Feb
16

Repackagers and the myth of AWP

From Jim Andrews of Cypress Care comes a heads-up of an article by a former California state representative who’s endorsing the doctor-dispensing trend, noting that it has “small costs and huge benefits.”
Perhaps to his consulting clients, who include the drug repackagers that supply the drugs to docs.
Here’s the deal. The CA fee schedule drastically reduced the amount paid for drugs under workers comp by requiring compliance with the Medi-Cal fee schedule. I have issues w the drastic reduction, but that’s for another post.
So, entrepreneurs sensed an opportunity. The new fee schedule applied to drugs speicfically listed under Medi-Cal; drugs that were not listed were to be paid at the old fee schedule, which was much much much more generous.
Surprise – these wily entreprenueurs figured out that if they repackaged drugs from lots of 100 into 90 or 50 or 101, they fell outside the fee schedule. And, there was no Average Wholesale Price per se, as these creative business folk were creating a whole new drug/dosage/count combination. Voila, they came up with their own “AWP”.
In the article on Workers Comp Exec, the ex-legislator (Thomas Calderon) notes that “The drug debate has centered on the so-called “loophole” created by SB 228 allowing doctors to bill at the pre-SB 228 fee schedule, which is 140 percent of the average wholesale price (AWP). But has this loophole raised rates to employers? Absolutely not (no proof statement provided by Calderon)…We could do as I suggested above by using 90 percent of AWP. Another way would be to increase the handling fee to reflect the costs of dispensing.”
Well, gee Tom, if your clients are setting the AWP, and then you are offering a 10% “discount” off that AWP, how exactly does that reduce payers’ costs? I should note that several of my payer clients are seeing costs for these repackaged scripts that are five to ten times higher than for scripts that are covered under the Medi-Cal fee schedule.
Calderon is disingenuous at best, and advocating cheating the system, patients, and employers at worst.
Repackagers could add value, patients could get their drugs faster, and docs could make a few bucks on the side, and everyone would be happier. But the only people making out on this deal are Calderon’s clients and a few docs who are taking advantage of the system.
What does this mean for you?
We need to fix this loophole.


Feb
15

The cost of life

Should insurance companies or patients pay $6000 to $10,000 a month for a cancer drug that extends life five months on average? Should oncologists be marking the drug up to make money on it? Should the drug manufacturer keep the price so high it keeps it out of the reach of many potential patients ?
Avastin is a drug approved by the FDA for colorectal cancer and is used primarily in advanced stages of the disease. Manufactured by Genentech, it works in conjunction with other, tumor-fighting drugs to slow the spread of cancer by reducing the blood flow to tumors. And it does appear to do this pretty well. This success has led physicians to consider using it in early stages, but there are two problems with this.
First, it has not been approved by the FDA for that usage. As a result, many insurance companies may not pay for it. Therefore this leaves doctors and patients facing the all-too-common financial conundrum – is it worth it? An article in the New York Times (free subscription required) describes the decision making process of several cancer victims, some of whom cannot afford the drug and are not taking it due to cost.
Before we start hurling invective at the insurance companies, remember that they are spending your dollars. So ask yourself the question – do you want your personal funds paying for these drugs?
Another medication, Gleevec, has shown excellent results for leukemia patients, extending life significantly albeit at a very high price.
Genentech’s executives describe Avastin’s pricing methodology as value-based; according to William M. Burns, the chief executive of Roche’s pharmaceutical division and a member of Genentech’s board; “”The pressure on society to use strong and good products is there.” And this pressure allows/enables pharma companies to charge what they want, knowing payers will face incredible pressure to cover the cost.
In contrast, or perhaps contradiction of Burns’ position, Dr. Desmond-Hellmann, the Genentech product development chief, was quoted in the Times as saying “I don’t think any patient should go without a Genentech drug for an inability to pay,” she said. “If this is about money, that would disturb me.”
(I can see the PR types at Genentech cringing…)
Avastin, with annual treatment costs around $100,000, provides about $7 billion in revenues for the company annually.
It is about money – who gets it and who pays it. And therefore it is about choices. Remember a significant portion of medical expense is for treatment of people in their last six months of life. Are we as a society willing to pay $40,000 for five more months of life for people with this horrible disease?
What does this mean for you?
More tough thinking and very uncomfortable debate.


Feb
11

Higher copays = higher costs

A post at “over my med body” (grahamazon.com) about the correlation between copays and adverse health outcomes pointed me to an interesting study published in the American Journal of Managed Care on the correlation between raising drug copays and decreased compliance.
Here’s the net – increasing copays for people on cholesterol-lowering drugs led to lower compliance. Lower compliance led to increased hospitalizations and other bad and costly outcomes. According to the report:
“Although many obstacles exist, varying copayments for CL )cholesterol lowering) therapy by therapeutic need (reducing them for those who would benefit the most) would reduce hospitalizations and ED use


Feb
11

McClellan’s rose colored glasses

Director of the Center for Medicare/Medicaid Services Mark McClellan was up on Capitol Hill yesterday testifying on Part D, conveying the message that all was going better, improvements were being made, and the cost of the program was lower than anticipated.
When one remembers that McClellan is the brother of White House press secretary Scott, his facile comments and ability to re-interpret reality are more understandable.
I’m reminded of the comments whispered to me by the mother of the young lad named “most improved” at a youth football dinner: “he was so bad at the start of the season that just running without falling down was a huge improvement”. While the Part D program is nowhere near running, and has yet to even advance beyond the crawling stage, it is likely to improve. That’s the good news. The bad news is the fatal flaw of adverse selection, discussed here ad nauseum, but still eluding the denizens of Capitol Hill.
One highly contentious issue continues to be the law preventing HHS from negotiating directly with pharmaceutical companies on drug prices. According to ABC News; Sen. Snowe (R ME) and what a great name for a senator from Maine…
“questioned the way the program was working and pushed for legislation that would allow the government to negotiate for better drug prices. The initial legislation included no such provision, an omission that at the time was seen as a boon to drug companies.
Snowe and Sen. Ron Wyden, D-Ore., have drafted bipartisan legislation that would give government the power to negotiate prices.
I can’t imagine why we’d spend $700 billion on this benefit and not allow the secretary to maximize the taxpayers’ money,” Snowe said.
Me neither.


Feb
9

Part D enrollment will fall short

A June 2005 CMS Office of the Actuary report estimated there would be a total of 36.8 million enrolled in Part D in fiscal year 2006. Thus HHS Sec. Leavitt’s stated goal of 28-30 million enrolled in Part D by the end of 2006 either reflects an updated guesstimate or indicates the previous goal is now viewed as unreachable, or perhaps both. (remember almost 22 million seniors were automatically enrolled in Part D on 1/1/06) Especially when one recalls that the calendar year has three more months than the fiscal one.
As Bob Laszewski points out, historically the big enrollment date for employee benefits and health plans has been January 1. With all the hype, publicity, politicians-on-the-road-show circuit and marketing leading up to that date, and with that date well behind us, it looks very doubtful that enrollment numbers will even come close.
The well-publicized enrollment mess surely has not encouraged seniors to jump into a plan that had already confused them.
So, despite the taxpayer funding 75% of the costs of the program, millions of dollars in advertising and strong support from elected leaders (sell, some of them at least) and six weeks into the program, we have enrolled a grand total of less than 4 million into the voluntary program.
Not exactly a ringing endorsement of a privatized health care plan based on competition in the private sector.
What does this mean for you?
Bad news for advocates of national health insurance provided by private payers. That was me too, but I’m not nearly as convinced today as I was this time last year…


Feb
8

PBMs and Part D

There is an excellent objective review of the role of PBMs in managing Part D costs at California HealthLine. While I hesitate to summarize what is already a summary, here are the main points.
1. The absence of any “transparency” requirements in the Part D enabling legislation makes it impossible to determine without legal investigation how PBMs may benefit from rebates and other confidential financial transactions.
2. There was an amendment proposed that would have addressed this but it was shot down due to the administrative expense ($40 billion over ten years).
3. Self-dealing, namely the direction of patients to a PBM-owned pharmacy, is not illegal, and is a likely fallout from Part D. This is not bad per se, as mail order costs are significantly cheaper, and the home delivery service means folks do not have to get out of the house to get their scripts (which may actually be a good or bad thing).
4. Not noted is the failure of the legislation to allow CMS to negotiate drug prices, not even as a last resort. I don’t get this.
PBMs Medco, Express Scripts, and Caremark have been besieged by allegations of impropriety, civil complaints, and customer action. While this PBM-pharmacy manufacturer-pharmacy-CMS-employer-patient thing is enough to make your head spin, this will confuse you even more –
If PBMs screw up really badly and lose a lot of money during the next two years, the taxpayers will bail them out .
What does this mean for you?
less faith in “free-market” capitalism?


Jan
27

Part D (D=Disaster)

Health policy expert (and good friend) Bob Laszewski was interviewed on NPR this morning about the Part D program, bringing a little much-needed perspective to this over-spun topic. The net – if enrollment among “voluntaries” (those without present coverage) does not increase 500% the program is a disaster.
Here are the quotes from Judy Rovner’s piece:


Jan
27

Docs as drug dealers

One of the emerging issues in workers comp is the dispensing of drugs by physicians on a grand scale. Clients (big WC payers) are seeing over half of their drug costs in California coming from doc-dispensed drugs. While that sounds great; injured workers get their meds quickly and without having to drive to a store and argue with a clerk over who pays, there are a few problems – and a couple really really big problems.
Drugs are reimbursed according to a fee schedule in work comp in many states. But, the fee schedule only applies to drugs that are “standard”; i.e. have an NDC number. So, when the fee schedule was slashed in CA two years ago creative capitalists simply repackaged the drugs, which now did not have an NDC number and therefore no state-set fee (showing the futility of price controls).
Actually, there is no state set fee, but there is a reimbursement methodology that results in drug costs much higher than the “regular” drug packages. CA law required payers to pay for these repackaged drugs according to the old OMFS fee schedule. And this is one generous fee schedule – 140% of AWP plus a $7.50 dispensing fee for generics and 110% plus $4 for brand. The margins on this for docs must be amazing.
BY way of reference, the new WC drug fee schedule in CA is about 90% of AWP…
Lesson here is price fixing creates opportunities for creative entrepreneurs; my bet is while this gaming has been going on, drug utilization in California WC has been increasing.
What does this mean for you?
If you are a WC payer in California, headaches (that may get treated with doc-dispensed drugs!).


Jan
25

Why should Medicare negotiate drug prices?

A reader asked why I’m in favor of allowing the Feds to negotiate prices with pharmaceutical manufacturers. The reader’s colleagues had the idea that since the PBMs and health plans in Part D are already negotiating, why have the Feds involved?
Here’s my response.
First, the whole Part D mess is a great example of how overcomplicated programs generate huge problems. Medicaid claimants were getting their drugs just fine before Part D went into effect, and are now having all kinds of problems. While those problems will likely go away in the near future, the problems did occur when the claimants were switched from a governmental to a private program. A little ammunition for the single payer advocates, if nothing else…
1. “price” is an elusive concept in pharma. The AWP and most other pricing mechanisms are based on the price but do not factor in rebates or any other funds transfer mechanisms that effectively reduce the actual, real “price”. So, while PBMs are in fact negotiating for “price”, we do not know in most cases what the actual real price is.
2. PBMs by definition have much less purchasing power than governments. As an example, the Veterans Administration is the only federal entity that is allowed under the law to negotiate drug prices. The VA is entitled under the law to receive either the minimum 24% discount off the non-federal average manufacturer price or the “best price” the manufacturer gives anyone, whichever is lower. These rates are much more favorable than any PBM gets.
3. The PBMs make money on the delta between what they buy the drugs for and what they charge CMS. So, while the PBM is incented to get the lowest possible price, they are more concerned w maximizing the price to CMS.


Jan
24

Why seniors are saying NO to Part D

More on the adverse selection problems with Part D from a research study by DSS Research. The study indicates more than half of eligible seniors have no plans to enroll in a Part D program. And, their characteristics should set alarm bells ringing at every Part D sponsor:
“Disinterested, non-buyers are lowest users of medical services. Those who said they had not chosen a plan and had no plans to do so take fewer prescriptions; spend less on prescriptions; go to the doctor less often; and make fewer ER, inpatient hospital and outpatient clinic / surgery center visits.”
In other words, they are healthy, aren’t likely to need the coverage any time soon, and aren’t interested in subsidizing the costs of their less-healthy fellow seniors. This is exactly why Part D is a really bad idea, poorly executed too.