Electronic health record (EHR) vendor Allscripts recently disclosed on an earnings call that it has reached a tentative agreement with the Department of Justice (DOJ) to pay $145 million to settle an investigation into the regulatory compliance of one of its recent acquisitions, Practice Fusion. This news, combined with DOJ’s other recent successful enforcement actions against EHR companies, represents a trend and should be a warning that compliance is a priority when it comes health IT. We anticipate that there will be more Anti-Kickback, HIPAA, and False Claims Act cases against similar health IT targets in the pipeline.

Allscripts acquired Practice Fusion, also an electronic health record company, in February 2018. According to the company’s public SEC filing from the first quarter of 2019, the investigation “relates to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA.”

Continue Reading Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

The Centers for Medicare and Medicaid Services (“CMS”) has included proposed changes to the implementing regulations for the Physician Payments Sunshine Act (“Sunshine Act”) as part of its proposed 2020 Physician Fee Schedule. The proposed regulatory changes fundamentally expand the scope of the Sunshine Act and will require reporting entities to make substantial updates to their payment tracking policies and procedures. Entities that are required to report payment data under the Sunshine Act should review the proposed rules, submit comments, and evaluate how these proposals will affect future financial relationships with health care providers on a going-forward basis.

CMS is accepting comments on the proposed rule until September 27, 2019. If finalized, the regulatory changes to be promulgated in 42 C.F.R. Part 403 would be effective for data collected during calendar year 2021 that must be reported by March 31, 2022 .

Continue Reading Sunshine Act/Open Payments Regulatory Changes in the 2020 Physician Fee Schedule

A patient has an emergency and goes to a hospital she knows is in her plan’s network. She receives treatment. She leaves the hospital. Weeks later, she receives a medical bill for tens of thousands of dollars. Unbeknownst to her, some or all of her treating doctors were out-of-network.

This all-too-common story has contributed to a significant medical debt crisis in this country, and has captured the attention of policymakers on all sides of the political spectrum—leading to the rare circumstance of executive and legislative alignment and the potential for bipartisan legislative action.

Proponents of price transparency hope that it will improve competition and allow patients to better understand their financial responsibility ahead of receiving services. The idea is that disclosing prices to individuals will incentivize them to “shop around” for health care services, which may drive down costs. On the other hand, opponents of price transparency argue that releasing such information could compromise bargaining leverage between third party payers and providers, and have the effect of driving up prices since information exchanges in concentrated markets can lead to tacit coordination that’s difficult to detect and punish under the antitrust laws.

Continue Reading Trump Administration and Congress Are Moving Quickly on Health Care Price Transparency and Lowering Costs

In a victory for the Trump Administration, on July 18, 2019, the United States District Court for the District of Columbia upheld a 2018 regulation designed to expand the sale of short-term, limited duration insurance policies and rejected claims that the regulation unlawfully undermined the Affordable Care Act (“ACA”) and would destabilize the ACA marketplaces. Plaintiffs have indicated that they will appeal the decision.

Short-term, limited duration insurance policies are not required to comply with ACA protections, including those relating to essential health benefits like maternity care and prescription drugs. Originally designed to fill very short gaps in coverage, these types of plans were not included in the definition of individual health insurance under the ACA. These short term policies can be designed with high out-of-pocket maximums, low coverage caps, and significant benefit gaps. They can also deny coverage to those with pre-existing conditions. For these reasons, these policies can be marketed at a lower cost. Plaintiffs representing insurers, providers, and consumer groups sued the administration arguing that the availability of short term plans would draw away younger and healthier individuals from risk pools and put insurers at an unfair disadvantage by forcing them to compete with short term plans that would not be required to comply with the same ACA protections.

Continue Reading Court Upholds Short-Term, Limited Duration Insurance Policy Rule

The HHS Office of Civil Rights (“OCR”) closed out the month of April with some updates to HIPAA civil monetary penalty (“CMP”) limits and clarifications to OCR’s stance on the Privacy Rule’s application to transfers of electronic protected health information (“ePHI”) to third-party applications and application programming interfaces (“APIs”).

Differential CMP Caps Based on Enforcement Discretion

Under the current HIPAA Enforcement Rule, HHS employs a four-tier level of culpability scale in line with the HITECH Act. These four tiers correspond to appropriate CMPs ranges for violations by covered entities and business associates of the HIPAA Privacy and Security Rules. These penalty tiers are adjusted for inflation pursuant to the cost-of-living formula set forth in the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

For instance, if a person did not know and, by exercising reasonable diligence, would not have known that the person violated the applicable HIPAA provision, the CMP range the person could be levied was $100-$50,000 for each identical violation, up to a maximum of $1.5 million for all such violations annually (before adjusted for inflation). The $1.5 million annual cap on CMPs for HIPAA violations applied across all four tiers, even though the minimum penalties for each tier increased in amount.

Since HHS began using this four-tier structure, however, there has been debate about whether the HITECH Act mandates different annual CMP caps for each of the tiers. OCR’s April 30, 2019 Federal Register Notice changes HHS’s prior position on this, and now imposes the following annual caps on CMPs for HIPAA violations:.

Continue Reading HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access

On March 27, 2019, the Centers for Medicare & Medicaid Services (CMS) announced a $1.65 million competition to accelerate development of AI solutions in health care. The Artificial Intelligence (AI) Health Outcomes challenge seeks innovative, AI-driven solutions that can predict unplanned hospital and skilled nursing facility (SNF) admissions and adverse events.

The challenge is a 1-year, three stage competition; the Launch State is open to the public and seeks to attract a wide range of ideas and solutions.

Stage 1 will be comprised of 20 participants and will focus on the development of algorithms that predict health outcomes using Medicare fee-for-service data as well as strategies for building clinician trust in the solutions. 5 participants will be awarded $80,000 and will advance to Stage 2.

Stage 2 will ask for finalists to refine their algorithm and run a number of analyses on more than 5 years of CMS claims data to demonstrate proof-of-concept. The grand prize winner will be awarded up to $1 million.

Economists have debated the use of prize systems for technological innovation. While some argue that the use of medical prize funds will lower prices and widen the availability of research results, others are skeptical of claims regarding the role of prize funds in inducing technological innovation. CMS is in a unique position to offer prizes for innovative solutions; as the country’s single largest payer for health care, it may be the one of the best entities to evaluate the efficacy of the proposals and can offer innovators with the data needed to develop their algorithms