Medicare facing cancer, cardiac care cuts
 

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Medicare facing cancer, cardiac care cuts

Reimbursements for oncologists and cardiologists are on the federal government's chopping block in the next six weeks.

By Arie Szatkowski, Special to The Commercial Appeal
Tuesday, September 15, 2009
As the health care debate continues in Washington, lost in the controversy is a little-known change in Medicare policy that threatens efficient access to lifesaving medical services for millions of heart and cancer patients.
If enacted as scheduled on Jan. 1, 2010, policy changes recommended by the federal Centers for Medicare and Medicaid Services (CMS) -- the government's insurer for the elderly and disabled -- will severely cut current Medicare reimbursements to cardiologists and oncologists for critical care services that are provided to patients in physicians' offices or other out-of-hospital setting, such as chemotherapy to treat cancer, and various cardiac procedures to monitor and treat heart disease, such as nuclear imaging and heart catheterization.


These cuts will force cardiologists and oncologists to limit care to their Medicare patients, withdraw from treating Medicare patients altogether or require their patients to pay more out of pocket to make up the difference in the cost of these services.
Unless these proposed changes are rescinded, current and future cardiac and cancer care patients will suffer the consequences, especially in rural areas where the proportion of Medicare patients is exceptionally high and patients have fewer choices of health care providers.
The changes certainly will force the closing of outreach clinics in rural areas, leaving many people without easily accessible cardiac or cancer care. They will be forced to travel to hospitals, sometimes long distances from home, and to wait for hours, if not days and weeks, for the tests and services they need.
It is difficult to think of the emotional, physical and financial burden this will place on people already suffering from heart disease and cancer.
Yet the policymakers at CMS, who base their decisions on numbers and statistics, are unilaterally and dramatically changing the delivery of heart and cancer care by proclaiming that care for heart disease and cancer is too costly, while treatment for other diseases has greater value.
Such decisions are based on flawed and incomplete data. They disregard the fact that heart disease and cancer kill more Americans than any other disease, and that advances in heart and cancer care have led to a 25 percent reduction in deaths due to heart disease during the past decade, and a marked increase in survival of cancer.
With the U.S. population aging, along with an expected rise in the number of cases of heart disease and cancer, the ability to manage these diseases in a cost-effective manner while maintaining a high standard of care through the use of advanced therapies and tests will be critical for prolonged life. Studies have proved that people with heart failure have better outcomes when their illness is managed by cardiologists in an outpatient setting. Yet the changes proposed by those who run Medicare will disrupt much of the progress we have made.
Many oncologists and cardiologists -- myself included -- in Memphis and the Mid-South and throughout the nation, are faced with this difficult dilemma: How can we afford to treat our Medicare patients when the proposed Medicare reimbursements in some cases are less than the cost of providing medical services? As with all businesses today, the costs of running medical practices have increased.
While these changes will have serious financial impact on medical practices, they also will erode a doctor's ability to provide patients with the very best quality of care that has proved to be cost-effective and beneficial. They will erode a doctor's ability to provide the same level of care for people who live far away from medical centers such as Memphis. And they will lessen a doctor's ability to be the primary advocate for his patients, as opposed to a group of hospital administrators, bureaucrats and lawyers.
At this point, the proposed CMS policy changes remain just that: proposed changes. During the next six weeks, CMS officials will be reviewing them, and they'll likely be enacted unless the people most seriously affected -- patients and the doctors who care for them -- contact CMS officials and their congressional representatives to protest these proposed changes.
Otherwise, the day is coming when Medicare patients -- often the most vulnerable in our society -- will wake up and realize they no longer have access to the timely and often urgent medical care they need.
Dr. Arie Szatkowski is a cardiologist with The Stern Cardiovascular Center in Memphis.

Re: Medicare facing cancer, cardiac care cuts
 

US Cardiologists in Short Supply, and the Problem Could Get Worse

Michael O’Riordan

September 14, 2009 (Washington, DC) — The demand for cardiologists in the US far exceeds the supply, and this shortage will continue to get worse with time, according to a new report published online September 10, 2009 in the Journal of the American College of Cardiology [1]. At present, there is shortage of more than 1600 general cardiologists and nearly 2000 interventional cardiologists, with electrophysiologists and pediatric cardiologists also in short supply.
More concerning, however, is that with an aging baby-boomer population, epidemics in obesity, and growing rates of the number of individuals with diabetes mellitus, as well as the fact that more patients with chronic heart disease are living longer, the number of practicing cardiologists will need to double by 2050 to keep up with the demand. If not, the US might find itself short approximately 16 000 cardiologists.
These are the conclusions of the American College of Cardiology Board of Trustees Workforce Task Force, which is headed up by Dr George Rodgers, a private-practice cardiologist in Austin, TX.
"The thought is that this is currently a problem, we have a huge gap," said Rodgers during a briefing with the media. "Our guess is that the deficit in the number of cardiologists is probably going to widen, even double, by the time we get to 2030 or 2050."
In their report, the task force noted that just 750 to 800 new cardiologists graduate from training programs each year. Rodgers pointed out that internal-medicine residents looking to do a cardiology fellowship don't always get the chance to become cardiologists because there are approximately 1200 applicants for 800 cardiology fellowship positions. Many institutions say they lack the funding to take on any more cardiology fellows, noted Rodgers.
The task force suggests that the current shortage is partially brought on by significant shortages in the number of women and minorities in cardiology. While women equal men in medical school, just 12% of the current cardiology workforce is female. Also, while African Americans and Hispanics constitute 25% of the US population, they represent just 6% of cardiologists in active practice. In addition, in 2006–2007, black and Hispanic fellows represented just 13% of internal-medicine residents and 10% of cardiology fellows.
Currently, more than 43% of US cardiologists are older than 55 years, notes the task force, and there are concerns that these doctors might retire early, especially with the proposed cuts to cardiology payments in the Medicare physician fee schedule for 2010.
During the media briefing, Rodgers said that one of the ways they are looking to make cardiology more attractive is by making the work environment more "sustainable and survivable."
"We need to see if we can work out a better kind of work-life balance," he said. "That's what we're hearing from the fellows coming out today, they're concerned about the work-life balance."
[ CLOSE WINDOW ]
References

1. Rodgers GP, Conti JB, Feinstein JA, et al. ACC 2009 survey results and recommendations: addressing the cardiology workforce crisis. J Am Coll Cardiol 2009; 54:1195-208. Available at: http://content.onlinejacc.org.

Re: Medicare facing cancer, cardiac care cuts
 

http://www.news-medical.net/news/200...re-system.aspx

11. September 2009 01:49

The Community Oncology Alliance (COA), a national non-profit organization that represents oncologists and other cancer care providers, strongly opposes cuts in Medicare reimbursement for cancer care outlined by the Centers for Medicare & Medicaid Services (CMS). In spite of President Obama’s vow to protect Medicare in his speech to Congress last night, the new rules scheduled to take effect on January 1, 2010 specify an additional 21.5% decrease in all physician-related services payments by Medicare. These cuts, which include massive payment reductions for medical oncology, diagnostic imaging and radiation oncology, are scheduled to occur regardless of the outcome of the healthcare reform process.
Over the past five years, the cancer care system has already been severely strained by a series of cuts to Medicare reimbursement for drugs and services. The new cuts are especially alarming, given that almost 50% of all cancer patients are Medicare patients. While the healthcare plan the President presented last night included only a limited public option under his proposed insurance exchange, some proposals call for a public insurance plan based on Medicare rates, which would only compound and perpetuate the problem.
Based on data from community oncology practices across the nation, COA estimates that the new cuts will result in a staggering 38% annual average reduction in Medicare reimbursement for chemotherapy infusion services alone. As a result of these cuts, cancer patients across the nation will experience delays in diagnosis and treatment, face longer waiting times, be obliged to travel farther for care and in some cases be unable to find local access to cancer care.
“President Obama recommitted in his speech last night to building on what works and fixing what does not work,” said Patrick Cobb,M.D., president of COA and managing partner of Hematology-Oncology Centers of the Northern Rockies in Billings, Montana. “But the cancer care system is already broken after a steady series of cuts to Medicare reimbursement for drugs and services each year over the past five years. The Medicare reimbursement cuts planned by CMS will kill cancer care as we know it. Community cancer clinics have already had to close satellite facilities and cut staff. Smaller clinics are struggling to operate and more will close.”
To measure the likely impact of the Medicare cuts on actual reimbursement, COA developed a financial analytical tool based on the data provided in the proposed CMS rule outlining the cuts. Detailed financial data resulting from nearly 200,000 patient visits was submitted to a certified public accountant that aggregated the results.
“The magnitude of the proposed cuts in the reimbursement for administration of life-saving cancer drugs will be tremendously damaging to patients depending on quality, accessible cancer care,” said oncologist Dr. Mark E. Thompson of The Mark H. Zangmeister Center in Columbus, OH. “These cuts are not reflective of underlying market costs and will seriously impair our ability to continue to treat cancer patients.”
Dr. Thompson and his staff have already taken a number of steps in the past year to deal with cuts in reimbursement from Medicare and private payors. They have eliminated staff positions, reduced staff hours, initiated a wage freeze and referred Medicare patients with inadequate supplemental insurance coverage to hospital inpatient infusion centers.
“The patients do not receive the same level of care in hospital infusion centers, often waiting longer for lab tests and the preparation of their treatments for each chemotherapy visit, and the cancer care is ultimately at a higher financial cost than we can provide in the community oncology setting,” Dr. Thompson said.
Fact Sheet
Scheduled Cuts in Medicare Reimbursement for Cancer Care by Centers for Medicare & Medicaid Services (CMS)

• New rules by the Centers for Medicare & Medicaid Services (CMS) scheduled to take effect on January 1, 2010 specify an additional 21.5% decrease in all physician-related services payments by Medicare.
• Based on data from community oncology practices across the nation, COA estimates that the new cuts will result in a staggering 38% annual average reduction in Medicare reimbursement for chemotherapy infusion services alone. COA estimated the likely impact of the Medicare cuts on actual reimbursement using a financial analytical tool it developed based on the data provided in the proposed CMS rule. Detailed data from nearly 200,000 patient visits was submitted to a certified public accountant that aggregated the results.
• The cuts, which include massive payment reductions for medical oncology, diagnostic imaging and radiation oncology, are scheduled to occur regardless of the outcome of the healthcare reform process.
• The new cuts are especially alarming, given that almost 50% of all cancer patients are Medicare patients.
• Reimbursement cuts to oncologists for cancer drug administration have already occurred every year since 2003, with a total decrease in reimbursement from 2003 to 2009 of 68%. This means if an oncologist was reimbursed $100 in 2003 for the net profit or loss on a drug plus its administration, in 2009 he or she is being reimbursed $32.
• These numbers are applicable for Medicare reimbursements (often 50% or more for community oncology practices) as well as third party payors that follow Medicare guidelines.
• Additional data from COA showing that, on average, current Medicare payments to community oncologists cover only 55% of the costs of services associated with the delivery of cancer care. This data was obtained through COA’s “Components of Care” study, a survey of oncology practices across the nation that quantified the clinical and operational components and associated costs for delivering cancer care.
• The areas of underpayment include life-saving chemotherapy infusion services as well as other vital cancer care services such as treatment planning, treatment evaluation, testing, care coordination, supportive and palliative care, and patient counseling.
• For as many as 40% of all cancer drugs, the Medicare reimbursement is already less than the acquisition cost.
• The CMS cuts will also impact essential diagnostic imaging and radiation therapy services. Reimbursement cuts in these vital services are counter-productive to coordinated care and will place additional financial burden on community oncology practices.
• COA and many community oncology practices have submitted comments to the Centers for Medicare & Medicaid Services opposing the planned cuts.

http://www.communityoncology.org/

Re: Medicare facing cancer, cardiac care cuts
 

http://www.helenair.com/news/opinion...cc4c03286.html

Support oncology amendment to bill

• Story
• Discussion

By Robert D. Pfeffer, IR Letter to the Editor | Posted: Sunday, September 27, 2009 12:00 am
I am an oncologist practicing in Helena. I am encouraging people to ask Sen. Baucus to support the amendment to the Senate health reform bill being offered by Sen. Lincoln. This addresses the shocking cuts in reimbursement for radiation oncology services contained in the CMS 2010 fee schedule proposed rule.
The proposed fee reductions will injure Montanans by removing the reimbursement for high technology medicine. High technology medicine is costly to install and maintain and must be supported by appropriate reimbursements. In my career, which began in 1990, I have seen tremendous improvement in the quality of radiation medicine in this state. Montana facilities in the early 1990s had to use equipment that was 15 years out of date. Montanans with means often left the state to go to Seattle or Salt Lake or Mayo knowing they could get better care out of state and Montanans without means stayed here and received lesser quality care.
Montana cancer care has gone from cobalt therapy to having the only Cyberknife between Seattle and Minneapolis. The old low-tech era is bygone but will certainly return after the proposed radiation oncology fee cuts go through.
As a senator with special standing regarding health care policy, Baucus can do much to help the ordinary Montanan continue to receive state-of-the-art cancer treatment at home. While the wealthy will always be able to jet off to Johns Hopkins, we want to provide technical excellence for the ordinary fellow and his family right here in Montana. The proposed 2010 fee schedule for radiation oncology services may once again force us to accept lesser quality cancer care than citizens of other states.
Robert D. Pfeffer, MD
5585 York Road

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Re: Medicare facing cancer, cardiac care cuts
 

ASCO clip on proposed Medicare cuts:

http://link.brightcove.com/services/...id=43015932001

Re: Medicare facing cancer, cardiac care cuts
 

www.medscape.com



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From Medscape Medical News

Current Estimates Predict Fewer and Younger MDs in the Future

Fran Lowry

October 20, 2009 — Estimates made using data from the US Census Bureau suggest that the future physician workforce may be younger and fewer in number, contrary to estimates made using the American Medical Association Physician Masterfile data, a source that is often used by workforce analysts to project changes in the supply of physicians, according to the results of a study published in the October 21 issue of the Journal of the American Medical Association.
"Recent projections indicate that the supply of US physicians may soon decrease below requirements, with some projecting a shortfall as high as 200,000 by 2020," write Douglas O. Staiger, PhD, from Dartmouth College, Hanover, New Hampshire, and the National Bureau of Economic Research, Cambridge, Massachusetts, and colleagues. "Although debate over potential shortages has focused largely on the number and type of physicians needed in the future, concerns have also been raised about data used in physician supply estimates and projections."
The Masterfile data have recently come under scrutiny because of concerns that the Masterfile overestimates the number of active physicians at older ages, the authors write.
The aim of this study was to compare physician workforce estimates and supply projections using Masterfile data with estimates and projections using data from the US Census Bureau Current Population Survey (CPS), a data source used extensively by the US Department of Labor.
Using annual data from the Masterfile and the CPS between 1979 and 2008, the investigators analyzed the number of active physicians by age and sex to estimate the annual number of physicians working at least 20 hours per week in 10-year age categories.
The authors found that in an average year, the CPS estimated 67,000 fewer active physicians (10%) than did the Masterfile (95% confidence interval [CI], 57,000 – 78,000; P < .001), almost entirely as a result of there being fewer active physicians aged 55 years or older.
They also found that the CPS estimated more young physicians (ages 25 – 34 years) than did the Masterfile, with the difference increasing to an average of 17,000 physicians (12%) during the final 15 years (95% CI, 13,000 – 22,000; P < .001).
The CPS estimates of more young physicians were consistent with historical growth observed in the number of first-year residents, and their estimates of fewer older physicians were consistent with lower Medicare billing by older physicians, the authors note.
Both databases projected that the number of active physicians will increase by approximately 20% between 2005 and 2020. However, the CPS data estimated that there will be almost 100,000 fewer active physicians (9%) than the Masterfile data (957,000 per CPS vs 1,050,000 per Masterfile). The CPS data also estimated that a smaller proportion of active physicians will be aged 65 years or older (9% vs 18%).
"The CPS-based projection indicates that 71% of active physicians will be younger than 55 years and only 9% will be older than 65 years, whereas the Masterfile-based projection indicates that 61% of active physicians will be younger than 55 years and 18% will be older than 65 years," Dr. Staiger and colleagues write.
In addition, the increasing proportion of female physicians had little effect on physician supply projections "because, unlike male physicians, female physicians were found to maintain their work activity after age 55 years," according to the authors.
The analysis was restricted to physician supply and projections of physician requirements also rely on estimates of the current number of physicians as a starting point for projections. "Thus, without more accurate estimates of the size and age distribution of the current workforce, projections of physician supply, requirements, and potential shortages may mislead policymakers as they try to anticipate and prepare for the health care needs of the population," the authors conclude.
In an accompanying editorial, Thomas C. Ricketts, PhD, MPH, from the University of North Carolina, Chapel Hill, writes that the controversy over the accuracy of the Masterfile data continues the "longstanding" debate over the supply of physicians and whether that number meets the US healthcare needs and promotes economic efficiency.
"The physician workforce is one of the most critical factors that must be considered in current health care reform and discussions," he writes. "Having accurate estimates for determining not only the number of physicians, but also current and future physician and workforce requirements and capabilities for delivering primary and specialty care, will be essential for achieving and sustaining effective health care reform."
Dr. Staiger and Dr. Ricketts have reported no relevant financial relationships.
JAMA. 2009;302:1674–1680, 1701–1702.
[CLOSE WINDOW]
Authors and Disclosures

Journalist

Fran Lowry

is a freelance writer for Medscape.




Medscape Medical News © Medscape, LLC
Send press releases and comments to news@medscape.net.

Re: Medicare facing cancer, cardiac care cuts
 

Proposed Payment Reductions Squeeze Oncologists

2009 Oct 28, Lee Schwartzberg, MD, PhD, Editor-in-Chief

This grim economic year has affected every health care sector, and oncology practices are no exception to this rule. In my recent travels around the country, I’ve witnessed clinics that have had to lay off staff, close satellites, sell their assets to hospitals, merge with competitors, and reduce office hours. Yet these changes may well represent just the tip of the iceberg.
Currently, 3 independent, but related, initiatives affecting the way physicians are paid are being hotly debated in Congress. These 3 concentric rings are tightening around oncologists, and unless favorable action occurs to loosen any (or all) of these belt-tightening initiatives, it is not a stretch to say that medical oncology as we know it may be irrevocably altered.
Proposed administrative pay cuts by CMS
The most oncology-specific issue is a proposed administrative pay cut by the Centers for Medicare & Medicaid Services (CMS) in services for chemotherapy administration, diagnostic imaging, and therapeutic radiation oncology. Such cuts in reimbursement could have potentially devastating effects on patient care. The origin of Medicare’s proposal stems from data provided by an American Medical Association (AMA) practice expense survey requested by the Medicare Payment Advisory Commission (MedPAC). The data used to justify such cuts is inherently flawed and misrepresentative of community oncology, given that only 50 oncologists responded to the AMA survey, and the mix of respondents was never characterized with respect to type of practice. It is a given that CMS reimbursement for chemotherapy administration is currently inadequate, and many constituent groups have replied to Medicare protesting these cuts.
Outpatient diagnostic radiology services
But what about diagnostic radiology services, which have been increasingly adopted in outpatient community offices? We incorporated computed tomography (CT) scanning into my own practice 20 years ago, and I still view this as the single best patient care decision we’ve ever made. Today, we have a full-service diagnostic radiology department, with the capability of performing the full spectrum of imaging studies, including CT, positron emission tomography (PET), magnetic resonance imaging (MRI), and ultrasound.
Having this radiology department at our clinic allows me to review every CT scan with our staff radiologists, who have vast experience in the presentation of various cancers. Not infrequently, such consultations lead to an alteration in a differential diagnosis, the suggestion for an alternative test, or a change in therapeutic approach. Wait time for patients to receive results is minimized, quality care is maximized, and productivity losses are greatly reduced. The reasons for these positive outcomes seem obvious: The on-site radiology department allows patients to receive all of their diagnostic and therapeutic care in a single facility, obviating the need for patients to schedule separate appointments in geographically remote facilities, where tests will likely be conducted by physicians who know nothing about their particular case or who have minimal insights into their specific circumstances.
Thus, the key question for me is: Will reducing reimbursement to outpatient radiology facilities, which will only serve to drive patients back to the hospital for testing, really decrease the cost of medical care? Or will this proposed reimbursement cut merely serve to lower the quality of such care?
Impact of proposed cuts, according to ASTRO survey
Moreover, the CMS rule proposes to cut radiation oncology services delivered in outpatient facilities by between 19% and 30%. A survey commissioned by the American Society for Therapeutic Radiation Oncology (ASTRO) demonstrated that two-fifths of respondents would actually close their practices if cuts in the 30% range were implemented. Half of rural practices would shut their doors under these circumstances, and the majority of practices that did manage to stay open would limit or no longer accept new Medicare patients.
Such cuts would have a huge impact on cancer care delivery in our country. Whether or not cuts of this magnitude will be implemented by CMS remains to be seen, however, so there is still opportunity for the oncology community to respond. Comments to CMS and unflagging communication with elected officials are absolutely critical to prevent these disastrous changes from being implemented on the basis of flawed information. A letter with bipartisan authorship signed by 32 senators protesting the cuts to radiation oncology was recently sent to Health and Human Services Secretary Kathleen Sebelius. The oncology community needs to maintain this type of pressure on our elected officials and the administration in the ensuing weeks.
Modifying the SGR formula
The second concentric circle relates to the long-standing need to modify the sustainable growth rate (SGR) formula. This formula, conceived to keep physician payments consistent with changes in the gross domestic product (GDP) over the years, has been a boondoggle requiring a temporary fix applied legislatively by Congress for each of the last several years to prevent huge and unsustainable cuts in physician payments. This issue was supposed to be resolved once and for all in 2009. Senator Debbie Stabenow (D-Mich) introduced legislation to alter the SGR formula and thereby correct the inequities. The bill, estimated to cost $240 billion over 10 years, was not accompanied by offsets in costs from other parts of the budget, however, and therefore actually added to the cost of Medicare—an approach that is very unpopular in Washington these days. This bill was soundly defeated on the Senate floor last week.
The Senate Finance Committee health reform bill does contain a 1-year SGR fix, which is fully offset by other reductions and therefore potentially more palatable. Nonetheless, even that potential solution does not provide a real fix for the SGR problem.
But if SGR is not fixed or if a comprehensive health reform bill does not pass, what’s in store for 2010? The most likely result will be a 21% reduction in Medicare fees. Such a drop in physician reimbursement would undoubtedly cause many, if not most, physicians to abandon Medicare. In the case of oncologists, for whom Medicare represents 45% of all patients, the ability to care for older individuals will become virtually impossible. And, if only a 1-year fix passes again, there is little realistic expectation that a fair solution to the SGR problem will survive the legislative process in 2010—especially after the exhausting year of debating health care reform that is now coming to a close. Still, this problem cannot be put off forever.
Health care reform bill
The third and widest initiative is, of course, the overall health care reform bill. Few would argue against the need for some form of health reform legislation, and signs still look good for a broad-based bill to pass Congress, even though it’s unclear whether a final bill reconciling the House and Senate versions will be brought to a final vote before the end of 2009. If this process extends into the early part of 2010, there are clear-cut political consequences for all Congressional representatives who are running for reelection, not to mention the impact on the President’s ambitious agenda beyond health care.
To date, the biggest sticking point between the Senate and House versions of health reform legislation is the public health plan option. Speaker of the House Nancy Pelosi (D-Calif) plans to keep the public option in the House version because of increasing pressure from liberal Democrats to do so. On the other side, the Senate seems strongly inclined to vote against any bill that includes a public option.
If a public plan is implemented, the greatest source of concern for oncologists is how well it is funded. The 2 basic proposals that have been advanced are as follows: (1) to pay providers at Medicare rates, or (2) to negotiate rates with providers, as would be done by private insurance companies. Most analysts believe any public plan would compete favorably with private payers and, in a few years, could be a dominant force in the non-Medicare market. If so, oncology providers paid at Medicare rates for their services could not afford to stay in business, since the current payment schedule is at or below cost and therefore is unsustainable. In my opinion, a public plan that negotiates with providers is a valid option, however. I believe that negotiating rates will ultimately drive down costs to patients in the private health insurance market. It should be noted that insurance premiums are rising significantly again this year, and are unsustainable for companies that provide health care insurance. A solution to the high cost of insurance premiums is necessary, but not on the backs of the providers.
Communication with elected officials is still key
So we head toward the holiday season with apprehension about what’s in store for Medicare, particularly with regard to oncology. However, uncertainty should not be confused with hopelessness or helplessness. Our elected officials do listen to their constituents. It’s incumbent upon all oncology practices and their patients to communicate with their elected representatives, and to explain what the stakes are for making decisions that fail to recognize the complexity of modern cancer care. Today’s oncology practitioners must not only plan treatment, assess treatment response, and provide coordination of care, but also offer disease surveillance, provide supportive and palliative care, and manage end of life. Most recently, we also have been charged with providing financial counseling to our patients who undergo expensive cancer treatments.
Current codes being used by the federal government fail to reimburse physicians for any of these services. Reach out to your representatives and ask them to support appropriate coding modifications that reimburse oncologists fairly for the work they do each day. Only by such outreach efforts will we be able to preserve access to the world’s best cancer care delivery system.

Re: Medicare facing cancer, cardiac care cuts
 

ASCO prez responds to cuts:
http://www.asco.org/ASCOv2/Press+Center/Latest+News+Releases/American+Society+of+Clinical+Oncology+(ASCO)+State ment+on+Cuts+to+Cancer+Care+in+2010+Medicare+Physi cian+Fee+Schedule

Re: Medicare facing cancer, cardiac care cuts
 

Ugggg..
http://weisenthalcancer.com/Professi...surancepro.htm
"Medical Insurance Coverage Insurance coverage for Functional Tumor Cell Profiling varies depending upon the reimbursement policies of the patient's insurance carrier and the provisions of his or her specific insurance policy. Many insurance carriers cover most or all of the testing fees, excluding normal co-payments and deductible amounts. However, other insurance carriers pay for only a portion of the costs and some carriers may deny claims completely. Patients will be billed for any co-payments, deductible amounts, or other balances that are not paid by the patient's carrier. As a courtesy to your patient, we gladly will submit insurance claims to the carrier before requesting payment from the patient. We will also assist in appealing an unfavorable coverage decision in the event that an insurance claim is denied. Our collections policy is liberal and humane. We always allow ample time for insurance claims work their way through the system, including carrier information requests and appeals when necessary

Effective July 1, 2008, Weisenthal Cancer Group elected voluntarily to opt-out as a Medicare provider owing to excessive delays in receiving payments and also due to Medicare's erratic coverage patterns, despite the fact that an exhaustive technology review by Medicare resulted in what was supposed to have been routine coverage for Medicare beneficiaries for functional tumor cell profiling beginning in February of 2007. We regret that Medicare's slow and inconsistent payment policies along with its lack of responsiveness to our inquiries necessitated this action on our part. This does NOT mean that we do not perform testing for Medicare beneficiaries. We offer our testing services equally to all patients. However, it means that Medicare beneficiaries assume financial responsibility for their testing services in the same manner as non-Medicare beneficiaries. "

Re: Medicare facing cancer, cardiac care cuts
 

Only physicians and suppliers can decide not to accept assignment. If your physician or supplier does not accept assignment for covered services, your physician or supplier may require that you pay most or all of the bill at the time you receive services or supplies. However, the physician or supplier is still required to file a Medicare claim on your behalf. Medicare then pays its share of the bill directly to you.

Re: Medicare facing cancer, cardiac care cuts
 

I thought opting out of Medicare assignment meant not having to operate according to Medicare guidelines. Or are you saying there are laws forcing them to file to any and all insurance entities?
If that's true, it's good information to know in the case of Medicare approved services. Maybe one could negotiate a good "pay as you go" discount with the provider and get full coverage upon Medicare reimbursement.

I think the Weisenthal statement indicates Medicare doesn't , or doesn't always, consider their services appropriate for coverage. So filing might not guarantee reimbursement.

Re: Medicare facing cancer, cardiac care cuts
 

Accepting assignment means they will bill the Medicare contractor directly and receive reimbursement from the Medicare contractor.

Not accepting assignment means, although they may require you pay most or all of the bill, they are still required to file a Medicare claim on your behalf, and the Medicare contractor pays its share of the bill directly to you.

Medicare does consider the services appropriate for coverage. In 2006, Medicare officially recognized cancer chemosensitivity tests as a special test category in Federal Regulations (42 CFR 414.510(b)(3), 71 FR 69705, 12/01/2006). The are now known as Oncologic In Vitro Chemoresponse Assays.

As with any other laboratory tests in cancer medicine, the determination of the efficacy of chemoresponse assays is based on clinical correlations (comparisions of laboratory results with patient response). The "standard" of retrospective correlations between treatment outcomes and laboratory results is sufficient in the case of ALL laboratory tests. It is what established FDA-approval for the test kit.

Two Medicare contractors (NHIC Medicare Services and Highmark Medicare Services) established reimbursement coverage policies for these tests, the same way that the Oncotype DX assay is being covered. Medicare bills for chemoresponse testing, from any Medicare patients, anywhere in the United States, are billed through NHIC and Highmark Medicare Services because the test is conducted by approved laboratories in Southern California and one in Pennsylvania.

The decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis. What is of particular significance is that they abandoned the artificial distinction between "resistance" testing and "sensitivity" testing and are providing coverage for the whole FDA-approved kit. Drug "sensitivity" testing is merely a point a little farther along on the very same continuum which "resistance" testing resides.

Cell-based assay tests based on "cell-death" have proven very effective in identifying novel treatment combinations for a variety of cancers. The value of cell-death assays is that they can and do accurately predict clinical outcomes and define novel chemotherapeutic synergies. It can help see what treatments will not have the best opportunity of being successful (resistant) and identify drugs that have the best opportunity of being successful (sensitive).

The current clinical applications of in vitro chemoresponse testing is ever more important with the influx of new "targeted" therapies. Given the technical and conceptual advantages of "functional profiling" of cell-based assays together with their performance and the modest efficacy for therapy prediction on analysis of genome expression, there is reason for renewed interest in these assays for optimized use of medical treatment of malignant disease.

This pre-test can help see what treatments have the best opportunity of being successful for "high" risk cancer patients. The test measures the response of "live" tumor cells to drug exposure. Following this exposure, the assays measure both cell metabolism and cell morphology (functional profiling). The integrated effect of the drugs on the whole cell, resulting in a cellular response to the drug, measuring the interaction of the entire genome. Assays based on "cell-death" occur in the entire population of tumor cells.

This cell-based assay technology has been clinically validated for the selection of optimal chemotherapy regimens for individual patients. It is a laboratory analysis based on tumor tissue profiling that uses "fresh" human tumor biopsy or surgical specimen to determine which drugs or combinations of chemotherapeutic agents have the highest likelihood of response for individual cancer patients.

Following the collection of "fresh" tumor cells obtained from surgery or tru-cut needle biopsies, a cell culture assay is performed on the tumor sample to measure drug activity (sensitivity and resistance). This will pinpoint which drug(s) are most effective. Tissue, blood, bone marrow, and ascites and pleural effusions are possibilities, providing tumor cells are present. At least one gram of fresh tissue is needed to perform the tests, and a special kit is obtained in advance from the lab. The treatment program developed through this approach is known as assay-directed therapy.

Effective September 2, 2008, Palmetto GBA (instead of NHIC, Corp.) is the Medicare Administrative Contractor for Jurisdiction 1, which includes California, Nevada, and Hawaii.

private & government sponsored health programs similar in regards to cancer reduction
 

Despite the endless rhetoric from United States politicians, the results of study published in the November 30 Annals of Oncology, indicate private and government sponsored health programs have achieved extremely similar results in the reduction of cancer.

In a comparison of public and private insurance and cancer rates, a study of European cancer rates showed marked parity with very similarly constructed reports from the American Cancer Society.

Cancer mortality in Europe, 2000-2004, and an overview of trends since 1975. Annals of Oncology. doi:10.1093/annonc/mdp530

http://annonc.oxfordjournals.org/cgi/reprint/mdp530

http://www.cancer.org/downloads/STT/..._2007_rev2.pdf

http://www.cancer.org/docroot/stt/stt_0.asp?from=fast

Re: Medicare facing cancer, cardiac care cuts
 

"they are still required to file a Medicare claim on your behalf"
Who/what requires this?

Re: Medicare facing cancer, cardiac care cuts
 

Re: Medicare facing cancer, cardiac care cuts
 

If they accept the medicare patient, that would apply. If they don't want the hassle, they can limit Medicare patients from making appointments. I know one cancer treatment facility that accepted Medicare patients up until they were 50% of their patients.

Life Without Health Care Reform
 

I've observed incessant complaints on various cancer blogs and discussion boards about BC/BS (Blue Cross/Blue Shield) "denial of coverage" on the backs of injured and diseased human beings during their fight with the great crab.

In one case, a patient was denied a Cat scan. The poster said, "because BC/BS is practicing medicine and deciding that such a thing is not medically necessary." The physician wasn't allowed to make a diagnosis based on the best available technique.

Another poster said that BC/BS had decided not to cover a Pet scan, even against the physician protest. And another said that BC/BS had denied covering treatment because it was just too expensive.

One poster goes on to say, "It would appear to me that we in the USA are rapidly closing in on having all of the drawbacks of socialized medicine, with none of the purported benefits." The controls are mostly privately financed, but are given over to remote corporate bureaucrats who determine who shall live and who just isn't worth it.

Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine. Evidence is based on data from medical journal articles, epidemiology and economics, which relies on randomized clinical trials, which doesn't even require a medical education.

Nonphysicians trained in social science, science or even public policy analysis, have judgement over medicine. Where doctors used to define the "standard of care," now payers redefine the standards for appropriate medical care, encouraging doctors to act in ways to promote their financial interest when they make medical decisions.

America has granted private insurance companies the right to create bottlenecks in the financing of health care in order to extract profits out of the suffering of ordinary people, without providing any actual health care whatsoever.

Re: Medicare facing cancer, cardiac care cuts
 

I thought we were talking about issues within Medicare, a public system. I too would like improved health care options. I think it's worth honestly looking at what's good and bad about the various approaches and figuring out how to proceed.

Re: Medicare facing cancer, cardiac care cuts
 

We hear complaints about publicaly run health programs and privately run health programs. According to the research published in the Annals of Oncology, private and government sponsored health programs have achieved similar results (for example) in the reduction of cancer. I agree, it is worth honestly looking at what's good and bad about both approaches and figuring out how to proceed.

Re: Medicare facing cancer, cardiac care cuts
 

Mayo Clinic in Arizona to Stop Treating Some Medicare Patients

http://www.bloomberg.com/apps/news?p...d=aHoYSI84VdL0

Mayo Clinic has two family medicine clinics in Arizona
 

Mayo said it will continue to accept Medicare for critical care and specialty services as well as lab services and physical therapy—but not routine primary care.

Over 50% of their practice is taking care of Medicare patients. Primary care is a small component of their practice, so apparently that is why Mayo decided to pull back on primary care, while continuing to provide critical care.

http://takingnote.tcf.org/2009/10/ma...-patients.html

Re: Medicare facing cancer, cardiac care cuts
 

Reviewing the info in this thread, this latest Mayo announcement seems fairly predictable. And that's in a mixed reimbursement system that shifts costs to private insurers. Primary care today, cardio and oncology tomorrow? I hope I'm wrong. But I've already been directly involved with a treatment center that had to look at their Medicare/private ratio before they could reserve an appointment for my mom. That was in Nov '08. A month ago, a cardiologist point blank told me my father's need for a defibrillator (vs pacemaker) had to be measured against "rationing" guidelines of Medicare. I didn't use the word, he did. The issue isn't feeling very abstract or academic to me.

Re: Medicare facing cancer care cuts
 

Oncotech was an American laboratory providing individual chemoresponse testing as a service to patients and physicians since the mid-1980s. It was co-founded by Drs. Robert Nagourney and Larry Weisenthal. They each left the company in the early 1990s, over disagreements with the controlling investors (4 venture capital companies) over the management and directions of the company. Dr. Weisenthal remained supportive of the company, over the years, and played an important role in securing and, later, retaining reimbursement by Medicare for their services. Drs. Nagourney and Weisenthal each started their own small private laboratories to offer related cell culture testing services.

Oncotech continued operations as a privately-held, venture-capital controlled company until February of 2008, when it was acquired by a Danish biotechnology company called Exiqon, Inc. for $45 million (US) in Exiqon securities.

Exiqon replaced the Oncotech CEO and installed its own management team, continuing to operate Oncotech as a wholly-owned subsidiary, with a business model centered around providing chemoresponse assays on a (US) national basis — importantly to Medicare patients.

In the case of Weisenthal Cancer Group, they opted out of Medicare, effective July 1, 2008, because the reimbursements received from Medicare did not cover our costs of providing our services (although they are still required to file a Medicare claim on your behalf).

Exiqon Oncotech, however, depended on Medicare reimbursement to support its business model. In the USA, Medicare coverage decisions for many types of medical services are made at the regional level (Local Coverage Decision or LCD), by the private insurance companies with which Medicare contracts to administer services to Medicare beneficiaries. Previous Medicare contractors for California made the determination that chemoresponse assays qualified as a Medicare covered service. These included the TransAmerica and National Heritage Insurance (NHIC) companies. Most recently, an insurance company called Palmetto was awarded the contract to administer Medicare services for California. Palmetto made the decision to discontinue Medicare payment for chemoresponse assays in California.

Last week, Exiqon Oncotech announced that it was discontinuing operations, because of the withdrawal of Medicare reimbursement for its services. This was an entirely understandable, if regrettable, decision. What was in no way understandable — or defendable, for that matter — was the way that they ceased operations.

Exiqon Oncotech sent out notifications to its client physicians that it was ceasing operations, virtually immediately. On a single day this past week, they received two dozen specimens from human tumor biopsies via FedEx and other couriers. All of these specimens were simply sent back to the hospitals and clinics which sent the specimens. Physicians were told that there were no other laboratories who could perform the tests requested.

While it is true that no other American laboratories have chosen to utilize Exiqon Oncotech’s non-proprietary technology for chemoresponse assays, it was well known to Exiqon Oncotech that there are a number of highly experienced, well qualified, well-published American laboratories which provide this service, utilizing different, but at least comparably valid, technologies (cell-death as opposed to cell-growth endpoints).

There have been only two previous, investor-backed, clinical laboratory companies which provided chemoresponse assays as a service to patients, only to make the decision that their business models were no longer viable. These companies were Analytical Biosystems and NuOncology Laboratories. When these latter companies ceased operations they did so in an orderly fashion, giving their clients adequate advance warning and winding down operations at a pace which enabled them to provide testing for those patients and physicians who had already planned and depended upon receiving these services, and these companies were open and helpful in providing their former client physicians with contact information for other laboratories within the US which continued to provide chemoresponse assay services.

In the case of Exiqon Oncotech’s two dozen tumor specimens simply marked “return to sender,” It can scarcely be imagined anything more irresponsible. In many of those cases, doubtless the physicians and/or surgeons discussed in advance with their patients the importance of sending their biopsies for cell culture analysis. In some cases, the surgical procedure may have been performed primarily for the purpose of this analysis. In other cases, the patients were doubtless comforted by knowing that this testing was to be performed.

Business is business, but, at a certain point, business is also about people, and cancer business is, or should be, about cancer patients.

Many are saddened by the shuttering of Oncotech’s doors, 25 years after its founding, and are ashamed at the way in which those doors were apparently shutterd.

It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provides the assays and accepts Medicare reimbursement as payment in full. California laboratories continuing to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services) include Rational Therapeutics, Anticancer, Inc., and Weisenthal Cancer Group.

This has been a double sign of irresponsibility, not only on what Oncotech did, but on what Palmetto GBA did.

The previous CMS administrator for Medicare in Southern California (NHIC) spent almost the entire 2006 doing a extensive, transparent tech assessment of chemoresponse assays and made the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a “non-investigational” basis.

What was of particular significance this time (as compared to approval for the resistance part of the testing in 2000) was that they abandoned the artificial distinction between “resistance” testing and “sensitivity” testing and provided coverage for the whole FDA-approved kit.

Why it was a local coverage decision (LCD) and not a national coverage decision (NCD)? Medicare has only about 20 doctors and 40 total clinicians working in its coverage office.

Also, Medicare doesn’t have a single oncologist on staff, yet since the year 2000, they issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools. Private insurers (like NHIC), on the other hand, employ thousands of doctors and nurses to do this.

Medicare wants to put off-lable drug decision making (which some 60% of cancer drugs are) in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs. I am just wondering if this had anything to do with what Palmetto GBA is doing?

It amazes me that they don’t emphatically mandate this testing as a requirement for obtaining chemotherapy reimbursement against ill-directed treatments. Evidence in support of these tests is more than sufficient to justify them, particularly in light of the Duke University impact study of chemoresponse assays on the treatment costs for recurrent ovarian cancer.

Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer.

Havrilesky LJ, Krivak TC, Mucenski JW, Myers ER. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, NC.

Objective

We sought to estimate mean costs of chemotherapy treatment for recurrent ovarian cancer with or without use of a chemoresponse assay.

Study design

We estimated mean costs for 3 groups: (1) assay assisted: 75 women who received oncologist’s choice of chemotherapy following chemoresponse testing (65% adherence to test results), (2) assay adherent: modeled group assuming 100% adherence to assay results, and (3) empiric: modeled from market share data on most frequently utilized chemotherapy regimens. Cost estimates were based on commercial claims database reimbursements.

Results

The most common chemotherapy regimens used were topotecan, doxorubicin, and carboplatin/paclitaxel. Mean chemotherapy costs for 6 cycles were $48,758 (empiric), $33,187 (assay assisted), and $23,986 (assay adherent). The cost savings related to the assay were associated with a shift from higher- to lower-cost chemotherapy regimens and lower use of supportive drugs such as hematopoiesis-stimulating agents.

Conclusion

Assay-assisted chemotherapy for recurrent ovarian cancer may result in reduced costs compared to empiric therapy.

PMID: 20417480

Medicare facing "more" cancer care cuts
 

It was noted above, the Medicare contractor for the state of Pennsylvania continued to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provided the assays and accepted Medicare reimbursement as payment in full.

The California laboratories that continued to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services) included Rational Therapeutics, Anticancer, Inc., and Weisenthal Cancer Group.

It looks like Novitas Solutions, Inc. (formerly Highmark Medicare Services) has arbitrarily made the decision, like Palmetto, GBA did in California, to discontinue Medicare payment for chemoresponse assays done by Precision Therapeutics in Pennsylvania.

The rationale for the non-coverage decision is totally bogus. It's a shame. The biggest thing is that the "expert reviews" upon which they rely on made no attempt whatsoever to determine the "accuracy" of the tests being evaluated.

They all used the phony, made-up criterion of test "efficacy" -- demanding rigorous proof that the use of the tests improves outcome -- which is a standard not achieved by any of the large number of laboratory tests currently used to assist in treatment/drug selection in oncology -- or for that matter, in medicine in general.

The only criteria ever used to evaluate laboratory or radiographic tests has been the accuracy of the tests. And this criterion was totally ignored in the reviews. They just made up their minds in advance that they didn't want to pay for the tests.

ASCO made up its mind in advance that it didn't want to have anything to do with the tests (for a lot or reasons, including the certainty that it would siphon patients away from their clinical trials). So they erected an impossibly high bar.

One of the major reasons academic cancer institutions don't like in vitro chemosensitivity test is that it may be in direct competition with their randomized controlled clinical trial paradigm - a fiercely defended relic of their ignorance.

Cell culture assay measure the "efficacy" of anti-cancer drugs. The randomized clinical trial measures the "efficacy" of anti-cancer drugs. And the new molecular testing rates the "efficacy" of population research vs rating the "efficacy" of drugs "actually" tested against an individual's cancer cells.

The oncologist’s trade group, American Society of Clinical Oncologists (ASCO) says oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient’s health status and treatment preferences. All the rigorous clinical trials identified are the best treatments for the “average” patient (do cancer cells like Coke or Pepsi). But cancer is far more heterogeneous in response to various individual drugs than are bacterial infections. The tumors of different patients have different responses to chemotherapy.

The ASCO tech assessments say that chemotherapy sensitivity and resistance assays (CSRAs) should not be used outside the confines of a clinical trial setting. The same people who maintain that assay-directed therapy should not be used until proven in prospective randomized clinical trials, are the same people whose entire careers are utterly dependent upon mega-trials 100% funded by pharmaceutical companies (that, plus fees from speeches they give for these companies), are the same people who control the clinical trials system, the grant review study sections, and the journal editorial boards.

No wonder ASCO doesn’t recommend the use of CSRAs (no matter how good they are) to select chemotherapeutic agents for individual patients outside of the clinical trial setting. Besides the authors of these tech assessments trying to invent a brand new criterion for validating a laboratory test, they’d like to have these tests in clinical trials. Tens of thousands of scientists pushing a goal of finding the tiniest improvements in treatment rather than genuine breakthroughs that fosters redundant problems and rewards academic achievement and publication above all else.

Why is ASCO (and others) protecting the status of treatments which are only marginally and minimally and inconsistently effective? This prevents serendipitous and fortuitous discovery. Truly effective treatment don’t need prospective randomized trials. Even ASCO points out, because the number of available chemotherapeutic agents has increased enormously over the past few years, the emphasis on the rationale for these assays have never been stronger. As the number of possible treatment options supported by completed randomized clinical trials increases, the scientific literature becomes increasingly vague for guiding physicians.

With all these uncertainties, would it be wrong to make a clinical decision based on CSRAs? Should it be denied to patients who walk in the door asking for it? Patients who want this testing, after a thorough discussion about the peer-reviewed studies and experience that supports it, should not be hindered by restrictive ASCO policy. I never heard that ASCO had been knighted a regulatory agency.

Until the controlled, randomized trialist approach has delivered curative results with a high success rate, the choice of physicians and patients to integrate promising insights and methods like chemoresponse assays, remains an essential component of this kind of treatment technology.

Michael Castro, M.D., stated on the Rational Therapeutics blog, "In 1992, the Church publicly forgave Galileo for his “crime” of the heliocentric theory…a lesson in the slow pace of circumspection by authoritative bodies… seems we haven’t yet overcome an analogous religious intolerance in medical oncology and I’m not holding out for an apology from ASCO any time soon, but eventually it may come… Certainly, the insistence on population medicine at a time when the technology for individualized medicine has arrived borders on religious intolerance, not the scientifically curious patient advocacy patients want and naively expect… I’m afraid this intolerance is buttressed by the economic incentives of giving drugs to as many individuals as possible – a double problem…."

https://www.novitas-solutions.com/po...ab/l32571.html

The High Cost of Cancer Care
 

Robert A. Nagourney, M.D.

An article by Scott Gottlieb, MD, in Forbes (Medicare Nixes Coverage for New Cancer Tests), described Medicare reimbursement for new molecular diagnostics. As many readers are aware, there have been a growing number of diagnostic tests developed and marketed over recent years designed to identify and monitor the progress of cancer. Many of these tests are multiplexed gene or protein panels that identify prognostic groups using nomograms developed from prospective or retrospective analyses. The 21-gene Oncotype DX and related Mammoprint, are among the most widely used. Related tests for lung, colon, and other cancers are in development.

With the explosion of assays designed to personalize cancer care, comes the expense associated with conducting these analyses. Medicare, as the largest provider of medical insurance in the United States, is at the leading edge of cost containment. Not surprisingly, HHS has a jaundiced view of adding tests without clear cost benefit.

The issue is far broader than cost analysis. It goes to the very heart of what we describe as personalized medicine. Every patient wants the right treatment for their disease. Every laboratory company wants to sell their services. Where the supply and demand curve meet however, is no longer set by market forces. In this instance, third party reimbursers set the fee and the companies then need to determine whether they can provide their service at that cost.

The problem, as with all economic analysis, is meeting patient’s unlimited wants with limited resources. Two solutions can be envisaged. On the one hand, medical care progressively moves to a scenario of haves and have nots wherein only wealthier individuals can afford to obtain those drugs and interventions that are beyond the price range of most. On the other hand, care is rationed and only those treatments and interventions that rise to the highest level of evidence are made available.

While the subject of this article was sophisticated diagnostic tests, it will only be a matter of time before these same econometric analyses begin to limit the availability of costly drugs like highly expensive targeted agents. In a recent editorial published in blood, leading leukemia experts pointed out that 11 of the 12 recently approved drugs each cost $10,000 or more per month.

As we examine the rather grim prospect of unaffordable or rationed care, a glimmer of hope can be seen. Using expensive and relatively insensitive molecular diagnostic tests to select expensive targeted agents could be replaced by less expensive testing platforms. The dramatic, yet brief responses observed for many targeted agents reflect the shortcoming of linear thinking applied to the manifestly non-linear human biology, characterized by cross talk, redundancies and unrecognized hurdles. To address these complexities phenotypic analysis (the phenotype being the end product of genomic, transcriptomic and proteomic events) provide global assessments of tumor response to drugs, combinations and signal transduction inhibitors. These more discriminating results identify cellular response at the level of biology, not just informatics. While it is theoretically possible that high-throughput genomic analyses using neural networks and high throughput computer analyses may ultimately provide similar information, it is unlikely that most patients will have ready access to a Cray computer to decipher their results.

We need to stop working hard and start working smart. The answers to the many questions raised by the Forbes article regarding resource allocation in cancer treatment may already be at hand.

* The Cray computer is an American supercomputer

Medicare Nixes Coverage For New Cancer Tests
 

Scott Gottlieb, MD

Medicare has sharply changed the way it pays for diagnostic tests, cutting payment rates and curtailing coverage for some new tests altogether.

The makeover in the way that Medicare reimburses molecular diagnostics has been foreshadowed for years, but was abruptly put into effect this summer.

Affected are the kinds of tests that probe for gene and protein markers found in our body’s tissues. These tests help doctors diagnose a multitude of diseases and monitor our response to drug treatments. They are used in a variety of medical settings. Some of their greatest promise has been in personalizing the treatment of cancer by tailoring drug therapies to a person’s unique tumor type.

The labs that perform the test are the same outfits that market them. The tests are typically sold as a laboratory service, rather than marketed as a medical device.

The new payment system has cut payment rates across the board, by an average of about 20% (and as high as 80% in some cases) from 2012 levels. Most of the new rates are being based on the work of one Medicare contractor, Palmetto GBA.

Hardest hit by the change, however, are many new diagnostic tests that aren’t yet a part of routine medical practice or may only benefit a small patient group, often with rare disease states. These diagnostics are being dubbed “tier 2” tests since they weren’t assigned discrete “codes” under the AMA’s new coding scheme.

In many cases, that also means that they haven’t been assigned a payment rate.

These tier 2 tests can try to file for Medicare payment under a so-called “miscellaneous” code for new tests. But that is often a dead end. In many cases, Medicare carriers have stopped paying for novel “tier 2” altogether, even tests that were previously reimbursed under the old scheme.

All of these tests typically probe for novel markers, or for a panel of (multiplexed) gene or protein markers whose combination of outputs are used to make predictions about things such as the potential for cancer to spread or respond to a medicine.

Previously, these tests were reimbursed under a “code stack” system that based payment rates on a sum of the cost of each of step used in conducting a particular test. Code stacking had a lot of problems. For one thing, the payment rates didn’t reflect the clinical value of a test, just the cost to perform it. The system also obscured from Medicare’s view what the agency was ultimately paying for.

When a bill arrived at Medicare, it merely listed the different markers that a particular test was probing for, and the laboratory steps being taken to identify these genes or proteins. Ultimately, the “code stack” didn’t reveal to Medicare what the test actually set out to do, and how doctors were using it.

So Medicare is replacing the ambiguous code stacks with a new set of discrete CPT codes that identify each common test by its own billing number. These codes are established by the American Medical Association at the behest of the Medicare agency. The AMA CPT Editorial Panel, which administers the development of new codes (but not reimbursement) for Medicare and all payers, made its first serious effort to come up with a new list of discrete codes back in 2010. After a long delay, the first tranche of 116 “tier 1” discrete codes finally went into effect January 1st.

As I wrote in an earlier article for Forbes, reimbursement for many of the tests were put on hold altogether while Medicare figured out what payment rates it wanted to assign to its new codes. Those rates are now starting to emerge, and the money is finally starting to flow again, although not all of the tests that fall under these “tier 1” codes are being reimbursed.

But the situation is even worse for tests that didn’t get one of the new codes. These novel tests don’t fit into one of Medicare’s new buckets. Many aren’t getting paid for.

This is having a profound impact on investment, and in turn, continued innovation and development. The policy change ends the established model for how novel tests got introduced into medical practice. With no suitable alternative, the new scheme will thwart the introduction of novel diagnostics and limit bets on new technology.

Labs traditionally don’t get paid for research and development. Nor are the sunk costs of R&D fully baked into the price of newly launched diagnostics. In this way, the pricing of diagnostic tests is very different than the pricing of drugs.

Except for a few exceptions, the intellectual property supporting a new diagnostic test is easy to engineer around. So it doesn’t support premium pricing for a new test.

As a result, most diagnostics get priced based on some measure of the cost of performing a test, not the cost it took to develop the novel diagnostic. So paying for diagnostic tests early in their product life cycle, before the clinical utility of a new test was fully demonstrated to Medicare’s approval, was a way of funding that R&D.

Early adoption of tests, often by clinical thought leaders at academic medical centers, wasn’t just a way to offset the cost of developing a new test. It also gave doctors a chance to start incorporating a new test as a part of medical practice. It enabled some doctors to practice medicine at its cutting edge. Typically academic doctors expert on a new marker were able to deploy a test and refine its role in medicine.

Absent a new process for financing the development and introduction of new diagnostics, a lot of promising innovation could be put on hold. Yet all of these tests are an integral part of efforts to “personalize” the delivery of care — a branch of medicine that is supposed to improve clinical outcomes, and hopefully lower costs.

In this way, Medicare threatens to undermine the very sort of personalized medical practice that Congress and the Administration is trying to underwrite by reforming regulations at the Food and Drug Administration and through parts of Obamacare.

There’s also a much broader principle at stake: Medicare as a business partner.

The old coverage model had flaws. But it had been static for years. The payment model conditioned expectations and formed the basis for investment in new test.

Medicare’s abrupt change to that payment model has created a lot of uncertainty that’s putting new investment on hold.

The problem is that Medicare is no ordinary payer. Private payers emulate the agency’s coverage decisions. So Medicare’s ends up setting the market standard.

If the political class wants to put most of the reimbursement of healthcare under the thumb of government, it needs to pay particular care to how its coverage and payment policies affect incentives to new innovation. Medicare isn’t just another payer looking to ratchet down on payment rates in the name of cost containment.

Its decisions end up having a profound impact on investment and development of new products. In short, if Medicare is going to flex so much power owing to its broad reach and government mandates, it needs to be mindful of its impacts.

Medicare’s payment changes are reverberating through the medical marketplace. It has created all kinds of problems for patients and doctors.

Sometimes, doctors’ won’t have enough tissue to run tests on a tumor in series, one at a time as the treatment or diagnosis evolves. Doctors need to use the small sample they have to get all the information right up front. But some of these sorts of “multiplexed” tests that probe for multiple gene mutations off the same sample of tissue are precisely the novel sorts of tests that are in a gray area right now.

Whether test will get covered also depends on where the laboratory doing the test is located, creating a very uneven marketplace for providers and patients.

Some regional Medicare carriers such as Palmetto GBA (which covers California; and North and South Carolina) have set rates that are close to the previous payment levels received by the largest labs for the simplest versions of common tests (versions that might only probe for one or a few variations of a marker). The molecular labs for LabCorp (NYSE:LH) and Quest (NYSE:DGX) are each located in Palmetto’s geographic area. So the carrier has more experience than others in the coverage of molecular diagnostics. Palmetto has also been more flexible than other Medicare contractors in continuing to pay for some “tier 2” tests.

But Medicare carriers in other parts of the country have been much slower to set rates for the 116 standard tests, and are denying coverage altogether for tests that don’t have one of the unique codes. For example, the Medicare carrier CGS, which oversees parts of the Midwest, is telling companies that it won’t pay for molecular tests that haven’t been incorporated into standard treatment guidelines, been substantiated by major clinical articles, and have become a routine part of practice.

That means just about any new test won’t get covered, and even some established tests might not fit the narrow criteria CGS is using.

A list of some of the tests that Medicare won’t pay for can be found on the Palmetto website. Palmetto is one of the few carriers publishing its “non-coverage” decisions.

At the core of this is a more central debate: What level of evidence should a test demonstrate before Medicare will pay it for.

What Medicare is saying, through carriers like Palmetto, is that tests need to show “clinical utility” before the agency pays for it. That means that labs need to prove that the test results will change treatment in a way that improves patient outcomes.

At first blush, this might sounds reasonable. But it’s an imprudent standard that’s at odds with the way that diagnostic tests get used as a part of the practice of medicine.

Diagnostic tests typically supply information that’s fitted into a mosaic of other data. All of this information, combined, helps inform an overall judgment about a patient’s condition and a proper course of treatment. It’s rare that the result of a single test is – in isolation — determinative in guiding a treatment decision. It’s even less common that the outcome of a single test will itself improve a patient’s outcome.

To take a simple example, consider a stethoscope that helps a physician hear a patient’s lungs. The information gleaned from that exam may help the doctor judge that a patient has pneumonia, or heart failure. But by itself, the stethoscope exam can rarely nail the diagnosis, nor select the right treatment.

The stethoscope yields incremental information that helps tip the balance of a physician’s judgment in one direction or the other. It adds to the clinical mosaic.

The problem is that Medicare’s new requirements thwart the introduction of almost any new test. If a test has to show that it improves clinical outcomes before it gets introduced to doctors and patients, it won’t get introduced in the first place.

The way that the best molecular tests have traditionally become a mainstream part of practice is through deliberate validation from real world use by providers with expertise around a particular marker. The tests are often first performed by a small number of clinical experts who deploy the tests at academic centers of excellence.

By allowing molecular tests to enter the market, they can gain adoption among a small number of clinical thought leaders who are closest to a particular marker. This process of slow introduction and integration into practice has enabled new technology to gain the sort of validation the Medicare program seeks. That is how tests for now more mainstream markers KRAS and EGFR first earned more widespread acceptance. It’s a model that has worked to enable new science to be deployed into clinical practice, by doctors best equipped to make good use of them.

The Medicare agency may think that this process has led it to pay for some molecular tests that didn’t pan out, or reimburse tests before the science fully supported their use. They would be right.

Yet molecular tests represent only about 1% of total spending on laboratory services. It is a fraction of a fraction of the agency’s annual spending.

That doesn’t mean it should be ignored. But the modest spending means that Medicare has the ability to be cautious in how it addresses this category of spending, especially given the potential for this technology to lower costs by enabling the more targeted delivery of medical care. The agency’s abrupt decision to step back from the prior structure has put the market for new technology into turmoil.

If proof of clinical utility is required before the Medicare agency will reimburse a new test then most of these technologies will simply go undeveloped.

This was always the risk to product developers once the new coding scheme went into effect. Medicare was always likely to use its new codes in a punitive fashion, to set coverage policies around the clinical circumstances where certain tests could be used, and what tests it didn’t believe merited any coverage. Now Medicare will be in the position of setting the standard for diagnostic testing, rather than leaving these decisions to be meted out by patients, providers, and the marketplace.

The new transparency this coding system affords is a powerful tool to the agency. It gives Medicare the leverage to further embed itself into decisions around when it judges certain tests to be clinically useful. And when it doesn’t want to pay for them.

Dr. Gottlieb serves as a director to two diagnostic companies that work in clinical areas that have not been affected by the new payment policies.

Citation: Medicare Nixes Coverage For New Cancer Tests. Scott Gottlieb, Forbes. June 05, 2013.

About Palmetto GBA
 

Scott Gottlieb stated in the Forbes article that most of the new rates are being based on the work of "one" Medicare contractor, Palmetto GBA.

Efficacy doesn’t mean proof that treatment decisions are changed; efficacy means that you prove that patient “outcomes” are improved as a result of the changed treatment decisions. It hasn’t been proven to improve outcomes and that is what is meant by “efficacy” in this context.

The standard used to judge the utility of laboratory and radiographic tests has always been “acceptable accuracy of clinical correlations” and “clinical utility.” Demanding (for demanding sake) proof of “efficacy” as opposed to proof of “accuracy” is completely unprecedented for laboratory tests in cancer (you just don’t make up another criteria for the sake of making it up).

Cancer is a disease which has always been managed on the basis of “best evidence” and not on the basis of “conclusive evidence,” which is lacking in virtually all situations in clinical oncology, including those situations in which clinical trials to identify the best treatment for the “average” patient have been performed and published and meta-analyzed.

Back in 1999, the Medicare Advisory Panel concluded that cell culture assay tests (functional cytometric profiling) offered “clinical utility.” After listening to detailed clinical evidence, the Medicare Coverage Advisory Committee found that these assay systems can aid physicians in deciding which chemotherapies work best in battling an “individual” patient’s form of cancer.

Although Medicare had been reimbursing for the cell culture drug “resistance” part of the tests since 2000, it wasn’t until the beginning of 2006 that they abandoned the artificial distinction between “resistance” testing and “sensitivity” testing and provided coverage for the whole FDA-approved kit. Their decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis.

Until Palmetto GBA came along in 2010!

Even though the new Medicare contractor, Palmetto GBA, arbitrarily reversed positions to reimburse the assays, the previous CMS administrator for Medicare, NHIC, let the cat out of the bag. They cannot try to put it back in. Previous Medicare contractors for California made the determination that chemoresponse assays qualified as a Medicare covered service, with the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a "non-investigational" basis. Too many patients know about something the cancer establishment tried to keep under a breadbox for too many years.

It was Medicare contractor Palmetto GBA, which is a subsidiary of Blue Cross/Blue Shield of South Carolina, that provides coverage for several states, unexpectedly posted a notice on its web site that it would no longer pay for Roche's Avastin medication for treating breast cancer after January 29, 2010. But Palmetto GBA did an embarassing about face and rescinded its decision.

Palmetto GBA also provides coverage in Ohio, West Virginia, Nevada, California and Hawaii, apparently acted too hastily. Some have said that Palmetto did not go through the usual motions before posting its decision, which was quickly scrubbed from its web site, and allow for public comment. And its action annoyed officials at the Centers for Medicare & Medicaid Services (CMS), since Roche's Genentech unit is appealing the decision by the FDA, which assured patients that Medicare would continue to cover Avastin while the appeals process played out.

Did Palmetto's indiscriminate action, without having an extensive, transparent tech assessment of the evidence annoy officials at CMS? No! Did Palmetto GBA do an embarassing about face and rescind its decision? No! CMS allowed Palmetto GBA to arbitrarily and capriciously stop reimbursements to cancer patient services. Business is business, but at a certain point, business is also about people and cancer business is about cancer patients.

It looks like Novitas Solutions, Inc. (formerly Highmark Medicare Services) has arbitrarily made the decision, like Palmetto, GBA did in California, to discontinue Medicare payment for chemoresponse assays done in Pennsylvania.

The rationale for the non-coverage decision is totally bogus. It's a shame.

According to this same Dr. Scott Gottlieb, former senior official at CMS, CMS doesn't have a single oncologist on staff, yet since the year 2000, they've issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools. And CMS has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs.