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27 posts categorized "Prescription Drugs"

August 07, 2014

Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer

6793824321_398d881757_mWe have been deluged with stories about the $100-a-pill medication for Hepatitis C. Is it really worth $87,000? (Well, it's cheaper than a $600,000 liver transplant.) I had the opportunity to speak with Cyndy Nayer, of the Center of Health Engagement, about the issues surrounding this drug and its use, value-based approaches to payment, and the question of whether we are able to solve this problem in our current environment at all.

Continue reading "Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer" »

May 14, 2013

The FDA Patient Network Website - Pretty Darn Patient-Centered

FDA Patient Network 2
The FDA launched an impressive patient network website this month, after nearly four years of research, focus groups, usability testing and more. The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically. James Valentine, Program Analyst in the Office for Health and Constituent Affairs put it simply and forcefully in a recent telephone conversation: “The idea is to engage the patient community, to have the patient voice heard at the FDA.”

Historically, the agency has been working with patients one-on-one, by phone and email, often when an extremely ill patient is seeking information on clinical trials or access to investigational products. The goal is to broaden the field of engagement. The agency has had patient representatives on its advisory committees since the late 1980s — an innovation that came about as part of the response to AIDS/HIV — and patient involvement in the FDA’s processes were further formalized in the late 1990s, as part of Clinton-era cancer initiatives. There are now about two hundred patient representatives involved in over 110 disease areas.

The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year, according to Valentine. Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants — just as scientific and clinical experts brought into the FDA process are recognized as consultants — and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses.

Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.

While the new website is a gateway to the FDA, Valentine assures us that “the Office of Health and Constituent Affairs is still here to help patients navigate the agency.”

The first FDA Patient Network live chat will be a town hall meeting with staff from the Office of Health and Constituent Affairs on May 21 at 3:00 p.m. EDT. Future chats will feature staff from throughout the agency.

Here’s hoping that the FDA will carry through on the promise of online openness.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

A version of this post first appeared on, the blog of The Society for Participatory Medicine.

May 18, 2011

Why do 10% of cancer patients on oral meds stop taking them?

Ten percent of cancer patients failed to fill their initial prescriptions for oral anti-cancer drugs, according to a new study published jointly today in the Journal of Oncology Practice (JOP) and American Journal of Managed Care (AJMC)[, based on data] . . . from 2007 to 2009. . . .

The study, “Patient and Plan Characteristics Affecting Abandonment of Oral Oncolytic Prescriptions,” finds that patients were primarily abandoning their anti-cancer drugs due to two key factors: high cost-sharing and higher prescription activity. For example, claims with cost-sharing over $500 were four times more likely to be abandoned than claims with cost-sharing of $100 or less. Across the sample of prescription claims studied, Medicare coverage and lower income were also related to higher rates of abandonment when each were compared individually.

The study shows that while anti-cancer medicines offer benefits to patients, access to them is difficult due to high rates of cost-sharing. While 73 percent of newly initiated oncolytic patients had a cost-sharing amount of $100 of less, 16 percent required an out-of-pocket cost of greater than $500. The study found that the abandonment rate increased with cost-sharing amounts. Claims with cost-sharing above $500 had the highest abandonment rate – 25 percent – as compared with an abandonment rate of six percent for claims with cost-sharing of $100 or less.

(Source: presser from Avalere Health, which conducted the study.)

In the bad old days, most cancer meds were delivered through infusion therapy (chemotherapy), but a sizable chunk of those now in use, and likely more of those that are in the pipeline (25-35%) are oral meds.

IV meds administered in a health care facility are, generally speaking, not subject to the same level of cost sharing by patients now common for prescription medications.  Thus, the confluence of changes in drug therapy and changes in insurance coverage has led to a dangerous drop in medication adherence for cancer patients, due to higher out-of-pocket costs, even if the total cost of a given course of treatment is lower than the cost of a comparable course of IV chemo.

This should be understood intuitively, but apparently it is not.  A couple months ago, we were treated to another study showing that as high deductible health plans become more prevalent, use of preventive services declines.

The solution being adopted to deal with this latter problem, across many commercial plans as well as Medicare, is the elimination of copays for certain primary and preventive care services.  This makes economic sense to payors, even as it makes eminent sense for individuals as well.  For short money up front, expensive care down the road may well be avoided.

While we need not return to the bad old days of infusion therapy only for cancer meds, payors should examine the results of this study carefully and reconsider coverage rules.  Reducing out-of-pocket costs for these meds will increase adherence, and would likely reduce the incidence of complications and relapses requiring more expensive care . . . good for everyone.

(While we're on the subject of cancer treatment, I would be remiss if I did not offer you the opportunity to sponsor my ride in the 2011 Pan-Mass Challenge -- the two-day, 200-mile annual bicycle fundraiser for the Dana Farber Cancer Institute.  Please follow the link and give as generously as you can.  Tell your friends and neighbors.)

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


March 22, 2011

Who owns patient data? (The Walgreens edition)

Walgreens is being sued by customers who are not happy that their prescription information – even though it has been de-identified – is being sold by Walgreens to data-mining companies. 

The data privacy and security concerns surrounding the transfer of de-identified data are significant.  To “de-identify” what is otherwise protected health information under HIPAA, some outfits will simply strip data of 18 types of identifiers listed in federal regulations.  However, the relevant regulation (45 CFR 164.514(b)(2)(ii)) also provides that this only works if “the covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” Thus, the problem with this approach is that, these days, nobody can disclaim knowledge of the fact that information de-identified by removing this cookbook list of 18 identifiers may be re-identified by cross-matching data with other publicly-available data sources. There are a number of reported instances of this sort of thing happening. The bottom line is that our collective technical prowess has outstripped the regulatory safe harbor.

Is this the basis of the lawsuit brought against Walgreens?  An objection to trafficking in health information that should remain private?  No.  The plaintiff group of customers is suing to share in the profits realized by Walgreens from trading in the de-identified data.

While I haven’t pored over the papers filed in this case, my guess is that there’s enough legal boilerplate in the Walgreens HIPAA notice of privacy practices given out and signed for up front by patients who fill prescriptions so that they do not have a claim worth much more than nuisance value.

This case reminds me of the landmark case of Moore v. Regents of the University of California, decided about twenty years back, where a leukemia patient wanted to share in the profits from a line of cells grown from cells harvested from his body by researchers who told him that his return hospital visits were for checkups and monitoring only.  He lost.

The specific governing rules in play are different, but I don’t see how the ultimate result would be much different this time around, especially since the Walgreens plaintiffs were probably given more information about how their goods might be used (in the notice of privacy practices) than Moore ever was.

Nobody asked me, but I would think that a more productive line of inquiry would lie with figuring out whether the data that is being sold – patient gender, state and age group; name of drug prescribed; and ID number of prescribing physician – could be combined with other data available out there to the folks buying these data from Walgreens and used to re-identify patient records.  Given the slightly-differently-de-identified insurance company records that are out there, and the profit motive of the data-mining companies, I would not be surprised if at least some of these de-identified records were easily re-identified, thus exposing Walgreens to liability for HIPAA violations.  The data-mining companies are almost certainly re-identifying the physicians, since that’s where the value in this whole exercise lies: targeted marketing to physicians based on their prescribing patterns.  (Regarding re-identification of patient information, consider the case of the Netflix prize, where de-identified video rental data could be re-identified by cross-matching with online consumer movie reviews – “Simply removing names does not ensure that data will remain anonymous. And the implications stretch far beyond the world of Netflix.”)   Of course, HIPAA violations just yield a fine, payable to the government (and we know how useful HIPAA CMPs can be in ensuring compliance) – there is no third-party liability under HIPAA – so it would be a stretch to translate them into a plaintiffs’ verdict involving cash.   

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

January 19, 2010

Healthcare Communications and Social Media - First Anniversary Tweetchat

Sunday night, Dana Lewis (twitter handle: @danamlewis) hosted a special two-hour edition of the weekly Healthcare Communications and Social Media Tweetchat to mark its first anniversary.  There was a guest moderator -- Lee Aase (@leeaase).  There was a raft of special guests: Nick Dawson (@nickdawson), Greg Matthews (@chimoose), Jonathan Richman (@jonmrich), Liza Sisler (@lizasisler), Jeff Livingston (@macobgyn), Christine Kraft (@christinekraft) and Val Jones (@drval).

While the background and institutional interests of the speakers and the participants is incredibly broad (integrated health care delivery system to payor to digital health care marketing consultant to physician to health care IT consultant . . . ), the focus on the group has been pretty clear over the past year: harnessing the power of social media for the benefit of the patient -- providing information to patients, empowering patients and enabling patient choice.  While part of the equation is, naturally, an effort to develop outreach that results in more volume at a particular health care provider, there is great attention paid to the need for authenticity and trust in this particular sort of online relationship.  As I always say, social media is just "one arrow in the quiver," but it is a relatively new and potent one, so this sort of examination of its uses is valuable. 

Read about the history of this weekly tweetchat, known by its twitter hashtag #hcsm -- which many of us heard vocalized for the first time Sunday night, as "Hic-Sum" as the chat also took place via Blog Talk Radio (the two-hour broadcast is archived and may be heard here; beware - audio starts as soon as you open this link).

There were many participants in the discussion as well -- participating via twitter at #hcsm and on the Blog Talk Radio chat room.  The ongoing discussion owes a debt of gratitude to Tom Stitt (@tstitt) for pulling together the infrastructure and to Meredith Gould (@meredithgould) for pitching on Sunday night, in particular.

I was tickled to be included in the #hcsm timeline: The legal #hcsm tweetchat in June featuring Mayo lawyer Daniel Goldman (@danielg280) and the HealthBlawger, David Harlow (@healthblawg), "reaches 1000+ tweet per hour intensity and is nicknamed the 'fire hose' #hcsm chat."  (See my post on the legal #hcsm chat.)

Here's to another year of interesting discussions online . . . and otherwise, as connections made via twitter leak into that parallel universe we call real life.  I look forward to making more of those connections as time goes on, and I encourage those of you not already following the health tweets mentioned in this post to start following them on twitter; and who knows, maybe we'll hear from you at the next #hcsm tweetchat.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 02, 2009

FDA and social media: The regulated community's current obsession overlooks off-label promotions by the advocacy community

This morning I received a tweet exhorting me to learn about Low Dose Naltrexone (LDN) for autoimmune diseases.  (Naltrexone, by the way, is approved by the FDA only to treat alcoholism.)  Within a few clicks, I found claims that LDN would be a good drug to take for dozens of conditions: everything from neuroblastoma to HIV to celiac disease, and learned of a network of tweeps promoting LDN. 

The above tweet linked to a blog promoting LDN which is part of the Health Central community.

All this got me thinking about a bunch of issues; for instance:

  • Does the promotion of off-label uses by a member blog comply with the HON Code, which has been adopted by Health Central?
  • Since folks are already using social media to promote off-label uses of prescription medications, what are, and what should be, the obligations of pharma companies to address the information put out by such folks?
  • Should we expect any of those obligations to change post-#FDASM (i.e., after the much-anticipated public hearing at the FDA on the use of social media in pharma marketing and subsequent anticipated rulemaking)?   

Well, marketing of drugs for off-label uses is supposed to follow certain FDA rules -- not very restrictive, and essentially self-policed, since the rules just say that only medical journal articles on off-label uses may be shared with docs. Of course, some drug reps cross the line, and one pharma company -- Allergan, the maker of Botox -- is seeking to have even these limits lifted as unconstitutional limits on free speech.  These rules apply to the pharma companies' reps, not independent bloggers, of course, but the HON Code (which ought to apply, given the Health Central endorsement of the blog in question) ought to impose some relevant standards.  Consider  Principle 5 - Justification of claims:

All information about the benefits or performance of any treatment (medical and/or surgical), commercial product or service are considered as claims. All claims have to be backed up with scientific evidence (medical journals, reports or others).

Pharma's concern about content created by others but posted on a pharma company web site or blog or other social media site should perhaps be extended to a concern about content posted by others on other sites.  Both may be found just as easily, given the plethora of web search and alert tools now available.  I am not suggesting that pharma companies be called upon to monitor the entire internet; rather, perhaps the time has come to create firmer rules about promotion of off-label uses of prescription drugs, to be enforced by state and federal authorities.

Without waiting for the public hearing to be completed and rules to be written (which could take a year), many pharma companies have already established a social media presence.  While the manner in which they use the medium is a topic for another day, we should expect at least some of them to become more actively engaged in social media in the future.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 26, 2009

The Lawyers Don't Always Say No: Bringing Legal into Health Care Social Media Strategic Planning

I led one of the roundtable discussions at last Thursday's Social Communications & Healthcare conference in New York City.  After a morning of back-to-back case studies presented by folks from the CDC (swine flu resources) to McNeil (online ADHD communities) to Pfizer (on twitter and other forms of transparency) to word-of-mouth marketing consultants (for all presentations, see agenda, audio and tweetstream at link), participants had two rounds of social media roundtable speed dating -- there were about 30 simultaneous sessions.  My sessions' topic: "The Lawyers Don't Always Say No: Bring Legal Into Health Care Social Media Strategic Planning."

The participants in my sessions included hospital administrators, pharma marketers, PR and media consultants, and one or two lawyers.

I kicked things off by observing that many organizations decide that they ought to have a social media presence and jump in without exploring why they are doing so, what they hope to accomplish, and what level of resources they plan to devote to such efforts.  Folks chimed in with the need to listen as a first step: listening to competitors, and listening to what the public is saying about you.  Listening to competitors allows you to benchmark what other folks are doing, and get a sense of best practices.  Listening to the public is a strategy followed by strong brands across the entire economy, not just in health care.  It allows you to pick up on complaints, problems, peeves, and step in and address them, either on line or off line, as appropriate, and to communicate publicly (within limits) about how issues have been addressed.

We focused on the following key areas of concern:

  • Privacy.  This realm is governed by HIPAA and related state law.  Particular conditions have additional layers of regulation and issues.  For example, one participant raised the issue of communication in a branded forum by a parent of a minor child with AIDS.  How can one establish consent to the release of such information in a public forum, and what is the exposure of the forum's sponsor with respect to an unauthorized release of that information?  My take: include disclaimers and warnings galore, so that posting in such a form constitutes consent to the public discussion.  The question of who has the right to grant such consent (parent vs. minor child vs. emancipated minor) is the same whether we are talking about the social media context or other situations.
  • Liability.  Several types of liability concerns seem to be holding back many healthcare and pharma organizations from getting their feet wet in social media.  
Many pharma organizations seem paralyzed when it comes to branded online social media forums, due to concerns about the obligation to report adverse events involving their products that come to their attention.  My take: this is ostrich-like behavior.  While the safest course is to wait for the FDA to come out with social media guidelines, some common sense can be applied in this situation: Don't set up an online forum unless you are prepared to moderate and filter comments, and forward reports of adverse events to regulatory and compliance departments for review and reporting if necessary.  Avoiding reports of adverse events doesn't mean they're not happening, and learning about more such events earlier on will ultimately lead to improvements to products and perhaps avoidance of the multimillion dollar lawsuit.  Finally, many online comments are made anonymously (or untraceably), and anonymous reports are not reportable.

Healthcare organizations are concerned about medical malpractice liability as well.  Again, disclaimers are the order of the day.  While one can conduct a physician-patient relationship online, best practice would be to initiate the relationship in real life, and obtain appropriate authorization from the patient to continue the dialogue on line.  Some folks are more open than others, and are willing to post details about themselves that others consider private.  If someone posts these details in a public forum, that constitutes consent to the disclosure itself.  A provider's response, however, should be more circumspect, absent a prior written authorization to communicate more publicly.

All organizations may be concerned about the public posting of derogatory or defamatory opinions or information about employees, administrators, patients.  My take: policies and procedures should be in place regarding the making or circulating of such statements in whatever form or forum: real life, web 1.0, web 2.0.  The social web does not always require the creation of new rules of the road; often, it requires a re-examination of organizational culture and approach in other contexts, and those approaches may then be extended into the web 2.0 environment.
  • Regulation.  I used the FDA's warning letter to General Mills about its marketing of Cheerios as a cholesterol-fighting drug as an example of the need to be flexible in anticipating the unexpected: the regulatory salvo fired across the bow with no warning, the issue coming at you out of left field.  Privacy and liability concerns seems to cover the waterfront of regulatory concerns right now, but other issues are likely to arise over time.
  • Flexibility.  There was consensus around the table that it is difficult, if not impossible, to establish a social media policy in a vacuum, and that it is paralyzing to think that one may not begin to allocate resources to the effort without putting such policies in place up front.  My take:  Social media strategy is a journey, not a destination.  There will be many mid-course corrections.  My main piece of advice to the social media practitioners around the table: talk to legal early and often, so that you don't find yourself too far down a path that turns out to be a legal or regulatory dead end.

My discussion notes (linked to above) include links to other posts of mine on social media topics.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 09, 2009

Large molecules, biosimilars, patent protection, and the cost of health care reform

As may be expected, interested parties are hard at work in our nation's capital lobbying key health care committee members and their staffs.  Today I want to share a small window into this usually closed-off world, informed in part by a conference call with a handful of bloggers yesterday, hosted by Jim Greenwood, President of BIO, the biotech industry association.

"Large molecule" biotech compounds used as next generation drugs for a whole range of diseases and conditions do not get the same sort of patent protection as "small molecule" drugs.  Small molecule drugs start the patent and FDA new drug application (NDA) process at the same time, with the usual effect that FDA approval for a new drug comes about 7 years after an initial application, thus giving the patent holder about 12 or 13 years of patent-protected time on the market before generic manufacturers can horn in.  Large molecules are not patented directly; the processes by which they are generated are.  Thus, a competitor may develop a means to generate a "biosimilar" -- a large molecule that has the same therapeutic effect as the original, even though its production and chemical formulation are not identical -- and market it without infringing on the innovator's patent.  The key to being able to do so is the ability to rely on the innovator's study data as part of its NDA.  The key to the innovator's ability to have the market to itself for the equivalent of the term of a patent in the small molecule world is a period of "data exclusivity" (when others can't use its data for their own applications regarding biosimilars) equal to the effective term of patent protection: 12 or 13 years.

Greenwood said yesterday that Peter Orszag and Nancy-Ann Min DeParle have suggested that 7 years' data exclusivity should be sufficient, and that the FTC opposes any data exclusivity.  Legislation filed in the last session supported by BIO would have provided 12 years of data exclusivity.  The Senate HELP bill provides for 9 years of data exclusivity, with the opportunity to get a 3-year extension in the case of a novel use for the product. 

While the arguments made by industry are reasonable, the issue must be placed in context.  Drugs and biologics, while undeniably a key component of our current health care system, have contributed greatly to the runaway cost inflation we have seen.  The proposed 21.5% cut to the Medicare Physician Fee Schedule -- the prospect of which horrifies not only physicians, but those of us who may ever want to obtain physician services in the future -- may be tempered by carving out physician-office-administered medications, which include some of the large molecule compounds at issue (an $87.5B line item, over 10 years).  Taking this expense out of the physician pot means it has to be dropped back in somewhere else; I mention this because it's an issue at the forefront of the debate, and the price tag (which is not the whole price tag for drugs and biologics) is a big number, which has the attention of policymakers.  The total annual cost of biologics has been pegged at $60B.  While the industry rightfully wants large molecule protection equivalent to small molecule protection, the public and the government are rightfully concerned about the ultimate cost of such protection, and are seeking an appropriate balance.

The lobbying on this and many other provisions continues in the Senate HELP Committee and other committees.  Many compromises lie ahead.

Update 7/16/09:  The Senate HELP Committee bill was reported out with 12 years of protection.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

April 06, 2009

CVS and Google Health: adding lots of prescription data to PHRs

Users of Google Health can now import their CVS prescription data into their PHRs.  Not the first pharmacy to hook up with Google Health, but perhaps the largest.  The more info there is in a PHR, the better; incomplete records only lead to misinformation or lack of information, and when we're talking about prescription medications, that can lead to unfortunate interactions and an additional burden of illness.  Until human nature and the medical-industrial complex can both be sufficiently tweaked to yield more rationality most of the time, the aggregation and sharing of data in this fashion (if it can be done in a comprehensive, secure, and auditable manner since, after all, we don't trust people to remember what color their pills are and report accurately to a string of docs and pharmacists, much less to update their own prescription drug data on line) is, on balance, a positive development.  Google Health does not have access to all pharmacy data in the country yet, but give them time, and they will. 

TechCrunch recognizes that privacy issues abound here, as they do for the rest of Google Health.  For me, these issues are heightened by the fact that, as far as I know, Google still insists that it is beyond the reach of HIPAA and the ARRA/HITECH son-of-HIPAA provisions.  For me (as for most), these risks may well be outweighed by the benefits.  (I think my medical records are of less interest to inquiring minds than those of Britney Spears or the "octomom" -- but I recognize the concerns of folks with medical conditions that info on chronic conditions may get into the wrong hands/be used inappropriately, e.g., for employemnt decisions, though I think the solution to that problem should be in improvements to employment discrimination law.)

The privacy nuts and technophobes out there won't sign up for this service, despite the (mostly) good privacy track record of the financial industry; at the other end of the spectrum, the early adopters are already all over this.  My expectation is that general adoption is going to depend more on easy porting of medical records beyond prescription histories.  As e-Patient Dave so vividly demonstrated recently, unfortunately, we're not quite ready for prime time in that department.  The porting may work, but the data that gets ported may or may not be accurate and up to date.  I'd be interested in learning more about the accuracy of the data that gets imported to the Google Health from the various pharmacy systems before being willing to rely on this system as an improvement over the status quo.

A tip of the hat to Richard Dale, the Venture Cyclist, for pointing me to the TechCrunch post today.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

March 19, 2009

Health Wonk Review: Spring has just about sprung

Michaels S C Welcome to Health Wonk Review, where everyone is above average.  We enjoy above-average health care costs per capita, above-average uninsured rates, and above-average obsession with health care reform.  That's what it's like today in America.  Our president has said, Change has come to America.  In the words of Robert Hayden's [American Journal]:

america     as much a problem in metaphysics as
it is a nation earthly entity an iota in our
galaxy     an organism that changes even as i
examine it     fact and fantasy never twice the
same     so many variables

Like Schrodinger's cat, America's health care system seems to change in the changing light as we examine it; one thing we can all agree on is that it needs some work. 

Franz Kline Steve Martin We begin with some broad brush strokes on form and amount of spending:

Len Nichols presents HEALTH REFORM: Moving Past the Impasse on the Public Plan | New America Blogs posted at New Health Dialogue

Maggie Mahar presents Health Beat: Thinking About Dr. Atul Gawande’s Congressional Testimony Part 1: Why Health Care Reform Will Require Additional Spending at Health Beat.

Lewis Hine Mechanic One cost, no matter what the payment system, is labor.  Lynn Nicholas, President of the Massachusetts Hospital Association writes about some pending changes to labor laws that might make it easier for labor to unionize, presenting the favored position of a non-union shop as one of worker, rather than employer, preference.  See Keeping Communication Lines Open in the Healthcare Labor Debate at CommonHealth, the Massachusetts health care reform blog of WBUR (a Boston NPR affiliate).

Who Will Pay for Prescription Drugs? asks Adam Fein at Drug Channels. CMS projections show that the government will have a very strong hand in managing retail drug spending and shaping the future of drug channels.  How will that affect pricing and R&D?  Richard Fogoros (DrRich) presents A Brilliant Plan For Preserving Pharmaceutical Progress at The Covert Rationing Blog, saying, The title says it all. Can we have our cake (drug price controls) and eat it too (continue drug innovation)? DrRich says, yes we can!  Check out his proposal.

Pills My dad used to say he wanted to listen to a radio station that broadcast only good news (not Good News, just good news).  Merrill Goozner, of GoozNews, suggests this week that there ought to be a journal dedicated solely to publishing negative results -- as soon as they're known -- as he is all hopped up due to delayed publication and/or suppression of data on adverse effects of drugs.  These issues in general, and a couple of current cases he discusses, have policy implications for the new leadership at the FDA.

At InsureBlog, Mike Feehan has a piece on Wellpoint's recent spinning off of its in-house PBM, About Wellpoint's PBM Auction, and future implications for prescription costs.


Ill and Uninsured in Illinois gives us a simple but eloquent presentation of the difficulty of accessing specialty care while uninsured: The Wait for Cook County Health Care.

At the other end of the spectrum, Health Access WeBlog's Beth Capell asks What are gold-plated benefits anyway? An interesting question, now that the president has indicated that he is open to signing a bill including taxation of health benefits.  (As an aside, Obama's approach -- White House Health Care Summit with stunning transparency, concluded with an invitation to Congress to send him a bill consistent with the policies he articulated throughout the campaign -- is both a refreshing change from the Clinton years and a strategy likely to insulate him from criticism on the exact contours of the plan when it reaches his desk.)

Mao_tse_tungJared Rhoads presents Less government, not more at The Lucidicus Project, discussing the recent report by Physicians for a National Health Plan (the single payor proponents).  I spoke with PNHP's David Himmelstein a little while back, and while he has a compelling argument for adopting a single-payor plan in this country (the savings would be impressive), I still believe that the more pragmatic approach is to make incremental changes in the system before us. 

Taking our cue from Dr. Himmelstein, we begin a bit of a grand tour by visiting our neighbor to the north. 

North of the border, Sam Solomon asks Can Canadian doctors fire their patients? at Canadian Medicine, and says in short, yes, but carefully.

At BNET Healthcare, Ken Terry writes that Massachusetts Needs to Deal With Primary Care Crisis, saying that while proponents of the healthcare reform program in Massachusetts tout it as a model for the entire country, and detractors point to the program's rapidly rising costs, neither side is really focusing on the need for better access to primary care in the state. He also observes that retail clinics are expanding in Massachusetts, and community health centers are pulling in federal cash for expansion.  One observation: retail clinics in Massachusetts are not currently expanding as they cannot find nurse pratitioners to hire.  Also, on a national level, Minute Clinic recently shuttered 90 sites for the season.  Even if they were growing, they are no substitute for primary care.

Looking at a new model of physician practice -- available 24/7, untethered to most of the traditional trappings of a physician practice (including that old-fashioned trope of accepting insurance payments), Ted Eytan, MD is Now Reading: Take Two Aspirin And Tweet Me In The Morning: How Twitter, Facebook, And Other Social Media Are Reshaping Health Care.

Great_Dictator_globe_scene_academy_print_bigGrrlScientist shares her overseas medicine story, Finnish Emergency Medicine: One American's Experience at Living the Scientific Life.  Seemed to work well for her without instantaneous contact back home.  (See my own tale of a close ecounter with an overseas health care system last year as well.)

Here at HealthBlawg, I recently interviewed the CEO of Satori World Medical, a medical tourism company that offers a twist: through an HRA, it funds patients' future years' insurance premiums with a portion of the savings their employers or insurers enjoy as a result of their overseas medical procedures.

Closer to home, many doctors are now leery of online ratings sites, and have started using a service, Medical Justice, to get patients to agree not to post negative reviews as a condition of being taken on as patients.  Dmitriy at Trusted.MD has been following this issue for a while and offers some insights.

Marx Brothers (A Day at the Races)_04_scrubbed_in Jaan Sidorov presents The Worrisome Outpatient Trend: What Does Disease Management Have to Offer? posted at Disease Management Care Blog.  Chronic care consumes 75% of the health care dollar in this country, and needs to be better managed.  Outpatient chronic care is a significant part of the equation.

Care management is also the theme of Julie Ferguson's post on The effect of obesity and other comorbidities on workers comp at Workers' Comp Insider.  In light of a new report which shows that workers comp medical claims can cost three times as much when the injured employee is obese, she makes the case for breaking down the silos between employer-based occupational health and general health programs.

David Williams' post on Wal-Mart and eClinicalWorks over at Health Business Blog concludes with a healthy bit of skepticism about this new EHR offering to small physician practices.

Using the cost per doc put out by Wal-Mart, John Moore does some calculations, and shows in his post The HITECH Challenge: Is $19B Enough to Drive HIT Adoption at Chilmark Research that docs getting wired and getting HITECH incentive dollars will be engaged in a money-losing proposition -- they'd actually be better off financially not implementing EHRs and getting hit with the penalty a few years down the road. 

Speaking of Wal-Mart, it bears mentioning that this day in history marks the anniversary of the Civil War Battle of Bentonville (No, not that Bentonville; the battle was in North Carolina.)

Tinker Ready, at Boston Health News, shares some insights from John Glaser, CIO of Partners Healthcare, on getting HIT right.

Shahid N. Shah presents Client/Server vs. ASP/Web-Based in Healthcare IT posted at The Healthcare IT Guy, since with the HITECH Act and stimulus bill making news, many users are asking if they should purchase software and use it on premises or if they should use a "cloud" package or an ASP/web-based solution.

Metropolis5 In addition to jump-starting HIT, current legislation is giving a boost to research funding.  One pot of funds is time-limited; Glenn Laffel looks at Beaker Ready projects ready for NIH funding at Pizaazz.

Jason Shafrin reviews some of the pros and cons of establishing a government body to conduct cost effectiveness research in Should the U.S. get NICE? at Healthcare Economist.

In The Color of Money: What Sort of School Doesn't Pay Its Faculty to Teach? Roy Poses at Health Care Renewal puts academic medicine on the spot, saying that some leaders have abandoned core missions in favor of collecting "taxes" from medical faculty, which makes faculty more dependent on commercial interests.  Strong words indeed, and an issue that needs to be rolled out front and center together with other payment issues if there is to be a wholesale revamping of health care financing in this country.

For those brave enough to enter the land of credit default swaps, Joe Paduda, at Managed Care Matters, examines the reasons for propping up AIG and why it may fail anyway.

And finally, to leave you with some doom and gloom from The Health Care Blog to ponder, Brian Klepper and David Kibbe ask Is the healthcare economy rightsizing?

Thanks for visiting HealthBlawg for this edition.  Please see me on twitter too, and join us again next time for Health Wonk Review.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting