Electronic Health Records (EHR)

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In a significant ruling among the first to analyze the application of information blocking regulations, the U.S. Court of Appeals for the Fourth Circuit affirmed a preliminary injunction against an EHR company in favor of a diagnostic analytics services company. The injunction grants the analytics company access to patient data, enabling the company to provide its analytics services to nursing facility customers who use the EHR vendor’s services.

The case, Real Time Medical Systems, Inc. v. PointClickCare Technologies, Inc., No. 24-1773 (4th Cir. 3/12/25), arises out of claims by Real Time Medical Systems, Inc. (“Real Time”) that PointClickCare Technologies, Inc. (“PCC”) implemented a technical protocol that cut-off Real Time’s appropriate access to its customers’ electronic health information (“EHI”) and that PCC did not implement this protocol for legitimate security or performance reasons as PCC claimed, but rather to interfere with Real Time’s business so that PCC could capture Real Time’s market share with its own competing analytics products.Continue Reading Information blocking victory in favor of access to health data

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations on information blocking.

Among the program criteria that the rule addresses include those related to decision support, electronic case reporting and standards-based application programming interfaces (APIs). To address the question of information blocking, the rule provides refined definitions of statutory terms and identifies practices that cannot constitute information blocking as they are considered by ONC to be “reasonable and necessary.”Continue Reading ONC Finalizes Information Sharing and Algorithm Transparency Rule

The U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) released earlier this year the Trusted Exchange Framework and Common Agreement (TEFCA), which is intended to improve electronic interoperability among health information networks (HINs) and facilitate the exchange of health information among connected organizations. 

Importantly, TEFCA is not just about HINs.  Under TEFCA, any organization that connects to a HIN designated as a Qualified HIN (QHIN) may be able to meet many interoperability and information sharing obligations without implementing technology integrations on a request-by-request basis.  ONC believes that TEFCA will “reduce the need for duplicative network connectivity interfaces, which are costly, complex to create and maintain, and an inefficient use of provider and health IT developer resources.” ONC stated that connected organizations “will be able to share information with all other connected entities regardless of which QHIN they choose.” 

However, participation in TEFCA comes with a price.  Organizations that connect to QHINs, either directly or indirectly, will likely need to agree to new contractual requirements that flow-down from QHINs.Continue Reading ONC’s Trusted Exchange Framework and Common Agreement (TEFCA): Impacts on Health Information Networks and Health Care Organizations

The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS’ ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.

The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability.
Continue Reading HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020

The House of Representatives has approved H.R. 987, the “Strengthening Health Care and Lowering Prescription Drug Costs Act,” which packages seven prescription drug and insurance-related bills recently approved by the House Energy and Commerce Committee.  The legislation is intended to:  increase generic drug competition; fund Affordable Care Act “Navigator” outreach and enrollment programs and…

Today the U.S. Department of Health and Human Services (HHS) announced that it would extend until June 3, 2019 the comment periods for the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) proposed interoperability and information blocking rules.  CMS also announced that as a result of public comments, it “will adjust the effective dates of our policies to allow for adequate implementation timelines as appropriate.”

In related developments, the ONC also released the second draft of the Trusted Exchange Framework and Common Agreement, along with a related Notice of Funding Opportunity.  In addition, HHS released a set of frequently asked questions (FAQs) from the Office for Civil Rights (OCR), addressing HIPAA’s right of access as related to apps designated by individual patients and application programming interfaces (APIs) used by a healthcare provider’s electronic health record (EHR) system.  The FAQs clarify, among other things, that once protected health information (PHI) has been shared by a HIPAA covered entity with a third-party app, as directed by the individual, the covered entity will not be liable under HIPAA for subsequent use or disclosure of electronic PHI, provided the app developer is not itself a business associate of a covered entity or other business associate. 
Continue Reading HHS Announces Extended Comment Period for Healthcare Interoperability Proposed Rules, Releases New HIPAA FAQs

The Office for Civil Rights (OCR) is requesting public input on reforms to Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules to promote care coordination and the health system’s transformation to value-based health care while protecting the privacy and security of individuals’ protected health information (PHI).  Specifically, in a request for information…

The Centers for Medicare & Medicaid Services (CMS) has released its final rule updating the Medicare inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2019.  The following are highlights of the lengthy rule, which is scheduled to be published August 17, 2018.

IPPS Payments to…

The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule updating the Medicare acute inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2019. The proposed rule also includes a request for information (RFI) on ways CMS can enhance interoperability in the health care system, along with a comment solicitation on ways to improve price transparency.  The agency will accept comments on the proposed rule and RFI through June 25, 2018.  The following are highlights of the sweeping regulation.

1.75% Increase in Medicare Acute Hospital Rates. CMS projects that total IPPS payments will increase by about $4.1 billion in FY 2019 compared to FY 2018 levels under the proposed rule.  The IPPS national standardized amount would increase by 1.75%, based on a projected 2.8% market basket update that is reduced by a 0.8% multifactor productivity adjustment; further reduced by 0.75% as mandated by the Affordable Care Act (ACA); and increased by 0.5% as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). CMS also proposes to boost uncompensated care payments, capital payments, and low-volume hospital payments.
Continue Reading CMS Proposes FY 2019 Medicare IPPS/LTCH Rates and Policy Changes

The Trump Administration has launched a new MyHealthEData initiative intended to make it easier for Medicare beneficiaries and other health consumers to control their medical data and share it with their choice of providers. The government-wide initiative, led by the White House Office of American Innovation, seeks to “break down the barriers that prevent patients…

The HHS Office of Inspector General (OIG) estimates that CMS made $729.4 million in Electronic Health Incentive (EHR) payments to providers who did not meet meaningful use requirements from May 2011 to June 2014 – representing about 12% of the $6 billion in total EHR payments made during this period. This dramatic finding is based…

Included in the 21st Century Cures Act are numerous changes to Medicare and Medicaid policies, including provisions with significant reimbursement impacts for certain types of Medicare providers and suppliers, along with changes intended to reduce the regulatory and administrative burdens associated with the use of electronic health records.  Furthermore, the law once again expands the…

In light of recent health information data breaches, the Government Accountability Office has issued a report examining whether HHS security and privacy guidance for electronic health records (EHRs) are consistent with federal cybersecurity guidance, and the extent to which HHS oversees compliance with HHS information security and privacy requirements. The GAO identified shortcomings in HHS…

CMS is hosting a call on November 1, 2016 to discuss how physicians and other providers can report quality measures during 2016 to maximize participation in Medicare quality programs, including the Physician Quality Reporting System (PQRS), Medicare Electronic Health Record (EHR) Incentive Program, Value-Based Payment Modifier (Value Modifier), and the Medicare Shared Savings Program.

The Centers for Medicare & Medicaid Services (CMS) has released its final rule to update Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) payments and policies for fiscal year (FY) 2017.  With regard to the IPPS, CMS projects that the cumulative rate and policy changes in the final rule will increase total IPPS payments by about $746 million in FY 2017 compared to FY 2016. The rule provides a 0.95% operating payment rate update for hospitals that submit quality data and are meaningful users of Electronic Health Records (EHRs).  This update reflects a 2.7% market basket update, adjusted by a -0.3 percentage point multi-factor productivity (MFP) adjustment and an additional -0.75 percentage point adjustment (as mandated by the Affordable Care Act, or ACA), resulting in a 1.65% update.  This update is subject to an additional -1.5 percentage point documentation and coding recoupment adjustment (required by the American Taxpayer Relief Act of 2012) and a one-time increase of approximately 0.8 percentage points to permanently negate the cumulative impact of a “Two Midnight Policy” adjustment adopted in the final FY 2014 rule.
Continue Reading CMS Finalizes FY 2017 Update to Medicare IPPS, LTCH PPS Rates and Policies

The House Ways and Means Committee has approved an amended version of H.R. 5273, the “Helping Hospitals Improve Patient Care Act of 2016.”  While most of the provisions address Medicare payment policies pertaining to hospitals (including long term care hospitals (LTCHs) and hospital outpatient departments), certain other reimbursement policies, including Medicare Advantage and physician payment…

CMS has published corrections to its November 16, 2015 Medicare physician fee schedule final rule with comment period for 2016, applicable beginning January 1, 2016. Among other things, CMS is correcting an omission of language restating the Consumer Assessment of Healthcare Providers and Systems (CAHPS) requirements that apply to groups of 100 or more eligible…

The OIG has released the 2016 edition of its “Compendium of Unimplemented Recommendations,” which identifies what the OIG considers to be its top 25 unimplemented recommendations in terms of HHS program savings and/or quality improvements. About one-third of the priority recommendations involve Medicare Parts A and B policies, including recommendations to adjust payment…

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on how to achieve widespread exchange of health information through interoperable certified electronic health record (EHR) technology nationwide by the end of 2018, as is called for by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  MACRA also mandates …