Physician Payments Sunshine Act of 2009

Interesting bill introduced in the 111th Congress (SB 301) by Mr. Grassley.  After recent settlements involving Medtronics and then a host of other medical device manufacturers in late 2007 (Johnson & Johnson subsidiary DePuy Orthopaedics, Zimmer, Biomet and Smith & Nephew) who provided lavish trips and sometimes sham consulting and IP royalty payments to physicians allegedly to induce their ordering of the firms’ devices, the Congress is considering forcing pharma and medical device manufacturers to disclose all financial arrangements with physicians and medical groups greater than $100/year.  The financial arrangements would be posted in a manner that would be accessible to the public.  Failure to disclose would subject the companies to up to $150,000 (if innocent) or $1m Civil Monetary Pentalties if knowingly.  It is of note that disclosure was used by the OIG in the deferred prosecution agreements with these companies.   See, for example, Zimmer’s home page at www.zimmer.com.

Search Results – THOMAS (Library of Congress).

Filed under: AKS, CMP, Conflicts of Interest, Health Law, AKS, CMP, Conflicts of Interest, Economics, Health Law

30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com

The Cleveland Plain Dealer reports on March 27, 2009:

A federal judge on Friday sentenced the founder of a failed health-care financing company to 30 years in prison for his role as “puppet master” in what prosecutors called the biggest fraud on record at a privately held company in the United States.*** National Century offered financing to small hospitals, nursing homes and other health-care providers by purchasing their accounts receivable, usually for 80 or 90 cents on the dollar, so they wouldn’t have to wait for insurance payments. National Century then collected the full amount of the payments. The company raised the money to fund its business by selling bonds to investors. Prosecutors said National Century executives authorized millions in unsecured loans to health-care providers, then misled investors about the loans.  As the money owed to the company mounted, National Century declared bankruptcy in November 2002 after the FBI raided its offices. Since then, at least nine former executives have been convicted of corporate fraud. The government originally alleged proceeds of the fraud topped $1.9 billion, a figure Squires said Friday had been reduced to $1.7 billion. He said investors’ total losses were around $2.8 billion. At its height the company employed more than 300 people, most of them in the Columbus area. Executives made millions, with Poulsen alone earning more than $9.1 million between 1996 and 2002, according to the government.

via 30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com.

Filed under: Fraud and Abuse, Health Law, Risk Management, Economics, Health Law

Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ

In its Health Blog, the WSJ reports on March 25, 2009:

GlaxoSmithKline last year promised to publish payments to U.S. docs for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is expanding on its promise.For clinical trials starting in 2010 and after, Glaxo said yesterday it will publicly report the money it pays U.S. doctors and their institutions to carry out the studies*** Disclosing more and more about payments to health-care professionals is a trend du jour in the industry. The list of drug companies and device makers that have said they’ll start reporting payments to docs includes Pfizer, Eli Lilly, Merck and Medtronic. Exactly what payments get reported varies from company to company.  All those self-imposed reporting plans could soon be moot. The Physician Payment Sunshine Act, which has been kicking around for a while, would create national rules for what payments drug and device makers have to publicly disclose.

via Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ.

Filed under: AKS, Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Conflicts of Interest, Economics, Health Law

Doctor’s (Gag) Orders : NPR

On the Talk of the Nation, March 24, 2009 (which you can download as a podcast or listen to on the link below), TOTN discusses the emerging trend of consumer driven web reviews of doctors.  Dr. Jeffrey Segal, CEO and founder of Medical Justice, talks about this trend and efforts of some providers of having patient sign waivers agreeing not to participate in them (or otherwise limiting what they say on them).  I had, a few years back, a limited experience with this.  A patient of a physician client of mine had posted an inappropriate post on a general comercial review site.  The site was not focused on reviews of physicians.  After quickly reviewing the post and the terms of service of the site, I emailed the service provider, indicated that the poster was violating its terms of service, and the post was quickly removed.  I hear (but have not researched) that Angies list is now getting into the physician review game.  Wonder where this will lead.  via Doctor’s (Gag) Orders : NPR.

Filed under: Health Law, Quality Reporting, Economics, Health Law

Healthcare Economist · Can Health Care Reform Save the Economy?

In his Healthcare Economist blog, Jason Shafrin discusses the problems with the current healthcare insurance model in the United States.  By tying health insurance to employment, individuals may lack the mobility to take on new opportunities, including starting their own business.  I think that this is interesting.  We’re probably getting a double whammy.  This is a structural problem that has been with us for a long time.  But now, with real estate housing market deflation, people are a locked to a geography.  If they seek another employment opportunity out of their area they then have to sell their house, realizing the new post-market clearing price.  Link to a paper writtne by Jason Safrin and an Economist article.  Interesting reading.  (Yuck.)

via Healthcare Economist · Can Health Care Reform Save the Economy?.

Filed under: Health Law, Reform, Economics, Health Law

Insurers Offer to Soften a Key Rate-Setting Policy – NYTimes.com

In  the March 24, 2009 NYT:

In effect, insurers said they were willing to discard an element of their longstanding business model — pricing insurance policies, in part, on the basis of a person’s medical condition or history.

In the past, insurers have warned that if they could not consider a person’s health status in setting premiums, the rates charged to young, healthy people would need to soar. But they said Tuesday that they were exploring ideas to prevent such sharp increases by spreading the risk and costs broadly across a larger population, including the healthy and the unhealthy.

Insurers said they could accept more aggressive regulation not just of their premiums, but also of their benefits, underwriting practices and other activities. Such strict regulation, they said, would make it unnecessary to create a new public insurance program offered through the federal government.

via Insurers Offer to Soften a Key Rate-Setting Policy – NYTimes.com.

Filed under: Health Law, Reform, Economics, Health Law, The Great Recession

Many Concerns About Health Insurance for All – NYTimes.com

The March 24, 2009 NYT reports:

[The Obama administration has been floating the possibility of a F]ederal, Medicare-like insurance plan to anyone, at any age…And let commercial insurers offer their private health plans alongside it. ***[T]he insurance industry and others wary of too much government intervention vehemently oppose the idea. They say the heavy hand of the government will eventually push out the private insurers, leaving the government option as the only option. *** [T]he details of a federal insurance plan remain vague, a central question is whether it would function like Medicare — wielding the government’s size and clout t to essentially dictate the prices it pays for medical care.  The main selling point for a government-run program would be its low cost.  It would have a much lower overhead than private plans, with no need to make a profit or spend money on marketing or brokers’ commissions. And, if allowed to flex its muscle, the government would buy medical care at much lower prices. *** Karen Davis, the president of the Commonwealth Fund,…estimates the average premium for a family of four would run around $9,000 a year under a public plan, in contrast to nearly $11,000 for a typical private alternative.***[M]any hospital executives object strenuously to the idea of a new program that would behave like Medicare. “Medicare has systematically been underpaying for services,” said Dr. Denis A. Cortese, the chief executive of the Mayo Clinic, the highly regarded health system in Minnesota. If more patients are enrolled in a Medicare-like program, he predicted, “your very best providers will go out of business” or stop seeing patients covered by the government plan.***Some policy experts say a compromise can be struck. They advocate a public plan that would be required to negotiate with doctors and hospitals on a level playing field with commercial insurers, rather than have the government set prices à la Medicare.

via Many Concerns About Health Insurance for All – NYTimes.com.

Filed under: Health Law, Reform, Economics, Health Law, The Great Recession

Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com

The March 25, 2009 NYT reports:

[T]he American Psychiatric Association announced on Wednesday that it would end industry-financed medical seminars at its annual meeting. ***The association, the field’s premier organization, said it would also phase out meals at the meeting paid for with industry money. ***The association has been reviewing the income it received from industry sources since early 2008, Dr. Stotland said, looking for potential conflicts. Since then, Congressional investigators, led by Senator Charles E. Grassley, Republican of Iowa, have found that several prominent psychiatrists who received hundreds of thousands to more than $1 million from drug makers did not report that income to their employers, as required by federal and most academic rules. ***The psychiatric association said it had no plans to eliminate drug advertisements in its journals, commercial exhibits at meetings, or industry-sponsored fellowships for doctors.

via Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Health Law, Conflicts of, Conflicts of Interest, Economics, Health Law

An Overseer of Medical Trials Comes Under Fire – NYTimes.com

The NYT reports:

“The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist. *** The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast. ***Over a five-year period, Coast reviewed 356 study proposals and rejected only one[.] *** In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation.***In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O. ***In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

via An Overseer of Medical Trials Comes Under Fire – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, Conflicts, Conflicts of Interest, Economics, Health Law

Coming Soon: Comparative Effectiveness Research for Biotech – Health Blog – WSJ

WSJ Health Blog reports:

[T]he NIH has published a list of high-priority projects it wants to fund, providing a clearer picture of just how that money may be spent. The list — online here — suggests scrutiny for some of the best-selling drugs for heart conditions and asthma, among others. The NIH would fund research laying the groundwork “to study clinical and cost-effectiveness of biologics to determine the best therapy for individual patients.” This could include reviewing existing research or computer-based modeling of clinical trials to predict outcomes. Spokespeople for some of the manufacturers told Dow Jones Newswires they believe the drugs are cost-effective, citing the severity of the diseases and the drugs’ effectiveness at treating them***The NIH plans to give out about $400 million of the comparative-effectiveness funding to researchers at academic and other institutions over the next two years. That’s not nearly enough to support multiple large-scale clinical trials, but it could add a therapy to an ongoing trial, an NIH spokeswoman said, or support other methods of research like analyses of past trials.

Wonder how quickly the Stimulus money for Comparative Effectiveness Research will spend out?

See also an earlier WSJ article prior to passage of the Stimulus law.

via Coming Soon: Comparative Effectiveness Research for Biotech – Health Blog – WSJ.

Filed under: Comparative Effectiveness Rearch, Health Law, Reform, Economics, Health Law

Health Reform Dialogue Issues Recommendations – Health Blog – WSJ

The WSJ reports the publication of a “Health Reform Dialogue” issued a set of recommendations today aimed at governing the debate over restructuring health care.  The WSJ observed it was generally consistent with the “direction the Democrats are heading.”  Reviewing the short report, I find the following notable:

The ultimate public policy goal is to increase value for America’s health care consumers and the system as a whole, that is, the highest quality of care delivered in the most efficient manner possible: significantly improving treatment of chronic disease; researching the effectiveness of comparative treatments; paying for quality care, not quantity of care; providing relief for patients, clinicians, and providers caught up in the web of medical liability processes; encouraging public reporting of information that clarifies the performance of individual clinicians and providers; creating a robust health information technology infrastructure; and beginning to significantly transform the health care delivery system through some much-needed payment reforms.

They then discuss some of the efforts that can be undertaken to do this including advocating clinical effectiveness research studies, quality measures and strong HIT infrastructure support by the federal government.

As the WSJ blog notes, while this shows some common agreement and coordination among an impressive cadre of provider, business, hospital, insurance and other interest groups, the agreement ends at, and punts on some of the more difficult policy questions, such as insurance mandates.   I found the language subject to wide interpretation even on the areas of agreement.

In any event, these groups will all have a significant and important seat at the table when the scope, provisions and cost of healthcare reform is debated.

Health Reform Dialogue Issues Recommendations – Health Blog – WSJ.

Filed under: Reform, Economics, Finance, Health Law, Law

Who’s To Blame For The Financial Crisis? : NPR

I, for one, am beginning to loathe that I waste any of my time watching cable TV news and opinion programs.  The quality of the talking heads on MSNBC, Fox and CNN is (perhaps always was) in free fall.  I can, perhaps, tolerate Chris Mathews a bit; I terribly miss Tim Russert — but he mainly did his Meet the Press show rather than much specific to cable.  But I don’t realize most of the cable programs are just so much cotton candy until I hear real debate.

I most realize it when I actually listen to real, substantive, witty, thoughtful, hard, and fact laden debate.   Like the difference between a quality hard-wood cabinet maker and a rough carpenter.  Yeah, they both work with wood, but one’s a craftsman and the other, well, a day laborer.

Listen to this recent debate on NPR’s program Intelligence Squared.  I’ve not heard the full podcast quite yet.  I caught the last half of it airing this evening on my way home from work (far too late).   The debate – the proposition – “Blame Washington More Than Wall Street for the Financial Crisis” – was timely and really made me think.   The panel exchanged polite barbs (distinct from the often thoughtless vitriol of left/right pundits on cable programs), pushed their position with both factual support as well as comical retorts.  There’s a few great lines in this — the best that I heard was from John Steele Gordon who stated that

While Wall Street constantly needs reform…it does not need reform as much as Congress…Institutions tend to evolve in ways that benefit their elites … the poster child for this is [not Wall Street but] Congress…People lament that Wall Street took its checkbook down to Washington to get the regulation it wanted rather than have stricter regulation.  But Wall Street was not [in Washington] debauching a virgin, it was paying a harlot.

In the end, the position taken by Mr. Gordon and Niall Ferguson (for the proposition) won more of the audience’s change over vote.  They convinced me.  While there’s plenty of blame to go around, when systemic risks crashes down the house, those holding the reigns of the regulatory structure are ultimately accountable.   In any event, if you are following the debate concerning the financial crisis, you’ll want to hear this and see who convinces you.

via Who’s To Blame For The Financial Crisis? : NPR.

Filed under: Personal Posts, Conflicts of Interest, Economics, Fun, Podcasts, Public Policy, The Great Recession

AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News

In the March 23, 2009 AMA News, a consulting firm reports that the heyday of the pharma detailer may have already peaked and is headed into decline:  “At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates’ U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.”

According the article and the survey, fewer physicians are spending less time with the detailers.  More types of providers are requiring advance appointments.

The article and survey reports that “[p]hysicians’ openness toward visits by pharmaceutical company detailers varies by practice ownership and size.

	Refuse to see	Require appointments
Practice size
1 to 2 doctors	14.3%	32.5%
3 to 5	16.7%	36.1%
6 to 10	23.1%	45.0%
More than 10	44.0%	45.5%
Practice ownership
Non-hospital	22.1%	37.8%
Non-health system	22.3%	37.5%
Hospital	31.2%	44.6%
Health system	34.7%	52.0%

Source: “Physician Access: U.S. Physicians’ Availability to See Drug and Device Sales Reps,” SK&A Information Services Inc., released February”

The article also reports significant decreases in detailing staff.  “Experts estimate the U.S. pharmaceutical sales rep force eventually will be cut 25% from its 2007 peak of more than 100,000. Here are some of the biggest layoffs announced in the last year.

Drugmaker	Sales rep cuts
GlaxoSmithKline plc	1,800
Merck & Co. Inc.	1,200
Wyeth	1,200
Schering-Plough Corp.	1,000
Sanofi-Aventis	650

Source: News accounts”

via AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News.

Filed under: Conflicts of Interest, Health Law, Conflicts of Interest, Economics, Health, Health Law, Pharma, The Great Recession

Running a hospital: Final budget decisions

Running a hospital: Final budget decisions.

Running a hospital: Good progress in budget deliberations.

In his “Running a Hospital” blog, Paul Levy, CEO of Beth Israel Deaconess Medical Center in Boston, writes two particularly remarkable posts concerning the decision-making process leading to budgetary cuts in these lean times for his hospital.  The posts are note-worthy due to the steps taken, the transparency through which the cuts are communicated (effectively to the world), and what appears to be the level of buy-in generated by the hospital management, personnel and medical staff.

Mr. Levy also posts that the accolades he is receiving are misplaced.  The process and the values demonstrated by the budgetary cuts, according to him, are more a reflection of the hospital’s community, then necessarily, his leadership.  Of interest to me, he references, in current events, a quote (that I also took) from Thomas Friedman’s recent op-ed, although focuses this, again, more on the institution’s own values as merely reflected by leadership, rather than leadership instilling the leader’s values on the organization.  Truth is probably somewhere in between.  Very much worth a read.

Filed under: Health Law, Personal Posts, Economics, Friedman, Health, The Great Recession

Op-Ed Columnist – Are We Home Alone? – NYTimes.com

In his New York Time op ed, Thomas Friedman thinks our political leadership is acting immaturely.  He believes that we are missing the bigger picture by riding a populist rage over the financial sector bonuses, and no one in Washington is showing adult leadership.  “There don’t seem to be any adults at the top — nobody acting larger than the moment, nobody being impelled by anything deeper than the last news cycle.”  He sees Republicans focusing on the AIG bonuses in a non-constructive, opportunistic way, and asks if they think that their “party automatically wins if the country loses?”  In addition, he thinks that the misplaced urge to “villify” persons like Geither will only lead to “ensure that no capable person enlists in government.”

But more than this, he thinks that Mr. Obama missed an important opportunity.  “[Had ]Mr. Obama given A.I.G.’s American brokers a reputation to live up to, a great national mission to join, I’d bet anything we’d have gotten most of our money back voluntarily. Inspiring conduct has so much more of an impact than coercing it.”

I liked the following passage, which summarizes, in my view, a prominent failure in the financial sector’s culture:

‘There is nothing more powerful than inspirational leadership that unleashes principled behavior for a great cause,’ said Dov Seidman, the C.E.O. of LRN, which helps companies build ethical cultures, and the author of the book ‘How.’ What makes a company or a government ‘sustainable,’ he added, is not when it adds more coercive rules and regulations to control behaviors. ‘It is when its employees or citizens are propelled by values and principles to do the right things, no matter how difficult the situation,’ said Seidman. ‘Laws tell you what you can do. Values inspire in you what you should do. It’s a leader’s job to inspire in us those values.'”

Of course, all this populist outrage does not fix the current mess.  It’s the absence of a clear plan to address the banking crisis that has allowed “all kinds of lesser issues and clowns [to ]have ballooned in importance and only confused people in the vacuum.”  But the “big issue — the real issue — [is ]the president’s comprehensive plan to remove the toxic assets from our ailing banks, which is the key to our economic recovery,” not punishing corporate executives, even those that are clearly receiving obnoxious bonuses that they should not.

Personally, I’m not sure we would not, in any event, have these “lesser issues” and “clowns” coming to the fore and distracting the policy debate.  I think there is such a pervasive sense that things have gone very wrong, that I am personally hurting, that my neighbor or family member is ‘really hurting’ through loss of home, loss of employment, and, certainly, loss of retirement savings, that outrage is real.  Let’s hope some adults can focus this outrage in a constructive way to establish some sound policy fixes.  I do hope, as Friedman concludes, that a Geither plan will be out next week, it will be specific and thoughtful, and the “president will pull the country together behind it” because “our country, alas, is not too big to fail.”    Edit Post ‹ humani nil a me alienum puto — WordPress

via Op-Ed Columnist – Are We Home Alone? – NYTimes.com.

Filed under: Personal Posts, Economics, Friedman, Fun, Op Ed, Personal, The Great Recession

Op-Ed Columnist – Perverse Cosmic Myopia – NYTimes.com

“As a tiger sinks its teeth into the world’s neck, we focus on the dust bunnies under the bed…[Obama is trying to tackle the four most intransigent policy problems of our times and cannot address the immediate economic problem and the furor over the AIG bonuses]…risk[s] destroying the entire bank-rescue plan”

“[All this ]is not the most idiotic of the distractions…[A] core lesson of the Great Depression is that a global crisis calls for a global response…But the G-20 process is heading toward global impotence because the Europeans are dismissing this approach…The world is in flames and they want directorates and multilateral symposia…Many people used to wonder how the world’s leaders could be so myopic at various points in history — like during the Versailles Treaty or the turmoil of the 1930s. We don’t have to wonder any more. We get to watch the cosmic myopia replay itself in our own times.”

Filed under: Personal Posts, Brooks, Economics, Fun, New York Times, Op, Op Ed, Personal, The Great Recession