Life Science Compliance Update

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


November 26, 2014

ACO Update: An Opportunity for CME?, Challenges Ahead

Clinical Trials

In recent months, we have written about the expansion of Accountable Care Organizations (ACOs) across the country. An estimate indicates there are nearly 289,000 total healthcare providers and business personnel aligned with this new model for delivering care. Other studies indicate the number of patients in organizations with an ACO arrangement is between 37 million and 43 million, or about 14 percent of the U.S. population. We have also previously noted across the country, large hospital systems are buying up physician practices with the goal of becoming ACOs that directly employ the majority of their providers. Because hospitals usually have access to capital, they are better able to finance the initial investment necessary to achieve the quality benchmarks, like the creation of electronic record systems in order to track patients.

CME and ACOs

The growth of ACOs also provides an opportunity for the continuing medical education community. In a November article in Insurance News Net by Robert Meinzer, Theresa Barrett, PhD, and Ray Saputelli, MBA of the New Jersey Academy of Family Physicians, the authors argue that ACOs represent a “paradigm shift in healthcare,” and to build competencies necessary to deliver care under this new model, there must be a fundamental change in the way education is provided.

At their most basic level, ACOs and CME providers share similar goals. Both are stakeholders in improving patient and population care, and as a result, collaboration between the two is a natural fit. However, there are challenges. The article notes that ACOs are not like other organizations CME providers work with, so the education community must first understand how ACOs work before they can get these new organizations to buy into the idea that CME can help them achieve goals.

Challenges Ahead for ACOs

Hurdles between ACOs and CME providers are only one piece of the larger ACO puzzle. As we have previously written, despite the growing number of ACOs, this new model faces significant challenges moving forward. Currently, as one physician noted, there exists a “perverse payment model,” whereby the fee-for-service payment model rewards volume of services, not necessarily superior clinical outcomes. With more complicated procedures and treatment, providers are reimbursed at higher levels. Ultimately, ACO providers will need to aggressively convert their practices and revenue streams from fee-for-service to a prepaid model.

Additionally, technological hurdles prevent the successful implementation of ACOs. While ACO technology platform solutions can be both simple and difficult, ACO providers must invest in connecting their information technology systems early on to prevent redundancy of care. Physician leadership and self-governance is also important when success depends on improvements in operational performance. Hospital administrators, for example, need to embrace physician leaders as equals while investing in physician leadership development.

Promise and Peril of ACOs

The benefits and challenges faced by ACOs were also recently discussed by Fred N. Pelzman, MD. Dr. Pelzman walks through a number of important topics involving ACOs. In the implementation stage, he describes the underlying pieces that must exist in an ACO and are already found in patient-centered medical homes. He cites safe transitions of care, robust information technology tools to monitor health trends, evidence-based care, and care coordination as four examples.

He argues, however, if a patient-centered medical home model is used to build an ACO, there must be additional infrastructure and support to coordinate care and stop excessive spending. One positive of this model is that an ACO built at an institution already providing patient-centered medical care will have pieces in place to create the best possible care, limiting redundancy and possibly improving transitions of care.

Dr. Pelzman further compares and contrasts patient-centered medical homes to an ACO model, noting that patient-centered medical homes build care coordination into their practice. This allows care coordinators to ensure patient care is delivered as planned and additional services are supplied effectively. Under an ACO model, Dr. Pelzman argues the world of care coordination would increase “massively,” becoming a major focus of care teams. He describes the point of ACOs as seeking to identify high-risk patients that need reductions in duplicate care, prevention of defensive medicine, and implementation of high-quality interventions.

But his concern is that ACOs would then become yet another monitor looking over the shoulder of caregivers, scrutinizing what they spend while caring for patients and telling them what can and cannot be done to provide care. Right now, bureaucratic hurdles already overwhelm the system, Dr. Pelzman points out.


Dr. Pelzman ends his article by noting that when money enters the picture of care and becomes too significant of a presence, it has the potential to take physicians away from the most important goal: caring for patients.

If ACOs are to benefit patients, he argues they must ensure for evidence-based care to prevent unnecessary emergency room visits, prevent patients from doctor-shopping, and keep them within systems where caregivers can better take care of patients. Dr. Pelzman acknowledges there is a business side to healthcare—ultimately someone is responsible for the bottom line—but when that becomes too much of a focus, there is a fear that linking the practice of medicine to the sometimes messy nature of healthcare delivery, with the goal of saving money, may create a paradigm where practitioners are pressured to avoid providing care they think is necessary and appropriate.

Ultimately, Dr. Pelzman provides a final warning: “But we are scared of having Big Brother look at everything we spend on our patients, because someone is always going to be worried that this is going to make us lose money.”

September 30, 2014

Physician Payment Sunshine Act: First Reports Likely Out this Afternoon; Physicians Concerned About Accuracy, Context

Sunshine Data

After over four years since the passage of the Affordable Care Act, September 30th marks the date for the release of the 2013 Sunshine Act data. Today, the Centers for Medicare and Medicaid Services (CMS) is set to publish a database on how much pharmaceutical and device manufacturers have paid to doctors for various engagements—including speaking fees, research grants, and the “value” of any snack a drug rep brings to a physician’s office. Sources say the agency will release the data sometime this afternoon. 

At its core, the Sunshine Act aims to better inform patients of the financial relationships their doctor has with manufacturers. The hope is that the public will see just how important these relationships are in the development of medicines and devices for heart attacks, strokes, multiple sclerosis, cancers and infectious diseases such as HIV, Hepititis C, and Ebola. While (almost) everyone opposes unethical interactions between physicians and pharma companies, the truth is that doctors collaborating with industry is an essential ingredient in patient care.

For example, physicians in academic medical centers often receive funding from industry as investigators in clinical research and as consultants who help design and evaluate clinical trials or develop new medical technologies. Such research is essential in order to find cures for many diseases. Physicians who engage with patients have invaluable practical knowledge to add to the process. Industry also supports physician education, and may provide reprints of peer-reviewed medical journals to busy practitioners.

Many physicians have supported the Sunshine Act’s goal to promote transparency, but are concerned about the potential for misrepresentation of information in public reports, and possible diminished innovation resulting from more limited physician-manufacturer relationships. 

The American Medical Association (AMA) has advocated specifically for more time for doctors to check the payment reports for accuracy. Physicians were allotted 45-days for a “dispute resolution” period with the companies that submitted data before the information went “live." This process was mired with a complicated registration process, missing data, and continuing website shutdowns. View our in-depth article on the physician registration and review period here

Things to consider when searching for doctors in the Open Payments system:

First, one of the fundamental issues that distorts the payment data is the fact that CMS will initially be withholding more than one-third of all the data from the system due to potential inaccuracies. Last month, we found issues in the way CMS matched doctor data for its system. The system relies heavily on physicians’ NPPES numbers, but we noted that this database is notoriously inaccurate. Physicians may have several NPI numbers, they may have entered the state license number incorrectly, or they may have moved states. Unless there is a particular time stamped date that CMS matches a company’s data with, even a completely identical transcription from NPPES to the Open Payments spreadsheet could be outdated and incorrect the very next day.

Second, payments may be incorrect.  One Massachusetts doctor we spoke with typed his name into the system to find that most of his payments were entered into the wrong Open Payments category--research and travel went in consulting, other payments went in travel, etc. No physician wants to see his or her name in the newspaper as receiving a huge sum of money from industry when that information is either untrue or misleading. However, due to the cumbersome "review and dispute process," many physicians were unable to check their data. This issue comes to a head when doctors have agreed not to accept consulting fees, and would have to explain why they have been reported. Thus, it is important for physicians to review and dispute the incorrect information they find next to their name.  The ability to dispute is always available to physicians even after the data is published.

Furthermore, because physicians do not have the option to register and view teaching hospital data, many physicians will be unable to view all of their allotted payments. Teaching hospital research payments in the thousands or millions of dollars may be attached to a single physician’s name who never had the opportunity to review the data for accuracy. The “review and dispute” process, in other words, will typically only reveal payments made by companies directly to the physician.

Due to potential inaccuracies, yesterday, the American Osteopathic Association, the professional membership organization for more than 104,000 osteopathic physicians and medical students, noted that the reports will cause further confusion to the public if released at this time. 

Third, this reporting year only includes data from August to December of 2013. 

Fourth, "payments" under the Sunshine Act are rarely money in a doctor's pocket. The best parallel for misleading reporting came out just a few months ago when CMS released the Medicare payment data. We saw a lot of "Find Out How Much Your Doctor Receives from Medicare” stories that were actually very misleading.  The least researched stories involved a doctor who worked at the Mayo Clinic, and was reported to have received $11 million from Medicare. All doctors at the Mayo clinic receive a salary. This doctor's name was just attached to a huge amount of payments because the Clinic conducts a large amount of research and employs a giant staff. A similar situation could happen with Sunshine Act reporting where the full expense of clinical trials are reported against one "principal investigator" physician. View our Medicare article here

Fifth, a fundamental issue with the Sunshine Act reporting requirements is that manufacturers will have drastically different methodologies for how they calculated certain types of payments--even when they may be for the exact same thing. For example, medical journal reprint valuation was a hotly contested issue among companies--are they worth the cost to the manufacturer, or the cost a physician needs to pay to order them? What if they are available for free online? Because the public will not have access to a manufacturer's "assumptions documents," a fair comparison is truly impossible.

Sixth, no one knows what kind of actual context CMS is going to post on or near the payment site, as CMS has kept this under wraps for months.

Seventh, many payment categories may be misinterpreted by those unfamiliar with the healthcare sector. For example, food and beverage expenses--what we anticipate to be one of the largest categories by number of payments but not dollar value--are often tied in with educational programs where the physician is learning about the safety or efficacy of a vital product. Thus, these meals (or trips for that matter) are almost never improperly lavish as certain articles may portray them to be. 


Concerns over the pending Sunshine Act data release are fairly simple: doctors don't want to be slammed in the press over either inaccurate payments or payments that reflect beneficial collaborations with industry.

We will follow the media coverage of the Sunshine payments in the coming days, as well as updates from CMS. 


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