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WHAT MACRA MEANS FOR MEDICAL MEETINGS

11/16/2017

 
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This post was originally published as a November 16, 2017 article on MeetingsNet. ​

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The Medicare Access and Chip Reauthorization Act of 2015, a congressional effort to solve the riddle of how to pay physicians under the Medicare program, does more than move what has traditionally been a fee-for-service model to a value-based model. It also just may offer some new areas of opportunities for continuing medical education.

Andy Rosenberg, senior advisor with the lobbying group the CME Coalition, laid out just what MACRA is—and why CME providers should be paying attention to it—in a recent MeetingsNet webinar. 

What MACRA Is

Calling the effort to fix a flawed Medicare reimbursement mechanism “remarkable,” Rosenberg said MACRA moves from a system that had based reimbursement on the number of services physicians provided, to one that reimburses based on physicians providing value. 

He explained that MACRA’s core idea came out of an article written by Donald Berwick in 2008 in Health Affairs; Berwick subsequently became the administrat or of the Centers for Medicare and Medicaid Services, or CMS. In the article, he outlined what he called the “triple aim” of healthcare:
  1. Providing better care for individuals in terms of safety, effectiveness, patient centeredness, timeliness, efficiency, and equity.
  2. Improving the health of populations by attacking what he called the “upstream” causes of ill health such as poor nutrition, physical inactivity, and substance abuse, said Rosenberg.
  3. Reducing the per capita costs of healthcare

“It seems easy, right? Let’s just start reimbursing providers for better quality, rather than just for providing more services,” Rosenberg said. But defining value depends on who you are—insurance payor, health system, provider, doctor, or patient. 

So, he said, this begs a few questions. “How do we measure quality? How do we value innovation? How do we make sure that we are being patient-centered, which means that we are actually allowing patients to define what they consider valuable? How do we develop quality measures by which to measure the performance of doctors and hospitals?” It turns out that improving quality is not straightforward at all; in fact it’s pretty confusing.

Part of a Broader Trend       

Rosenberg stressed that it’s important to note that what CMS is doing in driving value-based care is part of a broader industry trend towards value-based purchasing. For example, in the pharmaceutical space, a pharmaceutical company may have an expensive new product, but insurers only want to pay for that product if they know it will get results.  “This is a whole new area of interpreting and determining value, and setting the terms for reimbursement based upon a treatment’s success at actually achieving those goals.”

Say one of those goals is reduced hospitalization. “A hospital system or an insurer might enter into an agreement for a certain drug or to put a certain drug on formulary. The amount that that payor will actually pay the drug company will depend upon the performance of patients that are on that treatment.” Another example he shared is a recent drug that may potentially be able to cure a form of pediatric cancer. They are in the process of entering into agreements where, if the patient is not still alive after treatment or doesn’t show progress after a year, the company will reimburse the full cost of the drug, he said. 

Thomas Sullivan, founder and president of medical education company Rockpointe Corp., added that it’s also important to keep in mind that this trend is affecting more than just Medicare and other U.S. government programs—private payors also are embracing it.

“Part of our job as educators is to teach physicians, nurse practitioners, physician assistants, and other healthcare providers—basically the whole system—how to deliver this value of care,” he said. “That’s really the role of the meetings. How do we use parts of our meetings to teach not just the science, but also how the science applies to improving the value of care so they don’t lose out on the reimbursement that this train is moving towards.”

MIPS Payment Paths
To drive doctors under Medicare to practice the kind of medicine that will result in better quality rather than simply more services, MACRA provides two payment paths for doctors. One provides higher Medicare reimbursements for doctors who take part in what’s called an “alternative payment model”—a universal service healthcare provider system that only applies to about 5 percent of doctors currently. 

The second path is called MIPS, which stands for the Merit-Based Incentive Payment System. Under MIPS, starting in 2017 doctors are encouraged to begin to participate in the QPP, Quality Payment Program, by either receiving demerits and reductions, or bonuses in reimbursements, based upon their performing a certain quality measure or participating in improvement activities that are approved by CMS, said Rosenberg.

“All of a sudden, doctors who want to see their reimbursement level stay steady, if not increase, are going to become very attuned to how to practice medicine in such a way that they are meeting the goals CMS is providing,” he said. “By the way, this is all going to ramp up over the next couple of years. This was CMS’s effort to allow doctors to begin to test the waters and learn how to use this system to get credit. I don’t have to tell you that doctors have reacted, by and large, with concern about how to participate in this.” 

Doctors had four main options to get there.
  1. Penalty Avoidance. Between January 1 and October 2 of 2017, doctors had to provide 90 days of data to avoid penalty under their current Medicare reimbursement level. To do that, they need to have performed one CMS-approved quality measure, one clinical practice improvement activity, or five required advancing care information measures, and submit the data by March 31, 2018.
  2. Delayed Start. The submission due date for this option is also March 31, 2018, and it is also based on 90 days of data collected between January 1 and October 2, 2017. The requirements include doing at least one quality measurement, and at least an improvement activity and/or five advancing care information measures. While it does require more work—“They have to demonstrate that they’ve checked more boxes”—physicians can increase their reimbursement from between 2 percent and 4 percent under Medicare, said Rosenberg. 
  3. Ready to Go. If doctors have done six quality measures over this same time period, and four general improvement activities or two for small, rural, Health Resources and Services Administration, or non-patient-facing improvement activities, they can receive as much as 4 percent above what they normally would receive, he said.
  4. There is a fourth option that is even more advantageous for that 5 percent in the Alternative Payment model.

“Over the coming years, these are only going to ramp up and up with greater and greater incentives for doctors to follow the improvement activities and quality measures that CMS is laying out for them,” he said.

While doctors have a number of different boxes they’ll need to check to hit these different tiers of reimbursement, Rosenberg said, “What’s important for us is that starting in 2017, going all the way through 2021, 15 percent of their score will depend on whether or not they are meeting the CMS expectation of performance of improvement activities.” 
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The CME Angle
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CMS identified more than 90 improvement activities ranging from participation in Patient-Centered Medical Home care-delivery model to extra office hours. But how to get CME into the mix?

A CME working group that includes the Accreditation Council for CME, the Alliance for Continuing Education in the Health Professions, the American Medical Association, the American Academy of Family Physicians, the Council of Medical Specialty Societies, and other medical specialty societies got together to design and submit a proposed medium-weighted improvement activity for quality-improvement CME. 

According to Sullivan, “We said, ‘Hey, we need to have an improvement activity that includes CME, because they’re not going to be implementing something that they’re not getting credit to learn how to do, especially because it takes so much time to learn how to do it.’ We’ve gotten together and worked with CMS to get that approved.” It was adopted by CMS in the proposed rule in June; the final MACRA rule for 2018 was released on November 2. The improvement activity we proposed was adopted as written.  

For CME activities to be considered an improvement activity, they have to address a quality or safety gap that is supported by a needs assessment or problem analysis. The activity also must have specific measurable aims for improvement, or outcomes. Sullivan added, “You must have a measurable aim, such as lowering A1C in diabetics by one percentage point.” The activity also has to include interventions intended to result in improvement, collect and analyze performance data to assess the impact of the interventions, and it must define what constitutes meaningful clinical participation.
​

“Basically, MACRA is really about data and measurement,” said Sullivan. “We’re teaching physicians how to use their own data for clinical quality improvement.” The MACRA QI CME activity can be combined with other improvement activities, such as data registry and some claims data activities, he added. “It can count towards other things and contribute up to 40 percent of a physician’s composite performance score for earning more than the fee schedule reimbursement.” These activities also can qualify for Maintenance of Certification Parts 2 and 4.

“For the first time, physicians will get credit for learning how to do what the government has told them that they absolutely need to do—and what are other payors are going to be asking for in the future.” 

Note: The Quality Payment Program final rule with comment period (CMS-5522-FC and CMS-5522-IFC) can be downloaded from the Federal Register here. 
​
For a fact sheet on the Quality Payment Program final rule with comment period, please visit cms.gov. 

VIDEO: CME COALITIONS ANDREW ROSENBERG AND TOM SULLIVAN DISCUSS CME AND PHYSICIAN PAYMENT

5/26/2017

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On Tuesday, myCME's David Azevedo caught up with Andy Rosenberg and Tom Sullivan of the CME Coalition to discuss the latest developments related to MACRA and CME . “I think there’s an openness in the government to make things easier for physicians to get credit for the work they are doing,” noted Sullivan in the interview. "If I’m going to participate in a quality improvement program, that should qualify as quality improvement.” Rosenberg went on to comment that he is “hopeful” now that CMS has opened up the process to reconsider new measures. “I’m very bullish on our long-term chances of eventually getting them to recognize a role for CME in MIPS," he said.
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​Under the new Merit-based Incentive Payment System (MIPS), physicians will be reimbursed based on composite score, which reflects their performance in a number of defined areas, including "clinical practice improvement activities" (CPEA). The Coalition contends CME should be recognized as a clinical practice improvement activity within MIPS because CME has long been recognized as a means by which physicians demonstrate engagement in continued professional development. This encourages physicians to develop and maintain the knowledge, skills, and practice performance that leads to optimal patient outcomes. Additional information is available here.
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POLICY AND MEDICINE HIGHLIGHTS CME COALITION PARTICIPATION IN FDA MEETING ON SAFE OPIOID USE

5/26/2017

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On Tuesday, the CME Coalition was featured in an article by Policy and Medicine for its participation in the May 9-10 Food and Drug Administration (FDA) public meeting on the training of healthcare providers on pain management and safe use of opioid medication. CME Coalition’s Andrew Rosenberg and Tom Sullivan provided comments at the meeting to reinforce that education is a valuable tool in combating the opioid epidemic. “To encourage clinician's to participate in the Opioid REMS, the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program,” the article notes. The piece also goes onto acknowledge the value and importance of continuing medical education as an asset in reducing overdose deaths due to opioids.

​The article in its entirety can be read below. 
FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics

In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.
Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.
On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals.
In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them.
The FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017) lists draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The proposed Blueprint broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The draft also provided context for discussions at the public meeting.
Electronic or written comments to the Blueprint may be submitted by July 10, 2017.
The 2017 public workshop on May 9 and 10 attempted to build on one of the requests outlined in that RFI: the request for suggestions of additional activities HHS and its federal partners can implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.
The workshop had three main goals. First, participants discussed the role that health care provider training plays – within the broader context of ongoing activities – to improve pain management and the safe use of opioids. Second, participants commented the best way to provide health care providers who prescribe or are directly involved in the management or support of patients with pain appropriate training in pain management and the safe use of opioids. Finally, participants discussed various issues and challenges that are associated with possible changes to federal efforts to educate health care providers on pain management and the safe use of opioids.
Opening Session
During the opening session, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the extent of opioid prescribing and considerations in addressing prescriber training. She said that there are 200 million prescriptions for opioids dispensed annually, contributing to a “surge in opioid-related substance abuse disorders.”
Dr. Woodcock said that historically, “the liabilities of prescribing opioids were minimized” for an “entire generation of prescribers.” She cited alternative modalities, such as physical therapy and cognitive and behavioral therapy, and said the selection of a pain treatment modality should be a “sophisticated decision that weighs costs and benefits.” She noted that although opioids will remain a “mainstay in many situations,” including acute trauma, there should be a “renewed understanding that any opioid prescription confers risk.”
Dr. Doug Throckmorton, CDER’s Deputy Director for Regulatory Programs, said the meeting would focus on improving prescriber education while continuing access to appropriate treatment. He said healthcare worker education is a part of the FDA’s Opioid Action Plan. He pointed to a variety of inter-agency efforts, such as the Department of Health and Human Services’ multi-pronged opioid plan, the Surgeon General’s efforts, National Institutes of Health Centers of Excellence in Pain Education, and Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines.
Veterans Affairs Experience
Dr. Bernie Good, Chair of the Medical Advisory Panel for Pharmacy Benefits Management at the VA, provided an overview of the VA’s efforts to ensure appropriate prescribing of opioids and combat opioid abuse. He said that in 2000, the VA mandated pain as fifth vital sign, encouraging veterans’ feedback on their pain severity. Approximately 30,000 VA prescribers had written at least one opioid prescription and the thought was that if veterans have to provide regular feedback on their pain severity, perhaps less prescriptions would be written.
In 2014, the VA started an academic detailing programs on opioid medications involving one-on-one meetings between a clinical pharmacist and prescriber. The VA has 285 academic detailers, and 10,436 clinical staff have been detailed. Dr. Good said that there has been a 58 percent reduction in high-dose opioid prescribing among those receiving detailing compared with 34% reduction among those without detailing.
Dr. Good noted that VA providers have mandatory training on opioids and that as part of the VA’s Opioid Safety Initiative, the VA distributes individualized prescriber and regional reports and identifies high-risk patients.
Risk Evaluation and Mitigation Strategies (REMS) Options and Considerations
Doris Auth, Acting Director of the FDA’s Office of Medication Error Prevention and Risk Management, discussed options and considerations for using FDA REMS authority under Federal Food, Drug, and Cosmetics Act (FFD&CA) to assure prescriber training on opioid medications. She noted that REMS can have elements to assure safe use and can be restrictive or non-restrictive.
She provided examples of how prescriber education could be required under REMS. For instance, the acne drug isotretinoin has a REMS known as the iPLEDGE program to prevent fetal exposure and reduce the risk of birth defects. It requires informing providers and patients about the risk of fetal exposure, initial documentation of a negative pregnancy test, pharmacy authorization from the REMS program, a medication guide with each prescription, a voice or web-based authentication prior to dispensing, patient enrollment and informed consent, an ongoing monthly negative pregnancy test for female patients, and other dimensions.
Ms. Auth reviewed a potential structure for an opioid REMS involving training. She said there could be:
  • No patient enrollment or patient-specific requirements; and
  • Required prescriber training prior to dispensing.
She believes that such a program would be quite a bit larger than any existing REMS and at least double the size of the current extended-release/long-acting opioid REMS. If pursued, it would involve ninety manufacturers, some of which would have multiple products.
Andrew Rosenberg, JD with the CME Coalition, Thomas Sullivan of Rockpointe and others gave comments at the meeting to reinforce that education is a valuable tool in fighting the opioid epidemic.  To encourage clinician's to participate in the Opioid REMS the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program.
Overall the value of continuing education in the REMS program is perhaps the most valuable tool that the government and others can engage to help reduce opioid deaths.
Posted by Thomas Sullivan - Policy & Medicine Writing Staff at 05:02:00 AM in FDA, Opioids, REMS
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POLICY AND MEDICINE: OPEN PAYMENTS HAVING AN ADVERSE EFFECT ON PHYSICIAN-REP RELATIONSHIPS

11/2/2016

 
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​An article published in Policy and Medicine shows that since the release of Open Payments data, the percentage of physicians who do not allow access to medical industry salespeople have begun to increase. However, author Tom Sullivan argues that the increasing no-access rate might not be very beneficial for physicians. "Such high rates of no-access may not be the best thing for the health care industry as a whole" he writes. "Such visits from drug and device reps can be beneficial to doctors and their staff, as it provides a time for them to ask questions of the rep to see if the offered device or prescription is a good fit for any of their patients."

Open Payments Having an Adverse Effect on Physician-Rep Relationships

Open Payments, a program created by the Physician Payments Sunshine Act (part of the Affordable Care Act) has started to come between drug representatives and physicians. For quite some time, physicians and pharmaceutical reps have had a warm relationship, with the latter coming to the offices of the former, bringing food, small gifts (i.e., pens), and educational material.

The relationships between reps and physicians started to come under scrutiny prior to the first release of Open Payments data, which keeps track of payments drug and device companies make to physicians and teaching hospitals for things like travel, research, gifts, speaking fees, and meals. The data also includes ownership interests held by physicians or their immediate family members in drug and device companies.
Since the release of Open Payments data, many studies have been done, purporting to show a negative link between the relationships pharma and physicians have. Myriad negative press followed those studies, making doctors and pharma out to be bad people for their interactions. We have written many times on the subject, including why we feel as though the relationships between doctors and pharma can actually be beneficial.

Now, however, it seems as though the bad press the relationships received is starting to have an effect. According to a new survey by SK&A, the percentage of physicians who do not allow access to medical industry salespeople has grown to 36.5% in 2016, up from just 22.9% in 2010.

Interestingly, for physicians employed by hospitals and health systems, the no-access rate tops 50%. This may be in part because physicians working for such employers tend to not make their own rules on seeing drug reps, the employers do.

The study also found that the ability of drug reps to get inside a physician’s office varies considerably by region. The no-access rate is highest in the West and lowest in the South. The state with the highest rate of physicians not granting access to drug reps is Vermont, with 63.7%, while the lowest state is Mississippi, with only 24.6% of its physicians denying access to drug reps.

The survey did find one trend that seems to run counter to the rest of the results, however: as the no-access rates increase, the requirement for appointments seems to be trending downward. The percentage of those who don’t require, or prefer, an appointment with a rep has fallen, from 49.8% in 2010 to 35.2% in 2016.

Such high rates of no-access may not be the best thing for the health care industry as a whole. While we do not think that physicians should look to pharma for lavish dinners out or speaking fees at events that don’t exist, we do believe that physicians should not feel like they are being blacklisted because a rep comes to visit their office and brings Papa Johns for the office. Such visits from drug and device reps can be beneficial to doctors and their staff, as it provides a time for them to ask questions of the rep to see if the offered device or prescription is a good fit for any of their patients.

INSIDE HEALTH POLICY: PHYSICIAN GROUPS PUSH SENATE BILL WAIVING CME FROM SUNSHINE REPORTING

7/19/2016

 
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Today, Inside Health Policy reported on a letter sent by the American Medial Association (AMA) and other medical groups urging passage of Sen. John Barrasso's (R-WY) legislation (S. 2978) that would exempt continuing medical education (CME) activities from Sunshine Act reporting requirements. As the article notes, a Centers for Medicare and Medicaid Services (CMS) interpretation of the Physician Payments Sunshine Act has deemed that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of those articles are not directly beneficial to patients - and are therefore subject to reporting requirements. The physician groups note that the interpretation is "inconsistent with the reality of clinical practice" and that Sen. Barrasso's legislation would "ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge." 
​The CME Coalition has also spoken out against the CMS interpretation, and conducted research showing that 98 percent of public comments on the proposal support maintaining the exclusion or expanding it. 

The full article can be found below.

Physician Groups Push Senate Bill Waiving CME From Sunshine Reporting

​​The American Medical Association, joined by dozens of specialty groups and state medical societies, has thrown its support behind a Senate bill that would exempt certain continuing medical education from Sunshine Act reporting requirements. The groups say passage of the bill is urgently needed because CMS has already "chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals" and appears ready to also stifle access to independent certified and/or accredited CME.
 
The groups recently wrote to bill sponsor Sen. John Barrasso (R-WY) saying his measure "would protect the dissemination of peer and independent third-party reviewed services and products that improve patient care." The legislation is important, the groups say, because evidence-based medicine is facilitated by a practicing physician's ability to look at independent peer-reviewed journals, medical textbooks, and independent continuing medical education.
 
They say the bill's clarification that CME meeting the standard for independence must be exempt from Sunshine Act reporting has become necessary due to contradictory guidance from CMS that required several revisions to subregulatory guidance. "Adding to the concern, a recent New England Journal of Medicine article, which was co-authored by current and former CMS staff, says that 'payments related to all accredited CME activities must be reported beginning in 2017.' This statement only adds to the confusion surrounding the status of independent CME as it relates to Open Payments reporting," AMA and the other physician groups write to Barrasso.
 
Congress, when it first took the Physician Payments Sunshine Act, specifically intended to exclude independent sources of clinical information from sunshine reporting requirements, according to AMA and the specialty groups. The Sunshine law was created to promote transparency about payments and other financial transfers of value between physicians and the medical product industry. Congress wrote into the law 12 exclusions from the reporting requirements, including for "[e]ducational materials that directly benefit patients or are intended for patient use," according to the groups.
 
But CMS has interpreted the statute to mean that medical textbooks; reprints of peer-reviewed scientific clinical journal articles; and abstracts of these articles are not directly beneficial to patients, nor are they supposed to be for patient use.
 
"This conclusion is inconsistent with the reality of clinical practice where patients benefit directly from improved physician medical knowledge and is not supported by the statutory language on its face or congressional intent," the physician groups tell Barrasso.
 
The agency defended its policy in a proposed Sunshine rule, saying the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturers are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made. In 2014, the CME Coalition, which opposes CMS' proposal to do away with the continuing medical education exclusion as part of the Open Payments Act, said the overwhelming majority of comments to the agency ask the agency to keep or expand the CME exemption. The CME Coalition says it went over the more than 800 comments submitted on CMS' proposal in the 2015 Physician Fee Schedule and found that 820 -- or 98 percent -- of the comments support keeping the exclusion or expanding it, while "approximately 20" comments support the agency's proposal.
 
The physician groups say Barrasso's bill, the "Protect Continuing Physician Education and Patient Care Act" (S. 2978), would protect the circulation of peer and independent third-party reviewed services and products.
 
"This legislation would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive," the groups say.
 
They add: "Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for physicians to remain informed about the latest in medical practice and patient care. Independent, peer-reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."
 
The groups also note that 2009 FDA guidance, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," shows the "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."
 
CMS released 2015 Open Payments data last Thursday (June 30), but the AMA said because of data errors and registration challenges during the past two years, physicians have shied away from participating in the review and validation process.

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