On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.) Continue Reading Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency
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 that received Medicare EHR incentive payments between January 1, 2011 and December 31, 2016.
The OIG’s modification to its Work Plan follows last month’s report that CMS improperly paid an estimated $729 million in Medicare EHR incentives. In our prior client alert, we flagged these findings as a potential area for significant overpayment recovery actions and noted that such actions could pose risks for incentive payment recipients. Read our entire client alert on the OIG’s nationwide audit on hospitals that participated in the EHR Incentive Program Here.
On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language – to help facilitate the contracting process. While the guidance is largely an attempt to level the playing field for providers in the EHR arena, it also has broader applicability to contract negotiations for a variety of other digital health tools.
For the most critical “need-to-know” points from ONC’s new guidance, see our recent client alert.
The HHS Office of Civil Rights published a new FAQ response (OCR FAQ) detailing the agency’s position that generally information blocking will violate the HIPAA Privacy and Security Rules if it affects a covered entity’s access to its own protected health information (PHI) or its ability to respond to requests for access to PHI from patients. This follows a series of similar policy documents from HHS over the past 18 months that focus on preventing business arrangements or practices that would be defined as information blocking, and thereby, frustrating the goal of interoperability. Specifically, according to the OCR FAQ:
- An electronic health records (EHR) vendor or cloud provider’s actions to terminate a covered entity’s access to its own electronic PHI (ePHI) (e.g., in a payment dispute) would violate the HIPAA Privacy Rule because those actions would constitute an impermissible use of PHI.
- An EHR vendor or cloud provider’s refusal to ensure the accessibility and usability of a covered entity’s ePHI upon demand by the covered entity or to return a covered entity’s ePHI upon termination of the agreement, in the form and format that is reasonable in light of the agreement, would violate the HIPAA Security Rule.
- A business associate may not deny a covered entity access to the PHI the business associate maintains on behalf of the covered entity if necessary to provide individuals with access to their PHI under the HIPAA Privacy Rule.
- A covered entity that agrees to terms within a business associate agreement (BAA) that would prevent the covered entity from ensuring the availability of its own PHI as required would not be in compliance with the HIPAA Privacy and Security Rules.
OCR has increasingly ramped up its enforcement of violations of the HIPAA Privacy and Security Rules related to noncompliant BAAs, so the new OCR FAQ signals that information blocking provisions could be the source of future enforcement actions.
Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine the feasibility of establishing mechanisms to assist providers in comparing and selecting certified EHR technology products. Congress suggested that ONC consider mechanisms like establishing a website of aggregated survey results that would allow meaningful EHR users to directly compare the functionality of certified health IT products. Congress also suggested compiling information from vendors of certified health IT products, and making that information publicly available in a standardized format.
In response to its Congressional directive, and drawing upon recommendations from the Certified Technology Comparison (CTC) Task Force, public input, and its own market analysis, ONC’s report focused on two subgroups of the health care community – providers and comparison tool developers – and identified specific problem areas in the comparison tool marketplace. Ultimately, the report proposed four mechanisms to improve the health IT comparison marketplace:
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Spotlight on Best Practices, Litigation, Antitrust, and Tax for Health Care Companies
Crowell & Moring LLP is pleased to release its “2016 Litigation & Regulatory Forecasts: What Corporate Counsel Need to Know for the Coming Year.” The reports examine the trends and developments that will impact health care companies and other corporations in the coming year—from the last year of the Obama administration to how corporate litigation strategy is transforming from the inside out. This year will bring remarkable change for companies, as market disruptions and the speed of innovation transform industries like never before, and the litigation and regulatory environments in which they operate are keeping pace.