Sept. 4, 2012 – According to a recent article posted on Pharmalot.com, the pharmaceuticals industry is spending more on outcomes research. “Enabled by better research methods and driven by payer demands, better outcomes research can drive better clinical decision-making and, best of all, better patient care,” said Coalition for Healthcare Communication Executive Director John Kamp.
“Better health will advance quickly if this new spending shifts the existing reimbursement paradigm away from generalized study data and toward more personalized medicine and reimbursement,” he noted, “but that remains to be seen.”
The Pharmalot article, which quotes metrics from a Cutting Edge Information survey report, entitled “Health Economics and Outcomes Research: Aligning Clinical and Commercial to Meet Payer Demands and Win Reimbursement,” states that at the 50 largest drug makers, spending levels on outcomes research “average $7.5 million, with budgets growing nearly across the board.”
“You’ve certainly heard, ‘location, location, location,’ when it comes to real estate,” said Center for Medicine in the Public Interest President Peter Pitts. “If you follow Microsoft you’ve heard, ‘developers, developers, developers.’ buy generic viagra And now, if you’re a believer in patient-centric reimbursement policies, there’s a new triad: ‘outcomes, outcomes, outcomes.’”
Overall, outcomes research spending for the 30 drug and device makers in different countries surveyed by Cutting Edge rose 42 percent from 2011, but those who stated they boosted spending this year actually reported a 66-percent spending increase in this area. Interestingly, small drug companies reported the largest spending increase: 79 percent.
Although receiving FDA approval for a drug is a key hurdle in bringing a drug to market, gaining reimbursement for that drug is becoming an obstacle of almost equal proportions, because without reimbursement, many patients will not have access to medicines that can help them.
“Reimbursement based on real-world patient outcomes is a giant step toward recognizing the importance of personalized medicine and the folly of basing reimbursement decisions on large-scale general population studies,” Pitts said. “Imagine reimbursement programs that actually help advance the four rights of 21st century personalized medicine – the right medicine for the right patient in the right dose and at the right time.”
Pitts also remarked that focusing on outcomes not only means that pharma companies “will have to put their money where their mouth is – but that payers will have to put patients first. Now that’s healthcare reform.”
To read the full Pharmalot article, go to: http://www.pharmalot.com/2012/08/pharma-spending-on-outcomes-research-rises/
April 12, 2012 – The Association of Clinical Researchers and Educators (ACRE) announced yesterday the publication of a study in Nature Biotechnology
showing that top-tier medical journals focus on the “supposed problems from academic-industry interactions and not on the benefits,” which results in a bias against such interaction. According to an ACRE press release, the study demonstrates that “there is scant original evidence supporting claims that the industry-physician relationship is harmful to patients as is often reported in the top four medical journals.” To read more, go to: http://www.prlog.org/11847021-study-finds-high-impact-medical-journals-guilty-of-anti-industry-bias.html
Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care Act – known as the “Sunshine Act” – to ensure that the data submitted under the Act are accurate and are placed in the proper context for public understanding, according to the Coalition for Healthcare Communication Sunshine Act Comment submitted to the Department of Health & Human Services (HHS).
“Although the Coalition understands the importance of transparency, there are numerous issues that need to be resolved – and further commented on by all stakeholders – if the rule is to fulfill its intended purpose,” said Coalition Executive Director John Kamp. “To get transparency right, the HHS must do a further notice on accuracy and context,” he asserted.
The Coalition is concerned that the current proposal would have a chilling effect on important collaborations between industry and healthcare providers, lead to unnecessary and significant complexities, increase costs and create public perception issues. These concerns “must be addressed fully before final rules are adopted,” according to the Coalition comment.
“Rubber-stamping the proposal as written would be a huge mistake that, ultimately, would hurt, rather than protect, patients,” Kamp noted, adding that the public perception issues are particularly important.
“It’s time for the press and some politicians to stop treating every reported payment as a newly uncovered scandal,” he said. “The real scandal is the demonization of collaborations between industry, academia and government. Collaboration has enabled the great medical breakthroughs that have added 10 years to the average American life in just a generation.”
In addition to the call for a further notice on accuracy and context, the Coalition’s comments focus on several areas needing additional refinement and review, and make the following recommendations:
- HHS should hone the rules to more accurately reflect the legislative intent and the specific language of the statute, and “narrow its burdens and reach” accordingly. The Coalition cites indirect payments and vital prescriber education as examples of how HHS has expanded its purview under the proposed rule.
- HHS should take a closer look at the costs associated with the proposal, including the significant cost of industry and provider compliance. The Coalition believes that HHS has underestimated the direct compliance costs and largely ignored the indirect “intangible costs of possibly misleading patients, caregivers and professionals regarding the nature and value of these relationships.”
- HHS should clarify explicitly in the final statement of the rule that commercially supported meetings and educational enduring materials are not intended to be covered by the statute and are not subject to any reporting requirement.
Further, because many details of the proposed rule are unknown, the Coalition is concerned that entities involved in the medicines industry will simply avoid many collaborative programs that provide healthcare providers with valuable professional education. Such a result “would harm, not help, patients,” Kamp said. “There is a lot more work to be done.”
Jan. 26, 2012 – Avoiding conflict of interest in continuing medical education (CME) may seem like a daunting task, but companies can produce high-quality CME programs that skirt commercial bias if they implement several key strategies, including peer review, according to a recent article in Medical Marketing & Media.
The article describes a newly released video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – which includes the views of prominent CME stakeholders.
In the video, Coalition for Healthcare Communication Executive Director John Kamp states that “Providers of CME are following the rules. And things are getting better all the time in this area because people are essentially educated.”
The video stresses that peer review is an important tool in both resolving conflict of interest and ensuring high-quality content, the MMM article states.
“Resolution of COI is really pretty easy,” Kamp said. “If someone has a conflict on something they’re speaking about, they disclose it. And we make sure, as much as possible, using peer review and other ways, that it’s not a biased review or use or suggestion on those drugs,” he added.
To read the full MMM article, go to http://www.mmm-online.com/video-reflects-struggle-to-keep-bias-out-of-cme/article/224031/
By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Jan. 17, 2012 – The Affordable Care Act (ACA), passed to improve America’s healthcare system and reduce its costs, included the “Sunshine” provision to create a national registry of payments and transfers of other items of value from healthcare manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals. Recently, the Centers for Medicare & Medicaid Services (CMS) released a Sunshine Act Proposed Rule to implement the provisions and is soliciting public comments to be considered before final rules are published later this year.
The Coalition supports the purpose behind the Sunshine provision of the ACA – the transparency of relationships between industry and health care providers – but is very concerned that the current plan for implementation by CMS will create unnecessary compliance burdens and defeat the purposes of cutting healthcare costs and improving patient care. The Coalition also is worried that the burdens imposed by the proposed regulations will dissuade healthcare providers from participating in continuing medical education (CME) and other important relationships with industry
After reviewing the proposed rule, the Coalition is troubled that the endpoint of the proposed rule may be a sea of granular information that could cost billions of dollars over the next 10 years. The taxpayers will bear both the direct costs of the government administration of the program and the indirect costs of compliance by the medicines industry. There is little evidence to suggest that the program will improve the healthcare system or control costs.
CMS Proposed Rule
CMS’ proposal to implement the law enacted by Congress is incredibly complex and detailed, illustrating the complexity of this transparency initiative. This complexity and the attendant costs of compliance should cause rational people to step back and question whether these rules really contribute to better healthcare or simply are another government mandate that is likely to create several unintended consequences that may end up harming patients.
The 120-page CMS document deals largely with the administrative aspects of implementing the regulation. Compliance will cost the companies, the government and, ultimately, patients and taxpayers, millions of dollars per year. In short, the intended policy is simple, but its implementation is wildly complex.
CMS Estimates of the Cost of Compliance
As required by law, the government must estimate the impact of new regulations. Some examples of the impact this regulation will have on healthcare entities are below. Understand that these are CMS estimates, not those of industry, so they may well underestimate the actual costs of compliance. According to CMS, the Sunshine proposed rule will:
- Cost manufacturers collectively $195 million in the first year and $148 million each year thereafter.
- Cost physicians $24,000 per year to monitor and review the required reports in the first year, and $13,000 each year thereafter.
- Cost the federal government, on average, $183 million per year to administer the program. (There is no estimate provided for cost of possible additional state disclosure requirements allowed under the provision.)
- Potentially add to CMS coffers funds from civil monetary penalties (CMPs) derived from prosecuting those who do not follow the fine print of the regulation. However, CMS provides no estimate on the expected revenue from CMPs.
There also are a number of practical implications that will result from the proposed rule, including:
- In certified CME programs, CMS would required providers of education supported by industry to report the value of the education provided for each attendee. Under current CME accreditation rules, company sponsors do not know who the attendees are and do not compute an economic value of the program for attendees.
- For all other education and research activities sponsored by medicine companies, the industry will now be required to value and report on each event. This will undoubtedly have a chilling effect on the number of physicians willing to participate in any sort of company-sponsored information exchange. While this may be the objective of many of the rule’s supporters, it could well wind up hurting patients.
- For the communications industry, there is the potential of significant additional burdens, many of which are unforeseen at this point.
Although the overall cost of this regulation is just a drop in the bucket in relation to the entire cost of delivering healthcare in the United States, this rule stands out like a sore thumb. While Congress is attempting to reduce costs, this new program adds costs without demonstrating value.
Aside from the Coalition’s general concern as good citizens about government regulation strangling our country’s progress, the Coalition is primarily concerned that the Sunshine program will drive a wedge between the medicines industry and healthcare providers. Companies have both a right and a responsibility to enable providers to have the best available information on medicines. If providers avoid industry-provided education, it will inhibit this sharing of information.
In summary, the Coalition supports transparency and will support efforts to achieve it. But we believe that the regulations should be clear, reasonable, and no more complicated than necessary.
As we have said many times, government is not a spectator sport. Federal law requires CMS and other agencies to provide opportunity for citizens to comment on proposed rules. Individuals and organizations wishing to comment on this regulation must do so by Feb. 17, 2012. The Coalition will be commenting and welcomes your suggestions on the specific topics that should be addressed. Members should also feel free to comment directly to CMS. If you need assistance, we will be delighted to provide it.
[Editor's note: Jack Angel can be reached at email@example.com or (203) 661-3314.]
Dec. 22, 2011 – As industry groups focus on the details of last week’s proposals from HHS to implement the Sunshine Act provisions of the Affordable Care Act, veteran journalist Cole Werble in PrevisionPolicy recently made a set of predictions on how Sunshine may change the marketing spend of the medicines industry.
Among several predictions, Werble states that “the added burdens and specific rules of the disclosure provisions will continue to nudge pharma budgets away from the broad dispersal of speaking and research funds for practitioners and towards other forms of spending.”
The article highlights key provisions in the proposed regulations that will have an impact on pharma marketing and calls out pitfalls in the proposal.
Meanwhile, the Coalition for Healthcare Communication and other industry groups are sharing information and coordinating efforts to provide robust comments to HHS on many of the details in the Notice of Proposed Rulemaking published Dec. 19 in the Federal Register.
“While HHS wisely decided to postpone implementation, there are several devilish details in the proposed rules,” explains Coalition Executive Director John Kamp. “For example, the proposed rules inappropriately expand the scope of the statute, sweeping in activities not intended by Congress. In particular, many indirect payments to doctors for REMS and certified CME should not be included.”
Many of the relevant details in the proposal are outlined in the Medical Policy Blog published by Thomas Sullivan of Rockpointe Communication: http://www.policymed.com.
For more information on the proposed rule and to join the industry discussion on how to effectively participate in the HHS rulemaking process, contact John Kamp at firstname.lastname@example.org. Comments must be sent to the Centers for Medicare & Medicaid Services by Feb. 17, 2012.
Dec. 1, 2011 — Amidst budget cuts for nearly all other federal programs, the FDA received increased funding for the coming fiscal year, in large part due to “an unusual alliance of consumer advocates and industry groups,” according to a recent blog posting on The Washington Post Web site.
Blogger Dina ElBoghdady writes that the agency’s overall funding in the newly passed agriculture spending bill is up 3 percent from last year’s level of $3.8 billion. Consumer and industry groups pushed for a boost in FDA funding to implement “a landmark food safety bill adopted by a previous Congress.” Funding for that program received $39 million – the largest portion of the increased funding.
The Nov. 30 posting outlines how food groups and consumers came together to further mutual goals and demonstrates the importance of alliances between regulated industry and the public it serves. The Coalition for Healthcare Communication is an active member of the Alliance for a Better FDA, the group that coordinated the funding support effort.
“While we reserve the right to quibble around the edges, adequate funding for FDA is essential for every U.S. citizen and every industry it regulates,” said Coalition Executive Director John Kamp.
To view the full blog entry, go to: http://www.washingtonpost.com/business/economy/fda-funding-boosted-through-lobbying-effort/2011/11/23/gIQAXHQ6CO_story.html
Nov. 22, 2011 – Stating that “a robust dialogue” between pharmaceutical companies and the public “would be seriously chilled” if the U.S. Court of Appeals for the Ninth Circuit upholds the 2009 criminal conviction of former InterMune CEO W. Scott Harkonen for allegedly making false statements about Actimmune in a press release, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed an amicus or “friend of the court” brief in support of Harkonen’s appeal.
“The Coalition welcomes PhRMA’s participation in this case,” said Coalition for Healthcare Communication Executive Director John Kamp. “The PhRMA brief demonstrates widespread industry support for forcing federal and state law enforcers to recognize the value of industry communication in managing patient health and the power of the recent Supreme Court decision in Sorrell v. IMS Health to defend against these cases.”
The PhRMA brief asserts: “This case concerns an unprecedented prosecution of a pharmaceutical executive for expressing in a press release his scientific opinion about the development of a drug to treat disease. An affirmance of the decision … would threaten core First Amendment principles by establishing that scientific debate over how to interpret data can constitute a crime.”
PhRMA’s brief calls out the following points:
- The press release in question was not a misstatement of objectively verifiable fact, a trigger for criminal liability;
- The trial court unconstitutionally permitted the jury to find that the press release was false “not because no reasonable scientist could have reached the conclusion drawn, but because some scientists, mainly those of the [Food and Drug Administration (FDA)], disagreed with that conclusion”;
- The trial court’s approach violated the First Amendment because a person “may not be convicted for fraud based upon speech about scientific matters unless the level of scientific consensus is such that no reasonable expert could find the defendant’s statement to be true.”
The amicus brief reiterates the Supreme Court decision in Sorrell, which “confirmed that pharmaceutical manufacturers’ communications with doctors about the safety and efficacy of drugs fall within the First Amendment ambit.” PhRMA then states that “the courts should be particularly leery of a government’s attempt to criminalize speech concerning ‘the effectiveness of [a] particular method of treatment of disease.’”
“Sponsor companies have the best information available on the safe and effective use of their drugs,” according to the Coalition’s Kamp. “Systematically eliminating their participation in discussions with healthcare professionals harms patients. It’s time for government to rationalize these rules in court.”
In addition to the Harkonen appeal, other cases that the Sorrell decision may impact in the near future include:
- U.S. v. Caronia appeal: Alfred Caronia claims that FDA’s limitations on speech regarding off-label uses violated the First Amendment. The U.S. Court of Appeals for the Second Circuit requested additional information following the Supreme Court’s Sorrell decision.
- Par Pharmaceutical Inc. v. FDA: Par seeks to preserve its First Amendment right to provide truthful information to physicians and other healthcare providers about off-label uses. The case, filed with the U.S. Court of Appeals for the District of Columbia Circuit, calls into question the FDA’s authority to censor truthful speech by drug sponsors.
- An appeal by three former Purdue Pharma executives who pled guilty to misbranding charges regarding off-label marketing, is slated to be heard Dec. 6 by the U.S. Court of Appeals for the District of Columbia Circuit. The former Purdue executives are appealing their exclusion from federal health care programs.
“There is no doubt that Sorrell empowered companies and industry advocacy groups to question the government’s authority when it attempts to chip away at the protections afforded speech by the First Amendment,” Kamp said. “We applaud PhRMA for getting involved.”
By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Nov. 14, 2011 — In response to Opioid prescription drug misuse in this country, the FDA recently released a draft “blueprint” on the basic elements to be included in REMS (Risk Evaluation and Mitigation Strategies) educational programs required of the manufacturers by the FDA.
The guidelines set forth “core messages” intended for use by CME (continuing medical education) providers to develop educational materials for prescribers of long-acting and extended-use opioids. This Blueprint for Prescriber CME is a good foundation for what the FDA wants to accomplish, but raises questions that need to be addressed by the CME community.
In describing how CME providers “will conduct prescriber education” in a Nov. 7 Federal Register notice, the agency stated the following:
“The REMS notification letter expressed FDA’s expectation that the training would be conducted by accredited, independent continuing education providers. FDA later elaborated on its vision for prescriber education stating that we expect the CE training to be provided without cost to the healthcare professionals and that sponsors would offer unrestricted grants to accredited CE providers to develop CE for the appropriate prescriber groups.”
The concern on the part of the CME community is whether the regulated industry’s involvement in the process violates the basic tenets of certified CME. Although the new guidelines likely will generate greater commercial support for certified CME, many in the CME community are fearful of undermining the independence of certified CME providers, a significant industry self-regulation advance over the past decade.
The Coalition for Healthcare Communication strongly supports the provider independence principles. Moreover, it also is dedicated to the thesis that truthful education and industry communication contribute greatly to more effective and efficient healthcare delivery. Industry collaboration is key to advancing patient care through education of doctors and other healthcare professionals.
So, the question here is how do we support these principles while helping to address a pressing national emergency? It seems to make sense for the stakeholders to put their heads together to figure out a way to assist the government by utilizing information, talents, and resources that it may not have. In our view, everyone wins with this effort.
The government is seeking comment on this blueprint and the Coalition intends to weigh in. What do you think? Let us know.
Oct. 4, 2011 — According to a recent article posted today on the Policy and Medicine Web site, the authors of the Physician Payments Sunshine Act – Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.) — have sent a letter to Centers for Medicare and Medicaid Services Administrator Donald Berwick expressing their “severe disappointment” that proposed regulations to implement the Sunshine Act were not issued by Oct. 1, the deadline imposed by the Affordable Care Act.
To read the full article, which describes the Grassley/Kohl letter, provides details on the Sunshine Act provisions and discusses what the future may hold for these regulations, go to: http://www.policymed.com/2011/10/physician-payment-sunshine-act-cms-misses-deadline-creating-confusion.html
As always, feel free to leave comments on this important issue below.