Life Science Compliance Update

January 18, 2018

Study Highlights Physician QPP Preparedness

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Fewer than one in four physicians feel they are prepared to meet requirements under the CMS’ Quality Payment Program (QPP), a new American Medical Association and KPMG survey shows. Out of 1,000 physicians involved in practicing decision-making related to the QPP, only 8% said they were “deeply knowledgeable” about MACRA and QPP. In contrast, almost 92% said they were “somewhat knowledgeable” or not knowledgeable. All of this spells danger for the new program as CMS struggles to inform physicians about the new requirements even as a performance year has almost already been completed.

Study Results

According to the study, 7 in 10 respondents had in fact begun preparing to meet the requirements of the QPP for 2017. Nearly 9 in 10 feel somewhat prepared or well prepared to meet the low-bar requirements set forth by CMS in the first year. Of those participating in the MIPS track of QPP, only 65% felt prepared to meet the requirements, indicating that alternative payment model members have a higher likelihood of feeling prepared. Additionally, of those participating in MIPS, 90% felt the requirements are slightly or very burdensome, with over half responding they were at the higher level of burden.

Respondents to the survey indicated the reporting time required to comply is the most significant challenge and suggest it will be one in future years. Respondents also struggled to understand requirements like MIPS scoring and the cost of reporting.

Previous programs like PQRS and the VBPM contributed to the level of readiness for QPP. The legacy programs set up physicians to be more successful than those with no experience with them. Only 25% of physicians with prior reporting experience felt well prepared for the QPP, however.

An interesting finding in the study is that even among those who feel prepared, they do not fully understand the total impact of the QPP. While they may be prepared to check boxes and complete forms, they lack “long-term strategic financial vision to success in 2018 and beyond.” Only 8% of respondents feel they are very prepared for long-term success with 26% feel not prepared at all.

Findings Support Number of Assumptions About QPP

According to the study, its results confirm assumptions that are widely held regarding physician knowledge and preparedness for QPP requirements:

  • Some challenges are universal regardless of practice size, specialty, or previous value-based payment experience, particularly the time required and the complexity of reporting.
  • Physicians, especially in small practices, need more help to prepare.
  • Physicians want more alternative payment models available to them.
  • Physicians with value-based payment reporting experience are more confident about their preparedness regarding performance under MIPS.
  • Physicians remain deeply concerned about the long-term financial ramifications of the QPP.

January 17, 2018

Nevada Posts FAQ and Reporting Requirements on Transparency Law

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As we posted last week, the Nevada draft regulations are up and starting to become a hot topic. The same day as our last post, Nevada updated the Frequently Asked Questions and the SB 539 Reporting requirements.  

Frequently Asked Questions

The two-page FAQ document provides some helpful answers to common questions, such as whether the reporting for pharmaceutical representatives is the responsibility of the individual or of the manufacturer. Nevada notes that it is the responsibility of both and then lists specific requirements. For example, manufacturers are required to submit a list of names of all pharmaceutical representatives who market prescription drugs in Nevada while each pharmaceutical representative is required to submit a report of all compensation or prescription drug that was provided to a provider of health care that is licensed, certified, or registered in this State, among others.

The FAQ also confirms that the law applies equally to all pharmaceutical representatives and not just those who are engaging in the sales and marketing of the diabetes-related treatments state on the website.

The FAQ also includes links to report formatting and other specifics for prescription drug manufacturers and pharmacy benefit managers.

Reporting Requirements

Drug Manufacturers

As required under the law, prescription manufacturers must submit a report to the Nevada Department of Health and Human Services (DHHS) with the below information, for prescription drugs posted on the DHHS website. This report must be submitted via email annually by April 1st of each year for the previous calendar year. DHHS then compiles a report and posts it in accordance with NRS 439.

Manufacturer requirements

Pharmacy Benefit Managers

PBMs are also required to submit a report to DHHS by April 1st of each year. The required information for that report is as follows.

PBM

Pharmaceutical Sales Representatives

Pharmaceutical sales reps that are on a list submitted to DHHS by drug manufacturers anytime during the previous calendar year must submit their report by March 1st of the year, including the below items.

Pharma Rep

Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up

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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.

For life science compliance professionals, following the activities of the Office of Inspector General (“OIG”) for the Department of Health and Human Services is both a question of curiosity and necessity. With the limited amount of formal guidance available, the OIG’s actions provide vital clues as to the agency’s thinking and focus in the near future.

As we closed out 2017, two overarching themes emerged. The first was the need to invest in internal auditing and measurement of compliance programs, and the second the advent of more coordinated investigations involving pain management drugs. For 2018, as discussed below, we believe both themes will continue with the OIG being hyper-focused on anything involving opioids and pain management.

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