CIS Compliance Blog

By: | On: May 5, 2015 | In: CIS Compliance Blog | Commercial Compliance
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...
By: | On: May 4, 2015 | In: CIS Compliance Blog | Government Programs
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....
By: | On: April 13, 2015 | In: CIS Compliance Blog | Government Programs
In late March, VA published a “Special Edition” of its FSS e-Newsletter to resolve its long-standing disagreement with the Defense Logistics Agency (DLA) over payment of Federal Supply Schedule (FSS) Industrial Funding Fees (IFF) on purchases made through a DAPA of certain items also listed on FSS.  (This e-Newsletter...
The objective of conducting a risk assessment is to identify and categorize legal, regulatory and operational risk exposure associated with business operations, as well as provide key recommendations for risk mitigation.  When planning a risk assessment for healthcare compliance, potential risk associated with sales and marketing activities are most...
On April 8, 2015, HRSA submitted a 340B Civil Monetary Penalties for Manufacturers proposed rule (RIN: 0906-AA89) to the Office of Information and Regulatory Affairs (OIRA) for review.  The text of the rule has not yet been published, but according to the abstract at www.reginfo.gov, this rule, “would amend...
CIS audit experts recently attended the CBI conference, “Third-Party Risks, Audits and Oversights” in Philadelphia, PA. This conference focused on the managing the risks of working with third-party vendors across multiple markets both domestic and internationally. One of the key themes throughout the discussions was the importance of due...
We were asked recently about the enrollment numbers for Medicaid in Puerto Rico, so this initiated some research.  To give you a little history, the 2010 Patient Protection and Affordable Care Act (PPACA), included two major changes to Federal funding of Puerto Rico’s Medicaid program: (1) the law increased the...
Pharmaceutical, biotech, and medical device companies distribute copies of journal articles through sales reps, MSLs, and responses to medical information requests.  Ensuring that the correct copyright fee has been paid is important to avoid possible copyright infringement.
CMS posted Manufacturer Release 92 on March 30, 2015 and here are the highlights: BIOSIMILARS AND THE MEDICAID DRUG REBATE PROGRAM – The Affordable Care Act (ACA) amended the PHS Act to create an abbreviated pathway for licensure of biological products that are demonstrated to be biosimilar to, or...
Today’s guest blog post was provided by Donna Lee Yesner, a Partner from Morgan, Lewis & Bockius, LLP. On Thursday, March 26, 2015, Dr. George Jones, Chief of Pharmacy Operations Division, Defense Health Administration, announced that the agency is expecting to issue its final changes to the TRICARE Pharmacy...