Dorsey Health Law
Transactions
New Minnesota Health Care Transaction Oversight Law Imposes Additional Requirements on Nonprofit Health Care Entities
On May 26, 2023, the Governor of Minnesota signed into law Minnesota bill HF 402 to increase government oversight of health care transactions that occur in Minnesota or involve Minnesota-based health care entities. A general overview of the new law’s oversight provisions can be found in a previous Dorsey Health Law blog post. The new law also contains provisions specific to nonprofit health care organizations, including additional transaction requirements and extension of the moratorium on certain conversion transactions. Given the prevalence of nonprofit health care organizations in Minnesota, we expect this new legislation to materially impact both payors and providers in the State. This blog post summarizes those provisions, all of which have already gone into effect. Additional Transaction Requirements for Nonprofit Health Care Entities In addition to the general notice requirements now effective under this new law and summarized in our previous post, HF 402 imposes further requirements on (1) nonprofit health care entities that are either incorporated under the Minnesota Nonprofit Corporation Act or organized as a Minnesota nonprofit limited liability company, and (2) the subsidiaries of such nonprofit entities, regardless of their incorporation or organizational status. These entities are now required to ensure the following before proceeding with a transaction: The transaction complies with the Minnesota Nonprofit Corporation Act, the charitable trusts statutes, and other applicable laws; The transaction does not involve or constitute a breach of charitable trust; The transferring nonprofit entity will receive the full and fair value for its public benefit assets, unless the discount between the full and fair value of the assets and the value received for the assets will further the nonprofit purposes of the entity or is in the public interest; The value of the public benefit assets to be transferred has not been manipulated in a manner that causes or has caused the value of the assets to decrease; The proceeds of the transaction will be used in a manner consistent with the public benefit for which the assets are held by the nonprofit health care entity; The transaction will not result in a breach of fiduciary duty; and There are procedures and policies in place to prohibit any officer, director, trustee, or other executive of the nonprofit health care entity from directly or indirectly benefiting from the transaction. Currently, it is not entirely clear how or to what extent these additional transaction requirements for nonprofit health care entities will be reviewed in conjunction with the general notice requirements for health care entities. Moratorium on Conversion Transactions A moratorium on conversion transactions involving nonprofit health plan entities operating under the Minnesota Nonprofit Health Service Plan Corporations Act or Health Maintenance Act that was set to expire July 2023 has been extended through July 2026. The moratorium was initially enacted in response to concerns of some lawmakers that nonprofit assets could be transferred to for-profit carriers in a merger or acquisition. These nonprofit health plan entities “may only merge or consolidate with; convert; or transfer, as part of a single transaction or a series of transactions within a 24-month period, all or a material amount of its assets to” an entity that is incorporated under the Minnesota Nonprofit Corporation Act; “or to a Minnesota nonprofit hospital within the same integrated health system as the health maintenance organization.” A “material amount” is defined as the “lesser of ten percent of an entity’s total admitted net assets as of December 31 of the previous year, or $50,000,000.” The moratorium does not apply if the nonprofit health plan entity files an intent to dissolve due to insolvency of the corporation or if insolvency proceedings are commenced. Related Study and Recommendations HF 402 requires that the Minnesota commissioner of health study and develop recommendations on the regulation of conversions, mergers, transfers of assets, and other transactions primarily affecting Minnesota-domiciled nonprofit health maintenance organizations (HMOs). These recommendations must address the following: Monitoring and regulation of Minnesota-domiciled for-profit HMOs; Issues related to public benefit assets held by a nonprofit HMO, including identifying the portion of the organization’s assets that are considered public benefit assets to be protected, establishing a fair and independent process to value the assets, and determining how public benefit assets should be stewarded for the public good; Providing a state agency or executive branch office with authority to review and approve or disapprove a nonprofit HMO’s plan to convert to a for-profit organization; Establishing a process for the public to learn about and provide input on a nonprofit HMO’s proposed conversion to a for-profit organization; and Issues, including statutory language and regulatory implementation, related to a potential statutory requirement that nonprofit HMOs licensed under Minnesota Statutes chapter 62D, and health systems organized as a charitable organization, upon the sale or transfer of control to an out-of-state or for-profit entity, return to the state’s general fund an amount equal to the value of any charitable assets the HMO or health system received from the state. The commissioner is required to seek public comment on the regulation of conversion transactions involving nonprofit HMOs no later than October 1, 2023. A final recommendations report must be submitted to the appropriate legislative committees by June 30, 2024. If you have any questions regarding HF 402 and how your organization or transaction may be impacted, please contact the authors or your regular Dorsey attorney. Summer Associate Lindsey VerMurlen provided substantial assistance researching and drafting this blog post.
June 7, 2023
Business Planning
Top Three Current Revenue Stream Considerations for Tax-Exempt Organizations Providing Elder Care
Current economic conditions have put additional strain on organizations across the health care spectrum in unprecedented ways. However, along with new challenges, both market conditions and new guidance from the Internal Revenue Service (IRS) bring fresh opportunities for tax-exempt senior services and other elder care organizations to consider new efficiencies, maximize revenues, and even expand operations. In particular, organizations in acquisitive periods and large health care systems looking to expand their spectrum of elder care services may find significant opportunities in the current market. Evaluating related versus unrelated revenue streams and associated expenses. Under Sections 511 through 514 of the Internal Revenue Code of 1986, as amended (IRC), tax-exempt organizations are required to pay unrelated business income tax (UBIT) on income from activities that are unrelated to their charitable, educational, scientific, religious or other exempt (or “related”) purposes. The unrelated business income (UBI) rules are complex, and such complexity can deter tax-exempt organizations from taking a comprehensive analysis relating to revenue sources and expense allocations for UBI calculation purposes. Changes to methodology for categorizing related versus unrelated revenue and expenses have implications across an organization’s financial reporting, to include tax returns and other compliance filings in both future and prior years. In May 2020, the IRS issued proposed regulations to give guidance for tax-exempt organizations calculating UBTI on separate unrelated trades or businesses (commonly referred to “siloing” such revenue and expenses) under IRC Section 512(a)(6), which was added by the 2017 Tax Cuts and Jobs Act (TCJA). The proposed regulations provide organizations guidance on how to identify and calculate UBTI from separate trades or businesses for purposes of IRC Section 512(a)(6), which generally requires organizations operating more than one unrelated trade or business to compute UBTI separately for each siloed trade or business. Once the businesses are broken into separate silos, an organization must determine how to allocate expenses that may apply to more than one activity to each silo. The preamble to the Section 512(a)(6) proposed regulations indicates that the IRS intends to publish a separate notice of proposed rulemaking to provide further guidance on expense allocation in calculating UBTI. In the interim, tax-exempt organizations may allocate such expenses using any reasonable method. Shifting models of care and new payment models across the health care spectrum provide not only cost efficiencies but also opportunities to analyze whether a tax-exempt organization’s activities (and associated revenues and expenses) are actually patient revenue related to such organization’s exempt purposes. And, if any activities are deemed unrelated to a tax-exempt organization’s exempt purposes, the new Section 512(a)(6) guidance provides a new benchmark to analyze such revenues and make good faith determinations relating to expense allocations. Acquiring assets out of bankruptcy proceedings. Economic downturns are painful, but for organizations with an acquisitive mindset, such market events can provide opportunities to expand existing and add activities through purchasing assets or businesses out of bankruptcy proceedings. If a tax-exempt organization is merely purchasing assets out of bankruptcy, the tax status of the former owner is typically not relevant. However, if the tax-exempt organization is purchasing the shares or equivalent ownership units of a taxable entity, it may still be a good fit for the acquiring tax-exempt organization but such transactions will require proper planning to protect the acquirer’s tax-exempt status. _____________________________________ Acquiring for-profit entities or operations. Whether acquired through bankruptcy proceedings or by a straight equity purchase, acquiring existing operations or ownership of a for-profit organization may present beneficial opportunities to tax-exempt organizations to enhance or expand their elder care service spectrum. While many senior housing organizations operate as for-profit enterprises, converting to a tax-exempt organization as a stand-alone organization or by acquisition by a tax-exempt organization may be a win-win for both organizations with proper planning. Additional considerations include the applicability of IRC Section 337(d), which requires certain corporations that transfer all or substantially all of their assets to a tax-exempt entity or convert from a taxable corporation to an exempt entity to recognize gain or loss as if it had sold the assets at fair market value. Also, the IRS has recently stated that organizations formerly operated as for-profit entities prior to their conversion to Section 501(c)(3) entities are one of the issues included on the annual compliance strategy list, and therefore may have a higher chance of future examination. However, if the converted organization files a new application for tax-exempt status by filing a Form 1023, Application for Recognition of Exemption Under Section 501(c)(3) of the Internal Revenue Code, that is approved by the IRS the examination would seem fairly straightforward so long as the Form 1023 is an accurate representation of the entity’s activities. Despite the additional due diligence and planning required, the last several years have shown several high-profile mergers and acquisitions of both tax-exempt and taxable skilled nursing facilities by tax-exempt organizations. Tax-exempt organizations, especially those looking to expand operations geographically or to encompass a more comprehensive spectrum of care should not discount opportunities to acquire an existing enterprise based solely on its taxable status. If you want to review your organization’s current senior services activities and/or evaluate expansion of elder care, please contact the authors or your regular Dorsey attorney.
June 24, 2020
coronavirus
HHS Announces Additional Allocations of CARES Act Provider Relief Fund
On April 22, 2020, the Department of Health and Human Services (“HHS”) issued a press release outlining the allocation of an additional $70 billion dollars in appropriations allocated by the CARES Act to the Public Health and Social Services Emergency Fund. The initial $30B tranche of the total $100 billion provided for under the CARES Act was distributed earlier this month to providers based on a methodology taking into account those providers’ Medicare receipts from the prior year. This is the “second round” of the initial funding provided for under the CARES Act and includes both a “General Allocation” of $50 billion and smaller “Targeted Allocations.” In allocating the funds, HHS stated they are “working to address both the economic harm across the entire healthcare system due to the stoppage of elective procedures, and addressing the economic impact on providers incurring additional expenses caring for COVID-19 patients, and to do so as quickly and transparently as possible.” On April 21, 2020, the U.S. Senate passed a bill, colloquially referred to as “Stimulus Phase 3.5,” which provides for an additional $75 billion to replenish the Public Health and Social Services Emergency Fund. These latest allocations are not related to the potential Stimulus 3.5 funds. We are continuing to monitor Stimulus 3.5 funds and will update our website once that next round of stimulus funding is approved by the President. The guidance provided by HHS with respect to the latest allocation of the additional $70 billion in appropriations for providers is below. I. GENERAL ALLOCATION $50 billion of the Provider Relief Fund is allocated for general distribution to Medicare facilities and providers impacted by COVID-19, based on eligible providers' 2018 net patient revenue. To expedite providers getting money as quickly as possible, $30 billion was distributed immediately, proportionate to providers' share of Medicare fee-for- service reimbursements in 2019. On Friday, April 10, $26 billion was delivered to bank accounts. The remaining $4 billion of the expedited $30 billion distribution was sent on April 17. HHS said they used this formula to get the money out the door as quickly as possible. HHS stated that, beginning this week, they will begin distribution of the remaining $20 billion of the general distribution to these providers to augment their allocation so that the whole $50 billion general distribution is allocated proportional to providers' share of 2018 net patient revenue. On April 24, a portion of providers will automatically be sent an advance payment based off the revenue data they submit in CMS cost reports. Providers without adequate cost report data on file will need to submit their revenue information to a portal opening this week at https://www.hhs.gov/providerrelief for additional general distribution funds. Providers who receive their money automatically will still need to submit their revenue information so that it can be verified. Payments will go out weekly, on a rolling basis, as information is validated, with the first wave being delivered at the end of this week (April 24, 2020). Providers who receive funds from the general distribution have to sign an attestation confirming receipt of funds and agree to the terms and conditions of payment and confirm the CMS cost report. The terms and conditions also include other measures to help prevent fraud and misuse of the funds. All recipients will be required to submit documents sufficient to ensure that these funds were used for healthcare-related expenses or lost revenue attributable to coronavirus. HHS warned that there will be significant anti-fraud and auditing work done by HHS, including the work of the Office of the Inspector General. In the latest allocation, HHS reinforced President Trump’s directive that as a condition to receiving these funds, providers must agree not to seek collection of out-of-pocket payments from a presumptive or actual COVID-19 patient that are greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. II. TARGETED ALLOCATIONS A. ALLOCATION FOR COVID-19 HIGH IMPACT AREAS $10 billion will be allocated for a targeted distribution to hospitals in areas that have been particularly impacted by the COVID-19 outbreak. As an example, HHS said that hospitals serving COVID-19 patients in New York, which has a high percentage of total confirmed COVID-19 cases, are expected to receive a large share of the funds. Hospitals should apply for a portion of the funds by providing four simple pieces of information via an authentication portal before midnight PT, Thursday April 23. This portal is live, and hospitals have already been contacted directly to provide this information. Hospitals will need to provide: Tax Identification Number National Provider Identifier Total number of Intensive Care Unit beds as of April 10, 2020 Total number of admissions with a positive diagnosis for COVID-19 from January 1, 2020 to April 10, 2020 HHS stated that the authentication and data-sharing process should take less than five minutes via a system that should be familiar to most hospitals. HHS indicated this information is necessary for the government to determine what facilities will qualify for a targeted distribution. They added that supplying this information does not guarantee receipt of funds from this distribution. HHS will use the data it receives to distribute the targeted funds to where the impact from COVID-19 is greatest. The distribution will take into consideration the challenges faced by facilities serving a significantly disproportionate number of low-income patients, as reflected by their Medicare Disproportionate Share Hospital (DSH) Adjustment. B. ALLOCATION FOR TREATMENT OF THE UNINSURED As announced in early April, a portion of the $100 billion Provider Relief Fund will be used to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured. Every health care provider who has provided treatment for uninsured COVID-19 patients on or after February 4, 2020, can request claims reimbursement through the program and will be reimbursed at Medicare rates, subject to available funding. Steps will involve: enrolling as a provider participant, checking patient eligibility and benefits, submitting patient information, submitting claims, and receiving payment via direct deposit. Providers can register for the program on April 27, 2020, and begin submitting claims in early May 2020. For more information, visit coviduninsuredclaim.hrsa.gov. C. ALLOCATION FOR RURAL PROVIDERS $10 billion will be allocated for rural health clinics and hospitals. This money will be distributed as early as next week (April 27, 2020) on the basis of operating expenses, using a methodology that distributes payments proportionately to each facility and clinic. This method recognizes the precarious financial position of many rural hospitals, a significant number of which are unprofitable. Rural hospitals are more financially exposed to significant declines in revenue or increases in expenses related to COVID-19 than their urban counterparts. D. ALLOCATION FOR INDIAN HEALTH SERVICE Included in the allocation is $400 million which will be allocated for Indian Health Service (“IHS”) facilities, distributed on the basis of operating expenses. Indian Country is also being impacted by COVID-19. This money will be distributed as early as next week (April 27, 2020) on the basis of operating expenses for facilities. HHS indicated that this serves as a complement for “other funding provided to IHS and work we've done to expand IHS capacity for telehealth.” E. ADDITIONAL ALLOCATIONS HHS indicated that there are some providers who will receive further, separate funding, including skilled nursing facilities, dentists, and providers that solely take Medicaid. F. HELPING ENSURE ALL AMERICANS HAVE ACCESS TO CARE The Families First Coronavirus Response Act, as amended by the CARES Act, requires private insurers to waive an insurance plan member's cost-sharing payments for COVID-19 testing. The President also secured funding to cover COVID-19 testing for uninsured Americans. The Trump Administration has also touted secured commitments from private insurers, including Humana, Cigna, UnitedHealth Group, and the Blue Cross Blue Shield system, to waive cost-sharing payments for treatment related to COVID-19 for plan members. As a condition to receiving general funds, providers must agree not to seek collection of out-of-pocket payments from a presumptive or actual COVID-19 patient that are greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. We are keeping a close eye on the rapid developments surrounding COVID-19. If you have any questions about this latest guidance issued by HHS, the CARES Act, or any questions related to COVID-19, please contact the authors of this blog or contact your Dorsey and Whitney LLP attorney. You can access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here. You can also access Dorsey’s health law blog related to health law updates, including those applicable to tax exempt entities in the health care space, available here.
April 23, 2020
coronavirus
What All Employers Should Know About Disaster Relief Funds to help with COVID-19
The COIVD-19 pandemic is placing new and unprecedented demands on both taxable and tax-exempt employers and their employees. One option many employers may not have previously considered is the use of a tax-exempt employee assistance fund. Depending on the structure of the fund, declaration of qualified disaster is an important requirement for the fund to issue financial assistance to individuals. Although the Internal Revenue Service (“IRS”) has yet to issue official guidance confirming the COVID-19 pandemic as a “qualified disaster” under Section 139 of the Internal Revenue Code (the “Code”), the President declared a national emergency under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (“Stafford Act”) due to extraordinary circumstances resulting from COVID-19. A qualified disaster relief payment is defined under Section 139(c)(2) of the Code to include a federally declared disaster as defined by Section 165(i)(5)(A) of the Code, which defines the term as any disaster subsequently determined by the President of the United States to warrant assistance by the Federal Government under the Stafford Act. If employers do not already have an established employee assistance fund, deciding and implementing the most beneficial structure during a crisis can seem daunting. We have experience forming and implementing employee assistance funds, and quickly and efficiently navigating the application for tax-exempt status with the IRS. Below is an overview of issues employers should consider when contemplating a new employee assistance fund program. What is an employee assistance fund? The term employee assistance fund (“EAF”) is generally used to describe several types of employer-sponsored Section 501(c)(3) (all subsequent references to “Section” shall mean Sections of the Code) charitable tax-exempt organizations designed to provide emergency, need-based financial assistance to an employer’s work force in the event of disaster or personal hardship impacting individual employees or their families. EAFs are typically structured as a public charity, a donor advised fund, or a private foundation. A Section 501(c)(3) EAF must serve a charitable class, which must be large enough or sufficiently indefinite that the community as a whole, rather than a pre-selected group of people, benefits from the EAF grants. EAFs may restrict benefits to a certain company’s employees and still serve a charitable class so long as the EAF’s assistance policy is open-ended and include employees affected by any current or future disasters or emergencies. What are the distinguishing characteristics of an EAF structured as a public charity? An EAF established as a public charity described in Sections 509(a)(1) and 170(b)(1)(A)(vi) receives its funding primarily through donations from the general public, usually through donations from the company’s individual employees. A public charity EAF can provide financial assistance in response to any type of disaster or employee emergency hardship, so long as the related employer does not control the organization. Generally, these requirements are met when non-executive (i.e., rank and file) employees comprise a significant portion of both the board of directors and the committee that selects eligible individuals for need-based distributions from the EAF. Unlike a donor advised fund or a private foundation, a public charity EAF can provide assistance to eligible individuals in response to any type of disaster or employee emergency hardship situation. What are the distinguishing characteristics of an EAF structured as a donor advised fund? A donor advised fund is a community foundation-type of organization that maintains separate funds or accounts on behalf of individual or corporate donors. The donors then receive advisory privileges over the distribution of the donated funds, but such distributions must still be made for charitable purposes. While a donor advised fund is usually classified as a public charity, important distinctions for donor advised EAFs are subject to additional restrictions. Typically, a donor advised fund (whether or not an EAF) cannot make grants to individual persons. However, a donor advised EAF can make grants to individual employees and their family members if: the EAF makes need-based distributions adequately documented by the EAF; the EAF’s sole purpose is to provide relief after a qualified disaster as defined in Section 139; and eligible recipients are selected by a committee independent from the sponsoring employer. What are the distinguishing characteristics of an EAF structured as a private foundation? EAFs structured as private foundations are typically funded solely through donations by an employer, and not by contributions from individual employees or the general public. Like the donor advised EAFs, an EAF structured as a private foundation may only provide need-based assistance to employees or family members impacted by a qualified disaster as defined in Section 139. Also, the private foundation EAF’s selection committee must be independent from the employer, and payments to or for the benefit of individuals who are directors, officers, or trustees of the private foundation may subject the foundation to the self-dealing rules under Section 4941. Are payments from an EAF taxable to the individual recipients? No. Payments from a Section 501(c)(3) EAF as a result of a disaster or emergency hardship are considered to be gifts and are excluded from the recipient’s gross income under Section 102. Are disaster relief payments taxable if received directly from an employer and not made through an EAF? It depends. If the payment meets the definition of a qualified disaster relief payment under Section 139 for qualified disaster expenses that are not otherwise covered by insurance or other reimbursements, such payments are not subject to income tax, self-employment tax, or other employment taxes even if made directly from an employer. Are donations to an EAF tax-deductible? If recognized by the IRS as a Section 501(c)(3) organization, donations by individuals or corporations to an EAF may eligible as a deduction as a charitable contribution under Section 170. Changes included in the recently enacted Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) includes expanded Section 170 deductions for both individuals (itemizers and non-itemizers) and corporations. Are there restrictions on EAF payments to individuals? Yes, particularly when made by an EAF structured as a donor advised fund or a private foundation that are limited to Section 139 qualified disaster relief payments. As relevant to payments from an EAF, qualified disaster relief payments are defined in Section 139(b) to include any amount paid (regardless of the source) for the benefit of an individual: to reimburse or pay reasonable and necessary personal, family, living, or funeral expenses incurred as a result of a qualified disaster; to reimburse or pay reasonable and necessary expenses incurred for the repair or rehabilitation of a personal residence or repair or replacement of its contents to the extent that the need for such repair, rehabilitation, or replacement is attributable to a qualified disaster; and by a person engaged in the furnishing or sale of transportation as a common carrier by reason of the death or personal physical injuries incurred as a result of a qualified disaster. Qualified disaster relief payments do not include payments for expenses paid for by insurance or other reimbursements, or income replacement payments, such as payments of lost wages, lost business income, or unemployment compensation. Can an EAF provide assistance to other businesses? It depends, but an EAF structured as a public charity likely has the most latitude to provide financial assistance to other businesses as it is not limited to qualified disaster relief-type payments. For example, a charitable organization may provide assistance to a for-profit business if the assistance is a reasonable means of accomplishing a charitable purpose (e.g., relief of the poor and distressed or lessening the burdens of government), and any benefit to private interests is incidental to the accomplishment of such charitable purpose.
April 1, 2020
coronavirus
CARES Act Summary of Provisions that Support America’s Health Care System
On March 27, 2020, the President signed into law the “Coronavirus Aid, Relief, and Economic Security Act’’ (“CARES Act”). The CARES Act is the third phase of the federal government’s response to the coronavirus following two other laws to support American families and address health sector needs that were approved on March 6, 2020 (Phase I here) and March 18, 2020 (Phase II here). The CARES Act includes provisions which provide cash payments and other resources to help individuals, small businesses, state and local governments and hospitals/healthcare providers. The CARES Act includes four sections (called “Titles”) and each title addresses a different topic. This e-update summarizes Title III of the CARES Act titled “Supporting America’s Health Care System in the Fight Against the Coronavirus”. Title III provides much needed financial assistance to the health care industry, as well as additional guidance and other provisions which provide information on waivers and other benefits to help hospitals and others who are on the front lines of fighting the COVID-19 pandemic. The following is a summary of the major provisions of Title III, organized in order by section numbers under the CARES Act but does not address subtitle B – Education Provisions and subtitle C – Labor Provisions. We will provide links to summaries of other provisions in the CARES Act prepared by our colleagues throughout the firm as they become available. Click here to read the summary.
March 27, 2020
FDA
FDA Testing New Approaches for Review of Digital Health Device Applications
On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program (“Pre-Cert”). Pre-Cert was originally announced in 2017 as part of the FDA’s Digital Health Innovation Action Plan. The FDA envisions the program as a streamlined process for bringing digital health technologies to market. More specifically, the FDA hopes to develop Pre-Cert into a program by which certain digital health developers can become precertified as part of an “Excellence Appraisal.” Excellence-appraised developers could then take advantage of streamlined premarket submission processes for their digital devices. To date, the FDA has been working with a variety of stakeholders, including nine companies “represent[ing] a wide range of companies and technology in the digital health sector,” in developing the program. In connection with the announcement earlier this week, the FDA issued “three documents that, together, launch us into the next phase of the agency’s vision of Pre-Cert.” The first of the three documents is a Regulatory Framework for Conducting the Pilot Program within Current Authorities (the “Framework”). This document builds out the regulatory framework within which the FDA will implement Pre-Cert. Here are some highlights: At least to start, Pre-Cert is limited to software as a medical device (“SaMD”), defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. The FDA hopes eventually to expand the program to review all medical device software products, including software in a medical device (“SiMD”) and other software that could be considered accessories to hardware medical devices. The FDA intends to utilize the De Novo classification process (section 513(f)(2) of the FD&C Act), an existing pathway for certain new types of low to moderate risk devices to obtain marketing authorization as a Class I or Class II device as opposed to automatic Class III designation, for the next phase of Pre-Cert. Here is an overview of the proposed process: Participants with a SaMD product may participate in an Excellence Appraisal, as well as an optional Review Determination Pre-Submission. When submitting a product for De Novo Review, an excellence-appraised developer would submit a streamlined “Pre-Cert De Novo Request,” in which it would not need to re-submit information reviewed during the Excellence Appraisal or the optional Pre-Submission. Assuming premarket requirements are met, the FDA would classify the device by written order and, if the device is Class II, establish special controls, which may include Excellence Appraisal elements and postmarket data collection elements. Following a De Novo order, an excellence-appraised developer would also be able to take advantage of a streamlined “Pre-Cert 510(k)” process, in which the developer can again leverage submission requirements already documented during the Excellence Appraisal and optional Pre-Submission process. The FDA expects review of a Pre-Cert 510(k) to be more efficient than the review of a traditional 510(k). The Pre-Cert 510(k) can also be used for modifications to devices, assuming a 510(k) is required for the modification. The second document is a 2019 Test Plan (the “Test Plan”). The Test Plan lays out the scope and approach of the Pre-Cert pilot in 2019. The primary purpose of the Test Plan “is to assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a SaMD product… as compared to the traditional paradigm.” Here are some highlights: Consistent with the Framework, the scope of the Test Plan is limited to: (i) selected SaMD with De Novo Requests, and (ii) selected 510(k) submissions, which would be tested as if they were follow-on 510(k)s for devices classified through a Pre-Cert De Novo Request. The FDA plans to prioritize selection of submissions that will enable evaluation and testing of all four components (Excellence Appraisal, Review Pathway Determination, Streamlined Review, and Real-World Performance plan) outlined in the Working Model (discussed below), and to focus on cases representing a broad spectrum of software developers (e.g., small and large firms, low- and high-risk products, companies not traditionally considered medical device manufacturers). During the Test Plan, the FDA will apply both the proposed Pre-Cert pathway and the traditional review process to each test case, enabling it to refine Pre-Cert and confirm the validity of the overall program. Developers participating in the Pre-Cert pilot, after an Excellence Appraisal and optional Pre-Submission, will still need to submit full traditional marketing submissions. Internally, the FDA will then create a “mock Streamlined Review package” and review the submission on parallel paths, traditional and “mock Streamlined.” Similarly, the FDA will also be internally conducting retrospective tests of SaMD regulatory submissions previously reviewed. Finally, the third document released is an updated Working Model (currently v1.0). The Working Model, which has been updated over time with continuous public input, describes in greater detail the goal, vision, scope, and process for Pre-Cert. It also includes summaries of public comments that have been received and FDA responses to them. Pre-Cert, if implemented and successful in accomplishing FDA’s stated goals, could have a significant impact on the healthcare industry beyond the software developers it promises to impact directly. Digital health is increasingly becoming an important tool for healthcare businesses. Streamlining processes for bringing digital health technology to market and modifying existing technology will in turn increase the rate at which providers are able to utilize updated digital health technologies in practice. As this technology continues to garner the focus and support of regulatory bodies, it will be important not only for developers to understand the FDA’s streamlined approval process, but also for providers to prepare for the potential transformative effect digital health tools can have on the care they provide.
January 11, 2019
Accountable Care Organizations
“Pathways to Success” - CMS Finalizes Overhaul of National ACO Program
On December 21, 2018, CMS announced a final rule, subsequently published in the December 31 issue of the federal register, significantly overhauling the Medicare Shared Savings Program (“MSSP”). Among the important changes in the final rule is a redesign of MSSP’s participation options. Under MSSP, providers of services and suppliers participating in an Accountable Care Organization (“ACO”) continue to receive traditional fee-for-service payments under Medicare Parts A and B but may be eligible to receive shared savings payments if they meet specified quality and savings requirements. Originally launched in 2012, MSSP has grown such that CMS estimates more than a quarter of Medicare FFS beneficiaries now receive care from providers participating in a Medicare ACO. Prior to the redesign, MSSP included three tracks. Track 1 was “one-sided,” meaning ACOs received a share of savings they achieved for Medicare (i.e., spending less than a benchmark), but they were not required to pay back a share of any losses (i.e., spending exceeding the benchmark). Tracks 2 and 3, on the other hand, were “two-sided,” meaning ACOs were eligible to receive a share of savings but also had to pay back a share of any losses. In exchange for accepting risk of loss, ACOs in Tracks 2 and 3 were eligible to receive a larger portion of savings than ACOs in Track 1. ACOs were only permitted to participate in Track 1 for a maximum of six years (two, three-year agreement periods) before switching to a two-sided model. Given that 2019 marks the seventh year of the MSSP program, MSSP entrants from the initial program year in 2012 faced mandatory transition to Track 2 in 2019 if they wanted to remain in the program, with other early adopters facing the same fate in coming years. However, in reviews of the program, CMS found that the vast majority of ACOs were still participating under Track 1, and many Track 1 ACOs were reluctant and/or unprepared to move to a two-sided model under Track 2. Meanwhile, CMS found ACOs in one-sided models actually increased Medicare spending relative to their benchmarks, while ACOs participating in two-sided models generated significant savings for Medicare. As an initial step to address some of these issues, CMS created a temporary “Track 1+” model, which began in 2018, which incorporated into the Track 1 model a more limited downside risk payment design as compared to Track 2. The MSSP redesign in many ways builds on the experience of introducing the Track 1+ model, which CMS found to be an effective way to encourage ACOs to progress more rapidly to performance-based risk. Under the redesign, CMS has replaced the Track 1, Track 2, Track 3, and Track 1+ models with two tracks, a BASIC track and an ENHANCED track. The ENHANCED track is based on the existing Track 3. The BASIC track, on the other hand, replaces the rest of the existing tracks with a model aimed at aiding ACOs in transitioning to more significant downside risk, providing them with “pathways to success.” Under the BASIC track, ACOs begin under a one-sided model and incrementally phase-in higher levels of risk that, at their highest point, would qualify as an Advanced Alternative Payment Model under the Quality Payment Program (for background on QPP see some of our earlier posts, here and here). The BASIC track provides a one-sided model available for the first two years for most eligible ACOs (some ACOs that previously participated in Track 1 are restricted to a single year, while some low revenue ACOs are allowed up to three years). Following that, ACOs can take on progressively higher risk in third through fifth years (the MSSP redesign also replaces existing three-year agreement periods with minimum five-year agreement periods). In order to allow time to transition to the new BASIC or ENHANCED tracks, CMS finalized an agreement period start date of July 1, 2019 rather than January 1, 2019. Pursuant to an earlier rule, in anticipation of changes, ACOs with agreement periods that would have ended December 31, 2018 were able to opt for a six-month extension period. In addition, in this final rule, CMS provides for ACOs in a three-year agreement period not expiring in 2018 the ability to voluntarily terminate existing participation agreements and enter a new agreement period starting July 1, 2019 under one of the new tracks (prior to this change, ACOs would have faced a “sit out” period after termination). For ACOs entering into agreements with a July 1, 2019 start date, there will be an initial, six-month performance year through December 31, 2019, with five additional performance years to follow. The Notice of Intent to Apply for the ACO agreement period with a July 1, 2019 start date is available through January 18, 2019. As of this blog posting, CMS has yet to finalize the rest of the application timeline for the July 1, 2019 start date. Information on the timeline is available here. There are many other pieces to the final rule. Some highlights include: Updates to repayment mechanisms for two-sided model ACOs; Revisions to MSSP’s benchmarking methodology; Integrity-focused changes, including modifying review criteria for ACOs, providing additional termination options for CMS in ACO participation agreements, and revising consequences for agreement termination; A number of changes aimed at promoting innovation through regulatory flexibility, including annual choice of beneficiary-assignment methodology for ACOs, expanding the use of telehealth in ACOs, and expanding SNF 3-day rule waiver eligibility; and Changes aimed at promoting beneficiary engagement, including allowing certain beneficiary incentive programs and strengthening beneficiary notification requirements (CMS is developing template notices for ACOs and ACO participants to use). CMS also sought input on allowing a beneficiary “opt-in” methodology for assignment, or possibly using a hybrid claims-based and opt-in approach, but it continues to consider comments on this issue and did not finalize an opt-in based methodology in this rule. A CMS fact sheet including additional information on the highlights noted above can be found here. Overall, in its comments regarding the final rule, CMS expressed confidence that two-sided ACO models remain a viable, and promising, option for achieving savings in Medicare while also promoting greater quality in care. Through its final rule, CMS aimed to provide ACOs and ACO participants with new “pathways to success” in realizing these goals of the MSSP. Only time will tell if ACOs are able to successfully navigate these new pathways. In any event, the overhaul will begin affecting MSSP ACOs as early as July of 2019.
January 11, 2019
MACRA
OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement
On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction arrangement (the “Arrangement) between a medical center (“Medical Center”) and designated surgeons. The Arrangement called for the Medical Center to share with the designated surgeons a percentage of the Medical Center’s cost savings as a result of the cost-reduction measures agreed to by the parties. This advisory opinion is the first gainsharing advisory opinion issued since the passage of the Medicare Access and CHIP Reauthorization Act (“MACRA”) in 2015. MACRA clarified that the Gainsharing CMP was only violated if the payment to the physician is for the purpose of reducing medically necessary services. However, the clarification under MACRA does not appear to have changed the OIG’s analysis significantly. Gainsharing arrangements have long been considered suspicious by the OIG; although numerous gainsharing arrangements had been reviewed in OIG Advisory Opinions, and have been found to contain enough mitigating factors to not warrant sanctions. The OIG has analyzed these arrangements under the Gainsharing CMP and the Anti-kickback Statute, and has expressed concern that gainsharing arrangements could result in: (i) stinting on patient care; (ii) cherry picking healthy patients and steering sicker (and more costly) patients to hospitals that do not offer such arrangements; (iii) payments to induce patient referrals; and (iv) unfair competition among hospitals that offer incentive compensation programs in order to foster physician loyalty to attract more referrals. This advisory opinion joins the list of previous advisory opinions in which the OIG has analyzed detailed facts and circumstances about a proposed gainsharing arrangement with physicians, and has approved the arrangement because it included certain criteria for minimizing the risk of fraud and abuse. Advisory Opinion 17-09 is helpful to hospitals and physicians that are interesting in entering into gainsharing arrangements because it provides recent insight into the OIG’s perspective on the important factors to include in these arrangements. The Gainsharing CMP prohibits a hospital from knowingly making payments, directly or indirectly, to a physician to induce the physician to reduce or limit medically necessary services to Medicare and Medicaid beneficiaries who are under the physician’s direct care. The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Here, Advisory Opinion 17-09 addresses an Arrangement between a Medical Center and spine surgeons (“Neurosurgeons”) who are part of a larger multi-specialty physician group (“Group”). In order to participate in the Arrangement, physicians have to be in the Group and be a Neurosurgeon. In total, four physicians were identified as eligible for participation in the Arrangement. All of the Neurosurgeons have medical staff privileges at the Medical Center and all of the Medical Center’s spinal surgeries are performed by the Neurosurgeons. In an effort to reduce costs, a subsidiary of the Medical Center (the “Program Administrator”) conducted a historical practices study of spinal fusion surgeries performed by the Neurosurgeons and identified 34 cost-saving opportunities; including things such as using product standardization. Under the Arrangement, the Medical Center will pay the Neurosurgeons a share of the three-years of cost-savings attributed to the changes the Neurosurgeons make when selecting products to use during the spinal fusion surgeries, among other cost-savings measures. The payment will be distributed to the Neurosurgeons on a per capita basis and the amount allocated to each Neurosurgeon will be subject to a long-standing, pre-existing provision in the Group’s operating agreement that requires the Group to withhold a percentage of collections earned by all physicians for their personally performed services to fund the Group’s administrative and recruitment expenses. The Arrangement includes safeguards such as monitoring and documentation requirements, which are intended to maintain quality of care and protect against inappropriate reduction in services to patients. The parties certified that the cost-savings recommendations will not reduce or limit medically necessary services for patients. Anti-Kickback Analysis: In reaching a favorable opinion, the OIG specifically noted the following safeguards are present in the Arrangement which limit the risk under the Anti-Kickback Statute that the payments to the Neurosurgeons would induce or reward referrals or attract referring physicians: (1) the payment of the cost savings on a per capita (as opposed to an individual) basis reduces the risk the Arrangement creates for any one Neurosurgeon to generate disproportionate cost savings; (2) the potential savings are capped based on the number of spinal fusion surgeries performed by the Neurosurgeons on Federal health care program beneficiaries in the relevant base year, thus limiting the Neurosurgeons’ incentives to increase their referrals to the Medical Center; (3) the aggregate payment to the Neurosurgeons will not exceed 50 percent of the projected cost savings estimated at the beginning of the term of the Arrangement, which reduces the risk of incentivizing referrals; (4) the Program Administrator collects and reviews data on patient severity, age, and payor of the spinal surgeries to confirm historically consistent selection of patients, to prevent data-skewing based on selecting healthier patients; (5) the group of Neurosurgeons retains the portion of the savings, rather than the individual physicians, and the amount retained must be used exclusively for the group’s long-standing formula set forth in their governance documents related to payment of administrative and recruitment expenses, which reduces the risk of inducing or rewarding referrals from non-participating physicians or any particular physician; (6) an annual rebasing method removes savings from prior years and ensures that the performance year savings are calculated only as compared to the most recent base year therefore preventing improper duplicate payments that could constitute unlawful kickbacks; (7) evidence-based medical reviews were completed in order to establish clinical guidelines and evaluations related to the recommended cost-saving measures. Following these reviews, the Requester certified that the recommendations may require additional training for the Neurosurgeons, or changes in their clinical practices/processes, which provided support for the compensation to the Neurosurgeons; (8) the Arrangement ties the incentives to the actual, verifiable cost savings attributable to each recommendation implemented during spinal fusion surgeries, which creates transparency that reduces the risk of the Medical Center accounts being manipulated to “game the system”; (9) Neurosurgeons continue to make patient-by-patient determinations as to the most appropriate device or supply and continue to have access to the same selection of devices and supplies that they had prior to the Arrangement; and (10) no neurosurgeons from other physician groups participate in the Arrangement, thus the risk is reduced that the Medical Center would use the Arrangement to attract others from competitor hospitals to perform surgeries at the Medical Center. Gainsharing CMP: With respect to its analysis of the Arrangement under the Gainsharing CMP, the OIG stated that it relied on the truthfulness of the Requestor’s certification that none of the cost-saving recommendations in the Arrangement will reduce or limit medically necessary services for patients, and that the Program Administrator monitors any changes in cost, resource utilization or quality of patient care; and reports quarterly to a Program Oversight Committee, which is comprised of representatives from the Medical Center, an administrative subsidiary of the Medical Center, the Program Administrator and the Neurosurgeons. The OIG would not opine on whether the recommended cost-saving measures would reduce only non-medically necessary services, but the OIG did evaluate the Requestor’s methodology for developing the recommendations, monitoring safeguards and calculating the savings, and the OIG concluded the methodology was reasonable. The OIG concluded that together, the reasonableness of the methodology and the certifications from the Requestor reduced the risk appropriately that the payments to the Neurosurgeons would limit/reduce medically necessary services to Medicare and Medicaid patients. For more information about gainsharing arrangements, contact your Dorsey & Whitney attorney.
January 22, 2018

