The Department of Health and Human Services, Office of the Inspector General (OIG), modified its Work Plan to announce that the agency will be conducting a nationwide audit of hospitals that participated in the Medicare Electronic Health Records (EHR) Incentive Program (also known as the Meaningful Use Program).  The OIG review is focusing on hospitals

First 100 Days LogoOn Tuesday, April 18, 2017, our Health Care Group will hold a webinar on the health care policy and transition challenges still at play as the Trump Administration nears the end of its 100 days in power.  During the webinar, participants will hear important insights and predictions on what a Trump-led Executive Branch will mean

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

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

On August 24, 2016, Judge Edgardo Ramos of the Southern District of New York approved a settlement in which Mount Sinai Health System (Mount Sinai) will pay $2.95 million to New York and the federal government to resolve allegations that it violated the False Claims Act (FCA) by withholding Medicare and Medicaid overpayments in contravention

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.


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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]


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Barsky

Yesterday, our colleague Troy A. Barsky testified before the U.S. Senate Finance Committee led by Chairman Orrin Hatch (R-Utah) and provided recommendations for modernizing the Stark Law to regulate self-referrals without impeding the care coordination and value-based payment models promoted by health care reform legislation. Other witnesses before the Committee included Dr. Ronald A. Paulus

On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The conference provided a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The conference covered several topics including trends in the health care economy’s Internet of Things, setting up digital health platforms, legislative activity related to telehealth, and the use of digital health technology to support new payment models.

The fifth session of the conference, “New Payment Models and New Sources of Data for Care Coordination and Quality Improvement” featured John Brennan (Partner, Crowell & Moring), Dr. Elizabeth Raitz-Cowboy (Southeast Medical Director, Aetna Life Insurance Company), Barbara Ryland (Senior Counsel, Crowell & Moring), and Soph Sophocles (Associate General Counsel, Biogen).

The discussion addressed changes and themes in the wake of digital health technology and growing use of data. Key takeaways from the session:


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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.


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