Blog

| August 18, 2015
On August 20 and 28, 2015, the Texas Health and Human Services Commission (HHSC) Vendor Drug Program will likely formally propose changes to Texas drug price reporting regulations. If accepted, HHSC will eliminate the monthly price update reporting requirement for drug manufacturers and, instead, require manufacturers to respond within...
| August 11, 2015
On August 4, 2015, the long-awaited Average Manufacturer Price (AMP) Final Rule was sent to the Office of Information and Regulatory Affairs (OIRA) (a division of the Office of Management and Budget) for Executive Order (EO) 12866 Regulatory Review. EO 12866 requires OIRA review for all significant regulatory actions...
| July 9, 2015
On June 25, 2015, the Supreme Court upheld a key part of the Affordable Care Act (ACA) that provides health insurance subsidies to all qualifying Americans. The 6-to-3 ruling means that the authorized tax credits for eligible citizens are here to stay regardless if the state has its own...
| June 16, 2015
As pharmaceutical and medical device companies are aware, the OIG has issued compliance program guidance for various entities, including guidance for individual and small group physician practices. Each Guidance document has similar requirements when compared to the others, especially related to arrangements involving compensation. Recently, the OIG settled with...
| June 11, 2015
Texas Medicaid Update Texas Medicaid has mailed out 1Q2015 invoices for their new program which is referred to as the State of Texas Enhanced Federal Medicaid Assistance Percentage (EFMAP) program. Texas Health and Human Services has combined the old Qualified Aliens (QA) program and the new MCHIP program into...
| June 4, 2015
On June 1st, the CMS proposed rule for the Medicaid and Children’s Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability (RIN 0938-AS25) was published in the Federal Register. The summary on...
| June 4, 2015
This year’s 17th Annual Medicaid and Government Pricing Congress June 3-5 in Orlando has been a highly anticipated venue to discuss timely updates on Healthcare Reform, Medicaid Expansion, Gross-to-Net, VA/DoD, TRICARE, 340B and Compliance. Jake Keenan, Senior Director, Government Programs Consulting, shared perspective in CBI’s Content Connections Magazine distributed...
| May 15, 2015
On May 6, 2015 (as per reginfo.gov, under RIN  0906-AB08), HRSA submitted 340B Program Omnibus Guidelines to OMB for review (see screen shot below).  No additional detail about the guidelines is known at this time, but we believe this is the “mega guidance” OPA has been alluding to.  As...
| May 5, 2015
It starts at the top. We hear that a lot in reference to many aspects of an organization’s culture, and it’s also true for an organization’s compliance program requirements. The “tone at the top” sends a key message to employees about how they are expected to engage in activities...
| May 4, 2015
In an email sent to manufacturers on Friday, April 24th, the Health Resources and Services Administration (HRSA) announced it is developing a system to verify the accuracy of manufacturer-calculated 340B selling prices against HRSA’s calculated 340B ceiling prices, in accordance with Section 340B(d)(1)(B)(i)(II) of the Public Health Service Act....