Affordable Care Act
Escobar in Action: Physician-owners’ fraud claims against hospital defeated in Fifth Circuit appeal for lack of materiality
Following the passage of the Affordable Care Act (“ACA”), which placed new limits on physician-owned hospitals, St. Luke’s Health System (“System”) took action to change one of its hospital’s ownership structures through a buy-out of the physicians’ partnership interests pursuant to the Texas Securities Act (“TSA”). The TSA allows rescission for the original price paid for a security, plus interest, in exchange for a release of potential liability under TSA. Three of the physician-owners, who resisted the System’s attempt to rescind their ownership interests, sued the System and other defendants in connection with the buy-out alleging state-law violations and violations of the Anti-Kickback Statute, and by extension, the False Claims Act. To read the full article, view our FCA Now blog, linked here:
December 11, 2019
by Siena Caruso
Affordable Care Act
OIG Seeks Public Input on Anti-Kickback Statute and Beneficiary Inducements CMP as part of the “Regulatory Sprint to Coordinated Care”
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements. On August 27, 2018, the OIG published a Request for Information (RFI) seeking input from industry stakeholders on how the agency could modify existing or add new safe harbors to the AKS and exceptions to the beneficiary inducements CMP definition of “remuneration” in order to “foster arrangements that would promote care coordination and advance the delivery of value-based care, while also protecting against harms caused by fraud and abuse.” The RFI describes how transforming the healthcare system into one that better pays for value is a key priority for HHS, and that HHS has launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate this transformation, with a focus of removing “unnecessary obstacles” to coordinated care. This OIG RFI is part of HHS’s Regulatory Sprint. As we described in our blog post here, the Centers for Medicare & Medicaid Services (CMS) also recently published an RFI related to reforms to the federal physician self-referral law (or “Stark Law”) as part of HHS’s Regulatory Sprint. Comments are due from stakeholders to the OIG RFI by 5 PM on October 26, 2018. Specifically, OIG is seeking input on the following topics: Promoting Care Coordination and Value-Based CareThe OIG would like information about potential arrangements that the healthcare industry is interested in pursuing, which may implicate the AKS and CMP, such as care coordination arrangements, value-based arrangements, alternative payment models, arrangements involving innovative technology and other novel financial arrangements. The OIG requests a detailed explanation of the proposed structure and terms of the arrangements, and a description of how the arrangement promotes care coordination or value-based care. The description should also include an explanation of how the proposed arrangement prevents potential harms such as increased costs, inappropriate utilization, poor quality of care and distorted decision-making. For each detailed description, the OIG requests that stakeholders describe the new or modified AKS safe harbors or exceptions to the beneficiary inducements CMP definition of “remuneration” that may be necessary in order to protect the described arrangement. The OIG is also seeking input on several key definitions that are used in the regulatory provisions related to health care delivery reform, payment reform and the AKS, such as the definition of coordinated care, care coordinator and care coordination services. Beneficiary Engagement, including Beneficiary Incentives and Beneficiary Cost-Sharing Obligations The OIG is seeking feedback on the types of incentives that providers, suppliers and others want to provide to beneficiaries. For each incentive, the OIG wants to know how providing the incentive would contribute to or improve quality of care, care coordination and patient engagement (including adherence programs). The OIG published several specific questions in the RFI such as whether beneficiary incentives connected to medication adherence and medication management should be treated differently than other types of beneficiary incentives, and if so, how and why. Further, the OIG is seeking input regarding what disclosures the offer or should be required to make to beneficiaries regarding an incentive, such as the source of the incentive, as well as input regarding the risks and benefits related to certain types of incentives such as cash equivalents, gift cards, in-kind items and services, and non-monetary remuneration. Additionally, the OIG is also seeking input on whether the “nominal value” threshold under the CMP should be increased from $15 per item and $75 in the aggregate per patient on an annual basis, whether a similar nominal value “policy” should be applied to the AKS, and if so, how such policy would contribute to care coordination or value-based care. The OIG is also requesting information about how reducing or eliminating patient cost-sharing obligations might improve care delivery and promote quality of care. Other Related Topics of Interest The OIG is seeking feedback on a number of related topics of interest. These include: (a) current fraud and abuse waivers developed for purposes of carrying out the Medicare Shared Savings Program; (b) donated or subsidized cybersecurity-related items and services; and (c) new exceptions under the Bipartisan Budget Act of 2018 related to (i) incentive payments under the ACO Beneficiary Incentive Program and (ii) telehealth technologies. The Intersection of the Stark Law and the AKSFinally, the OIG would like feedback regarding circumstances in which Stark Law exceptions and AKS safe harbors should align for purposes of the goals of the RFI and circumstances in which Stark Law exceptions related to care coordination/value-based care should not have a corresponding AKS safe harbor. The OIG noted that, where relevant, it intends to review comments submitted in response to the CMS RFI related to the Stark Law (described above), but that it urges commenters to resubmit any relevant comments to the OIG RFI to ensure that they are considered by the OIG, given the volume of questions included in the CMS RFI and the separate authorities of the OIG and CMS. Please contact the authors or your regular attorney at Dorsey & Whitney if you want more information about the RFI process or desire to submit comments to the RFI by the October 26, 2018 deadline.
August 28, 2018
by Alissa Smith and Laura B. Morgan
Affordable Care Act
CMS Proposes Affordable Care Act Exchange, Individual, and Small Group Insurance Market Changes
Not relying on Congress to take action on the Affordable Care Act, the Centers for Medicare and Medicaid Services (“CMS”) has proposed new regulations intended to attract health insurance issuers back into ACA health insurance exchanges and stabilize the individual and small group insurance markets. On February 17, 2017 CMS proposed a set of modifications to regulations promulgated pursuant to The Patient Protection and Affordable Care Act (Pub. L. 111-148) and The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), collectively known as the “Affordable Care Act” or “ACA.” A primary goal of the proposals is to improve the insurance risk pool in the ACA exchanges, individual, and small group markets by promoting continuous health insurance coverage and reducing incentives for individuals to enroll in health insurance plans only when they require services. For example, the proposed rule would allow CMS to verify that individuals seeking to enroll in the Exchanges within a special enrollment period (i.e., outside of the annual open enrollment period) are eligible for special enrollment. Current CMS policy allows individuals to self-attest that they meet special enrollment period eligibility requirements and enroll without further verification. The proposed rule would also reduce the annual Exchange open enrollment period for 2018 so that it begins November 1, 2017 and ends December 15, 2017 (current regulations have the 2018 plan year enrollment period lasting until January 1, 2018). CMS states that the 15 day enrollment period reduction may have a positive impact on the Exchange risk pool by reducing the adverse impact of enrolling individuals who learn they will need services in late December. Another proposal aimed at promoting continuous insurance coverage (rather than enrollment when services are needed) is to permit insurance issuers to attribute an individual’s premium payment for new coverage to any debt the individual owes for premium non-payment for coverage from the same issuer within the prior 12 months. The issuer would be permitted to deny enrollment for the new coverage and apply payment to the past debt. Regulations at 45 C.F.R. § 147.104 state that issuers must guarantee availability of coverage to individuals and employers, and current interpretation of that regulation allows an individual to avoid premium payment for current coverage at the end of a plan year, yet obtain new coverage from the same issuer so long as one month’s premium is paid at the beginning of the plan year. CMS also proposes to increase the flexibility issuers have to design health plans that meet the Affordable Care Act’s required coverage level. Under the proposal, health plans that have an actuarial value ranging from -4 to + 2 percentage points from the required actuarial value of health coverage would be considered a de minimis variation, and would meet the individual and small group market standard. Current regulations allow a variation of -2 to +2 percentage points. CMS proposes that the States review the adequacy of an issuer’s provider network, rather than requiring issuers to comply with CMS network adequacy guidance. Where a State does not have a sufficient network adequacy review process, CMS would rely on an issuer’s accreditation from the National Committee for Quality Assurance, URAC, or the Accreditation Association for Ambulatory Health Care as a network adequacy review. Lastly, the proposal would reduce by 10% the minimum percentage of Essential Community Providers (providers that serve predominantly low-income and medically underserved individuals) in a plan service area that an issuer must include in its network, and would allow greater flexibility to identify Essential Community Providers. Whether these proposals are finalized and are enough to attract health insurance issuers back to the Exchange marketplace remains to be seen. And legislation to repeal or significantly modify the ACA could make the latest CMS proposals moot. Nonetheless, CMS is not assuming the ACA Exchanges will disappear, and appears to be moving forward with efforts to stabilize the Exchanges and individual and small group markets. A copy of the proposed rule is available here: https://www.gpo.gov/fdsys/pkg/FR-2017-02-17/pdf/2017-03027.pdf
February 23, 2017
by Ross C. D'Emanuele
Affordable Care Act
One In - Two Out and Healthcare Regulation
President Trump signed an executive order (the “Order”) on January 30th, 2017 aiming to reduce bureaucracy by requiring agencies to remove two regulations for every one new regulation they implement. The cost of any new regulation should be offset by the elimination of these other two previously issued regulations. The Order could have major consequences in the healthcare industry but the changes it may bring are at this point unpredictable. Some in the healthcare field welcomed the “one in, two out” idea. Rules and regulations in the healthcare world come from several agencies and cover a broad array of practices. 2016 brought several including the Nondiscrimination in Health Programs and Activities Rule, which expands on nondiscrimination requirements found in Section 1557 of the Affordable Care Act, and regulations to implement the Medicare Access and CHIP Reauthorization Act (MACRA) physician payment system, among others. The Order has also brought about confusion. First, the Order left the future uncertain as to what may happen with these most recent regulations and the many other regulations that have helped shape the healthcare industry. While regulations have costs associated with them, regulated entities have already invested in compliance, and will now have to pay close attention as requirements may shift in this upcoming year. Second, it is unclear how the Order may affect any Medicare and other health care payment system regulations, including MACRA, which may involve costs to implement, but are ultimately designed to streamline CMS payment systems. Finally, the Order is vague and may turn out to have no effect on the healthcare industry at all. The executive Order allows the Office of Management and Budget (“OMB”) director the flexibility to interpret and carry out the Order, which could mean the Order will change nothing at all with regard to healthcare regulation. A few days following the Executive Order, a Memorandum offering interim guidance on the Order was released. This clarifies that the Order applies only to “significant regulatory actions” as defined in Section 3(f) of a separate Executive Order. In addition, it only applies to those regulations released between January 20th and September 30th of 2017. Federal spending rules that cause income transfers from taxpayers to program beneficiaries, for example Medicare spending, are not covered by this Order. It appears, then, that the Centers for Medicare and Medicaid Services (“CMS”) may not need to adhere to the “one in, two out” framework when promulgated annual rulemakings for Medicare payment for hospital inpatient, hospital outpatient, and physician and other Medicare Part B services. In addition, the Memorandum stated that agency guidance or interpretive documents that are not formal rulemakings may or may not be covered by the Order; OMB will address these guidance documents on a case by case basis. Purely deregulatory actions that confer only savings will not trigger the Order, but if there are costs associated with the rulemaking the agency will need to offset those costs. The “one in, two out” idea is simple and attractive, from a regulatory burden perspective. However, the healthcare industry and its regulation involve complex systems with numerous stakeholders, and a variety of perspectives from which one could view the cost burden of regulations. How the Order will be implemented and the magnitude of its impact on health care regulation is at this point unpredictable, and ultimately will be in the discretion of the Executive Office of the President.
February 20, 2017
by Grace Fleming
Affordable Care Act
The Affordable Care Act in the Trump Administration
One of President Trump’s first actions in office was to sign an Executive Order stating that his Administration will seek to repeal the Affordable Care Act (the “Act”). In the meantime, President Trump directed the executive branch to take “all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the Act, and prepare to afford the States more flexibility and control to create a more free and open healthcare market.” The Order directs the Secretary of HHS and the heads of other executive departments and agencies with authority under the Act to have all “authority and discretion” to waive, defer, grant exemptions from or delay implementing any provisions of the Act that would impose a fiscal burden on a State, individual, health care provider, health insurer, medical device maker, etc. The Order states that the heads of applicable departments and agencies shall encourage the free and open market to preserve maximum options for patients and consumers. To the extent any rulemaking is needed to carry out the directives in the Order, the heads of agencies are directed to follow through with notice and comment rulemaking. The Executive Order regarding agency actions pending the Act’s repeal is in today’s federal register, and can be found here: https://www.federalregister.gov/documents/2017/01/24/2017-01799/minimizing-the-economic-burden-of-the-patient-protection-and-affordable-care-act-pending-repeal. There are a large number of regulations that could be impacted in a short time frame. It is unclear whether and what agency action would be taken at the present when there is not yet in place an alternative system to the Affordable Care Act. Dorsey attorneys will be closely following the changes to the Affordable Care Act and will provide updates as developments unfold.
January 24, 2017
by Alissa Smith and Ross C. D'Emanuele