On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking
electronic health record
HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations
By Robinson+Cole's Health Law Group on
Posted in Academic Medical Centers, Accountable Care Organizations, Ambulatory Surgical Centers (ASC), False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Home Health Agencies, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Pharmaceuticals and Biologics, Pharmacy Law, Physicians and Allied Health Professionals, Telemedicine
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil…
HHS Finalizes Joint Rules on Electronic Health Record Interoperability and Access
By Robinson+Cole's Health Law Group on
On March 9, 2020, the Department of Health and Human Services (HHS) announced final rules seeking to give patients more access to, and control of, their health data. The final rules were issued by the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS). The ONC rule is available here and the CMS rule here. Both rules implement interoperability and patient access provisions from the 21st Century Cures Act and the Trump administration’s MyHealthEData initiative.
Continue Reading HHS Finalizes Joint Rules on Electronic Health Record Interoperability and Access
CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug Benefit Program
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare…
Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements
By Conor Duffy on
Posted in Accreditation, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Hospitals and Health Systems, Life Sciences, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement, Stark Law
The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems (EHRs). The respective settlements enable recovery by DOJ of over $100 million, and immediately precede the government’s recent proposal of new rules to promote the interoperability of EHRs. The settlements thus serve as an important reminder of the importance of adhering to federal fraud and abuse laws and regulations as hospitals and other health care providers continue to implement EHR technology.
Continue Reading Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements
OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care
On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) with the goals of removing “regulatory obstacles” and decreasing “regulatory burdens” in furtherance of the health care industry’s transition to value-based care models.
In the RFI, OCR requests input on whether and how the HIPAA regulations (i) can be modified to remove regulatory obstacles and burdens to efficient care coordination and case management, (ii) may inhibit the transformation to a value-based health care system, and (iii) may be modified to facilitate efficient care coordination and case management, and promote the transformation to value-based care. OCR also solicits comment on four specific proposals for modifying the HIPAA regulations to accomplish some of its stated goals:
Continue Reading OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care