May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of a First Amendment lawsuit by affected parties” if it does not consider medical textbooks to be “educational materials that directly benefit patients” which are excluded from a reporting requirement under the final rules implementing the Physician Payment Sunshine Act, according to a May 15 letter to CMS from the Washington Legal Foundation (WLF).
In its letter (CMS Textbook Policy), WLF asks CMS to delay application of reporting requirements to medical textbooks until it has had an opportunity to examine the First Amendment implications of including these items as “transfers of value” from manufacturers to doctors.
Coalition for Healthcare Communication (CHC) Executive Director John Kamp remarked that the WLF letter “is strong, balanced, nuanced and likely to be effective. Indeed, if WLF convinces CMS to reverse itself on textbooks, the same reasoning applies to journal supplements, reprints and Website publications that are distributed with company support.”
Specifically, WLF contends the following in its letter:
- The distribution of medical textbooks is speech protected by the First Amendment;
- Although CMS is not banning speech, it is substantially burdening speech (and such burdens are subject to First Amendment constraints);
- The Sunshine final rule’s disclosure requirement imposes a substantial burden on the right to speak by distributing medical textbooks;
- Application of the Sunshine Act to medical textbooks does not serve any substantial government interests; and
- CMS can avoid First Amendment difficulties by construing the Act as inapplicable to medical textbooks.
“Applying the reporting requirements to medical textbooks would constitute a serious infringement on the First Amendment rights of pharmaceutical companies to disseminate medical texts and the First Amendment rights of doctors to receive such information,” WLF Chief Counsel Richard A. Samp wrote in the letter to CMS Acting Administrator Marilyn Tavenner.
“The U.S. Supreme Court has repeatedly held that disclosure requirements of this sort [imposed by the final rule] are subject to ‘exacting scrutiny’ and can pass muster under the First Amendment only if shown to serve important government interests that outweigh the burdens they impose on speakers,” the letter states.
The WLF also states that the burden of reporting and doctors’ concerns about being included on a list of those receiving payments from drug companies will cause doctors to decline offers of medical textbooks and cause companies to cease disseminating them. Because medical textbooks communicate truthful information that helps doctors treat patients, the WLF asserts that they are fully protected by the First Amendment, as demonstrated by multiple U.S. Supreme Court decisions. “By all accounts, medical textbooks supplied by drug companies to doctors ‘directly benefit patients’ – doctors regularly use information gleaned from the textbooks in their treatment of patients,” according to the WLF.
As further evidence that medical textbooks constitute protected speech under the First Amendment, the WLF states that its 1998 lawsuit against the Food and Drug Administration (FDA) resulted in the FDA being subject to a permanent injunction limiting FDA authority to suppress manufacturer dissemination of medical textbooks discussing off-label uses of their FDA-approved products.
“There is little evidence that Congress intended to single out textbook dissemination and other expressive activities for special disapprobation, but the effect of the Act (as interpreted by CMS) is to burden this expressive activity to such an extent that much of the activity will cease,” the WLF letter states. Samp concludes the letter by stating that “in light of the grave constitutional issues raised by CMS’s rule, courts will not defer to CMS’s reading of the Act … even if they deem it a plausible reading,” and advises CMS to reconsider and allow these educational materials to be excluded from reporting requirements.
“Exempting these as educational items not only makes sense under the Sunshine Act, it makes great public policy sense,” CHC’s Kamp said. “Informing doctors about the latest science and practice guidelines drives improved patient care. Everyone can salute that result.”
May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to note that many physicians and investigators still are unaware of the regulation, a majority are not in favor of making information about physician-industry financial relationships available to the public, and a small percentage would consider not engaging in clinical trials to avoid a perception that they are too involved with one sponsor.
A recent study conducted by Industry Standard Research (ISR), “Sunshine Act: Pharma Impact – Changes in U.S. Physician Behavior,” found that physicians are worried that the Sunshine Act will have a negative effect on their practice. ISR surveyed physicians and other stakeholders affected by the Sunshine Act. Of 103 physician respondents, 74 percent said they were not in favor of sharing these data; 18 percent of the 100 investigators surveyed said they would stop participating in some clinical trials if they started to do “too many” trials for one sponsor, as reported in a recent article in Policy and Medicine (http://www.policymed.com/2013/05/physician-payment-sunshine-act-principal-investigators-and-primary-care-physicians-largely-unaware-of-regulation-1.html).
“If physicians are concerned that interacting with the pharmaceuticals industry has a negative connotation, there could be a chilling effect on those relationships, which are vital to the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “The Sunshine Act is supposed to lend transparency to these relationships, not undermine them.”
Although the report states that “few physicians believe the rule will have an impact on how they treat patients,” 38 percent of physicians and surveyed say that they are not at all familiar with the Sunshine Act and 23 percent of principal investigators surveyed state that they have never heard of the Sunshine Act.
As part of the study, ISR researchers evaluated physicians’ frequency of use and the value they place on specific communications channels, as well as which channels might be less likely to be used following Sunshine Act implementation. “While the channel expected to be impacted most significantly is ‘group/practice-level detail sessions’ where doctors and their staff typically receives free lunches, we did see a 12-percent drop in the level of interaction expected across all ‘in-person’ activities,” said Andrew Schafer, ISR president.
Indeed, the report states that the Sunshine Act “will have a dramatic impact on the ability of pharma sales representatives to frequently detail physicians, both one-on-one and in a group setting.” The report adds that although 47 percent of physicians indicated that they participate in a group detail on a weekly basis currently, only 30 percent said they plan to continue this practice after the Sunshine Act requirements kick in.
Interestingly, 71 percent of physician respondents stated that they expect pharmaceutical companies to inform them of the value of a service or benefit prior to it being offered to them. However, even though physicians are worried about the potential negative publicity surrounding their interaction with pharma companies, they “mention that they use pharma sales representatives as a key source of information for new medicines and treatments.” One physician quoted in the report said the Sunshine Act rules “will reduce availability to new information about existing and new products.”
“These findings support the fact that industry needs to do all it can to ensure that context regarding the industry-physician relationship is provided and included in press reports about the data that ultimately will be made public,” Kamp said. “The Coalition raised this issue in comments to the Centers for Medicare & Medicaid Services, and we cannot stress enough that getting this point across will make a huge difference in the public’s perception of this information. We have to make clear that these relationships are crucial to keeping physicians informed and to ensuring that patients receive the most effective treatments for their conditions.”
For details on the ISR survey report, go to: http://isrreports.com/industry-reports/sunshine-act-pharma-impact-changes-in-us-physician-behavior
Oct. 29, 2012 – A recent op-ed piece in Forbes about the federal government’s sponsorship of “academic” detailing reiterates what industry proponents have been saying for some time: This government program may “gloss over the fact that less-expensive treatment options that are effective for most patients often won’t work for some of them,” and “can be harmful to patients who don’t respond to medicine in the same way as a majority of patients.”
“Bringing widespread attention to this issue, which is likely to result from this op-ed in a major publication, is vital to ensuring that there is not a double standard for the biopharma industry, whereby the industry’s hands are tied but the government gets a helping hand and patients have reduced access to drugs that can really benefit them,” said Coalition for Healthcare Communication Executive Director John Kamp.
The Oct. 24 Forbes article, authored by Henry I. Miller and Jeff Stier, states that a House Appropriations subcommittee has voted to support legislation that would eliminate funding for the Agency for Healthcare Research and Quality (AHRQ) and therefore put an end to the AHRQ’s academic detailing program. The program, which sends government representatives into the offices of healthcare providers “to offer a supposedly more disinterested viewpoint,” … “sounds good in theory, but a glaring lack of transparency in the program makes it hard to know how it functions in practice,” the article states.
Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, has been critical of academic detailing from the start. In his view, the program, which “is not academic detailing or government detailing, but counter detailing, is ill-advised and poorly constructed.”
Pitts told the Coalition that two significant problems in the program lead to an unlevel playing field:
(1) The government can offer free continuing medical education credits as enticements for scheduling appointments with government detailers (which cannot be offered by industry); and
(2) Government program materials do not have to be vetted by the Food and Drug Administration (FDA), even though industry materials are subject to FDA review.
“The ACCME has stated that the federal government has
no conflicts warranting greater transparency, even though it is the largest payer of health care technology,” Pitts said. “That’s like saying an insurance
company has no conflicts and it’s just the wrong position.”
In an article published earlier this year in the Drug Information Journal, Pitts stated that the government program’s supposed goal of cutting costs has not been proven, noting that “a strategy that’s good for payers” often is “bad for patient outcomes.” The program and other policies like it “are pernicious to both the public purse and the public health,” Pitts wrote. To view the full Pitts article, go to: http://media.drugwonks.com/media/attachments/501e56cc2017a8354f00001e.pdf?1344165580
Miller and Stier underscore this point: “The program is plagued by the same sort of conflict of interest as drug detailers, just in reverse. The law exempts the feds from the same transparency standards applied to the drug industry.”
The authors also cite concerns about several issues: the government failing to note that drugs may be metabolized differently by certain individuals; a lack of reporting requirements for government detailers; and a lack of transparency. The government’s agents “should have to abide by the same degree of scientific oversight and transparency standards demanded of others,” they state.
Pitts is pleased that the Forbes authors have taken up this issue. “I am glad there are now more voices in this argument,” he said.
To view the Forbes article, go to: http://www.forbes.com/sites/henrymiller/2012/10/24/a-lack-of-government-transparency-the-devil-in-the-detailing/
May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for a program on academic detailing and the “communication of CER results to physicians.”
One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education.
(TTM is a company that focuses on chart abstraction, data mining, and physician and patient education for a predominantly commercial client base – health plans, pharmacy benefit managers, employers, and pharmaceutical companies, etc.)
The goal of this contract is to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals.
I recently interviewed the Barry Patel, the president of TTM. Here are some snippets from our conversation:
How will the government decide which doctors are to be visited? Will “high prescribers” of on-patent medicines be on a priority list?
TTM’s top priority is “high volume” practices across 150 Metropolitan Statistical Areas (MSAs). So, rather than focusing on offices with disproportionately high negative patient outcomes, the government is directing its efforts against those doctors who are high prescribers – which is a pretty good indicator about what government detailing is all about – decreasing cost rather than improving care.
When it comes to government detailing (at the taxpayers’ expense), what are the metrics for success?
According to Mr. Patel, the only metrics are whether or not a physician says the sessions have been useful and asks the detailer to come back to discuss other topics. In other words, the metrics are subjective and anecdotal – not clinical.
Interestingly, Mr. Patel doesn’t even agree with either the term academic detailing or counter detailing. “We aren’t counter anything. We’re not there to undo anything. It’s not good versus bad. Our visits aren’t details, they’re the beginning of a process.” And, as far as “academic” goes, Mr. Patel uses that term because “that’s the phrase AHRQ uses and placed in the contract. Our people are patient-centered outcomes consultants, PCOCs.” And “his people” are largely pharmacists and nurses.
A former Merck employee, Patel likens his PCOCs more to pharmaceutical company Medical/Science Liaisons (MSLs) than field representatives. “They’re not discussing product-specific information, but the findings of comparative effectiveness studies.”
How does TTM schedule their appointments with targeted physicians?
According to Mr. Patel, when his “outreach experts” phone physicians to request appointments, the fact that the meeting will result in CME credits is always mentioned. Would a pharmaceutical company be permitted to offer such an enticement? Would such an offer be “sunshine-able” under state and federal guidelines? And, if so, why don’t government detailers have to share the details of their valued benefactions?
Interestingly, according to the Accreditation Council for Continuing Medical Education (ACCME), government is exonerated from having a commercial interest. (A commercial interest is any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients.)
Our nation’s single largest payer, Uncle Sam, is not deemed to have a conflict of interest when it comes to designing and providing physician CME.
What’s wrong with this picture?
[Editor’s Note: Peter Pitts is president and co-founder of the Center for Medicine in the
Public Interest. This article appeared May 3 on DrugWonks.com. Read more from Pitts on Government Detailing.]
March 19, 2012 – A new video produced by CME Peer Review – “Conflict of Interest: The Bottom Line” – features Coalition for Healthcare Communication Executive Director John Kamp and other continuing medical education (CME) experts who are moving ahead with strategies to minimize CME conflicts of interest.
Highlights of the video are discussed in a March 19 article in Policy and Medicine, where Kamp is quoted. In the article, Kamp states that CME stakeholders “have gotten the message” on conflict of interest disclosures and that “CME is the solution to many problems in our health care system because CME can help improve the delivery of efficient and effective health care to patients.” Read the full article and access the video by clicking on this link: http://www.policymed.com/2012/03/continuing-medical-education-and-conflict-of-interest-the-bottom-line.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 firstname.lastname@example.org 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 email@example.com. Comments must be sent to the Centers for Medicare & Medicaid Services by Feb. 17, 2012.
Dec. 15, 2011 – The Centers for Medicare & Medicaid Services (CMS) issued its long-awaited Proposed Rule for implementing the Physician Payments Sunshine Act yesterday, just a day before the Senate Special Committee on Aging was slated to hold a hearing about the need for the “timely release of regulations” and the impact on industry and consumers of CMS missing its Oct. 1, 2011, regulation deadline.
“It’s high time the affected communities got to see the proposed rules,” remarked Coalition Executive Director John Kamp. “Obviously, CMS listened to concerns of the Coalition and others in developing this proposal and provided more reasonable deadlines for comment and compliance.”
The statutory deadlines had been an important sticking point for industry and others. Until today, industry was expected to begin data collection starting Jan. 1, 2012, and report it on March 31, 2013. Under yesterday’s notice, data collection will not begin until after final regulations are issued. Data submission is slated to occur on the original date of March 31, 2013, but CMS is proposing that only a partial year’s data will need to be reported.
As the details of the national Sunshine Act rule emerge and when the resulting data eventually are released, stakeholders must play a role in how they are interpreted, according to Kamp. “Our most important job is ensuring that our clients, healthcare providers and patients get past the headlines, understand the underlying issues and move forward,” he added.
“It’s time for politicians and the press to stop the finger pointing and get us all refocused on patient care,” he said, because “collaboration among medical providers, researchers, industry and government is key to patient care. It must be encouraged.”
For additional background on what the industry must do to fully prepare for the new rules see the feature story Kamp wrote on the Sunshine Act in Communiqué this fall (“Don’t Get Burnt”: http://www.communiquelive.com/features/archive/2011/september/dont_get_burnt).
Among other comments, Kamp notes in the piece that although transparency is important, the value of communications between industry and medical professionals must be managed carefully. He recommends several steps need to be taken to help patients, policymakers and the press better understand the data when published. “Doctors with strong industry ties are better informed,” Kamp stated, adding that these relationships should be considered “a credential, not a cause for concern.”
Meanwhile, today’s hearing has now been postponed as the Act’s developers, Sen. Herb Kohl (D. Wis.) and Sen. Charles Grassley (R-Iowa), take time to review the proposed rule, which is slated to be published in the Dec. 19 Federal Register.
“The Sunshine Act guidance is a welcome, if late, step toward ensuring that the financial links between physicians and the drug, biologics and medical device industries are transparent,” Kohl said in a statement postponing the hearing to early 2012. “As we move forward, it’s vital that stakeholders have a voice in this process to ensure transparency and accountability in our health care system.”
Both Kohl and Grassley sent a letter to CMS Administrator Donald Berwick expressing their “severe disappointment” that the agency missed the Oct. 1 deadline to issue regulations as mandated by the Affordable Care Act.
“The completion of the guidance is good news,” Grassley said. “It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS. It shows Congress has a responsibility not just to make the laws but also to see that they’re carried out as intended. Companies need this guidance to do their part.”
CMS will be accepting comments on the Sunshine Act Proposed Rule until Feb. 17, 2012. To view a comprehensive summary of the proposed rule, go to: http://www.policymed.com/