The Centers for Medicare & Medicaid Services (CMS) promised the government, industry and the public that it would release the first round of data in connection with the Physician Payment Sunshine Act by September 30, 2014, and that promised was delivered on today. The CMS Open Payments database contains 4.4 million payments totaling approximately $3.5 billion for payments, transfers of value and investment interests for the period August 1, 2013 – December 31, 2013. According to CMS, approximately 60 percent of the records released today are fully identifiable, whereas the other 40 percent were de-identified due to inconsistent or inaccurate payment information; data that was not available during the review and dispute period; or disputes that were not resolved. CMS expects this information to be fully identifiable when the database is updated in 2015. CMS also announced that it plans to roll out a simplified version of the database for consumers next month.
We are evaluating the information reported in the database. We also will monitor media reports and other information released by CMS related to the CMS Open Payments database.
Last week, the National Institute of Standards and Technology (“NIST”), in conjunction with the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”), hosted a conference entitled “Safeguarding Health Information: Building Assurance through HIPAA Security.” Both OCR officials and others within the industry spoke regarding HIPAA developments. Perhaps the most anticipated presentation at the conference was the OCR Update, delivered by Iliana Peters, Senior Advisor for HIPAA Compliance at OCR. Continue reading
On September 16, the American Medical Association (AMA) released a new framework intended to improve the development and integration of Electronic Health Record (EHR) systems. While the AMA recognizes the potential value of EHRs, it notes that adoption and effective use has been slow due, in large part, to poor optimization for efficient and effective clinical work. This call for a new framework follows up the joint AMA and Rand Corporation study documenting physician discontent with EHRs.
As we discussed in Part 1 and Part 2 of this ongoing story, the Centers for Medicare & Medicaid Services (CMS) has received significant criticism related to issues with the Open Payments database and its plans to release the information by the end of this month despite data concerns. The latest development is that the industry groups BIO, PhRMA and AdvaMed sent a letter this week to CMS Administrator Marilyn Tavenner regarding continued concerns about a potential lack of “clear background information and context” related to the relationships between industry and health care professionals that will be meaningful to patients and the public as they review the data. This has been a concern voiced by the industry groups since CMS issued the draft rules in December 2011. The letter further states that this context is even more critical when CMS intends to post only a portion of the data submitted by manufacturers, a situation in which CMS still has not provided significant transparency.
Will CMS make the Sunshine data publicly available by September 30th as planned? Stay tuned . . .
The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to a request by a group of mobile app developers asking for clarification, Tom Marino, R-Pa, and Peter DeFazio, D-Ore., wrote a letter to HHS Secretary Sylvia Mathews Burwell outlining four steps that regulators should take to clarify how HIPAA applies to mobile medial apps. Continue reading
Earlier this week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled, Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs (Report). Copayment coupons are offered by pharmaceutical manufacturers in many forms, including print coupons, electronic coupons, debit cards and direct reimbursements, in order to reduce or eliminate a consumer’s immediate out-of-pocket costs for a specific pharmaceutical product. Because these “coupons constitute remuneration offered to consumers to induce the purchase of specific items”, the federal Anti-Kickback Statute may be implicated. The Report and Bulletin state that, while many manufacturers have measures in place to prevent the use of coupons when a pharmaceutical product will be paid for by a federal health care program (FHCP), the OIG has determined that current safeguards may not be sufficient.
During a speech at the annual Taxpayers Against Fraud Education Fund conference this week, Assistant Attorney General Leslie R. Caldwell announced that the U.S. Department of Justice’s (DOJ) Criminal Division “recently implemented a procedure so that all new qui tam complaints are shared by the Civil Division with the Criminal Division as soon as the cases are filed” to determine whether to open a parallel criminal investigation. This allows the prosecutors to coordinate early with the DOJ Civil Division and U.S. Attorney’s Offices regarding parallel investigations.