Life Science Compliance Update

August 31, 2015

EHR: Congress Moves to Delay and Modify Timeline for Meaningful Use


There is a growing movement in Congress to push the Department of Health and Human Services (HHS) to postpone Stage 3 of the electronic health record meaningful use program. Recently, Rep. Renee Ellmers (R-N.C.) introduced a bill (HR 3309) that would delay federal rulemaking for Stage 3 of the meaningful use program until 2017 or when certain conditions are met. Under the proposed Stage 3 rule, eligible providers would have the option of applying for the incentives in 2017 and would have to attest to meeting the criteria in 2018. The comment period on the proposed rule ended May 29, and the CMS is expected to finalize it soon.

During a hearing on meaningful use Stage 3, interoperability and patient access to data, Sen. Lamar Alexander (R-Tenn.) stated: "To put it bluntly, physicians and hospitals have said to me that they are literally terrified of the next implementation stage ... because of the complexity and because of the fines that will be levied,” Fierce Health IT writes.

Industry and Medicine’s Response

As reported in Medscape, industry's response to the Stage 3 proposal has been mainly negative. The Medical Group Management Association (MGMA), for example, said that Stage 3 should not be finalized until more providers had participated in Stage 2. As of May 2015, just 50,983 eligible professionals and 1461 eligible hospitals had attested in Stage 2, according to the CMS. The MGMA also wants CMS to eliminate Stage 3 objectives that require patient engagement.

The American Medical Association (AMA) also criticized the proposal, saying more time is needed to evaluate the impact of the first two stages and that the Stage 3 criteria were too ambitious. And both the American Hospital Association and the College of Health Information Management Executives (CHIME) said the CMS should not finalize Stage 3 until it had had more experience with Stage 2.

It comes as no surprise the AMA strongly supports Congressional intervention to delay Stage 3. "The AMA thanks Rep. Ellmers for sharing our deep concern with a Meaningful Use program that continues to move ahead without first fixing barriers faced by physicians, hospitals, vendors and patients," said AMA President Steven J. Stack, M.D. "Under Rep. Ellmers' leadership, federal regulations would be revised to provide greater flexibility for physicians to meet the Meaningful Use requirements and ensure that Stage 3 of the program is developed in step with other efforts to modernize our nation's health care system."

The bill also addresses key interoperability challenges by ensuring EHR systems are capable of sending, receiving, and seamlessly incorporating patient data.

"This important bill addresses many of the fundamental shortcomings in government regulations that have made many EHR systems very difficult to use," said Dr. Stack. "We heard loud and clear from physicians at the AMA's first-ever town hall meeting on EHRs and the Meaningful Use program that the systems they use are cumbersome, poorly designed and unable to 'talk' to each other thereby preventing necessary transmission of patient medical information."

Struggling to Adopt

Physicians are struggling, as noted in a recent AMA report. One physician the article profiled is in his fourth year of meaningful use, and said the program has slowed down productivity in his practice by about 25-30 percent.

“There are so many more things that you have to report on that I don’t think really add to patient care,” the doctor said. “I’m trying to work with it. I think meaningful use is not necessarily a bad thing. But I don’t think [patients] have an idea what we’re going through. To give them a copy of their note, it’s not just printing it … there are four or five steps just to give somebody a copy of their note.”

The government has known about the problems cited by physicians for a long time. Back in May 2014, CMS delayed for a year the compliance date by which certain early participants in the program meet Stage 2 requirements. The relatively high percentage of providers—62%—still stuck on Stage 1 in the fourth full year of the program bears out the wisdom of the CMS' Stage 2 compliance extension.

The latest data tracks with an analysis done earlier this year by the American Academy of Family Physicians, according to Dr. Steven Waldren, director of the AAFP's Alliance for eHealth Innovation. Waldren said the number of family physicians who attested to meaningful use in 2014 fell nearly 40% to about 23,500 practitioners compared with 2013. Physicians specializing in internal medicine experienced a similar drop-off, he said.

Additionally, a new study from Weill Cornell Medical College describes the emergence of "systematic differences" between physicians who participated in the Medicare and Medicaid EHR Incentive Programs and those who did not. That "could lead to disparities in patient care," according to Weill Cornell researchers, who examined 26,368 physicians across New York State, using payment data from 2011 to 2012, the first two years of meaningful use.


This issue raises serious questions for broader federal health care goals. As we previously wrote, HHS aims to tie 30 percent of payments to quality, including the use of electronic records, by the end of 2016, and 50 percent by the end of 2018. The new MACRA legislation and recent CMS Medicare proposed rules operate as if meaningful use is moving forward as scheduled. Should Congress delay implementation of the next stage of meaningful use, it could have a ripple effect across HHS goals, possibly causing added confusion for physicians and hospitals. It will be important to monitor this as it develops; legislation may need to be passed soon, as CMS wishes to finalize its Stage 3 meaningful use regulations.


July 30, 2015

Congressional Briefing on the Importance of Medical Communication


This past month, the House of Representatives convincingly passed the 21st Century Cures Act. This bill contains important provisions related to how life science companies can communicate information about their products to patients, doctors, and payers. As the Senate contemplates a similar measure, it is important that legislation includes provisions that are needed to update the current regulatory constraints on communicating the latest medical information to those most in need.

The Coalition for Healthcare Communication provided a great writeup of a recent congressional briefing, sponsored by the Medical Information Working Group, that addressed the limitations and challenges of the current legal and regulatory framework, how this affects patient access to critical therapies, and how Congress can improve regulatory oversight of medical information.  

During the hearing, Sandra Raymond, CEO and president of the Lupus Foundation of America, spoke to the importance of open channels of communication for doctors looking to best treat patients with lupus. She stated that for patients with lupus, current treatments primarily are off-label uses of drugs approved for other purposes, such as immunosuppressants, anti-malarials and steroids. Without a steady flow of information from companies about these uses, physicians are “uninformed about the current treatments for a disease they don’t understand well,” she said. “The result? Patient care is impacted.” Raymond told congressional staffers that regulators need to balance patient benefit and risk to determine appropriate healthcare communications, permit adequate directions for use on approved and alternative uses, and encourage approval for additional instructions.

Alan Bennett, senior counsel at Ropes & Gray. and co-leader of the Medical Information Working Group, also weighed in from the legal perspective. Currently, the regulation of medical information seems trapped in the past, with a promotional system that was “designed in the 1970s for 1970s conditions” that do not account for significant changes in reimbursement, technology, and evolving case law regarding free speech, according to told the Coalition for Healthcare Communication that MIWG wants to work with the FDA on making the regulation of medical information communication more clear and expansive.

“This would be a major change in the way the agency regulates, and major changes tend to take a lot of time, but recent First Amendment developments and marketplace factors, such as reimbursement and technology, are causing the FDA to pay attention,” Bennett said.

At the briefing Bennett highlighted three recent cases — Sorrell v. IMS Health Inc.U.S. v. Caronia, and Amarin Pharma Inc. et al. v. U.S. Food and Drug Administration et al. – that are bolstering the First Amendment right to speech or to hear a message. Although the Amarin case is still pending, Bennett noted that “if it comes out in favor of greater First Amendment rights, the agency will have to address that.”

Bennett also touched on other major issues that affect medical information communication:

  • Payer communication. Congress thought that enacting Section 114 of the Food and Drug Administration Modernization Act of 1997 would allow companies to disseminate healthcare economic information to payers for formulary decision making, but in practice, the provision “remains unclear and FDA has muddied the waters further,” he said. He added that companies need a roadmap so dissemination is not ambiguous and companies can communicate with payers late in the FDA approval process to ensure that their drugs can be covered upon approval.
  • Scientific Exchange. “Everyone relies on this, but no one really knows what it is,” Bennett said. “It is clear at the margins, but there are a lot of activities that go on between the poles,” he remarked.
  • Definition of Labeling (and Advertising). The statute provides some definition, but that definition has been broadened by the FDA, according to Bennett. “We want the FDA to align its definition with the statute and case law,” he said.
  • Substantial Evidence Standard for Claims. For comparative claims, the regulations state that claims based on any study that is not a randomized, controlled clinical trial is automatically false and misleading, even for an on-label claim, Bennett explained. “There are data today that didn’t exist in the 1970s – real-world data – that companies ought to be able to use to support claims,” he said. “The standard needs to be more flexible.”
  • Intended Use. If a company knows its product is being used off-label, communicating that intended use is against the law, according to Bennett. Although the FDA is not enforcing this provision, “it is still on the books for the Justice Department to use and it needs to be clarified, especially when the standard of care for various conditions is an off-label use of an approved drug.”
  • Guidelines. The FDA’s guidelines for unsolicited requests for information and textbook dissemination need to be updated and streamlined so that truthful and non-misleading information about treatments can be communicated in a timely and effective manner, Bennett told briefing attendees.

The bottom line, Bennett added, is that “a patient’s role in his or her own healthcare has become more important, so that patient and his or her physician should have access to the best information, for which companies are the most valuable source.”

Bennett also asserted that addressing this issue legislatively “is appropriate and necessary to provide the FDA with guidance to align with the statute and the Constitution,” he said. Although the House’s 21st Century Cures legislation “is a start, more comprehensive changes are essential and Congress needs to address the specific issues we have raised.”

Thanks to the Coalition for Healthcare Communication for their coverage of this important event. 


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