Trump Administration’s Executive Order Calls for Innovation in Services, Technology, and Payment Models for Medicare and Medicare Advantage
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OCR Announces First Enforcement Action Under Its Right to Access Initiative
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…
New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges
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…
Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues
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…
Trump Administration and Congress Are Moving Quickly on Health Care Price Transparency and Lowering Costs
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…
HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access
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…
CMS offers $1.65 million in AI Health Outcomes Challenge
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…
HHS Releases Voluntary Cybersecurity Practices Guidance
In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to…
Closing the Health Information Privacy Divide
More of our health information is becoming digital every day, as new technology companies enter the health care and wellness markets.
Many companies that hold a wealth of consumer health information are not covered by HIPAA.
Many consumers may not realize that their health information only is protected and they only have certain rights with respect to that information when it is held by certain entities, but not when it is held by others.…
Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule
CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.
Virtual Check-Ins
CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”…