to receive a check within the next few weeks. The amount of the payment will reflect the receiving provider’s proportionate share of the $30 Billion, allocated based on the ratio of the provider’s 2019 Medicare FFS receipts (payments from MA plans are not included) to total 2019 Medicare FFS expenditures. Unlike the AAPP, these payments are grants, not loans, and need not be repaid by eligible providers who certify their willingness to abide by the Terms and Conditions within 30-days of receipt.

While the distribution will be welcome news to providers and achieves HHS’s goal of providing an immediate infusion of much needed capital into the nation’s health care system to address additional costs and losses associated with COVID-19, not all of those who receive these funds will benefit. Indeed, providers should look this gift horse carefully in the mouth since, contrary to HHS’s press release, many providers may not qualify for the funds and may end up needing to repay these deposits or risk exposure to liability under the federal False Claims Act.

Contrary to public statements by certain representatives of the administration, the funds do have strings attached and do come with limitations on their use. For example, only those providers involved in diagnosing, testing or treating actual cases of COVID-19 are eligible for these funds and dollars received must be used to prevent, prepare for, or respond to coronavirus and may cover only expenses or losses related to COVID-19 response.

Providers who receive and chose to keep at least $150,000 total in funds paid under various relief acts, will be responsible for providing quarterly reports detailing how the funds were spent and will also be required to adhere to Office of Management and Budget financial management and record-keeping rules. For these reasons, providers receiving these first tranche distributions would be well advised to take the following steps within 30-days of receipt: (a) segregate these funds or create a separate ledger entry to track these funds for internal accounting and possible external reporting purposes; (b) validate the amount of funds received using the formula provided by HHS; (c) determine their eligibility to retain the funds; (d) determine their ability to implement the necessary administrative requirements associated with retaining the funds; (e) submit the required certification if they elect to retain the funds; (f) assess whether any revisions or adjustment of their compliance programs will be necessary to comply with the Terms and Conditions for the funds; and (g) be on the lookout for further administrative requirements.

FCC Releases $200M COVID-19 Telehealth Program Guidance: Your Questions Answered

By Timothy Hatfield and Ronak Chokhani on April 11, 2020 Posted in COVID-19, Reimbursement

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