If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)! The publication of this Final AMP Rule follows the 2012 publication of CMS’s highly controversial proposed policies implementing various changes to the Medicaid Drug Rebate Program enacted under the Affordable Care Act. This rule has significant potential to impact drug manufacturers’ calculations and policies regarding the Medicaid Drug Rebate Program and pricing more generally, and should be carefully reviewed by all interested parties. It is being issued as a final rule with comment period.
We are currently reviewing the 657 pages of material, and plan to provide more substantive commentary in a subsequent post. For those of you playing along at home, the rule is expected to appear in the February 1, 2016, Federal Register, and comments are expected to be due by 5:00 PM Eastern April 1, 2016 (which is also the effective date of the rule). Separately, State Medicaid Agencies must comply with certain rule requirements by submitting a State Plan Amendment (SPA) by June 30, 2017 to be effective no later than April 1, 2017.
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and transfers of value related to continuing medical education (CME). As we previously discussed, there has been confusion in the industry regarding CMS’ changes to reporting requirements for CME beginning in January 1, 2016, which were implemented as part of the 2015 Medicare Physician Fee Schedule. In sum, CMS reiterated that it expects applicable manufacturers to report payments and other transfers of value related to CME if the payment or transfer of value meets the definition of “indirect payment” and the manufacturer “knows or finds out the identity” of the physician speakers and/or attendees within the reporting year or by the end of the second quarter of the following reporting year. “Indirect payment” is defined as “a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.”
There remains some concern among industry regarding its obligation to identify physician speakers and attendees. Although CMS uses in several instances the “knows or finds out the identity of” language, one FAQ uses slightly different and potentially more problematic language – “knows or can determine the identity of the covered recipient.”
CMS also released last week another round of Open Payment FAQs primarily related to its June 30, 2015 release of data. The new FAQs are the following:
UCLA Health announced today that it was the victim of a cybersecurity attack. The press report disseminated by UCLA Health noted there is evidence that computer systems containing sensitive personal data and health data was accessed; however, at this time UCLA Health maintains that no personal or health data itself was accessed or acquired. It is estimated that 4.5 million individuals may have potentially been involved in the attack. Continue reading
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.
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 . . .
As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when the payments are made public this month. Last week, ProPublica published an article that states: “Now, a source familiar with the matter tells ProPublica that CMS won’t disclose another batch of payments: research grants made by pharmaceutical companies to doctors through intermediaries, such as contract research organizations. In these cases, doctors apparently have not been given a chance to verify and dispute payments attributed to them, as required by law.” CMS has not yet provided this information directly to industry, further highlighting concerns raised by the American Medical Association and other physician organizations regarding widespread confusion and poor communication related to the public release of the data this month.
We will continue to monitor and provide updates as CMS’ publication deadline nears.