In the latest episode of Payers, Providers, and Patients – Oh My!, Shelley Rosenberg talks with Joe Records and Payal Nanavati about how health care defendants can use ERISA preemption as a way to remove litigation to federal court.

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On Monday, the Office for Civil Rights (“OCR”) at the U.S. Department of Health & Human Services (“HHS”) announced an enforcement action against Bayfront Health St. Petersburg (“Bayfront”) for allegedly failing to provide a mother timely access to her unborn child’s prenatal medical records. The enforcement action is noteworthy in that it marks OCR’s first enforcement action under its Right of Access Initiative, announced earlier this year to focus more on enforcing patients’ rights to access their medical records without being overcharged.

After receiving a complaint in August 2018, OCR conducted an investigation indicating that Bayfront, a trauma and tertiary care center based in St. Petersburg, Florida, failed to provide the mother timely access to her unborn child’s fetal heart monitor records in accordance with the Health Insurance Portability and Accountability Act (“HIPAA”). HIPAA generally requires health care providers such as Bayfront to provide patients with access to their medical records, as well as those of their minor children, within 30 days of a request. HIPAA also prohibits charging more than a reasonable cost-based fee for such access.

Bayfront agreed to pay $85,000 to OCR to settle the potential HIPAA violation while not admitting to any wrongdoing. Bayfront also agreed to a corrective action plan including training, updating policies and procedures, and OCR monitoring.

This enforcement action signals a continued push from HHS to hold the health care industry accountable for giving individuals access to their health information. Earlier this year, the Office of the National Coordinator for Health Information Technology released proposed regulations on interoperability and information blocking and CMS released proposed regulations on interoperability also aimed at promoting patient access to their health information. In light of this enforcement action and regulatory activity, we recommend that covered entities carefully review their policies and procedures regarding individuals’ access to health information.

HHS’s Substance Abuse and Mental Health Services Administration (“SAMHSA”) proposed updated rules to clarify the scope of perceived barriers to sharing information regarding treatment for substance use disorders (SUDs) among providers, with research entities, and for law enforcement purposes. The proposed changes to the 42 C.F.R. Part 2 (“Part 2”) regulations appear in two Notices of Proposed Rulemaking (“NPRMs”), which are also summarized in a Fact Sheet. These proposals are part of HHS’s Regulatory Sprint to Coordinated Care, an agency-wide effort to remove regulatory obstacles to care coordination and information-sharing. HHS is anticipated to release proposed rules on HIPAA, the Physician Self-Referral Law and Anti-Kickback Statute by the end of 2019 as part of this effort as well.

The proposed Part 2 updates could have significant impacts on how health care providers, researchers, and health technology companies protect and share SUD information with each other, so interested parties should submit comments on the NPRMs before the deadlines, and prepare to submit comments in response to HHS’s other Regulatory Sprint to Coordinated Care efforts in the coming months.

Background

Continue Reading New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges

In the latest episode of Payers, Providers, and Patients – Oh My!, Troy Barsky and Alice Hall-Partyka talk with Joe Records and Payal Nanavati about how recent litigation challenging the constitutionality of the Affordable Care Act may impact providers and payers. The discussion focuses on the authority for innovative health care models and important fraud and abuse provisions that were enacted in the ACA.

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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