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Troy Barsky is a partner in Crowell & Moring's Washington, D.C. office and a member of the firm's Health Care Group, where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels all types of health care entities, including hospitals, group practices, and health plans on the physician self-referral law (Stark Law) and the Anti-Kickback Statute, innovative healthcare delivery models, such as Accountable Care Organizations (ACOs), and Medicare & Medicaid payment and coverage policy. He also defends clients seeking resolution of government health care program overpayment issues or fraud and abuse matters through self-disclosures and negotiated settlements with the U.S. Department of Justice, U.S. Health & Human Services Office of the Inspector General and the Centers for Medicare & Medicaid Services (CMS).

On November 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) filed the pre-publication version of the CY 2019 Physician Fee Schedule Final Rule (“2019 PFS Final Rule”). Within this massive publication, CMS finalized two regulatory changes affecting the exceptions at 42 CFR § 411.357 to the Physician Self-Referral Law (also known as the “Stark Law”) for compensation arrangements. The 2019 PFS Final Rule reconciles the regulations with the statutory changes made to the Stark Law enacted by the Bipartisan Budget Act of 2018 (“2018 BBA”) with respect to (1) how arrangements may fulfill the “writing” requirement under the compensation exception and (2) how arrangements that initially proceed without a signed agreement may still meet the signature requirement of an applicable exception. Parties to financial arrangements in effect on or after February 9, 2018 that implicate the Stark Law may rely upon these new modifications.

The Stark Law generally prohibits a physician from making a referral of designated health services (“DHS”) to an entity with which he or she (or an immediate family member) has a financial relationship. Section 411.357 details several excepted compensation arrangements carved out from the “financial relationship” definition for the purposes of the Stark Law. These exceptions include arrangements for the rental of office space and equipment, bona fide employment relationships, group practice arrangements with hospitals, certain fair-market-value compensation arrangements, among others. Continue Reading 2019 Physician Fee Schedule Rule Modifies Stark Regulations to Reflect Statutory Changes

In an Interim Final Rule with Comment Period (IFC) published on March 21, 2017, CMS provided that implementation of the EPMs for cardiac and orthopedic care improvement, the cardiac rehabilitation incentive payment model, and the changes to the Comprehensive Care for Joint Replacement (CJR) model would be delayed from July 1, 2017 to October 1, 2017.

The final rules being delayed were published on January 3, 2017 by the outgoing administration. The EPM rules call for mandatory participation by hospitals within certain geographical areas—a feature that drew criticism from current Secretary of Health and Human Services Secretary Tom Price, among others.

Further changes or additional delays to the EPMs may be forthcoming. The IFC indicates that the implementation “delay is necessary to allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment rulemaking to modify the policy if modifications are warranted, and to ensure that in such a case participants have a clear understanding of the governing rules . . . .” The delay may be designed to afford time for the development and promulgation of substantive changes to the models.

The IFC also specifically requests “comment on a longer delay of the applicability (model start) date, including to January 1, 2018 . . . .” CMS notes that the delay from July 1 to October 1 would leave performance year 2017 uncommonly short at only three months. This express invitation for comments suggests that CMS is at least open to—and likely is already considering—the possibility of further delay.

Comments on the delay are due to CMS by April 19, 2017.

On November 28, 2016, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an unfavorable advisory opinion (No. 16-12) that addresses the permissibility, under the federal Anti-Kickback Statute (AKS), of a laboratory’s proposal to label test tubes and collect specimen containers at no cost to, and for the benefit of, dialysis facilities. The OIG found that the arrangement may violate the AKS, potentially subjecting the laboratory to civil monetary penalties and exclusion from Medicare.

The laboratory in question provides testing services to dialysis patients pursuant to service contracts with dialysis facilities. Testing services provided by the laboratory are reimbursed by Medicare. Under the proposed arrangement, the laboratory would provide some of the dialysis facilities with free labeling services; the laboratory would label test tubes and specimen collection containers that would later be used by those dialysis facilities when sending specimens to the laboratory for testing. These labeling services would be provided to the dialysis facilities at no cost.

The OIG analyzed the applicability of the personal services and management contracts AKS safe harbor and found that the safe harbor would not apply. The safe harbor requires that the compensation paid for services be consistent with fair market value in an arms-length transaction. In the proposed arrangement, however, the dialysis facilities would not pay any compensation to the laboratory for the labeling services despite the value of those services to the dialysis facilities. As a result, the OIG determined that the proposed arrangement is inconsistent with fair market value, rendering the safe harbor inapplicable.

Under a factual analysis, the OIG found that the laboratory’s provision of services to dialysis facilities at no cost would be a tangible benefit to the dialysis facilities. The advisory opinion states that from such arrangements, an inference arises that the service is offered to induce the referral of business. In addition, an inference arises that the free labeling services would be intended to influence the dialysis facilities’ selection of a laboratory – an inference supported by the representation by the laboratory that the labeling services would be offered when necessary to retain or obtain business from dialysis facilities.

Interestingly, the same laboratory sought an advisory opinion of a factually identical arrangement in 2008 (No. 08-06) at a time when Medicare employed a composite rate reimbursement system for laboratory testing services. At that time, the OIG issued an unfavorable advisory opinion of the arrangement. Medicare now employs a bundled payment system in which all laboratory tests related to end-stage renal disease (ESRD) are reimbursed as part of the ESRD prospective payment system bundle (ESRD PPS). Reviewing the arrangement under the ESRD PPS, the 2016 advisory opinion found that OIG’s previous analysis of the arrangement applies, particularly since physicians are currently able to order separate laboratory tests unrelated to a patient’s ESRD. Due to this fact, the labeling services may constitute prohibited remuneration intended to induce or reward referrals for services reimbursed by Medicare. The arrangement viewed under both the composite rate reimbursement system and the ESRD PPS raise AKS concerns.

The AKS risk may be lessened in circumstances where laboratories bill for fewer separately reimbursable tests; however, the offering of such free services remains a concern. This advisory opinion highlights challenges laboratories may face in providing free services to entities with which they contract. As payment models shift toward bundled payments and value-based care, it remains important for providers to consider fraud and abuse risks that may arise.

On December 14, 2016, CMS issued an interim final rule with comment period to amend Medicare’s dialysis facility conditions for coverage to require certain disclosures to patients and health insurance issuers to address widespread concerns over inappropriate steerage of dialysis patients to individual market plans. After issuing an RFI about “inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans” by third parties in August 2016, CMS decided to focus on dialysis providers given the “overwhelming majority of comments [received in response to the RFI] focused on patients with [end-stage renal disease (ESRD)]” and “the high costs and absolute necessity of transplantation or dialysis” for people with ESRD.

CMS explained that reimbursement rates for dialysis and other ESRD treatment are “tens or even hundreds of thousands of dollars more per patient when patients enroll in individual market coverage rather than public coverage.” As such, providers have strong incentives to steer patients to private coverage and pay a few thousand dollars in premiums on their behalf. But doing so places patients at substantial health and financial risk. As CMS noted, third-party payment of premiums to enroll a patient in individual market coverage may interfere with transplant readiness, expose the patient to substantial financial harm for services beyond dialysis, and may result in mid-year coverage disruption.

To address these concerns, the interim final rule requires Medicare-certified dialysis facilities to disclose the array of costs and coverage options available to a patient, including the availability of Medicaid, Medicare ESRD coverage, and individual market plans, and to ensure that health insurance issuers are aware of and willing to accept a third-party’s payment of premiums on behalf of the patient. As summarized by the CMS Fact Sheet, providers must:

  • Make up-front disclosures to patients regarding their health insurance coverage options, including information about available individual market plans, Medicaid or Children’s Health Insurance Program (CHIP) coverage, and available options and costs of Medicare ESRD coverage.
  • Provide a summary of short- and long-term cost estimates of various health coverage options for patients and information on enrollment periods for those health coverage options.
  • Inform issuers of the individual market plans for which they make payments of premiums for individual market plans.
  • Receive assurance from the issuer that it will accept these payment of premiums for individual market plans for the duration of the plan year, or else not make such payments.

The interim final rule does not preclude providers from making charitable donations that support access to health care. CMS also noted that it remains concerned about third-party payment of premiums for persons who are eligible for public coverage, such as Medicaid or Medicare, and is considering whether to issue a blanket prohibition on third-party payment of premiums for such persons. CMS has solicited comments on this and alternative approaches, such as whether to allow third-party payments upon a showing that it was in the individual patient’s best interest. The comment period for the interim final rule closes on January 11, 2017 and the rule is effective on January 13, 2017.

On August 18, 2016, CMS issued a request for information on “inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans” by third parties. CMS voiced concern over “anecdotal reports” that Medicaid or Medicare eligibles received premium and cost-sharing assistance from third parties so they could enroll in Marketplace plans, enabling providers to receive higher reimbursement rates. In November 2013, CMS had issued guidance discouraging third-party payment of premiums because it has the propensity to “skew the insurance risk pool and create an unlevel field in the Marketplaces.” Almost three years later, it appears that CMS has determined that more decisive action may be necessary.

In July, UnitedHealthcare filed suit against American Renal Associates LLC in the United States District Court for the Southern District of Florida (complaint), alleging ARA violated Florida’s deceptive and unfair trade practices act, fraud, unjust enrichment, conspiracy, and other causes of action. The suit alleges that ARA coordinated with the American Kidney Foundation to pay premiums of low-income enrollees to switch from government health care programs to private insurance coverage. The suit alleges that by steering enrollees from Medicaid and Medicare to private insurance, ARA was able to increase billing from about $300 to $4,000 for the same services. The complaint also alleges that ARA did not collect copayments or deductibles from the enrollees after covering their premiums for private insurance and so committed negligent misrepresentation and tortious interference with a contract by misrepresenting the charges of claims submitted to UnitedHealthcare.

Continue Reading CMS Renews Focus on Third-Party Payment of Insurance Premiums Steering Medicaid & Medicare Eligibles into Marketplace Plans

The Medicaid Managed Care Final Rule aims to align Medicaid regulations with those of other health coverage programs, modernizing the post-Affordable Care Act healthcare landscape. Among other goals, the Final Rule seeks to bolster the transparency, accountability, and integrity of Medicaid managed care by imposing and clarifying requirements meant to reduce fraud, waste, and abuse. The rule finalizes a number of changes that address two types of program integrity risks: fraud committed by Medicaid managed care plans and fraud by network providers. It also tightens standards for managed care organization (MCO) submission of certified data, information, and documentation used for program integrity oversight by state and federal agencies.

First, the Final Rule places new responsibilities on both states and managed care plans. State Medicaid programs will now be required to screen and enroll all network providers that order, refer, or furnish services to beneficiaries under the state plan unless a network provider is otherwise enrolled with the state to provide services to fee-for-service (FFS) Medicaid beneficiaries.[1] This requirement, which will take effect in July 2018, may delay the growth of provider networks; to address this concern the Final Rule allows programs to execute network provider agreements pending the outcome of the screening process of up to 120 days. However, upon notification from the state that a provider’s enrollment has been denied or terminated, or the expiration of the 120 day period without enrollment, the plan must terminate the network provider immediately and notify affected enrollees. In addition, the Final Rule requires states to periodically, but no less frequently than once every 3 years, audit patient encounter data and financial reports for accuracy, truthfulness, and completeness. States must also post on their website or otherwise publicize a range of programmatic data, including the results of past audits and information related to entity contracts.[2]

Second, beginning July 2017, managed care plans will also have to submit and certify a range of data—including data related to rate setting, compliance with Medical Loss Ratio (MLR) standards, accessibility of services, and recoveries of overpayments—to their respective states. In order to comply with this requirement, the Final Rules permits the executive leadership of an MCO to delegate the certification to an employee who reports directly to the plan’s CEO or CFO.[3]

Continue Reading Medicaid Managed Care Final Rule: Prevention of Fraud, Waste, and Abuse

On Tuesday July 12, 2016, the Senate Finance Committee (“Committee”) will hold a hearing on “Examining the Stark Law: Current Issues and Opportunities.” Crowell & Moring Partner Troy Barsky will be testifying before the Committee as a Stark Law subject matter authority.

In advance of this hearing, the Committee released last week the white paper “Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models.”  Amid growing support for Stark law reform, the white paper deems the Stark law, as currently drafted, both an impediment to implementing health care reform, e.g., the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), and of limited value given shifts from fee-for-service to alternative payment models that reward quality health care rather than the volume of services.

The white paper focuses predominantly on modifications to the Stark law that would remove obstacles to implementing health care reform. After a roundtable held in December, 2015, that was co-moderated by Troy Barsky, the Committee had solicited and received a range of stakeholder comments that proposed various Stark law reform solutions: repeal the law in its entirety; repeal the compensation arrangement prohibitions; implement new exceptions and modify existing exceptions; implement new or expand existing waivers; and expand CMS’s regulatory authority pertaining to waivers, exceptions, and advisory opinions. These comments are catalogued and discussed throughout the white paper. The white paper also examined the need to distinguish between technical, e.g. documentation requirements, and substantive violations of the Stark law.  Commenters generally agreed that a separate set of sanctions should apply to technical violations and that such violations should not give rise to False Claims Act exposure.

Continue Reading In Advance of Senate Finance Committee Hearing on Stark Law Next Week, the Committee Releases Stark Law White Paper

The Office of the Inspector General of the Department of Health and Human Services (OIG) last week replaced a 20-year old policy statement, and issued guidance on the criteria the agency will use to evaluate whether to exclude certain individuals and entities from billing or “participation in” Federal health programs under its permissive exclusion authority. The new guidelines supersede and replace the OIG’s December 24, 1997 policy statement and set forth “non-binding” criteria that the OIG may consider in exercising this authority under circumstances involving fraud, kickbacks and other prohibited conduct. The newly-memorialized policy is yet another effort by the agency to encourage healthcare providers to implement robust compliance mechanisms that can timely identify and voluntarily self-disclose to the government any unlawful conduct.

Under Sections 1128(b)(1)-(b)(15) of the Social Security Act (the “Act”), the Secretary, by delegation to the OIG, has discretion to exclude individuals and entities based on a number of grounds. This so-called “permissive exclusion” authority grants significant discretion to the OIG.  The new policy provides guidelines for permissive exclusions that are based on Section 1128(b)(7) of the Act, which permits the OIG to exclude persons from participation in any Federal health care program if the OIG determines that the individual or the entity has engages in fraud, kickbacks and other prohibited activities.

Continue Reading OIG Updates Policy on Permissive Exclusions Based On Fraud and Kickbacks

On April 8, 2016, the IRS released a private letter ruling denying tax-exempt status under Code section 501(c)(3) to an accountable care organization (“ACO”) that was not participating in the Medicare Shared Savings Program (“MSSP”).  PLR 201615022 (the “2016 PLR”) is the IRS’s first public written guidance on the tax-exempt status of ACO activities since 2011.

Since the MSSP became operational in 2012, it has been supported by a multi-agency effort to provide participants’ assurance that the application of existing laws and regulations governing tax-exempt status and permissible practices under the fraud and abuse laws would not be used against them. Recently, there has been increasing debate about whether the protected status that federal agencies have provided MSSP participants should also apply to ACOs in the private sector.  In fact, the Centers for Medicare & Medicaid Services and the Department of Health & Human Services’ Office of the Inspector General addressed this issue in their joint issuance of the final rule discussing the waivers of fraud and abuse laws for MSSP ACO arrangements in October 2015.  Now, with the 2016 PLR, the IRS has added its own views on the outer limits of protections for tax-exempt entities that create ACOs outside the MSSP.

Continue Reading IRS Denies Tax-Exempt Status to Non-MSSP ACO

This month, the Centers for Medicare & Medicaid Services (CMS) announced the beginning of the second application cycle for its Next Generation ACO Model (Next Gen Model).  We discussed the goals of the Next Gen Model and how it compares to the Medicare Shared Savings Program and Pioneer ACO models in this post from last year.

The Next Gen Model, along with other value-based payment initiatives being run by CMS, advances the goals of the Affordable Care Act by moving providers away from fee-for-service reimbursement models. Since CMS began implementing its ACO-based initiatives in 2012, over 477 ACOs nationwide have partnered with the agency to test the theory that coordinated care provide higher quality at a lower cost for beneficiaries.

Twenty-one ACOs are currently participating in the Next Gen Model – more than the 15-20 CMS anticipated accepting. Like last year, the Centers for Medicare & Medicaid Innovation (“CMMI”) is holding a series of Open Door Forums to explain key aspects of the Next Gen Model on the following dates:

ACOs (including MSSP participants and Pioneer ACOs) have until May 2, 2015 to submit a Letter of Intent (LOI) using CMS’s designated portal.  Applicants must electronically complete the narrative portion of the Next Gen Model application by May 25, 2016 and submit their participating provider lists and geographic service areas no later than June 3, 2016.

This will be the final year for ACOs to participate in the Next Gen Model. It is hard to predict what will happen to the Medicare payment reforms tested in the Next Gen Model and other ACA-related programs as the United States enters into a new administration after the 2016 elections, but CMS is currently staying the course to reduce health care costs while improving quality.