Monday, December 29, 2014

Procedure Costs and Treatment Decisions

There have been a number of articles (1,2,3) discussing the financial incentives built into the healthcare system in the United States.  Built into these discussions are two key assumptions: (1) that financial incentives are influencing treatment decisions and (2) that changing those financial incentives will lead to substantial cost savings for the same quality of care.  The recent release of Medicare Part B payment data from 2012 has made available some anecdotal evidence that these two key assumptions are in fact correct.  With this data it is possible to identify both the level of use and cost of individual therapies.  Here are some examples of inefficiencies that are built into the way that healthcare decisions are incentivized in the USA.

Example: Hemophilia. The treatment with the highest minimum annual out-of-pocket expenses from the CMS data is “Factor VIII recombinant NOS”.  This is a replacement for a missing protein in the blood of patients with Hemophilia A (also used to treat Von Willebrand disease).  The disease causes spontaneous bleeding and according to the World Hemophilia Foundation children with severe, untreated Hemophilia A typically do not survive to adulthood.  However, with treatment life expectancy is close to normal.  Based on the CMS data table, the average cost to treat a senior with this condition is nearly $250,000/year with Medicare covering almost $200,000.  In addition, the treatment is not a cure; it must be continued for the life of the patient. 

In the portion of Medicare Part B that we can see, over $70 million – about $0.62 for every working American – was spent treating 357 seniors with Factor VIII recombinant NOS; those 357 seniors themselves were responsible for around $18 million in total costs.

There are other first line therapies for the treatment of Hemophilia A.  In particular there is a non-recombinant version of factor VIII that is derived from blood plasma (also listed in the table).  The major difference in these two products is the chance of transmission of communicable disease through the use of plasma products.  However, due to modern techniques for detecting HIV and Hepatitis as well as pasteurization techniques, “no blood-borne transmission of hepatitis viruses or HIV has occurred in the last 20 years." Nonetheless, there are only 55 patients (13 percent of those treated with factor VIII or factor VIII recombinant) who are receiving plasma based factor VIII.  If CMS had a mechanism for moving the patients on recombinant factor VIII to the non-recombinant version, it would lower its own costs by at least $34 million per year - $68 million if we extrapolate to the full size of Part B. 

Example: Rheumatoid Arthritis. There is a similar comparison that can be made for two of the rheumatoid arthritis (RA) drugs listed in the "expensive treatments" table, and while the price differences are not nearly so dramatic, the number of patients affected is much larger.  Infliximab ($13,430.70/year) and Tocilizumab ($10,997.55/year) are two competing therapeutics for RA.  The two have been compared head to head in a clinical trial with Tocilizumab either equivalent or outperforming Infliximab on all measures of disease progression.  Nonetheless, Infliximab was given to 42,645 patients in 2012 while Tocilizumab was given to only 2216.  This comparison is not perfect because Infliximab is also an approved treatment for inflammatory bowel disease (IBD). However, the prevalence of IBD among seniors is much lower than that of RA.  Even if we suppose that only a quarter of the Infliximab patients could be moved to Tocilizumab, Medicare would have saved $26 million on just this change in 2012.

Example: Prostate Cancer. Many of the most expensive treatments on the list are cancer therapies.  Sipuleucel-T auto CD54+ is a treatment for end-stage, hormone refractory prostate cancer. Based on the three clinical trials that have been run using the treatment, it adds an average of about 4 months to the lifespans of treated patients.  With the relatively high cost, it is likely that Sipuleucel-T auto CD54+ is inaccessible to most of the population of Medicare patients.  If we estimate the prevalence of late stage prostate cancer based on statistics from cancer.org concerning death rates, then the problem afflicts around 30,000 men per year.

How do we, as a society, value those four months? Is it obvious that all 30,000 men with late stage prostate cancer be treated with Sipuleucel?  This would require that every working American contribute approximately $2/year. Is it obvious that they shouldn’t?  Similarly, it is difficult to deny factor VIII replacement to the 412 seniors in our data set who needed treatment in 2012, but do we as a society need to pay double for the recombinant version? 

Perhaps even more important than these questions is this one: if patients are responsible for 20% of the cost of their therapies, why aren’t they demanding less expensive therapies when they are equally effective?  The answer to this is probably very simple; Americans – and this sometimes includes physicians – simply don’t understand or think about the financial consequences of medical decisions.  Very few people realize that if you order “J7190” instead of “J7192” from the menu of therapeutics (see the table), you get the same result, but your medical bill will drop by almost $10,000 per month.

Of the 4,309 different procedures that are commonly practiced and for which Medicare made at least a partial payment under Part B in 2012, 37 of them cost more than $10,000 per year.  Of these procedures, 31 of them are medications. Currently, CMS is legally banned from bargaining with pharmaceutical companies for the price of medications.  Instead it is bound on one side by the prices those companies set and on the other by the working definition of medically necessary.  Physicians and pharma companies are generally making the purchasing and pricing decisions and both of them benefit from higher prices!

One solution to this problem is to demand that prices for medications be set in some way other than asking the companies who produce them how much they would like us to pay.  On the other hand, letting the manufacturer set the price is the way that a free market society works.  Another option is to change the incentive structure for the buyers.  Under Part B, physicians generally get a percent of the cost back in profit. What would happen if this profit were unrelated to the cost of therapy or even inverted?  Alternatively, perhaps the best solution is to ensure that the patients understand how much they are spending and what they are getting for their – and taxpayer – money.

Saturday, December 6, 2014

Billing and financial incentives in healthcare

In order to bill the insurance company, your physician must boil down each interaction and procedure performed into one of around 7,400 medical codes.  In essence, when you seek medical care you are actually ordering from a precisely defined menu of around 7,400 dishes – even more than Cheesecake Factory.  Important points to keep in mind: (1) no restaurant (clinic) serves every dish, (2) the prices are hidden, (3) the waiter (physician) has a very strong influence – almost complete in many cases – on what you order and (4) the tip is automatically included on the tab.  If the analogy were complete, then you might expect to order a very nice bottle of wine every time you go out to eat. 

To prevent people getting sick from all that wine, physicians have developed a society built around a very particular set of social norms, dating back at least to Hippocrates, that encourage priorities that are more in line with the patients’ needs.  As in any society, the strength of influence of social norms varies from individual to individual, but the combination of norms, legal penalties and rewards tends to work for most.

If we generally trust physicians to keep the interest of their patients paramount, the next question becomes, how are those hidden prices set?

Medicare payments for Part B

Medicare uses a criteria for setting prices for each of the 7,400 therapies that can be described as “reimbursement for costs” (see this fact sheet for a description).  The overall strategy is to compute three types of Relative Value Units (RVUs) – modified for cost of living – for each procedure that is reimbursed.  These are associated with (1) the cost of performing the procedure, (2) the cost of maintaining a medical practice and (3) the cost of malpractice insurance.  Any provider who has “accepted assignment” is required by this agreement to accept the agreed upon dollar amount for their services. There is an important caveat to this; physicians may accept assignment from Medicare but then refuse to see any patients who have Medicare as their primary insurance.

Medicare is supposed to pay for 80 percent of the allowed amount, but as can be seen from Figure 1 showing payments for Pemetrexed (a cancer medication), this percentage can vary.  The usual reasons for this variation are supplemental insurance and deductibles.

There are two obvious difficulties with this approach to defining payments for medical services. First, there is the challenge of deciding who will estimate RVUs for each procedure. This is the task of the Relative Value Scale Update Committee. Ideally this sort of problem would be settled in a free market, but that is challenging because patients have poor information about the costs and quality of services in different healthcare settings.

Second, the actual efficacy of the procedure is nowhere to be found in the computation of payment. For the most part, therapies are deemed to be either appropriate or not as determined by whether they are medically necessary for the patient. For medications, this definition usually equates to FDA approval although there are some counter-examples.  Under this system, assuming CMS has done a good job of estimating costs, there is a perverse financial incentive for healthcare providers to choose whichever medically necessary therapy costs the most since providers will make a percentage of that back in profit.

While this is the standard in the United States, there are systems in the UK and elsewhere designed to set reimbursement based on Quality Adjusted Life Years (QALY).  This is an attempt to quantify the efficacy of a medical treatment and incorporate that into the reimbursement computation.  It addresses the second issue associated with health insurance reimbursement decisions, but is still susceptible to bias in the estimation of efficacy.

Is it possible to take advantage of free market ideas to drive efficiency and improve health?

A free market economy becomes a force for good when the goals of earning money and benefiting society can be aligned.    However, the incentive structures in healthcare are all wrong.
  • Hospitals are paid to do more, not make people healthier.
  • Physicians can earn more by choosing more expensive therapies.
  • Drug developers earn more from palliative drugs that must be taken continuously rather than cures.
As things stand now, market forces are often in strong opposition to the benefit of society.  Momentous changes such as risk sharing arrangements between hospitals and payers, public health exchanges, "big" data and the availability of data to patients and the imposition of payment penalties based on quality metrics are all leading to changes in important financial aspects of healthcare decisions.  If their combination leads to better alignment between financial incentives and patient health, then we are at the beginning of a healthcare renassaince in the United States.

Thursday, October 16, 2014

Medicare release of 2012 Part B data

Recently the Centers for Medicare and Medicaid Services (CMS) released Medicare provider utilization and payment data to the public. The data released accounts for a relatively small and biased view of total Medicare spending (Table 1). Nonetheless, it does make public the cost, to both Medicare and to patients, of most of the procedures performed for seniors in the United States.

Table 1 - Understanding the data. The Medicare data release contains a subset of Medicare Part B.  Spending for the “Part B data release” row was computed directly from the data. Otherwise, spending reported here was derived from this article.
Medicare
Spending (billions of dollars)
Description
Part A
$214
Hospital fees, home health, skilled nursing
Part B
$145
"Medically necessary" services and supplies
Advantage Plans
$123
Accountable care and other risk sharing arrangements
Part D
$54
Drugs
Part B data release
$77
Filtered to protect patient anonymity. Contains cases where physician performed procedure > 10 times.

We have seen a number of articles recently utilizing the data (1,2) to focus on the large sums of money being collected from Medicare by relatively few physicians.  This should not, however, be particularly surprising, as the 80/20 principle is a relatively ubiquitous phenomenon in many industries.  On the other side of the healthcare coin, similar observations (1,2) have been made regarding a relatively small percentage of patients who account for a large percentage of overall healthcare spending.

Before digging into this data it is worth understanding some of its weaknesses. First, the data has been filtered in order to protect the anonymity of patients.  Specifically, if a physician has performed a particular procedure less than 10 times, then data on that procedure from that physician isn’t available. Second, the data covers only Medicare Part B “fee-for-service” claims from 2012.

Because of the type of data filtering being used, non-specialists – who may not meet the 10-time threshold on any particular procedure – appear to collect a lower percentage of the Medicare dollars than they actually do. This filtering plus unavailable data from Parts A, C and D make articles claiming that particular portions of the pie go to particular individuals somewhat suspect.

While in the process of analyzing the CMS physician payment data it is tempting to focus on the practices of individual physicians – the data lists the names and work addresses of over 880,000 different healthcare providers – that should not be the main purpose of this data.  In addition to that, because of the biased filtering and missing data from Medicare Parts A, C and D, it isn’t even what the data is best suited for. 

In a companion article to this one, we look at the prices of various treatments that are approved by the FDA and paid for by Medicare.  This data release offers the opportunity to examine the way that Medicare pricing combined with healthcare market forces lead to decisions about the value of human life. If by releasing it CMS makes it possible to move our healthcare system closer to a free market – in which providers compete on prices and quality metrics that are transparent – then we are closer to addressing the inefficiencies and huge costs of our healthcare system.

List of procedures that cost Medicare (and patients) the most money

Data from the recently released Medicare provider utilization and payment data contain cost information for over 5000 procedures performed for seniors in the United States in 2012. The data is a little complicated and contains some biases.  However, with a little care it is possible to identify the most expensive procedures and get an understanding of the monetary value our healthcare system has assigned to human life.

The costs that are reported in the data set are for a single procedure. However, if a course of therapy requires that a procedure be repeated multiple times, then the real cost is higher. In order to get an understanding of annual cost, we need the number of procedures in a course of therapy. To get this we divide the number of times a procedure was completed by the number of unique patients receiving that procedure (both available in the data). This is still an underestimate because we only have data on procedures performed in 2012 while the course of therapy may have extended into either 2011 or 2013.

 The table lists 37 therapeutic options that cost more that $10,000 for a course of therapy in 2012. Focusing just on treatments for cancer that are listed in the table (in orange) we see that the value of a month of life varies from $2,333 for Oxaliplatin to treat colorectal cancer to $29,709 for Ipilimumab to treat melanoma.

By not specifically setting a price on human life, we are allowing the free(ish) market to make those decisions. That isn't inherently good or bad, but free market in the American healthcare system is distorted by perverse incentives and high levels of information asymmetry. The patients, physicians, payers and makers of therapeutics all have vastly different levels of understanding of the value and cost of therapies. In a later article, we will look at some specific examples of how this leads to therapeutic decisions that aren't necessarily optimal for patients.


Code
Procedure
Therapeutic Indication
Average Allowed Payment
patients in dataset
Bosted overall survival (months)
Cost per month of life ($)
J7192
Factor viii recombinant NOS
Hemophelia
249877.5
357
continuous
20,823
J7187
Humate-P, inj              
Hemophelia
211461.2
12
continuous
17,622
J7193
Factor IX non-recombinant  
Hemophelia
186561.1
13
continuous
15,547
J7195
Factor IX recombinant      
Hemophelia
185380.8
43
continuous
15,448
J1786
Imuglucerase injection     
Hemophelia
133782.8
35
continuous
11,149
J7190
Factor viii                
Hemophelia
132205.5
55
continuous
11,017
J9228
Ipilimumab injection       
Melanoma
118836.5
71
4
29,709
Q2043
Sipuleucel-T auto CD54+    
Prostate cancer
63459.8
274
4.1
15,478
Q3025
IM inj interferon beta 1-a 
Multiple sclerosis
28033.83
17
J1561
Gamunex/gamunex c          
Primary Immuno- deficiency
26335.92
1393
Continuous
2,195
J9043
Cabazitaxel injection      
Prostate Cancer
25994.92
29
2.4
10,831
J2353
Octreotide injection, depot
Cancer supportive care
20100.57
906
J0490
Belimumab injection        
Lupus
19702.11
122
J2796
Romiplostim injection      
Chronic ITP
18650.44
82
Continuous
1,554
J9055
Cetuximab injection        
colorectal cancer  head/neck cancer
18291.55
708
colorectal: 1.1  head/neck: .8
colorectal: 16,628 head/neck: 22,864
77523
Proton trmt intermediate   
various cancers
17700.16
887


L8687
Implt nrostm pls gen dua rec
16881.23
95
J9305
Pemetrexed injection       
lung cancer
16869.75
3048
non-squamous: 2.8  mesothelioma: 2.8
non-squamous: 6,025 mesothelioma: 6,025
0182T
Hdr elect brachytherapy    
various cancers
16852.01
540


J2323
Natalizumab injection      
Crohn's disease, multiple sclerosis
16348.39
2716
J1572
Flebogamma injection       
Primary Immuno- deficiency
15625.81
209
Continuous
1,302
J9310
Rituximab injection        
Leukemia, lymphoma
15078.95
35654
J2562
Plerixafor injection       
non-Hodgkin lymphoma, multiple myeloma
14181.41
12
J9355
Trastuzumab injection      
HER2 Gastric cancer    HER2 Breast cancer
13762.43
2773
Gastric: 2.4
5,734
37231
Tib/per revasc stent & ather
revascular- ization surgery
13452.13
441


J1745
Infliximab injection       
Crohn's, Ulcerative Colitis, Arthritis
13430.7
42645
J1568
Octagam injection          
Primary Immuno- deficiency
12171.14
1397
Continuous
1,014
77600
Hyperthermia treatment     
various cancers
12111.14
77


J1569
Gammagard liquid injection 
Primary Immuno- deficiency
11939.5
1586
Continuous
995
J1459
Inj IVIG privigen 500 mg   
Primary Immunodeficiency, Chronic ITP
11832.02
663
Continuous
986
37227
Fem/popl revasc stnt & ather
revascular- ization surgery
11535.57
4319


J9263
Oxaliplatin                
Colorectal cancer
11196.69
8164
4.8
2,333
J3262
Tocilizumab injection      
Rheumatoid arthritis
10997.55
2216
Continuous
916
36516
Apheresis selective        
Various
10901.78
42


J9264
Paclitaxel protein bound   
pancreatic cancer, lung cancer, breast cancer
10605.92
1041
pancreatic: 1.8 
pancreatic: 5,892
J0129
Abatacept injection        
Arthritis
10231.23
13916
Continuous
853
J2357
Omalizumab injection       
asthma, idiopathic urticaria
10042.75
2770
Continuous
837