As always, I’ll close out the month with a few tidbits that didn’t merit a full post in September.
Please keep emailing me your story ideas and links. I don’t have time to cover every topic that I receive, but I respond to anyone who takes the trouble to send me something.
1) Supply Chain Ethics
In case you missed it, I was recently quoted in the Wall Street Journal’s In the Lead column regarding supply chain ethics. See Recent News Events Should Have Executives Reviewing Priorities. My main comment: “Supply-chain management has moved from the back room to the board room and become an ethical issue.” My point: How much do you know about what your distributors or resellers are doing with your products? Johnson & Johnson did not, as I noted last month. (BTW, my kids love to see me in the paper, but to be honest I think a guest spot on Hannah Montana would impress my tween daughter more -- the best of both worlds!)
2) Blog Kudos from a Pharmacist
I was very gratified to read this review of Drug Channels in the 9-21 issue of Illinois Pharmacists Association e-newsletter: “One of the more interesting blogs I have run across. It is a thoughtful examination of the drug delivery system in the country and how Pharmacists are reacting to AMP and Medicare and the viability of Pharmacy. It is not always a comforting examination (from the Pharmacist’s viewpoint, anyway), but it is thoughtful and in a lot of ways hard to argue with. He is worth reading and perhaps arguing with as he will take comments from all. Worth a look.” Thanks!
3) Raise a Glass to the Beer Hunter
Beer and scotch guru Michael Jackson (a.k.a The Beer Hunter) recently passed away. I had the privilege of meeting Mr. Jackson in May, discussing a memorable bottle of scotch with him (The Macallan Gran Reserva from 1982), and getting him to sign my copy of Complete Guide to Single Malt Scotch. Please join me in the national toast to Mr. Jackson this Sunday at 9 PM EST in honor of his unique legacy.
Friday, September 28, 2007
Thursday, September 27, 2007
Wal-Mart adds some $4 generics (yawn)
Wal-Mart Stores (WMT) announced an expansion of its (mostly) $4 generic drug program this morning. The 8 AM call was hosted by Dr. John Agwunobi, senior vice president and president for the Professional Services Division, and Bill Simon, executive vice president, chief operating officer, both from Wal-Mart Stores, Inc. The company also published a 4-page fact sheet.
I listened to the call (and even got to ask the final question). There was not much new news here, but here are my initial reactions:
Old news in a new pill bottle
This announcement is much less significant than the September 2006 announcement. Wal-Mart has expanded the list of drugs on their $4/$9 (a new tier) generics list, but is not fundamentally changing the program. Contrary to my earlier expectations, some of the blockbuster generics of brands such as Zocor and Zoloft are still not on the expanded list. No real explanation. They will probably still get some good press, especially because health care is becoming part of the Presidential election.
The program has generated profitable growth for Wal-Mart’s pharmacies.
Wal-Mart confirmed that they have increased pharmacist staffing more slowly than script count growth. In other words, my December 2006 analysis was correct in concluding that the program is generating incremental prescription volume to a typical Wal-Mart pharmacy by leveraging a relatively fixed pharmacy overhead. They stated that this profitable growth is "fully loaded" pharmacy profit, not just gross profit (revenues minus cost of goods).
Loads of of data, but little information
The company claims to have saved consumers $613,581,398.70 (!) as of September 24, 2007. The math was “simple” according to the speakers: They computed the difference between the old sell price and the new price ($4 or $9), and then multiplied it by the number of scripts filled. But this simple math doesn’t really tell us some key numbers, such as incremental script volume or where the scripts came from. They did note that dollar growth comps have been mid-teens for pharmacy, but “script counts are a multiple of that.”
Wal-Mart can still hurt independents where it counts
Last year, NCPA issued a series of blistering press releases, the first of which claimed that Wal-Mart was using a classic bait-and-switch. On this morning’s call, one of the speakers contrasted Wal-Mart’s generics program approach with the strategies of companies that have a “profitable, vested interest in the status quo.” Hmmm, wonder who they are talking about? Don’t forget that generics are much, much more profitable for pharmacies than brands.
What’s up with third-party payers and PBMS?
Chains such as CVS Corp (CVS) or Walgreens (WAG) are presumably not very vulnerable to Wal-Mart’s program because customers with third-party insurance do not save much versus standard co-pays. So I asked the speakers how Wal-Mart’s generic plan is working for patients with third-party coverage. Surprisingly, one of the speakers stated that Wal-Mart always files a claim on behalf of patients, but will often choose not to seek reimbursement. They even mentioned waiving dispensing fees offered by Medicaid. Presumably, Wal-Mart’s total reimbursement (dispensing fee plus their share of the co-pay) is less than a $4 cash payment, plus Wal-Mart gets the payment immediately instead of waiting a few weeks. I'd like to know more, but didn’t get a chance to ask a follow-up question.
----
Pharmacists had a generally negative view of Wal-Mart’s program in an October 2006 Drug Topics survey. Any pharmacists care to comment (anonymously, if you want) on Wal-Mart’s latest announcement?
I listened to the call (and even got to ask the final question). There was not much new news here, but here are my initial reactions:
Old news in a new pill bottle
This announcement is much less significant than the September 2006 announcement. Wal-Mart has expanded the list of drugs on their $4/$9 (a new tier) generics list, but is not fundamentally changing the program. Contrary to my earlier expectations, some of the blockbuster generics of brands such as Zocor and Zoloft are still not on the expanded list. No real explanation. They will probably still get some good press, especially because health care is becoming part of the Presidential election.
The program has generated profitable growth for Wal-Mart’s pharmacies.
Wal-Mart confirmed that they have increased pharmacist staffing more slowly than script count growth. In other words, my December 2006 analysis was correct in concluding that the program is generating incremental prescription volume to a typical Wal-Mart pharmacy by leveraging a relatively fixed pharmacy overhead. They stated that this profitable growth is "fully loaded" pharmacy profit, not just gross profit (revenues minus cost of goods).
Loads of of data, but little information
The company claims to have saved consumers $613,581,398.70 (!) as of September 24, 2007. The math was “simple” according to the speakers: They computed the difference between the old sell price and the new price ($4 or $9), and then multiplied it by the number of scripts filled. But this simple math doesn’t really tell us some key numbers, such as incremental script volume or where the scripts came from. They did note that dollar growth comps have been mid-teens for pharmacy, but “script counts are a multiple of that.”
Wal-Mart can still hurt independents where it counts
Last year, NCPA issued a series of blistering press releases, the first of which claimed that Wal-Mart was using a classic bait-and-switch. On this morning’s call, one of the speakers contrasted Wal-Mart’s generics program approach with the strategies of companies that have a “profitable, vested interest in the status quo.” Hmmm, wonder who they are talking about? Don’t forget that generics are much, much more profitable for pharmacies than brands.
What’s up with third-party payers and PBMS?
Chains such as CVS Corp (CVS) or Walgreens (WAG) are presumably not very vulnerable to Wal-Mart’s program because customers with third-party insurance do not save much versus standard co-pays. So I asked the speakers how Wal-Mart’s generic plan is working for patients with third-party coverage. Surprisingly, one of the speakers stated that Wal-Mart always files a claim on behalf of patients, but will often choose not to seek reimbursement. They even mentioned waiving dispensing fees offered by Medicaid. Presumably, Wal-Mart’s total reimbursement (dispensing fee plus their share of the co-pay) is less than a $4 cash payment, plus Wal-Mart gets the payment immediately instead of waiting a few weeks. I'd like to know more, but didn’t get a chance to ask a follow-up question.
----
Pharmacists had a generally negative view of Wal-Mart’s program in an October 2006 Drug Topics survey. Any pharmacists care to comment (anonymously, if you want) on Wal-Mart’s latest announcement?
Wednesday, September 26, 2007
Chinese Take-Out
The Sunday Times (London) has a fascinating peek behind the scenes of a Chinese drug counterfeiting operation. See Factory for Fake Prescription Drugs.
One of their reporters posed as a UK drug wholesaler (!), which was apparently a very convincing disguise. It's easy to locate a counterfeit supplier – just post an online ad. The initial order: 200,000 packs a month of three drugs (Plavix, Casodex, and Zyprexa).
Is this all true? Since the Times reporter is not law enforcement, the Chinese businessman denied making or selling any counterfeit drugs. Of course, he was forced to admit that he did happen have machines to make counterfeits. And the photo gallery for the story shows his factory making much more than the standard Poison Me Elmo dolls. Look carefully at the last few pictures.
The Times says: “One of the problems appears to be Britain’s reliance on drugs bought through parallel trade – the system in which drugs are bought and sold several times because prices vary between different European countries.”
Importation Illusions, I say.
One of their reporters posed as a UK drug wholesaler (!), which was apparently a very convincing disguise. It's easy to locate a counterfeit supplier – just post an online ad. The initial order: 200,000 packs a month of three drugs (Plavix, Casodex, and Zyprexa).
Is this all true? Since the Times reporter is not law enforcement, the Chinese businessman denied making or selling any counterfeit drugs. Of course, he was forced to admit that he did happen have machines to make counterfeits. And the photo gallery for the story shows his factory making much more than the standard Poison Me Elmo dolls. Look carefully at the last few pictures.
The Times says: “One of the problems appears to be Britain’s reliance on drugs bought through parallel trade – the system in which drugs are bought and sold several times because prices vary between different European countries.”
Importation Illusions, I say.
Monday, September 24, 2007
PDUFA & Supply-Chain Security
Like you, I spent Sunday reading through the just-passed Food and Drug Administration Amendments Act of 2007, a.k.a. Prescription Drug User Fee Act (PDUFA), which now awaits the President’s signature. What, you had something better to do on the last Sunday of the summer?
In case you missed it, section 913 is entitled “Assuring Pharmaceutical Safety.” See page 355 of H.R.3580 (424 pages) or simply print this handy-dandy 4-page extract.
Subsection (a) states: “The Secretary [of HHS] shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.”
Ah yes, just what the industry needs – more standards! Standards must be totally awesome because we have so many of them in the pharma industry.
In plain English, the Act requires the following:
We are already dealing with California law, which requires a “unique identification number…that is uniformly used by manufacturers, wholesalers, and pharmacies.” Pedigree in California must be at the “smallest package or immediate container,” but probably only for high-risk products. (See California Dreamin'.)
So, how will the new Federal ID number relate to the numbers developed in California? Or interact with the mysterious Rx SafeTrack initiative being pursued by HDMA, NACDS, PhRMA, and GPhA? Will this Act upsize the smallest package to a pallet because of the pesky "or" written into the legislation?
Brenda Kelly of SupplyScape, which is helping companies get ready for California’s January 2009 deadline, strikes an optimistic note: “This reinforces patient safety efforts like California’s. With two and a half years to define a standardized numerical identifier and consider a wide range of technologies, the Agency can benefit from the states’ initiatives.”
I certainly hope that Brenda is right. Since my web logs show many visitors from State and Federal agencies, anyone care to post some comments on the new Act for their benefit? (Yes, you can post anonymously, if you want.)
In case you missed it, section 913 is entitled “Assuring Pharmaceutical Safety.” See page 355 of H.R.3580 (424 pages) or simply print this handy-dandy 4-page extract.
Subsection (a) states: “The Secretary [of HHS] shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.”
Ah yes, just what the industry needs – more standards! Standards must be totally awesome because we have so many of them in the pharma industry.
In plain English, the Act requires the following:
- The development of a standard numerical identifier at the package or pallet level
- The identifier must link repackaged products back to the original product
- The standard must be developed within 30 months (September 2010?)
- The evaluation of “promising technologies,” including RFID, nanotechnology, encryption technologies, and “other track-and-trace or authentication technologies.”
- Interagency cooperation by FDA with Federal and State agencies
- “As a manufacturer, I am pleased with the 30 month timeframe to evaluate/develop a standardized numerical identifier. I also like the fact that it encourages some degree of harmonization with coding requirements outside the U.S.”
- “I don't know who drafts this language, but either (A) they intentionally include vagaries so that makes it impossible to execute, or (B) they don't really understand what their talking about. I think it is the latter.” (AJF: ROTFL!)
We are already dealing with California law, which requires a “unique identification number…that is uniformly used by manufacturers, wholesalers, and pharmacies.” Pedigree in California must be at the “smallest package or immediate container,” but probably only for high-risk products. (See California Dreamin'.)
So, how will the new Federal ID number relate to the numbers developed in California? Or interact with the mysterious Rx SafeTrack initiative being pursued by HDMA, NACDS, PhRMA, and GPhA? Will this Act upsize the smallest package to a pallet because of the pesky "or" written into the legislation?
Brenda Kelly of SupplyScape, which is helping companies get ready for California’s January 2009 deadline, strikes an optimistic note: “This reinforces patient safety efforts like California’s. With two and a half years to define a standardized numerical identifier and consider a wide range of technologies, the Agency can benefit from the states’ initiatives.”
I certainly hope that Brenda is right. Since my web logs show many visitors from State and Federal agencies, anyone care to post some comments on the new Act for their benefit? (Yes, you can post anonymously, if you want.)
Friday, September 21, 2007
The Real Wal-Mart Effect
Inflation in drug prices has dropped to its lowest rate in three decades, as reported in Helped by Generics, Inflation of Drug Costs Slows from today’s New York Times. Bonus for fans of Drug Channels: I’m quoted in the article.
BLS economists cite the effect of Wal-Mart’s $4 generics program:
A Labor Department economist, Francisco Velez, said his office noted a drop in generic drug prices shortly after the large stores’ promotions began, particularly in the South, where Wal-Mart started its program.
To be honest, I’m not sure how much of the drop is attributable to Wal-Mart versus the overall market penetration of new generics and resulting shorter life cycle of brands. A 1998 CBO study found that the average market share of 21 generic drugs launched from 1991 to 1993 was 44% after one year. Today, blockbuster generics get 80%+ substitution within one month due to the efforts PBMs, wholesalers, and chains. Wal-Mart is a relatively small part of the overall pharmacy market, as I note in the article.
I suspect that the real Wal-Mart effect has been the negative impact of its $4 generic program on supermarkets, independents, and other discount chains.
Exactly one year ago, I correctly predicted that Wal-Mart’s $4 generics would shift generic market share away from independents, particularly in rural counties that have low chain pharmacy penetration. In the article, I discuss the increase in Wal-Mart’s pharmacy traffic due to its $4 generics program, which come from Sloppy reporting about Wal-Mart. (Ironically, my original post is highly critical of the Times!)
Perhaps NCPA should look at the companies competing with independents before blaming Part D and PBMs for the all of the marketplace challenges facing their members.
BLS economists cite the effect of Wal-Mart’s $4 generics program:
A Labor Department economist, Francisco Velez, said his office noted a drop in generic drug prices shortly after the large stores’ promotions began, particularly in the South, where Wal-Mart started its program.
To be honest, I’m not sure how much of the drop is attributable to Wal-Mart versus the overall market penetration of new generics and resulting shorter life cycle of brands. A 1998 CBO study found that the average market share of 21 generic drugs launched from 1991 to 1993 was 44% after one year. Today, blockbuster generics get 80%+ substitution within one month due to the efforts PBMs, wholesalers, and chains. Wal-Mart is a relatively small part of the overall pharmacy market, as I note in the article.
I suspect that the real Wal-Mart effect has been the negative impact of its $4 generic program on supermarkets, independents, and other discount chains.
Exactly one year ago, I correctly predicted that Wal-Mart’s $4 generics would shift generic market share away from independents, particularly in rural counties that have low chain pharmacy penetration. In the article, I discuss the increase in Wal-Mart’s pharmacy traffic due to its $4 generics program, which come from Sloppy reporting about Wal-Mart. (Ironically, my original post is highly critical of the Times!)
Perhaps NCPA should look at the companies competing with independents before blaming Part D and PBMs for the all of the marketplace challenges facing their members.
Thursday, September 20, 2007
CAH + AB = ??
Cardinal Health (CAH) and Alliance Boots (AB) just announced an agreement to bring AB’s Almus brand of generic drugs to the U.S. market. See Alliance Boots, Cardinal Health Announce Joint Sourcing and Marketing Agreement.
This agreement could be merely routine – or the beginning of something very significant.
Private Labels Come to Pharma
If Almus is merely another generic supplier to Cardinal, then today’s announcement is only mildly interesting. AB’s success with Almus should not shock anyone who read my new book Facing the Forces of Change®: Lead the Way in the Supply Chain. I found that private label products (products branded by a wholesaler) will be expanding substantially in all industries over the next five years.
The economics are straightforward. A private label generic drug increases profits because the channel captures the margin that would otherwise flow to an upstream generic drug maker. The wholesaler—Alliance Boots in the case—also gains the ability to control the entire profit stream from production to sale, allowing for more flexible internal sales compensation models and higher commissions to drive sales.
Going Global
The big three wholesalers—AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson Corp (MCK)—already have active private label programs in other parts of their business. In fact, McKesson’s private label EverFRESH toothpaste got caught up in this summer’s tainted food recall after laboratory tests found small amounts of diethylene glycol.
From my point of view, it’s inevitable that wholesalers will be moving closer to production in order to source products for which there is limited brand preference. It’s not a stretch to imagine the combination of a generic manufacturer and wholesaler.
Seen in this light, today’s announcement may signal that Cardinal is gaining a bigger foothold in the global sourcing market. Such a move would give them the opportunity to sell generics in high volume to large pharmacy buyers sourcing directly from generic drug makers. (See CVS' Channel Power.)
Here's another idea to ponder. Alliance Boots recently entered the Chinese market and is planning to enter India. I already warned you over the summer that The British are Coming. So, could this agreement signal the beginning of a more significant relationship between Cardinal and Alliance Boots?
This agreement could be merely routine – or the beginning of something very significant.
Private Labels Come to Pharma
If Almus is merely another generic supplier to Cardinal, then today’s announcement is only mildly interesting. AB’s success with Almus should not shock anyone who read my new book Facing the Forces of Change®: Lead the Way in the Supply Chain. I found that private label products (products branded by a wholesaler) will be expanding substantially in all industries over the next five years.
The economics are straightforward. A private label generic drug increases profits because the channel captures the margin that would otherwise flow to an upstream generic drug maker. The wholesaler—Alliance Boots in the case—also gains the ability to control the entire profit stream from production to sale, allowing for more flexible internal sales compensation models and higher commissions to drive sales.
Going Global
The big three wholesalers—AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson Corp (MCK)—already have active private label programs in other parts of their business. In fact, McKesson’s private label EverFRESH toothpaste got caught up in this summer’s tainted food recall after laboratory tests found small amounts of diethylene glycol.
From my point of view, it’s inevitable that wholesalers will be moving closer to production in order to source products for which there is limited brand preference. It’s not a stretch to imagine the combination of a generic manufacturer and wholesaler.
Seen in this light, today’s announcement may signal that Cardinal is gaining a bigger foothold in the global sourcing market. Such a move would give them the opportunity to sell generics in high volume to large pharmacy buyers sourcing directly from generic drug makers. (See CVS' Channel Power.)
Here's another idea to ponder. Alliance Boots recently entered the Chinese market and is planning to enter India. I already warned you over the summer that The British are Coming. So, could this agreement signal the beginning of a more significant relationship between Cardinal and Alliance Boots?
Wednesday, September 19, 2007
AMP: Unloved and Unwanted
Average Manufacturer Price (AMP) gained a new set of enemies. The three major manufacturer associations -- PhRMA, BIO, and GPhA – just submitted a joint letter asking CMS acting administrator Kerry Weems to delay implementation of the AMP Final Rule. (Source: FDANews. The letter has not been made public yet.)
It’s pretty clear to me why pharmacists hate this rule, hence their swift and universal condemnation for AMP shortly after the Final Rule was published. But manufacturers have their own reasons to dislike the rule. Here are three that come to mind:
Please post a comment (anonymously, if you choose) and tell me the pro-AMP story because I can’t locate any AMP fans outside CMS right now.
It’s pretty clear to me why pharmacists hate this rule, hence their swift and universal condemnation for AMP shortly after the Final Rule was published. But manufacturers have their own reasons to dislike the rule. Here are three that come to mind:
- Compliance – Any new government rule will inevitably create implementation headaches, as the folks behind the Pharma Compliance Blog point out. The risk level went up last week when Weems highlighted compliance with regulations as a major priority.
- Reimbursement risks – As the AWP litigation slogs on, private payors will look to AMP as a new, credible benchmark for pharmacy reimbursement. See The ASP Future is Here for details on my prediction. It’s not clear what will happen when the product price (revenues to the manufacturer) gets unbundled from the costs of the distribution system (revenues to pharmacies, wholesalers, PBMs, and providers).
- Transparency – As currently implemented, AMP data will be made public for both brands and generics on a website at the 11-digit NDC level and updated monthly. Average Sales Price (ASP) data are already available for Medicare Part B drugs.
Please post a comment (anonymously, if you choose) and tell me the pro-AMP story because I can’t locate any AMP fans outside CMS right now.
Tuesday, September 18, 2007
Pharmacists React to Drug Channels
Last week’s posts on UT’s pharmacy reimbursement study generated an unprecedented number of thoughtful comments from pharmacists. The comments are listed below the two original posts:
Here are some highlights.
Tom Connelly took issue with my comment about how independents have been financially hurt because cash pay customers now have access to a comprehensive drug benefit. I responded that the shift from cash-to-third party payment has been a double-edge sword for pharmacy. The loss of cash pay (which has 0 days DSO) is traded off against the increased script volume b/c more people have access to drugs.
I doubt that NCPA would directly claim to oppose Part D, but that is indeed the implication. Ironically, Monday's Washington Post published Small-Town Pharmacists Closing Doors, in which pharmacist Dave Redden complains that the Part D benefit was good for consumers, but not for his business.
Joe argues that pharmacists should be paid within 5 business days. Unfortunately, eliminating “float” would undermine profit models throughout the pharmacy supply chain. For example, the wholesalers’ economic model would collapse if they accepted 30 days terms from pharmacies, even though NCPA criticizes wholesalers for requiring 14 day payment terms.
Right now, pharmacy customers pay wholesalers about two weeks before the wholesaler has to pay the supplier (drug manufacturer). Wholesalers earn interest income on the “float,” which can be meaningful given the large dollar amounts involved. Hmmm, I wonder if wholesalers could be the next target of pharmacy’s wrath?
PBMGuru suggested that pharmacies have a reconciliation problem, not a reimbursement problem. He cites an example of a small mail order pharmacy that had underinvested in technology resources to manage claims. He also cites payment problems related to “failure of the pharmacy to keep their tax ID current, failure of the pharmacy to keep their Medicare Provider Number current, or mismanagement by the NCPDP (once).”
Finally, one owner of an independent pharmacy is especially bitter about chain pharmacies, essentially accusing chains of treating pharmacy as a commodity and of professional malpractice (“…an error due to an overworked pharmacist mislabeling or giving the wrong medicine.”)
All in all, a fascinating and thought-provoking series of comments about an alleged dark side to the Medicare Part D benefit.
-------------------
Did anyone else notice that Monday's Pink Sheet reported on the CVS-Prasco lawsuit, which is the story that I broke almost two weeks ago? Ed Silverman at Pharmalot also did some nice coverage of my story (and added a cool graphic, too.)
Friday, September 14, 2007
Scientific Convinction from Partisan Passion
I laughed through my Fruity Pebbles this morning at Most Science Studies Appear to Be Tainted By Sloppy Analysis from today's Wall Street Journal.
The article's core premise -- most published research findings are wrong -- seems too extreme to me. However, the following sentence caught my eye:
"In a wilderness of knowledge, it can be difficult to distinguish error from fraud, sloppiness from deception, eagerness from greed or, increasingly, scientific conviction from partisan passion."
A fitting capstone to my controversial postings on pharmacy reimbursement from Tuesday and Wednesday.
The article's core premise -- most published research findings are wrong -- seems too extreme to me. However, the following sentence caught my eye:
"In a wilderness of knowledge, it can be difficult to distinguish error from fraud, sloppiness from deception, eagerness from greed or, increasingly, scientific conviction from partisan passion."
A fitting capstone to my controversial postings on pharmacy reimbursement from Tuesday and Wednesday.
Wednesday, September 12, 2007
Hype vs. Research
On Tuesday, I posted A Misleading Study on Pharmacy Reimbursement, a critique of a new study describing pharmacy reimbursements under the Medicare Part D program. The full research paper from the Journal of the American Pharmacists Association can now be downloaded here: Prescription drug payment times by Medicare Part D plans.
The complete article naturally offers a much more nuanced perspective than either the Executive Summary or NCPA’s press release. However, the authors and NCPA overreach by drawing conclusions that are not supported by the study. Their attempts to shift blame to payers, customers, and wholesalers are designed to influence health care policy in a way that benefits pharmacies at the expense of everyone else.
Thus, my primary critique remains valid – the results of this study are being marketed in a misleading way to the public and to Congress. The evidence in this study certainly does not warrant having Congress interfere in the working of a competitive free market.
What the Study Really Says
The actual paper is well-reasoned and carefully worded. The researchers – Dr. Shepard, Dr. Richards, and Ms. Winegar –present detailed statistical summaries information broken out by month, by year, and by Part D plan.
One hidden bias comes in the aggregation of time frames for analysis. The authors show us only four points in the distribution: less than 15 days; 15-30 days; 31-60 days; 60 days or more. Thus, a claim paid on day 32 is treated the same for the purposes of their analyses as a claim paid on day 60. The impact of this choice is not readily apparent, but would be quite significant for concluding anything about the cash flow impact on a pharmacy.
As I correctly deduced from the Executive Summary, the median number of days to payment after adjudication dropped below 30 days for the last five months of 2006. Amazingly, one of the headline conclusions of the summary – “50.0% of claims were paid more than 30 days after adjudication” – is actually false for the last five months of 2006! (See Table 1 in the paper.)
The academic tone stands in sharp contrast to the summary and NCPA press release that I wrote about on Tuesday. The Executive Summary is attributed to the same researchers and presented on the letterhead of the Center for Pharmacoeconomic Studies. My critique of the summary remains valid, especially with regard to changes over time throughout 2006.
Strategy #1: Blame Payers
NCPA desperately wants to conclude that PBMs and third-party payers are guilty of “destroying” independent pharmacies. NCPA even goes so far as to make the following claim: “This study presents strong evidence that PBMs are ‘gaming the system’, making interest on the ‘float’ they get by not paying pharmacies in a timely manner.”
The actual research paper provides no support (strong or otherwise) for such a conclusion. NCPA appears unwilling to consider possible alternative explanations for declining numbers of independent pharmacies. As I noted on Tuesday, the amount of financial hardship facing an average independent pharmacy may not be enough to tip a healthy, well-run business into bankruptcy. It’s a stretch to blame payers based on the paper.
Strategy #2: Blame the Customer
What if the decline of independent pharmacy is really part of a larger shift in consumer preferences? Many U.S. consumers prefer to shop at larger stores. As a result, retailing is become more concentrated and increasingly dominated by chain stores, warehouse clubs, home centers, and big box superstores. (I discuss these issues in more depth in Chapter 8 of my new book Facing the Forces of Change®: Lead the Way in the Supply Chain.)
As the table below shows, pharmacy is on par with other retail sectors dominated by large chains, at least judging by the decline in the number of small companies (less than 20 employees. (Source: Statistics of U.S. Businesses.)
The complete article naturally offers a much more nuanced perspective than either the Executive Summary or NCPA’s press release. However, the authors and NCPA overreach by drawing conclusions that are not supported by the study. Their attempts to shift blame to payers, customers, and wholesalers are designed to influence health care policy in a way that benefits pharmacies at the expense of everyone else.
Thus, my primary critique remains valid – the results of this study are being marketed in a misleading way to the public and to Congress. The evidence in this study certainly does not warrant having Congress interfere in the working of a competitive free market.
What the Study Really Says
The actual paper is well-reasoned and carefully worded. The researchers – Dr. Shepard, Dr. Richards, and Ms. Winegar –present detailed statistical summaries information broken out by month, by year, and by Part D plan.
One hidden bias comes in the aggregation of time frames for analysis. The authors show us only four points in the distribution: less than 15 days; 15-30 days; 31-60 days; 60 days or more. Thus, a claim paid on day 32 is treated the same for the purposes of their analyses as a claim paid on day 60. The impact of this choice is not readily apparent, but would be quite significant for concluding anything about the cash flow impact on a pharmacy.
As I correctly deduced from the Executive Summary, the median number of days to payment after adjudication dropped below 30 days for the last five months of 2006. Amazingly, one of the headline conclusions of the summary – “50.0% of claims were paid more than 30 days after adjudication” – is actually false for the last five months of 2006! (See Table 1 in the paper.)
The academic tone stands in sharp contrast to the summary and NCPA press release that I wrote about on Tuesday. The Executive Summary is attributed to the same researchers and presented on the letterhead of the Center for Pharmacoeconomic Studies. My critique of the summary remains valid, especially with regard to changes over time throughout 2006.
Strategy #1: Blame Payers
NCPA desperately wants to conclude that PBMs and third-party payers are guilty of “destroying” independent pharmacies. NCPA even goes so far as to make the following claim: “This study presents strong evidence that PBMs are ‘gaming the system’, making interest on the ‘float’ they get by not paying pharmacies in a timely manner.”
The actual research paper provides no support (strong or otherwise) for such a conclusion. NCPA appears unwilling to consider possible alternative explanations for declining numbers of independent pharmacies. As I noted on Tuesday, the amount of financial hardship facing an average independent pharmacy may not be enough to tip a healthy, well-run business into bankruptcy. It’s a stretch to blame payers based on the paper.
Strategy #2: Blame the Customer
What if the decline of independent pharmacy is really part of a larger shift in consumer preferences? Many U.S. consumers prefer to shop at larger stores. As a result, retailing is become more concentrated and increasingly dominated by chain stores, warehouse clubs, home centers, and big box superstores. (I discuss these issues in more depth in Chapter 8 of my new book Facing the Forces of Change®: Lead the Way in the Supply Chain.)
As the table below shows, pharmacy is on par with other retail sectors dominated by large chains, at least judging by the decline in the number of small companies (less than 20 employees. (Source: Statistics of U.S. Businesses.)
Note that the most recent data are from 2004, well before Part D.
Here’s an even more controversial explanation—maybe independents are upset at losing cash pay customers who now have access to a comprehensive drug benefit. As pharmacist Tom Connelly pointed out in his comment on Tuesday’s post: “Our biggest problem with Medicare Part D was seeing a minor, but not insignificant, portion of our prescription revenue going from immediate pay--cash on the barrel head--to 30 to 40 days out.”
Would pharmacists really prefer that seniors reach into to their own pocket simply to alleviate their cash flow problem? (No, of course not.)
Strategy #3: Blame the Wholesaler
It also defies economic logic to point the finger at the wholesalers for their payment terms. Smaller retail customers rely on wholesalers for many services—delivery, credit, generic sourcing, retail management. As a result, an independent pharmacy provides higher profits for a wholesaler than a large, powerful, self-distributing pharmacy chain such as CVS Corp or Walgreen (WAG).
Why would wholesalers want to kill their most profitable customers? In reality, wholesalers are working hard to help independent pharmacies survive in an increasingly competitive industry. (See Trouble Ahead for Independent Pharmacies for more background.)
Making Policy
Based on an objective look at the available evidence, there seems to be little compelling reason for Congress to interfere in a free market that will ultimately arrive at a reasonable solution for all parties. The marketplace reality is that third-party has overtaken cash pay at the pharmacy. We can’t rewind the world to make it more convenient for operators of independent pharmacies.
Perhaps I am too skeptical, but I wonder how many policymakers will venture beyond the Executive Summary and NCPA’s press release on this issue. The high level talking points are likely to crowd out an appropriate discussion of the costs and benefits to consumers and our health care system. Hopefully, my blog posts can make a small contribution to a more fact-based debate.
Tuesday, September 11, 2007
A Misleading Study on Pharmacy Reimbursement
NCPA is touting the results of a new study that purports to provide “incontrovertible evidence of the slow reimbursement pharmacies have endured with Medicare Part D prescription drug claims.” (See the press release.) NCPA is quite forthright in their desire to influence two bills pending before Congress: S.1954 (Pharmacy Access Improvement Act of 2007) and H.R.1474 (The Fair and Speedy Treatment of Medicare Prescription Drug Claims Act of 2007).
I strongly disapprove of the manner in which this study’s results are being presented to the public and to Congress. It would be foolish to base health care policy based on the partially-disclosed results of this incomplete and biased study.
Bikini Research
The full study has not been released so we can only rely on the skimpy Executive Summary. And like a skimpy bikini, what the summary reveals is interesting -- but what it conceals is essential.
Consider this example of selective disclosure.
As we all remember, the Part D launch in January 2006 was fraught with operational difficulties, many of which were subsequently resolved. According to IMS Health, Part D scripts grew from 0% to 17% of the retail market during the first six months of 2006 before stabilizing at 17% for the second half of 2006.
Yet the Executive Summary conveniently averages all of 2006 together, thereby artificially inflating the magnitude of the "prompt payment problem."
Here are the implied median number of days between submission and adjudication as reported in the summary:
January 2006: 106 days
February 2006: 93 days (-12% vs. January)
March/April 2006: 54 days (-49% vs. January)
May through December: No disclosure
The trend is clear, but where are the data from the rest of the year? If the Executive Summary was intellectually honest, then it would have provided more information about changes over time. At a minimum, the summary should show the results for the first half versus second half of 2006.
These omitted data are crucial for interpreting the overall 2006 results. Figure 1 implies that the annualized median is 30 days for independent pharmacies and much lower for chains. Thus, the trend shown for the first four months must have continued. The median may have even dropped below 30 days for certain months in 2006!
Real-World Impact?
I published some Heretical Questions about the AMP War last month. Let me ask another heretical question: Is the magnitude of the allegedly slow payment worthy of a legislative fix?
The average independent pharmacy in this study filled 4,138 Part D scripts in 2006. The average retail script generated $60 in revenue at an independent pharmacy in 2006 (Source: NACDS). Therefore, Part D represented about $250,000 in annual revenue (about $21,000 per month) for a typical independent pharmacy in 2006. If half of these reimbursements come after 30 days, then the pharmacy is floating an additional $10,500 for a few weeks throughout the year.
Is this estimated float amount financially significant enough to require an Act of Congress? The study is silent on this matter, as well as other relevant questions. Are Part D claims being paid faster or slower than the other 90% of scripts? How are Days of Sales Outstanding (DSO) changing? What else should pharmacies be doing to better manage their balance sheet? What explains the performance gap between independents and chains? How sensitive are the results to the choice of break points (15 days, 30 days, etc.)?
The Full Story, Please
In my opinion, NCPA and the researchers will ultimately damage their credibility by peddling these partial results, which do nothing more than reinforce NCPA's longstanding preconceptions about PBMs. In the meantime, I call on the researchers and the NCPA to immediately release the raw data underlying the Executive Summary so that it can be subject to independent analysis and scrutiny.
I’d love to hear from you about this post. Email me or post a comment (anonymously, if you choose).
I strongly disapprove of the manner in which this study’s results are being presented to the public and to Congress. It would be foolish to base health care policy based on the partially-disclosed results of this incomplete and biased study.
Bikini Research
The full study has not been released so we can only rely on the skimpy Executive Summary. And like a skimpy bikini, what the summary reveals is interesting -- but what it conceals is essential.
Consider this example of selective disclosure.
As we all remember, the Part D launch in January 2006 was fraught with operational difficulties, many of which were subsequently resolved. According to IMS Health, Part D scripts grew from 0% to 17% of the retail market during the first six months of 2006 before stabilizing at 17% for the second half of 2006.
Yet the Executive Summary conveniently averages all of 2006 together, thereby artificially inflating the magnitude of the "prompt payment problem."
Here are the implied median number of days between submission and adjudication as reported in the summary:
January 2006: 106 days
February 2006: 93 days (-12% vs. January)
March/April 2006: 54 days (-49% vs. January)
May through December: No disclosure
The trend is clear, but where are the data from the rest of the year? If the Executive Summary was intellectually honest, then it would have provided more information about changes over time. At a minimum, the summary should show the results for the first half versus second half of 2006.
These omitted data are crucial for interpreting the overall 2006 results. Figure 1 implies that the annualized median is 30 days for independent pharmacies and much lower for chains. Thus, the trend shown for the first four months must have continued. The median may have even dropped below 30 days for certain months in 2006!
Real-World Impact?
I published some Heretical Questions about the AMP War last month. Let me ask another heretical question: Is the magnitude of the allegedly slow payment worthy of a legislative fix?
The average independent pharmacy in this study filled 4,138 Part D scripts in 2006. The average retail script generated $60 in revenue at an independent pharmacy in 2006 (Source: NACDS). Therefore, Part D represented about $250,000 in annual revenue (about $21,000 per month) for a typical independent pharmacy in 2006. If half of these reimbursements come after 30 days, then the pharmacy is floating an additional $10,500 for a few weeks throughout the year.
Is this estimated float amount financially significant enough to require an Act of Congress? The study is silent on this matter, as well as other relevant questions. Are Part D claims being paid faster or slower than the other 90% of scripts? How are Days of Sales Outstanding (DSO) changing? What else should pharmacies be doing to better manage their balance sheet? What explains the performance gap between independents and chains? How sensitive are the results to the choice of break points (15 days, 30 days, etc.)?
The Full Story, Please
In my opinion, NCPA and the researchers will ultimately damage their credibility by peddling these partial results, which do nothing more than reinforce NCPA's longstanding preconceptions about PBMs. In the meantime, I call on the researchers and the NCPA to immediately release the raw data underlying the Executive Summary so that it can be subject to independent analysis and scrutiny.
I’d love to hear from you about this post. Email me or post a comment (anonymously, if you choose).
Thursday, September 06, 2007
CVS' Channel Power
A new lawsuit gives us a peek into the behind-the-scenes economics of the CVS Corp-Caremark deal and highlights the challenges facing generic drug makers. I have not seen any news stories on this lawsuit yet, so perhaps this story is a Drug Channels exclusive.
In July, CVS filed suit against Prasco, LLC, a company that had a contract to supply generic Allegra to CVS. I posted the complaint online here since it is a matter of public record.
The contract allegedly specified that CVS had a “Most Favored Nation” clause to guarantee than CVS paid the lowest price of any customer, regardless of class of trade. (See paragraph 11.) But paragraph 21 of the complaint states: “As a result of the merger, CVS learned that, contrary the Agreement, Prasco had not, in fact, charged CVS the lowest price offered to any other customer. Instead, CVS learned that Caremark had been charged a lower price than CVS.”
CVS is following a time-tested post-merger purchasing strategy – compare contracts and ask for the best price. They are taking advantage of the fact that generic companies compete for supply contracts and “shelf space” by lowering prices to the biggest customers. In fact, CVS reported strong Q2 financials because they claim to have already reaped their projected $500 million in purchasing power synergies.
Of course, CVS’ synergies are coming at the expense of generic drug manufacturers such as Teva Pharmaceutical Industries (TEVA), Watson Pharmaceuticals (WPI), and Mylan Laboratories (MYL). Generic drug makers now have nine major U.S. customers:
Exhibit B of the Prasco complaint also demonstrates the power of a big buyer in the generic drug supply chain. “CVS Generic Pharmaceuticals Business Standards” (as of 2004) gives CVS price protection as a generic drug’s price falls. In other words, they can recover any decline in inventory value for products in their distribution centers plus five week’s inventory at store level (apparently without regard for actual store inventories.) This is the opposite of the investment buying by the channel that occurs for branded pharmaceuticals.
All in all, it’s a scary time to be a generic drug manufacturer, but a good time to be a big buyer of generic drugs.
In July, CVS filed suit against Prasco, LLC, a company that had a contract to supply generic Allegra to CVS. I posted the complaint online here since it is a matter of public record.
The contract allegedly specified that CVS had a “Most Favored Nation” clause to guarantee than CVS paid the lowest price of any customer, regardless of class of trade. (See paragraph 11.) But paragraph 21 of the complaint states: “As a result of the merger, CVS learned that, contrary the Agreement, Prasco had not, in fact, charged CVS the lowest price offered to any other customer. Instead, CVS learned that Caremark had been charged a lower price than CVS.”
CVS is following a time-tested post-merger purchasing strategy – compare contracts and ask for the best price. They are taking advantage of the fact that generic companies compete for supply contracts and “shelf space” by lowering prices to the biggest customers. In fact, CVS reported strong Q2 financials because they claim to have already reaped their projected $500 million in purchasing power synergies.
Of course, CVS’ synergies are coming at the expense of generic drug manufacturers such as Teva Pharmaceutical Industries (TEVA), Watson Pharmaceuticals (WPI), and Mylan Laboratories (MYL). Generic drug makers now have nine major U.S. customers:
- The Big 3 wholesalers – AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson (MCK)
- The Big 6 largest chain and mail-order pharmacies – CVS Corp with CareMark (CVS), Express Scripts (ESRX), Medco (MHS), Rite-Aid (RAD), Walgreens (WAG), and Wal-Mart (WMT).
Exhibit B of the Prasco complaint also demonstrates the power of a big buyer in the generic drug supply chain. “CVS Generic Pharmaceuticals Business Standards” (as of 2004) gives CVS price protection as a generic drug’s price falls. In other words, they can recover any decline in inventory value for products in their distribution centers plus five week’s inventory at store level (apparently without regard for actual store inventories.) This is the opposite of the investment buying by the channel that occurs for branded pharmaceuticals.
All in all, it’s a scary time to be a generic drug manufacturer, but a good time to be a big buyer of generic drugs.
Tuesday, September 04, 2007
GSK bashes RFID but quickly recants
Welcome back! Let's kick off September with some RFID anti-hype.
Now, I have nothing against RFID, which has many useful applications. However, I think RFID has been massively oversold relative to its actual ability to be a cross-company supply chain solution to counterfeiting and diversion. Read the many comments to my RFID Un-Hype post to get a flavor for the debate.
I must be developing a reputation as an RFID skeptic because multiple people sent me last week's story from The Times (London) reporting that GlaxoSmithKline’s (GSK) may abandon RFID in favor of “more reliable, less costly technology.” See GSK plan to beat drug counterfeiters may be scrapped. According to the article:
“[T]he programme, which uses technology developed by IBM, has been riddled with technical hitches. They include RFID tags breaking as they are attached to products, a failure of tracking technology to read them during transit and a widespread failure by wholesalers and retailers further down the supply chain to embrace the technology.”
Oooh, that’s gotta hurt!
Apparently GSK had second thoughts about this statement because their PR flack quickly recanted three days later in the not-quite-objective RFID Journal saying:
“RFID remains in place,” says GSK spokesperson Mary Ann Rhyne. “In fact, we've extended the RFID testing, and no cut-off time has been determined.”
Personally, I’m skeptical about anything in RFID Journal because it is a primary source of unabashed boosterism. They run polls that ask leading questions such as “Should the FDA mandate the use of RFID?” (68% of RFID Journals say yes!) I almost expect them to run a poll asking: “Is RFID a great technology for the pharma supply chain … or the greatest technology?”
So, what’s going on? Here are two theories:
One, I’ve learned that GSK will be presenting at the California Board of Pharmacy’s September 20 Enforcement Committee Meeting, so it would be bad form to suggest any delays with only 16 months left before the deadline. I’m curious to see how much they spin the Times story there. BTW, Pfizer (PFE) gave a very thorough and insightful presentation at the June 20 meeting, which I’ve posted online here. (Be patient -- it’s a 10MB file.) See page 3 of the meeting minutes for highlights. FYI, I discussed Pfizer’s doubts about RFID back in June.
Two, GSK may also feel embarrassed because the Times story mentioned IBM, who just two weeks earlier released its latest hype-filled press release about ePedigree. This time, they tout IBM's proprietary RFID Information Center (RFIDIC – pronounced “Riffy-Dick”?). One tech trade mag notes that IBM has nothing more than a reporting mechanism to "churn out a so-called ePedigree report."
Gosh, it seems like only yesterday that Paul Chang of IBM went on CNBC to announce that the pharmaceutical industry is rallying around RFID technology. Actually, it was August 8, 2006, and yes, I still have the transcript. Since it looks like IBM is planning to make this an annual summer event, I hope you will plan to join me in August 2008 for the Third Annual IBM RFID Barbeque and Pedigree Roast!
But seriously, I was quite impressed with how much Miss Teen USA (South Carolina) knew about geography. So, I've asked her to guest blog in a future Drug Channels posting so she can explain how RFID will make the pharma supply chain safer. Stay tuned!
----
Coming on Thursday: An exclusive peek behind the curtains of the CVS-Caremark combination.
Now, I have nothing against RFID, which has many useful applications. However, I think RFID has been massively oversold relative to its actual ability to be a cross-company supply chain solution to counterfeiting and diversion. Read the many comments to my RFID Un-Hype post to get a flavor for the debate.
I must be developing a reputation as an RFID skeptic because multiple people sent me last week's story from The Times (London) reporting that GlaxoSmithKline’s (GSK) may abandon RFID in favor of “more reliable, less costly technology.” See GSK plan to beat drug counterfeiters may be scrapped. According to the article:
“[T]he programme, which uses technology developed by IBM, has been riddled with technical hitches. They include RFID tags breaking as they are attached to products, a failure of tracking technology to read them during transit and a widespread failure by wholesalers and retailers further down the supply chain to embrace the technology.”
Oooh, that’s gotta hurt!
Apparently GSK had second thoughts about this statement because their PR flack quickly recanted three days later in the not-quite-objective RFID Journal saying:
“RFID remains in place,” says GSK spokesperson Mary Ann Rhyne. “In fact, we've extended the RFID testing, and no cut-off time has been determined.”
Personally, I’m skeptical about anything in RFID Journal because it is a primary source of unabashed boosterism. They run polls that ask leading questions such as “Should the FDA mandate the use of RFID?” (68% of RFID Journals say yes!) I almost expect them to run a poll asking: “Is RFID a great technology for the pharma supply chain … or the greatest technology?”
So, what’s going on? Here are two theories:
One, I’ve learned that GSK will be presenting at the California Board of Pharmacy’s September 20 Enforcement Committee Meeting, so it would be bad form to suggest any delays with only 16 months left before the deadline. I’m curious to see how much they spin the Times story there. BTW, Pfizer (PFE) gave a very thorough and insightful presentation at the June 20 meeting, which I’ve posted online here. (Be patient -- it’s a 10MB file.) See page 3 of the meeting minutes for highlights. FYI, I discussed Pfizer’s doubts about RFID back in June.
Two, GSK may also feel embarrassed because the Times story mentioned IBM, who just two weeks earlier released its latest hype-filled press release about ePedigree. This time, they tout IBM's proprietary RFID Information Center (RFIDIC – pronounced “Riffy-Dick”?). One tech trade mag notes that IBM has nothing more than a reporting mechanism to "churn out a so-called ePedigree report."
Gosh, it seems like only yesterday that Paul Chang of IBM went on CNBC to announce that the pharmaceutical industry is rallying around RFID technology. Actually, it was August 8, 2006, and yes, I still have the transcript. Since it looks like IBM is planning to make this an annual summer event, I hope you will plan to join me in August 2008 for the Third Annual IBM RFID Barbeque and Pedigree Roast!
But seriously, I was quite impressed with how much Miss Teen USA (South Carolina) knew about geography. So, I've asked her to guest blog in a future Drug Channels posting so she can explain how RFID will make the pharma supply chain safer. Stay tuned!
----
Coming on Thursday: An exclusive peek behind the curtains of the CVS-Caremark combination.