March 24, 2012. Today, the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB) in the Executive Office of the President showed that it had received the much-delayed Department of Health and Human Services (HHS) Office for Civil Rights (OCR) Final Rules entitled: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (RIN: 0945-AA03). Following review by OMB, the rules will be published in the Federal Register, most likely in April if OMB’s review is timely. The Abstract of the Rules reads: “The Department of Health and Human Services Office for Civil Rights will issue final rules to modify the HIPAA Privacy, Security,…
Category: Enforcement
BCBST Pays $1.5 Million to HHS to Settle Potential HIPAA Privacy and Security Violations
On March 13, 2012, Blue Cross Blue Shield of Tennessee (BCBST) agreed to a payment of $1.5 million to the Department of Health and Human Services (HHS) and to a corrective action plan as part of a Resolution Agreement with HHS for potential violation of Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rule violations. According to a HHS Press Release of the same date, “the enforcement action [by HHS’ Office for Civil Rights (OCR)] is the first resulting from a breach report required by the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule.” According to the HHS Press Release: “The investigation followed…
CMS Publishes Stage 2 Meaningful Use Incentive Program NPRM
On March 7, 2012, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register its 132-page notice of proposed rule making (NPRM): Medicare and Medicaid Programs; Electronic Health Record Incentive Program–Stage 2. Comments to the Department of Health and Human Services (HHS) may be made until 5 PM on May 7, 2012. The summary of the NPRM is included here: “This proposed rule would specify the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it would specify payment adjustments under Medicare for covered…
CMS Initiates 90-Day Enforcement Discretion for 5010 Compliance
January 1, 2012, is the date for covered entities to achieve compliance with ASC X12 Version 5010, NCPDP Telecom D.0, and NCPDP Medicaid Subrogation 3.0 transaction standards. Covered entities include healthcare providers, health plans, and healthcare clearinghouses. Small health plans have until January 1, 2013, to comply with the NCPDP Medicaid Subrogation 3.0 standard. The Center for Medicare & Medicaid Services (CMS) Office of E-Health Standards and Services (OESS) is responsible for enforcement of compliance with electronic transaction standards. CMS announced on November 17, 2011, that “[w]hile enforcement action will not be taken [from January 1-March 31, 2012], OESS will continue to accept complaints associated with compliance with Version 5010,…
OCR Announces November 2011 Start of Privacy and Security Compliance Audits
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for privacy and security enforcement under Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act provisions. OCR has announced that it is initiating compliance audits beginning this month, as authorized by the HITECH Act. This action precedes the imminent release of the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rules, expected before the end of 2011, and will strengthen enforcement and accountability for compliance with existing and forthcoming Rule modifications. To avoid the consequences of potential penalties for non-compliance, covered entities and business…
HITECH Act Breached Individuals Skyrocket in Latest OCR Web Site Posting
Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the U.S. Department of Health and Human Services (HHS) any privacy or security breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate. The HHS Office for Civil Rights (OCR), which is responsible for privacy and security enforcement under the Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act provisions that strengthened privacy and security enforcement, is required to post those breaches…
HITECH Act Privacy and Security Final Rules Needed Now
Since September 23, 2009, the enforcement arm of the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), has been required to publicly disclose breaches involving 500 or more individuals discovered and reported by covered entities and their business associates. As of October 25, 2011, OCR has reported 345 such breaches involving a total of 11,959,488 individuals. Not reflected yet in the OCR disclosed breaches are two involving 6.5 million individuals: a Nemours breach of 1.6 million individuals and a TRICARE breach involving 4.9 million individuals. Together, these two recently reported breaches represent 54.4% of the total number of individuals affected by the publicly disclosed breaches…
Get Ready Now for Toughened HIPAA/HITECH Act Privacy and Security Rules and Enforcement, and Big Noncompliance Fines
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted on August 21, 1996, as Public Law 104-191. HIPAA Administrative Simplification provisions in Subtitle F, Title II included transactions and code sets, privacy, security, and unique identifiers. Except for several identifiers, the federal government promulgated enabling regulations under the Administrative Procedure Act. For example, the Privacy Rule required compliance by healthcare providers, healthcare clearinghouses, and health plans—Covered Entities—by April 14, 2003, and the Security Rule required compliance by April 20, 2005, with small health plans for each rule having an additional year in which to comply. On February 17, 2009, the Health Information Technology for Economic and…
OMB Clears HITECH Act Accounting of Disclosures NPRM
The Department of Health and Human Services (HHS) Office for Civil Rights (OCR), responsible for enforcement of the HIPAA Privacy, Security, and Breach Notification Rules, will issue a Notice of Proposed Rule Making (NPRM) to modify the HIPAA Privacy Rule as necessary to implement the accounting of disclosures provisions of Section 13405(c) of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) (Title XIII of the American Recovery and Reinvestment Act of 2009–Public Law 111-5). Section 13405(c) is entitled: Accounting of Certain Protected Health Information Disclosures Required if Covered Entity Uses Electronic Health Record. The NPRM was submitted on February 9, 2011, by HHS to the Office…
Over 10 Million Individuals Now Affected by Large Data Breaches, as Reported on OCR Web site
Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the U.S. Department of Health and Human Services (HHS) any privacy or security breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate. The HHS Office for Civil Rights (OCR), which is responsible for privacy and security enforcement under the Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act provisions that strengthened privacy and security enforcement, is required to post those breaches on…