Comparative Effectiveness Research under attack

Physical therapists who support research comparing surgical interventions with physical therapy for chronic, painful spinal stenosis are under attack.

A group of 56 congressmen have written a letter asking President Barack Obama to withdraw the nomination of Dr. Donald Berwick to head the Centers for Medicare and Medicaid Services (CMS).

Their opposition to Dr. Berwick is based on his support of Comparative Effectiveness Research. The congressmen who wrote the letter are House Republicans not involved in Dr. Berwick's upcoming Senate confirmation meeting. They called Dr. Berwick's beliefs "rationing":

“We believe that Dr. Berwick’s recommendation for the federal government to use ration-based, cost-effective research to restrict patients’ access to medically necessary care is wrong.”

...the letter said.

But, according to White House spokesman Reid H. Cherlin,

“The fact is, rationing is rampant in the system today, as insurers make arbitrary decisions about who can get the care they need.

Don Berwick wants to see a system in which those decisions are transparent – and that the people who make them are held accountable".

The White House continues to support Dr. Berwick who was nominated April 19th. His Senate confirmation hearing has yet to be scheduled.

There is ample need for head-to-head studies examining both the indications for and the outcomes the following:

• surgery for lumbar spinal stenosis,
• all treatments for lower back pain,
• diagnostic imaging

Spine fusions alone cost Medicare $575 million dollars in 2007. That money would buy a lot of physical therapy.

Who can think of other, promising areas where PT might compare favorably with dangerous and expensive surgical options?

MedPAC Report Fails to Sway Congressmen

The Congress prefers not to give up its power over Medicare reimbursement even though its main advisory authority - the Medicare Payment Advisory Commission (MedPAC) - has asked it to 'loosen the reins' a little bit to allow Medicare to save money and provide better care for American citizens.

In a presentation June 23rd, 2010, MedPAC Chairman Glenn M. Hackbarth, J.D. delivered its new report Aligning Incentives in Medicare and asked the Committee on House Energy and the Commerce Subcommittee on Health for additional regulatory authority to make changes.

The changes of great interest to physical therapists focus on limiting the "in-office ancillary services" exception to the Stark II anti-kickback statutes ("the Stark loophole").

MedPAC recommends changes in the short run that limit the ability of physicians to qualify for the "in-office ancillary services" exception. MedPAC also recommends changes in the long run that reduce physicians' financial incentive to order excessive physical therapy services.

Here is part of Chairman Hackbarth's statement (from CQ.com):

"...Therefore, the preferred approach to address self-referral is to develop payment systems that reward providers for constraining volume growth while improving the quality of care.

Because it will take several years to establish new payment models and delivery systems, policymakers may wish to consider interim approaches to address concerns raised by the growth of ancillary services in physicians` offices.

The Commission had not yet made recommendations, but it does explore the pros and cons of several options in more detail:

• excluding therapeutic services such as physical therapy and radiation therapy from the IOAS exception,
• excluding diagnostic tests that are not usually provided during an office visit from the exception,
• limiting the exception to physician practices that are clinically integrated,
• reducing payment rates for diagnostic tests performed under the exception,
• improving payment accuracy and creating bundled payments, and
• adopting a carefully targeted prior authorization program for imaging services."

The House sub-committee, however, doesn't want to cede the Congress' control of Medicare to Health and Human Services (HHS) or to the Centers for Medicare and Medicaid Services (CMS).

Here is the statement of Frank Pallone, Jr., Chairman, U.S. Subcommittee on Health:

"I am not in favor of giving carte blanche to the Secretary of HHS or the CMS Administrator.

I believe that this Committee and the Members who serve on it carry out an important oversight and regulatory role and I am not eager to hand over all of our responsibilities to effectively manage this program to our good friends at HHS."

Can the Congress effect MedPACs recommendations despite the political power of the American Medical Association (AMA)?

The recent failure of Senate Republicans to support HR 4213 (American Jobs and Closing Tax Loopholes Act of 2010) on Friday June 18th lead to enactment of the 22% negative update to the Medicare Physicians' Fee Schedule for the first time in years.

Have Republicans Senators abandoned the AMA? How much political clout do doctors have left?

If the Congress wants to retain its authority to regulate Medicare but doctors are losing their influence over Congress can physical therapists step in and effectively advocate to close the Stark II "loophole"?

Physical Therapist Joins Committee to Advise Medicare Contractor

My local Part B Medicare contractor is asking for help with its provider education strategies and efforts so, on June 10th, 2010 I made the early-morning drive down Interstate 4 to Orlando, Florida to meet about 20 like-minded health care providers for a two-hour question & answer session.

Our mandate is to...

• Reviewing new and existing Medicare education programs
• Recommending changes to these programs
• Alerting FCSO to problems or concerns affecting providers
• Networking with other professionals interested in Medicare
• Disseminating information from the POE-AG to the organizations each member represents.

Our meeting agenda covered these topics:

• Enrollment
• Site surveys, PECOS
• Original signatures vs. electronic signatures
• HIPPA 5010
• ICD-10
• The new FCSO website
• CERT/RAC audits
• Issues with E/M coding

For those providers interested in joining and contributing your expertise please contact FCSO here.

Stark Loophole not the only bright light in the new MedPAC report

The new MedPAC Report to the Congress: Aligning Incentives in Medicare is gaining attention amongst physical therapists primarily for its recommendation to close the "Stark Loophole" but also should be credited for emphasizing the collection of clinical data as a condition of payment.


MedPAC suggested in its recent report that the US Congress remove outpatient therapy from its list of services qualifying for the "in-office ancillary services exception" because physicians are not using the exception for its intended purpose and because costs are climbing too quickly.

MedPAC also suggested collecting clinical data as a condition of payment, called Coverage with Evidence Development (CED).

I propose Medicare could deliver better OUTCOMES, save more MONEY and get better VALUE for beneficiaries and taxpayers if collection of clinical data is in place of burdensome, centrally-mandated process measures that waste time, generate excess paperwork and distract highly-paid and well-educated physical therapists from face-to-face interactions with their patients.

Asking physical therapists to examine, evaluate and record patient data is 100% in line with the Guide to Physical Therapist patient management model.

Coverage with Evidence Development could be a positive force leading to a change in physical therapist culture: a shift to a culture of measurement.

If CED were in place of arbitrary process measures as a condition of payment then we could reduce Medicare audits by accountants and lawyers.

However, if CED is just one more centrally-mandated and administrated process measure then we'll all just be working harder.

Can physical therapists make decisions like doctors?

Try this interactive worksheet from First Coast Service Options (FCSO) - the Medicare Administrative Contractor for A/B services for Florida. The worksheet is intended for physician training to improve correct coding of Evaluation and Management CPT codes.

I tried it.

Plug in your actions from your evaluation is the areas of History, Examination and Medical Decision Making and the Worksheet will spit out its best guess of which E/M code you should bill as if you were a physician.

The interesting thing is that my typical physical therapy evaluation corresponds to a Level 3 E/M codes (99203). Of course, physical therapists can't bill E/M codes because we are not physicians.

If you consider, however, the condition of our patients, the tests and measures physical therapists use, the complexity of our decisions and the risks we face I wonder if altering payment systems to allow PTs to bill E/M codes for certain patients makes sense?

Consider an uncomplicated ankle sprain. Evidence-based decision rules can rule out an ankle fracture with greater precision than a physician's diagnosis.

Physical therapists can refer for imaging when appropriate or treat immediately - saving costs and getting patients productive more quickly.

Similar characteristics between my PT eval and a physicians' eval include the following:

• History: Detailed
• Examination: Detailed
• Medical Decision Making: Moderate Complexity

You try it and see what you get - can you make a decision like a doctor?

Physicians Behaving Badly

Can we trust physicians with the responsibility and the scope of practice society gives them? Do we need a 'systems approach' to help them manage their scope?

Physicians' scope of practice is increasing - driven by many big social drivers:

1. High technology health care.
2. Demand fueled by over-capacity but not by need for their services.
3. A Fee-for-service payment model that rewards doctors for doing 'stuff' unrelated to actual patient characteristics.
4. No naturally antagonistic professional group applying 'top-down' political pressure to limit increasing scope of physician practice.
5. Expansion of American healthcare system under Obama's heath care reform.
6. Medicalization of social ills (eg: alcoholism and 'medical marijuana').

Are physicians qualified to handle this increased scope? Is public safety assured? Can we help them behave better?

Evidence over the last 10 years indicates that the American health care system kills 98,000 Americans per year and loses $60 billion to thieving Medicare pirates every year.

I think we're throwing good money after bad by trusting physicians to lead the way. The current private practice model - where 70% of American healthcare happens - is analogous to the "airplane pilot flying the plane and serving us drinks, too".

The difference is pilots, airplanes and airports have adopted a 'systems approach' that makes flying much safer than 20-years ago. Without a similar safety approach to healthcare patients will keep dying, getting poor outcomes and spending our money.

A systems approach places more power into process measures that define 'how' healthcare happens - but not process measures defined by centralized Medicare policymakers. The process measures that lead to better outcomes need to be defined by clinicians that see the patients and the managers that take care of the clinicians.

For our purposes, process measures are a specific type of healthcare quality measure encompassed by the term 'systems approach' that tries to lower cost and improve care without blaming the people involved in the care.

But, speaking of blame, here are examples of how physician (and physical therapist) bad behavior over the last two decades have wasted our money.

Excessive diagnostic variation

Song et al in the May 2010 NEJM examined the diagnostic variation in 306 hospital regions in the United States from 1999-2006. Diagnosis drives procedures so the finding of diagnostic variation is not particularly surprising given the wide variation in costs and intensity seen in other studies.

The worrisome feature is that diagnostic intensity will affect future payment using risk adjustment. The Dartmouth group has consistently managed to highlight an embarrassing feature of American healthcare: differences in how folks are diagnosed and treated is not driven by their clinical characteristics.

Increasingly complex fusion surgeries

Dr. Richard Deyo et al published a follow-up study in 2010 to Dr. Weinstein's study (see below) that showed COMPLEX fusion surgeries (more than 2 levels, 360-degree operations, etc) increased FIFTEEN-fold in five years, from 2002-2007. That's 300% per year!

What's more, most of these surgeries are being done on the oldest, sickest Americans - Medicare beneficiaries who may have an outdated trust in their physician. Life-threatening complications increased from 2.3% for simple spinal decompression to 5.6% for the complex fusion surgeries.

Dr Deyo states:

"Financial incentives to hospitals and surgeons for more complex procedures may play a role..."

Increased costs but decreased outcomes for spine problems

Martin et al in Spine Magazine (2009) describes outcomes from ALL spinal treatments during the period from 1997 to 2006...

"...the proportion of patients who reported any limitation in physical functioning increased steadily and significantly..."

Costs, however, increased between 37% and 134% for outpatient settings, prescription drugs, inpatient and emergency settings.

Rapid increase in spinal fusions

Weinstein et al in 2006 in Spine found a 500% increase in lumbar fusion surgeries from 1992 to 2003. There was a 20-fold variation from high- to low-intensity regions that may not have been driven by patient need. Spending for spinal fusion increased from $76 million to $482 million over this period - consistent with Dr. Martin's 2009 study should we anticipate getting more VALUE for our dollars?

Its not that we don't trust these PEOPLE - physicians and physical therapists - but that these aren't PEOPLE problems, they're problems with the system.

Maybe its time to put our trust in systems that help physicians and physical therapists better help people.

What kinds of processes do you use at your work that lead to better outcomes?