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Another Example Of Good Medicine That Does Not Follow “Protocol”

As far as I can tell, there are very few physicians currently involved in the innermost circles of healthcare reform. This is concerning to me, not because I’m one of those “paternalistic doctors” who “drive up in their Porsches threatening to pull out of Medicare” but because I think that many policy makers don’t really understand the incredible complexity associated with doing the right thing for patients. Here is an excerpt from the WhiteCoat’s Call Room blog that perfectly illustrates why practicing good medicine often requires a break from protocol:

It isn’t just the patients who think I’m a bad doctor.

Based on the information from all the pinheads at Medicare’s “HospitalCompare” web site, I’m downright dangerous.

For those who don’t know about Hospital Compare, it is a site where the general public can compare the “quality indicators” for hospitals on measures deemed important by the AHRQ.

I failed to meet a couple of indicators recently, so I received notices from our hospital administration that I am now considered out of compliance with the HospitalCompare guidelines and am bringing down our numbers on the HospitalCompare.gov web site.

In other words, Medicare thinks I’m a bad doctor.

Let me tell you about the patients I screwed up on.

The first patient was a gentleman in his 70’s who started having chest pain at home. He got sweaty, passed out, and hit his head on the concrete floor in his house, causing a nice goose egg on the back of his noggin. When he arrived in the emergency department, he was still having chest pain, so we hooked him up to an EKG and … lo and behold … he was having a myocardial infarction.

According to the quality indicators at “HospitalCompare”, if a patient with a heart attack is going to receive thrombolytics (”clot busters”), the thrombolytics must be given within 30 minutes of the patient’s arrival at the hospital. If a health care provider takes longer than 30 minutes to administer thrombolytics to someone with a heart attack, the government considers that provider to be practicing bad medicine.

Now I’m faced with a choice:
A. Do I give clot busters to someone who sustained a significant head injury (and may be bleeding internally) so that I can look like a “good doctor” to Medicare and HospitalCompare.hhs.gov? If there is bleeding inside his brain, clot buster medications will make the bleeding worse and could kill him.
-OR-
B. Do I perform a CT scan on the patient to make sure that there is no bleeding inside his brain before I give the clot-buster medications? If I do the CT scan, there is no way that we’ll get the results and be able to give the patient thrombolytics within the 30 minute window.

If I choose “A,” the hospital stays in the upper echelon of facilities that meet HospitalCompare.hhs.gov’s guidelines. Doesn’t matter if the patient dies – according to Medicare, “We’re Number ONE!”

If I choose “B” I’m doing what is right for the patient, but our hospital will look bad and HospitalCompare.hhs.gov will plaster it all over the internet that our hospital doesn’t follow Medicare’s rigid and sometimes life-threatening guidelines.
I chose “B.”

According to HospitalCompare.hhs.gov, my decision made me a bad doctor…

Medicare Policy Summit: Pharma Speaks Candidly About Their Healthcare Reform Jitters

Dan Todd, Senior Manager of Reimbursement for Amgen Pharmaceuticals, recently presented a candid view of how current healthcare reform initiatives may negatively impact his industry. Here are the highlights from the Medicare Policy Summit in Washington, DC:

1. Comparative Effectiveness Research: while the Obama administration’s new emphasis on comparative effectiveness research is not supposed to influence coverage decisions or draw conclusions about “cost effectiveness” – there is no current policy to prevent that from happening. Pharmaceutical companies are nervous about coverage being denied for their products that don’t fare well in head-to-head studies with alternative treatments.

2. Physician Payment Reform: as payment mechanisms move away from fee-for-service and towards episodic care compensation, physicians will no longer be directly influenced by price differences between drugs.  Specialist physicians who used to purchase drugs (such as in-office administered chemotherapy agents) under a competitive acquisition program from pharmaceutical companies (and then seek reimbursement from Medicare), will now have less incentive to select one drug over another based on price. Physician compensation will not be dependent on the price difference between drugs – but on the overall bundled services for an episode of care for each patient.

3. The Rise Of Primary Care: as more emphasis is placed on improving compensation to primary care physicians, specialist services will likely receive lower reimbursements to cover the higher payments for PCPs. Since specialists are more likely to prescribe more expensive drugs that have more generous margins (under Medicare Part B), the pharmaceutical industry will be negatively impacted by the improvements in primary care reimbursements for cognitive services.

4. Stifling Innovation: perhaps the most compelling argument made by Mr. Todd is the potential stifling of innovation that a comparative effectiveness regime could impose. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.

5. Timing The Release Of Drugs: Navigating the complexities of Medicare reimbursement, with its separately funded Part B and Part D, is a pharmaceutical company nightmare. With the additional scrutiny on comparative effectiveness and functional equivalency proposed in reform measures – timing of drug releases make a big difference in reimbursement. Take a subcutaneous (SQ) versus an intravenous (IV) version of a given drug for example. The market for the SQ administration is much larger than that of the IV route, but if the drug company releases the SQ version too soon, denial of payment for the more expensive IV version will begin to eat away at profitability. As Dan summarizes, “there’s a fine line between expanding your market and cannibalizing it.”

How Medicare Controls Costs: Insight From Biotech

At the recent Medicare Policy Summit, Tim Hermes, the Senior Director of Government Affairs for Sepracor, offered an overview of Medicare’s current cost control strategy. These six strategies are part of Medicare’s policies, but are not necessarily applied evenly or consistently.

1. Functional Equivalency: if 2 drugs are deemed to be functionally equivalent, then their average sales price may be linked so they are reimbursed at the same rate.

2. Inherent Reasonableness: CMS has the right to decrease payments for treatments, that are deemed not to be inherently reasonable, by increments of 15% at a time.

3. Widely Available Manufacturing Price (WAMP): when the average sales price of a drug is higher than the WAMP, CMS has the right to reduce the drug’s price to the WAMP.

4. Coverage Restrictions: CMS can choose to restrict coverage for any drug, especially for off-label uses.

5. Judicial Bar: Only Medicare beneficiaries can sue CMS. Manufacturers may not.

6. Congress: there are several committees that have jurisdiction over Medicare, including the Senate Finance Committee, the House Ways and Means Committe, and the House Energy and Commerce committee. Congress can enact legislation to decrease the average sales price of drugs, and can influence Medicare cost control mechanisms.

Congressman Paul Ryan Offers A Roadmap For America’s Future At The Medicare Policy Summit

paul-ryanRepublicans do not support Barack Obama’s economic stimulus bill, nor are they too keen on the democratic approach to healthcare reform. Congressman Paul Ryan outlined an alternative approach to healthcare reform at the recent Medicare Policy Summit conference. His key points:

1. All Americans should have access to the same health benefits that federal employees have. They receive a medical savings account, with subsidies offered when they are sick, according to their need. Full support is available for low-income beneficiaries, while partial support is offered to high income beneficiaries. Ryan argues that targeting Medicare according to need will keep the program solvent (rather than offering full coverage to the very wealthy, etc.)

2. Tax credits should provide the basis for healthcare coverage so that individuals are not dependent on their employers for health insurance. Individuals would purchase their own health insurance either via their employer or on an open market that would promote competition between the plans to drive prices down. Individuals would be able to keep the remainder of their tax credit if they select a health plan that costs less than their yearly credit.

3. Americans will be allowed to purchase health insurance across state lines, allowing them further coverage options and increasing competition among the plans to decrease costs.

4. Small businesses may join a national group (Associations Health Plans) to pool risks and drive down the cost of providing health insurance to their employees.

5. States would create “high risk pools” for people with pre-existing conditions who could not afford insurance premiums. Federal funding would help to offset the cost of insuring these individuals.

Ryan explained that the Ways and Means Committee that oversees Medicare is basically “a bunch of politicians sitting in a room playing Caesar – giving either a thumb’s up or thumb’s down to healthcare reform and finance issues.” He warns that they will be doing a lot more of that if America continues on its current course of “more regulation, with the federal government dictating the practice of medicine, and rationing our healthcare.”

Ryan’s predictions are grim:

1. Within 2 years 17% of our economy will move from the private sector column to the public sector column.

2. Pete Stark will lead the charge for an Institute of Comparative Effectiveness to direct care choices in medicine. Physicians will have fewer treatment options to offer their patients.

3. Small health plans will go out of business, leaving only a few large plans, with decreased competition and fewer choices for consumers.

***

For more information about Ryan’s views, please check out The Roadmap For America’s Future.

Medicare Summit Debate: Is Medicare A Good Model For Universal Coverage?

One of the highlights of the Medicare Policy Summit was a panel discussion entitled “Medicare Expansion, Entitlement Reform, and National Health Coverage.” The goal of the discussion was to explore the potential role that Medicare could have in serving as a model for universal health insurance coverage in America. I’ve captured some of the key points that each panelist made:

First panelist: Grace Marie Turner, President, Galen Institute.

Grace Marie Turner has been instrumental in developing and promoting ideas for reform
that transfer power over health care decisions to doctors and patients.
She speaks and writes extensively about incentives to promote a more
competitive, patient-centered marketplace in the health sector.

Top 5 reasons why “Medicare for all” will not work:

1. The provider payment rate is not sustainable.

2. It cannot be sold as a free-standing health insurance policy. Medicare is full of gaps in coverage which must be covered with a series of supplemental plans like Medi-Gap.

3. The centralized nature of the benefit structure limits patient choices.

4. There will be political opposition by seniors to opening the flood gates to millions more beneficiaries, which would reduce their current coverage.

5. Medicare is already in debt to the tune of 38 trillion dollars.

What is a better solution to achieve universal coverage?

Private, competing plans can better provide tailored benefits to groups of uninsured. This would also increase patient choice and customization of care. Medicare Part D is run under a private sector model and is currently 40% under budget. This is evidence that the private sector, influenced by market forces, is better at cost containment.

The bottom line is that we have to decide if we want to reform healthcare with top-down directives or by aligning incentives. I believe we need to do a better job of coordinating care – it’s a financial issue.

Second panelist: Robert E. Moffit, Ph.D., Director of the Center for Health Policy, The Heritage Foundation.

Moffit has been an advocate of the free market principles of consumer choice and competition since the early 1990s, when he chastised Congress for keeping such a system of choice and competition ” exclusively for itself and federal workers while considering ways to impose vastly inferior systems on almost all [other] Americans.”

Who do you want to make key healthcare decisions for you?

1. Your employer

2. The government

3. Individuals and families

Other industrialized countries have accepted option #2, but America is a very different culture. We must enlist the states as the laboratories of democracy that they should be. The Medicare Advantage plan is revolutionary.

Third panelist: Robert Berenson, M.D., Senior Fellow, The Urban Institute

Dr. Berenson’s current research focuses on modernization of the Medicare program to improve efficiency and the quality of care provided to beneficiaries.

The consumer-directed healthcare system is not what the public wants or needs. We need supply-side solutions, not demand-side solutions. Medicare has been more successful than private plans at reducing costs.

There’s no doubt that a government-run healthcare system is not what Americans want – but I see no other alternative. The Massachusetts (state level solution) is not going to be successful because they provided universal coverage without any cost containment mechanisms in place, so costs simply sky rocketed.

Currently, 20% of Medicare beneficiaries discharged from the hospital are readmitted, and half of those are due to avoidable complications. Follow up care (after hospital discharge) is not well managed. Most patients discharged from the hospital don’t see a healthcare professional for follow up within 30 days of their discharge. We have to do better.

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