Life Science Compliance Update

May 27, 2016

CMS Administrator Goes to Twitter to Explain the Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA)

In an very unusual move for a government regulator, the CMS acting administrator Andy Slavitt took to Twitter to explain his agency's strategy around the new Medicare payment law, also known as MACRA. This comes as CMS released the long-awaited proposed MACRA rule which is open for comment until June 27. The proposed rule creates a "Quality Payment Program" to replace old reporting programs. There two tracks, the first called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program. A second track involves alternative payment models (APM). Because of the high bar set to qualify for the APM track, CMS projects that only 30,000 to 90,000 clinicians will be in the APM track. An estimated 687,000 to 746,000 physicians will be in MIPS.

Here are the highlights from Slavitt's tweet-storm:


1- Today I will summarize how much listening we've been doing around #MACRA & lay out the opportunities to hear the basics & get engaged.

3:04 PM - 21 May 2016


2. Our goal is to close the gap between Washington DC and front line realities of patient care. In May, we have over 35 events on #MACRA.

3:06 PM - 21 May 2016


3. We've hosted ten #MACRA webinars this month with over 30,000 attendees.

3:06 PM - 21 May 2016


4. To join one of our five upcoming #MACRA webinars, visit: …

3:07 PM - 21 May 2016


5. We're hosting #MACRA listening sessions. We've visited specialties, PC, & rural. You can invite #CMS to events …

3:10 PM - 21 May 2016


6. With each event, we take common Qs & answer them through fact sheets. Our latest is on #MACRA & small practices: …

3:11 PM - 21 May 2016

7. We post new content each week. Join the #CMS #MACRAlistserv to keep up-to-date: …3:11 PM - 21 May 2016


8. Or you can visit our #MACRA website to learn the latest: …

3:12 PM - 21 May 2016


He continued the next day:


Today, I will lay out some of the top interest & feedback areas we have heard for the Quality Payment Program under#MACRA.

11:32 AM - 22 May 2016


1. One area of input is the need to use #MACRA to increase focus on practice of medicine/pt care, not reporting/measurement & paperwork.

5:30 PM - 22 May 2016


2. A 2nd area is how small practices will fare relative to larger sized practices under #MACRA. We put this out: …

5:33 PM - 22 May 2016


3. A 3rd area is the availability of payment models like med homes, ACOs, including how they overlap & how to ease the path in to qualify.

5:34 PM - 22 May 2016


4. We have received other questions around flexibility, burden, timing, specialty care & payment adjustments.

5:37 PM - 22 May 2016


5. Will create fact sheets 4 key questions as we answer them as we've been doing.

5:39 PM - 22 May 2016


6. My takeaways: first, very encouraged by all the engagement, particularly the critics.

5:42 PM - 22 May 2016


7. My takeaways: Second, people want a philosophical change- a program that doesn't get in the way of practicing medicine, but supports it.

5:44 PM - 22 May 2016


8. My takeaways: third, walking thru basics has been critical. Payment adjusts., measurement, paperwork r all better than today's Medicare.

5:49 PM - 22 May 2016


9. My takeaways: fourth, more time, more to learn, more#MACRA meetings coming up. 35 in May alone. Grateful for all the engagement.

5:54 PM - 22 May 2016



Stakeholders have been struggling with the rule's complexity and length, so it is not surprising that CMS wants to explore all possible avenues for communication. It is unlikely these tweets will do much to change the confusion and challenges facing physicians, but it is laudable that the government is thinking outside of the box and looking to connect over social media. But the biggest takeaway seems to be that CMS recognizes the complexity of the rule and this could be insight into the possible comments that should be sent to the agency. 60 days to analyze one of the most important Medicare regulations in a quarter century is simply not sufficient. CMS is bound by difficult congressional deadlines, but it may be smart for all of Washington, D.C. to rethink the MACRA implementation process. It is too important for physicians and patients alike to rush through massive changes that almost no physician truly understands.

May 26, 2016

New Report: Industry and Physician Interaction Considered Acceptable by Many Patients

In this contentious election year, favorable coverage of the pharmaceutical industry is, for some reason, hard to come by. However, Wayne Pines, the President of Healthcare at APCO Worldwide and former Associate Commissioner of the Food and Drug Administration, recently authored a post at The Hill, where he acknowledged how "unfortunate" it is that the industry has been the target of much negative publicity. He further acknowledges that those "who have worked with the pharmaceutical and medical device industries for many years recognize that medical advances since World War II, continuing to this day, have extended lifespan and enhanced the quality of lives for hundreds of millions of people."

As many of our readers know, the Physicians Payment Sunshine Act was the result of industry critics who felt that industry relationships with healthcare providers are reprehensible and that disclosure of payment information would curtail their interactions with industry. When the law was enacted, it was not clear how the information would be accessed, nor how patients would be able to find it.

APCO Insight recently polled Americans in an attempt to learn whether the data was useful to them and whether it has actually changed their relationships with their physicians. The study, Return on Reputation, has provided insights into how stakeholders view medical products companies.

Report Results

The majority of both Opinion Leaders and Policy Leaders indicated that they were either very or somewhat interested in knowing how much money their healthcare providers receive from companies (90%/86%), but fewer were likely to check online information to see if their own doctor was receiving payments (85%/75%). Unsurprisingly, even fewer were likely to ask their doctor directly about their payments (66% of Opinion Leaders and 42% of Policy Leaders).

Further, while the majority of patients want to know how much industry spends on healthcare providers, few patients are so "angry" with industries that they take any action. Patients are more likely to be okay with industry and healthcare provider interaction when it leads to benefits, such as discussing a medical advance or new research.

A majority of respondents were okay with healthcare providers receiving payments/items of value if they are receiving those financial benefits in connection when: communicating with other medical professionals to share experiences and learn about best practices; conducting research studies or clinical trials to develop new medicines or medical devices; continuing physician education by receiving educational materials, such as textbooks, journal reprints, or patient demonstration kits; consulting with companies on specific projects that require specialized medical expertise; or speaking at events as a medical expert on a specialized health topic.


The report has shown that there is no indication that public disclosure has changed how patients relate to their healthcare providers, or how they view the pharmaceutical or medical device industries. The report also shows that patients actually may look favorably upon doctors who receive financial benefits from the pharmaceutical industry, provided they are received through education and interaction with industry and other providers, a position we have long held.

The pharmaceutical industry is unfortunately a large target, and will continue to remain the target of politicians. It is incumbent upon the industry to work to educate the public and other stakeholders about their contributions to healthcare and how collaboration with healthcare providers actually benefits patients, not hurts them.

NIH Asks for Input on NCAB Cancer Moonshot Blue Ribbon Panel

Recently, the National Institutes of Health (NIH) released a Request for Information (RFI), asking for both public and cancer research community input on the National Cancer Advisory Board (NCAB) Blue Ribbon Panel. The Blue Ribbon Panel is part of the National Cancer Moonshot Initiative, which is led by Vice President Joe Biden and aims to make more cancer therapies available, while continuing to improve cancer prevention and early detection. Additional details of the National Cancer Moonshot Initiative can be found at

The purpose of the NCAB is to ensure that the National Moonshot Initiative's goals and approaches are grounded in solid science. The Blue Ribbon panel is a panel of experts assembled to guide the NCAB's work and is composed of leading experts from a broad range of scientific areas including biology, immunology, genomics, diagnostics, bioinformatics, and cancer prevention and treatment. The panel does not just include researchers, however, it also includes clinicians and nurses, as well as representatives of cancer advocacy organizations and the pharmaceutical and biotechnology industries.

NIH is seeking community input to help "enable the Blue Ribbon Panel to consider a wide range of input from researchers, scientists, physicians, advocates, students, data scientists, and members of the public." They are requesting input in the following specific areas: expanding clinical trials; enhanced data sharing; cancer immunology and prevention; implementation sciences; pediatric cancer; precision, prevention, and early detection; and tumor evolution and progression.

The request for information is for planning purposes only and should not be construed as a solicitation for applications or proposals, or as an obligation on the part of the United States federal government.

If you have any questions about this particular RFI, you can contact Kelli Marciel at the National Cancer Institute at 9609 Medical Center Drive, Bethesda, MD 20892-9760,, or (301) 594-3330.

NIH is asking for responses to be submitted to either the National Cancer Institute (NCI) or NIH before July 1, 2016 at 5:00 pm EST. Responses can be submitted electronically through the online platform or via email to While electronic responses are preferred, non-electronic responses can be accepted by calling the NCI Cancer Information Service at (800) 422-6237, or by mail to Blue Ribbon Panel, National Cancer Moonshot Initiative, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892-9760.



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