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.


January 27, 2015

Secretary Burwell Announces HHS Quality Payment Goals, Introduces Timeline For Shifting Medicare Reimbursements From Volume to Value


Big changes are on the horizon in how Medicare reimburses healthcare providers. Yesterday, the Secretary of Health and Human Services (HHS), Sylvia Burwell, announced a timeline and measurable goals to move the Medicare program toward reimbursing providers based on the quality, rather than the quantity, of care they give their patients. 

The shift from the traditional fee-for-service Medicare payment structure to a more outcome-based model hinges on "alternative payment models." These payments emphasize patient outcomes over getting paid for individual medical services, notes Burwell. "In alternative payment models, providers are accountable for the quality and cost of care for the people and populations they serve moving away from the old way of doing things, which amounted to 'the more you do, the more you get paid.'"

In 2011, Medicare made almost no payments to providers through alternative payment models, according to HHS. Today, alternative payments tied to "quality" represent approximately 20 percent of Medicare payments. HHS aims to get that up to 30 percent by the end of 2016, and 50 percent by the end of 2018. 

Burwell expounded upon these models in yesterday's blog post announcing the government's plan: 

[T]hrough Accountable Care Organizations, providers partner together on a patient’s care and get rewarded for delivering better care while spending less. In a Patient Centered Medical Home model, instead of doctors working separately in their own siloes, care coordinators oversee all the care a patient is getting.  That means patients are more likely to get the right tests and medications rather than getting duplicative tests, procedures, etc. These medical homes typically offer patients access to a doctor or other clinician 7 days a week, 24 hours a day including through extended office hours on evenings and weekends.

Another example is a “bundled payment” model.  In this model, providers are reimbursed together for the entire cost of what’s called an “episode of care” – something like say a hip replacement.  So lab tests, pre-visits, hip replacements, and so forth are all paid for in the same lump sum – whether the same test is conducted once, twice or five times.  This creates an incentive to deliver better care that makes patients healthier and keeps them out of the hospital.

A major aspect of the government's effort relies on incentives to drive providers to these alternative payment models. Burwell lists two other strategies. First is a focus on "care delivery," which Burwell indicates will be developing policies to encourage greater integration within practice sites, coordination among providers, and attention to population health with a priority on prevention and wellness. “With more emphasis on coordinated care, patients are more likely to get the right tests and medications rather than taking tests twice or getting procedures they do not need,” her announcement states. Second, CMS is also working on information sharing to create more "transparency on the cost and quality of care, to bring electronic health information to inform care, and to bring the most recent scientific evidence to the point of care in order to bolster clinical decision-making."

HHS also announced the creation of a Health Care Payment Learning and Action Network, through which HHS will work together with private payers, employers, consumers, providers, state Medicaid programs, and other partners to expand alternative payment models beyond Medicare. 

A blog announcing the new value goals from Secretary Burwell is here, and a perspectives piece in the New England Journal of Medicine from Secretary Burwell is here.


The response to the reforms has been cautiously optimistic.  American Medical Association President Robert Wah said many of his members were frustrated and anxious about changes in the system and that while he was “encouraged” by the announcement, physicians needed more flexibility in the way the payments would be administered to be able to participate, the Wall Street Journal reports

Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive officer John J. Castellani issued the following statement on Secretary Burwell’s announcement:

“PhRMA supports Secretary Burwell’s goal of advancing affordable, high quality and patient centered health care, and today’s announcement represents an important step forward."

“New medicines make important contributions to value in health care for patients, payers and policymakers, and we look forward to working with the secretary on this new initiative. As HHS works to evaluate and expand new models of health care payment and delivery, we believe it is essential they:

1)    Incorporate clear mechanisms for recognizing the value of new treatment advances, such as precision medicine and other new tests and treatments;

2)    Are grounded in strong quality measures and incentives, with emphasis on outcomes that matter to patients;

3)    Support shared decision making between providers and patients, which is informed by high quality evidence about the full range of available treatment options; and,

4)    Are transparent and enable manufacturers and other stakeholders to work collaboratively in support of high-quality, high-value health care.

Read PhRMA's Principles for Payment Delivery and Reforms here



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