CMS Reopens Open Payments System After Rejecting One-Third of Reported Payments

The Centers for Medicare & Medicaid Services (CMS) announced last week that the Open Payments system was available again after it was taken off-line on August 3, 2014 to “resolve a data integrity issue.”  Because the Open Payments system was taken off-line during a critical period in which physicians and teaching hospitals were able to review data reported by manufacturers and group purchasing organizations (GPOs) and, if necessary, dispute incorrect information, CMS extended the review and dispute process by the number of days that the system was off-line until September 9, 2014.  Manufacturers and GPOs will have until September 23, 2014 to resolve disputed payments before the data is posted publicly by CMS on September 30, 2014.

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Filed under Federal Transparency

Federal Health Insurance Marketplace Sends Notices Regarding Citizenship and Immigration Data Inconsistencies

The Centers for Medicare & Medicaid Services (“CMS”) announced that the Federal Health Insurance Marketplace (“Marketplace”) began sending follow-up notices to consumers with citizenship or immigration data inconsistencies who have not responded to previous notices via mail, email, and phone. CMS cautions that consumers who have not yet responded must act now and submit supporting documents by September 5, 2014 or their Marketplace coverage will end on September 30, 2014. CMS estimates that there are 310,000 consumers with citizenship or immigration data inconsistencies who still have not responded to prior requests for documentation. Continue reading

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Filed under Health Reform, The Affordable Care Act

HHS Delays ICD-10 Implementation Requirements

On August 4, 2014, the United States Department of Health and Human Services (HHS) issued a final rule delaying the compliance date for health care providers, health plans, and health care clearinghouses to transition to the International Classification of Diseases, 10th Revision (ICD-10) until October 1, 2015.   Continue reading

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Filed under Coverage and Reimbursement, Industry Codes

Federal Prosecutors Bring Criminal Charges against Individual for Alleged HIPAA Violation

Federal prosecutors in the Eastern District of Texas recently brought criminal charges under the Health Insurance Portability and Accountability Act (“HIPAA”) against a former East Texas hospital employee.  The former employee has been indicted on charges of wrongfully disclosing Protected Health Information (“PHI”).  Allegedly, he obtained PHI with the intent to use the information for personal gain. Continue reading

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Filed under Government Enforcement, Health Information Privacy, HIPAA, Privacy and Security

Rhode Island Hospital Reaches Settlement with Massachusetts AG to Resolve Data Security Allegations

Last week, Women & Infants Hospital of Rhode Island (“W&I”) reached a settlement with the Massachusetts Attorney General to resolve allegations that W&I failed to adequately protect personal data stored on unencrypted backup tapes, violating both state and federal data security laws.  W&I has agreed to enhance its data security compliance program and to pay a total of $150,000. Continue reading

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Filed under Government Enforcement, Health Information Privacy, Health IT, HIPAA, HITECH Act, Privacy and Security

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products.  The FDA has made the PowerPoint and webinar Q&As publicly available for review.  Specifically, as we informed you here and here, the FDA issued the following three draft social media guidance documents:

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Filed under FDA, FDA Draft Guidance, Social Media

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014.  This is the process that allows physicians and teaching hospitals to review and dispute information regarding payments and other transfers of value that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) recently reported to CMS, before CMS publicly discloses this information by September 30, 2014.

To assist with this process, CMS released an updated Open Payments User Guide to provide a comprehensive overview of the Open Payments system and requirements.  CMS also released the following Quick Reference Guides:

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Filed under Federal Transparency