Showing posts with label Physician Sunshine Act. Show all posts
Showing posts with label Physician Sunshine Act. Show all posts

Proposed Rules for Physician Payment Sunshine Act: Some Clouds on the Horizon

The Centers for Medicare and Medicaid Services (CMS) released their proposed rule for the Physician Payment Sunshine provision of the Affordable Care Act (see "CMS Releases Proposed Physician Sunshine Act Regulations", where you can also download the proposed rule). Because CMS was late issuing this rule, the drug industry will NOT have to begin data collection on Jan. 1, 2012, as "required" by the Sunshine provision, and will not need to begin data collection until final regulations are issued. Final regulations come AFTER comments on the proposed rule are accepted through Feb. 17, 2012.

That means that only PART of the 2012 payments may be submitted on Mar. 31, 2013 and available for public scrutiny by Sep. 30, 2013.

It's possible, however, that CMS may be further delayed if the comments received are plentiful and difficult to respond to before the agency issues the final rule.

Of course, pharma companies by now should be ready to begin data collection by January 1, 2012. Which means that they could theoretically submit a full year's (2012) worth of data regardless of the timing of the final rule. CMS said "we recognize that some manufacturers and GPOs may begin to collect certain data voluntarily." How many companies, however, will do this when they can claim they were waiting for CMS? It's just another test of willingness of the industry to be pro-actively transparent and open.

Also, CMS is seeking comments "on the amount of time applicable manufacturers and applicable GPOs will need following publication of the final rule in order to begin complying with the data collection requirements." I anticipate that many comments might cite CMS's estimate of 90 days to be too little and request more time. Thus, we may not see any 2012 data at all!

CMS's Tardiness in Issuing Sunshine Act Rule May Mean We'll See No 2012 Data!
"Finally," says CMS, we also seek input on specific challenges that applicable manufacturers and applicable GPOs may face when setting up the necessary data collection and reporting systems."

This is the Achilles' Heel that may mean that we will not see any 2012 data at all! If drug and device companies cite significant challenges that CMS's final rule must mitigate, that could delay issuance of the final rule or significantly limit how the information is reported. The industry may claim, for example, that it is "challenged" to breakdown payments into specific categories and ask that payments be lumped into larger, more encompassing categories. This would make it more difficult to analyze the data to see exactly what physicians are being paid to do, especially research versus marketing assistance.

Here are some other tidbits from CMS's proposed rule:

Foreign Drug Companies Must Also Report Payments
CMS proposes that any drug or device company that sells or markets products in the U.S. are subject to the rule regardless of where their corporate headquarters are located. Thus, says CMS, "Under this definition, manufacturers of a covered drug, device, biological, or medical supply are deemed to be an 'applicable manufacturer' if their products are sold or distributed in the United States (U.S.), regardless of where the covered drug, device, biological, or medical supply is actually produced or where the entity is actually located or incorporated... The opportunity for undue influence or inappropriate relationships caused by payments or transfers of value to covered recipients is the same for manufacturers of drugs, devices, biologicals, or medical supplies sold or distributed in the United States regardless of where the product is actually manufactured, and we, therefore, propose to treat them the same."

"Common Ownership" Loophole Closed
CMS wants to be sure that a wholly or even partially owned subsidiary of a drug or device company set up to dole out payments to physicians cannot escape the regulation. Such companies under "common ownership" -- as when "the same individual, individuals, entity, or entities, directly or indirectly, own any portion of two or more entities" -- "are also subject to the reporting requirements under this provision, even though they themselves may not be involved in the "manufacturing" process." CMS is seeking comments regarding its definition of "common ownership" to see if changes are necessary.

OTC Drug Manufacturers Excluded
CMS's proposed rule excludes manufacturers/marketers of drugs and biologicals that are considered "over-the-counter" (OTC) from being covered by the regulations. "We believe that this exclusion may be appropriate for manufacturers that manufacture only these products (and not also products which fall within the proposed definition of 'covered drug, device, biological, or medical supply'), since physicians and teaching hospitals have less influence over patients' choice of OTC products."

Perhaps physicians have less influence over patients' choice of OTC products, but they surely play a role in Rx-to-OTC conversions. They sit on FDA advisory boards, for example, which determine if an Rx drug can be sold OTC.

Identifying "Covered Physicians"
There is some confusion on how to uniquely identify physicians. There are more than one "unique identifier" for physicians. The law refers to a National Provider Identifier (NPI) number, which is required under HIPAA.

CMS states "We seek comments on what other unique identifiers could be used, including whether these unique identifiers are readily obtainable by applicable manufacturers."

CMS is also closing a loophole I noticed in data already being reported by some drug companies; ie, certain payments are reported to be made to institutions or organizations rather than to individual physicians. CMS proposes that "payments or other transfers of value provided through a group or practice should be reported individually under the name(s) of the physician covered recipient(s)."

Categories of Information to be Reported
This is probably the most important issue that needs clarification. CMS provides details of how data such as names, addresses, medical specialty, date of payment, etc. are to be reported.

Name of Drug: The Sunshine Law requires that manufacturers to report the name of the covered drug, device, biological, or medical supply associated with that payment, if the payment is related to "marketing, education, or research" of a particular covered drug, device, biological, or medical supply.

"In cases when a payment or other transfer of value is reasonably associated with a specific drug, device, biological, or medical supply, the name of the specific product must be reported," says CMS. "For example, if a sales representative takes a physician to dinner to explain the benefits of the applicable manufacturer's new product, the name of the product must be included since it was associated with the dinner."

The Multiple Drug Conundrum
If the payment relates to multiple drugs, only one drug needs to be named. CMS, however, does not mention how the named drug should be chosen.

As an alternative, however, CMS is considering "allowing applicable manufacturers to report multiple covered drugs, devices, biologicals, or medical supplies as related to a single payment or other transfer of value. Allowing the reporting of multiple covered drugs, devices, biologicals and medical supplies may be easier for applicable manufacturers since many financial relationships are not specific to one product only, but would make aggregating payments by product difficult. We seek comment on this approach."

I'm betting the drug industry would prefer the one-drug naming approach where they have the option to name the drug of choice. This could make it difficult to link specific payments to specific drugs or assign payments to specific drugs to "even out" the distribution, Say, for example, that a sales rep is responsible for promoting 2 drugs at a dinner meeting, but is given a physician payment budget that apportions 80% to just drug A. The total budget could be reported under drug B, thus diverting attention away from drug A. I think you get what I mean!

Nature of Payment - Nondisclosure of Assumptions Make an Ass Out You and Me!
This is important. The Sunshine Act lists the following categories of payment:
  • Consulting fees. 
  • Compensation for services other than consulting. 
  • Honoraria. 
  • Gift. 
  • Entertainment. 
  • Food. 
  • Travel (including the specified destinations). 
  • Education. 
  • Research. 
  • Charitable contribution. 
  • Royalty or license. 
  • Current or prospective ownership or investment interest. 
  • Direct compensation for serving as faculty or as a speaker for a medical education program. 
  • Grant. 
  • Any other nature of the payment or other transfer of value (as defined by the Secretary).
CMS suggests that manufacturers explain the reasoning behind how they categorize payments (in a mandatory "assumptions document") since there may be significant differences among manufacturers on this issue. However, CMS will NOT make these"assumption documents" public because "they may contain information applicable manufacturers would consider proprietary."

That's a pretty big "transparency loophole," IMHO. Although CMS will monitor the assumptions, there is no way for the public to monitor CMS! The drug industry can be free to define these categories as it sees fit and not run into trouble unless different companies use wildly different assumptions and raise red flags at CMS. Also, the politically-appointed HHS Secretary may overrule the CMS as she did with the FDA!

Also, the CMS is seeking comments on whether or not the "assumption document" submission should be mandatory or voluntary! I can only guess what industry's comments will be about that!

One Category for ALL Speakers' Fees
CMS does, however, specify how manufacturers should interpret "Direct compensation for serving as faculty or as a speaker for a medical education program." CMS proposes that this category be "interpreted broadly to encompass all instances in which applicable manufacturers pay physicians to serve as speakers, and not just those situations involving 'medical education programs.'"

Under that rule, accredited CME programs would be lumped in with all other speaking activities, such as satellite symposia.

"We are considering, and welcome comments on, whether to limit this category to CME-accredited speaking engagements and report other speaking engagements in another category, such as compensation for services other than consulting, or additional category."

I anticipate a lot of comments on this issue will be submitted.

There are many more proposed rules in the CMS document, which runs to 121 pages! I have gotten only as far as page 34 in this summary. I hope to publish a more complete summary with comments from experts in an upcoming issue of Pharma Marketing News (subscription required).

I invite you to submit comments to this post.

Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year

The pharmaceutical industry has been very generous in making payments to physicians. Last year (2010), for example, a mere dozen pharmaceutical companies paid $760 million to physicians and other health care providers for consulting, speaking, research and expenses, according to ProPublica's "Dollars for Docs" project. ProPublica has taken "translucent" -- ie, difficult to analyze -- data reported by pharmaceutical companies and created a single database that makes comparisons simple (see here).

The database contains information about payments made to about 500,000 doctors. That's about half of ALL doctors in the US (including Peurto Rico). That works out to about $1,520 per doctor (or about $760 per EVERY doctor in the US), on average.

Of course, some doctors were paid MUCH more than this -- eg, pain specialist Gerald M. Sacks raked in $270,825 from Pfizer, Johnson & Johnson, Lilly and Cephalon in 2010, up from $225,575 in 2009. And some doctors received only $50 for lunch. At least 20 doctors, however, received "meals worth $2000 or more from Pfizer between July 2009 and March of this year," said ProPublica reporter Charles Ornstein.

According to the ProPublica database, Pfizer paid my doctor -- Catherine Spratt-Turner -- $388 for meals and $1,500 for speaking in 2010. This worries me because she wants me to come in and discuss my high cholesterol. Apparently, generic pravastatin is not doing the job and I suspect she wants to switch me to another anti-cholesterol medication. Will she suggest Pfizer's LIPITOR? I'll let you know when I see her. Previously, she was hot to get me on AstraZeneca's CRESTOR, which I resisted because of its published side effects. BTW, Spratt-Turner did NOT get any money from AZ last year.

This is exactly what worries some physicians who receive payments from pharmaceutical companies. As more and more searchable data becomes easily available to the public, they fear that patients will rebel and resist their advice if it appears that payments are influencing that advice. Oh, well! Welcome to the social media age!

The table above shows physician payments made by some pharma companies compared to sales. Surprisingly, Lilly spent about 2 times as much as did Pfizer despite having only about half Pfizer's sales volume. Perhaps Pfizer is more efficient than Lilly in targeting influential physicians? Nah! Viagra sales don't need much physician goosing to prescribe, whereas Lilly's Cialis needs as much help as money can buy. [I suspect, however, from the fees paid to pain docs like Dr Sacks, that Lilly is more concerned with promoting Cymbalta for pain.]

Overall, it appears that pharma companies tend to spread payments among physicians such that there is a more or less direct correlation between the number of physicians in a state and the amount of payments made to physicians in that state (see chart below).


Of course, $760 (or $1,520) per every physician is not going to improve a physician's lifestyle very much (although I am sure YOU and I would be happy to have an extra thou to spend every year!).

No, this money is central to what I call pharma's "prescribing recovery act" designed to grease the drug prescribing economy.

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

Mass General & Harvard Not Transparent About Cause of Docs' "Honest Mistakes"

Harvard Medical School and Massachusetts General Hospital (MGH) have disciplined three faculty members as part of a conflict-of-interest (COI) case, which was "a prime exhibit in the debate over the federal Physician Payments Sunshine Act of 2010," reports NPR Health Blog (see "Harvard Punishes 3 Psychiatrists Over Undisclosed Industry Pay").

Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens -- faculty members at Harvard Medical School -- were accused of accepting more than $4.2 million from drug companies for psychiatric research and other activities between 2000-2007 without reporting the income to Harvard, MGH or the federal government, according to NPR blog.

In their "Dear Colleagues" letter sent on Friday just before the 4th of July holiday weekend -- when not many of their colleagues would be in town -- the docs said it was an "honest mistake" (find their letter here).

The offending physicians -- one of whom (Biederman) is a "leading proponent of the off-label use of antipsychotic drugs to treat bipolar illness in children" -- claim they should have spent "more time and attention to the detailed requirements of these [COI] policies and to their underlying objectives."

It seems that a lot of doctors and medical schools make these "honest mistakes."

I reported previously that when it comes to enforcing COI policies, universities have "allowed permissive interpretations and relied on the honor system," said the authors of a ProPublica article. ProPublica’s review shows many physicians are in apparent violation of policies, and "ignorance or confusion about the rules is widespread" (see "Medical Schools Don't Ask & Faculty Don't Tell If They Violate Ban on Paid Pharma Speaking Gigs").

A commenter to the NPR blog post said "They were 'mistaken' for a seven-year period...then that's how long they should be barred from such activities." In fact, Harvard and MGH barred the three physicians from accepting payments for "all paid industry-sponsor outside activities" for only one year.

NPR said "Harvard and the MGH didn't allow much sunshine in on the outcome of its lengthy investigation of the case." Such sunshine might reveal what contributed to the 7-year "mistake" regarding compliance with the COI policies. Perhaps the policies themselves need investigation?

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

Medical Schools Don't Ask & Faculty Don't Tell If They Violate Ban on Paid Pharma Speaking Gigs

ProPublica -- the non-profit newsroom that produces investigative journalism in the public interest and which received a Pulitzer Prize for investigative reporting -- recently published a story revealing that physicians from Stanford, Penn and the Universities of Pittsburgh and Colorado Denver have faculty members who have accepted money to promote drugs despite the fact that these universities have conflict of interest policies that restrict their doctors from accepting pharma money (see "Medical Schools Don't Verify Faculty Compliance with Ban on Pharma Speaker Fees").

This is just the latest revelation made possible by comparing names in ProPublica’s Dollars for Docs database of payments publicly reported by seven drug companies with names of faculty members at a dozen medical schools and teaching hospitals.

Here's an example:
The University of Pennsylvania health system’s 2006 policy states that faculty “should not participate in industry marketing activities.” Penn’s chief medical officer, Dr. P.J. Brennan, said he interprets that to prohibit delivering drug company lectures.

“It flies in the face of what a professional ought to be,” he said.

ProPublica found 20 Penn speakers in its database. Five, including one who left Penn last month, made more than $40,000.

The top paid, according to Dollars for Docs, was Dr. Corey Langer, director of thoracic oncology at Penn’s Abramson Cancer Center. He received nearly $70,000 speaking for Lilly since 2009.

Langer also received unknown amounts from other companies, including Genentech Inc., OSI Pharmaceuticals Inc., Bristol-Myers Squibb Co. and ImClone Systems, according to his disclosure for a medical education program this month.

In an e-mail, Langer said he was “now fully aware” of Penn’s policy and is “taking measures to curtail speaking for pharmaceutical companies.”
"When it comes to enforcing the policies, universities have allowed permissive interpretations and relied on the honor system," said the authors of the article. "ProPublica’s review shows that approach isn’t working: Many physicians are in apparent violation, and ignorance or confusion about the rules is widespread."

Several physicians claimed they didn't know they were in violation of their school's policies. This is similar to what you might say to a cop after being caught running a late-night blinking red stop light.

“For God’s sake, if the media can look at these websites, why can’t we?” said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Why trust if you can verify?”

But it's not yet easy for all schools to verify compliance using ProPubica's database or any other database of pharma payments to physicians. For one thing the majority of drug companies in the United States don’t report such payments. This is supposed to change by 2013 when the Physician Sunshine Act will require all drug companies to report these payments (see "Capturing & Reporting HCP-Related Meeting Spending"; use discount code 'HCP399' to get it FREE!).

Abbott Fetes Barred Cardiologist with High Cholesterol Pig Roast

Practically every week I read amazing stories about stupid, immoral, unethical, or illegal activities perpetrated by the pharmaceutical industry. Stories that are bolstered with juicy quotes from internal corporate emails written by dumb executives. And I don't have to wait for Wikileaks to publish this stuff when the U.S. Senate and the Wall Street Journal (WSJ) are already doing it!

Take today for example. A story in the WSJ titled "Abbott Hired Barred Doctor" caught my attention (find it here). At first, I thought it was nothing new -- I already know that pharmaceutical companies have hired questionable physicians in the past, so it's not too exciting to learn that Abbott "hired a Baltimore-area cardiologist as a sales consultant after he was barred from practicing at a local hospital last year for allegedly putting heart stents in hundreds of patients who didn't need them."

What's interesting is the juicy stuff that the Senate learned from internal emails written by Abbott executives.

For example:
"In 2008 Abbott paid more than $1,000 for a pig roast, complete with mobile pig pit, at a party to fete the cardiologist the same week Dr. Midei, then head of the cardiac catheterization lab at St. Joseph Medical Center in Towson, Md., set a possible company record by implanting 30 stents in a single day."
and
"Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the [Senate report to be released today] that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email."
and
"Around that time, an Abbott executive complained to a colleague by email about one of the [Baltimore] Sun's journalists [who reported on the alleged overuse of stents at St. Joseph] 'Somebody needs to take this writer outside and kick his ass. Do I need to send in the Philly mob?' he wrote, according to the report."
What's really amazing is that a company supposedly dedicated to saving lives of patients with cholesterol-blocked coronary arteries would host a $1,407 pig roast complete with a mobile "Alabama pig pickin' pit," a whole pig smoked for 15 hours, Memphis-style ribs, chicken, hot dogs, cole slaw and two big peach cobblers. The only thing heart-healthy on that menu may have been the cole slaw! I can forgive the threat to kick the reporter's ass, but a pig roast in a cardiologist's back yard? Unforgivable!

Certain Physician-Industry Relationships Have Declined Dramatically Over the Past 6 Years. Why?

According to a recent survey published in today's issue of Archives of Internal Medicine, 83.8 percent of physicians reported some type of relationship with the drug industry during 2009. This included nearly two-thirds (63.8 percent) who received drug samples, 70.6 percent who received food and beverages, 18.3 percent who received reimbursements and 14.1 percent who received payments for professional services. This is despite a number of efforts over the past several years that were aimed at reducing or eliminating certain types of physician-industry relationships (PIRs).

There has been some decline, however, in the percentage of physicians receiving PIRs from 2004 to 2009. "In 2004," reports the study authors, "more than 80% of physicians reported that they received food and beverages in their workplaces and 78% received drug samples. More than one third (35%) were reimbursed by companies for costs associated with professional meetings or continuing medical education (CME), and more than one-quarter (28%) received payments for consulting, speaking, or enrolling patients in clinical trials."

I plotted some of the more relevant survey results to more easily compare the 2009 data with data from 2004 (click for an enlarged view):


What's immediately striking to me is sharp drop in % of physicians receiving payments for consulting, participation on speaker bureaus and advisory boards, and for enrolling patients in clinical trials. That percent decreased from 28% in 2004 to 14% in 2009 (see last group of bars in chart above). This is in contrast to modest decreases seen for other PIRs.

It can be assumed that this is due to two factors: (1) passage of the Physician Sunshine Act as part of the Healthcare reform passed last year, and (2) the increase in the number of drug companies required by legal settlements to report payments to physicians (eg, see "Drug companies paid N.J. doctors millions to promote their products". Eventually, all pharma companies will have to report payments to physicians unless, of course, healthcare reform is repealed or scaled back by the new US Congress.

The authors of the study conclude "given that 83.8% of physicians have PIRs, it is clear that industry still has substantial financial links with the nation’s physicians. These findings support the ongoing need for a national system of disclosure of PIRs." Such a system is part of the Physician Sunshine Law, which is scheduled to go into effect in 2013. As I said above, a national disclosure of PIRs may be among the first items on the new GOP agenda's chopping block.

However, one other factor may be at play here: the decreasing number of new brand name drugs coming to market in last several years. While the authors cite cut backs in marketing due to the global financial crisis as a possible contributing factor, they do not mention that PIRs may be declining in part because of the depressed number of new drugs in the pipeline that require marketing to physicians.

Pfizer Reveals (Almost) All Payments to Physicians

Pfizer recently published its list of physician payments it made during the last half of 2009 (Q3 and Q4). The list, which is presented on this web page using javascript, includes these categories of payments:
  • Professional Advising
  • Expert-Led Forums
  • Research, including Phase I-IV clinical trials and investigator-initiated research
  • Meals, business travel expenses and educational items that are greater than or equal to $25 in value, and where the aggregate amount paid to an individual health care professional is greater than or equal to $500 in a calendar year.
Pfizer is the only pharma company to reveal how much it pays healthcare physicians and/or institutions for research. GSK and Merck, whose payments I analyzed in a recent Pharma Marketing News article ("Pharma Begins to Reveal Payments to Physicians"), only revealed payments for educational activities (speaker fees) and consulting. Neither Merck nor GSK revealed payments related to clinical research, or travel and entertainment expenses. None of these companies included payments for continuing medical education (CME) activities.

I asked Pfizer last Wednesday for the data in Excel format, but so far they haven't sent it to me, although they said they are looking into it. Meanwhile, Eric Milgram, author of Pharma Conduct Blog gave me his copy of the data in Excel format. Eric has looked into which physicians and organizations got paid the most. I looked at how the money was distributed on a state-by-state basis and by category of payment.

For my analysis, I used these categories:
  • Pfizer Research (Pfizer Sponsored Research)
  • Speaking (Expert-Led Forums)
  • Consulting (Professional Advising)
  • Travel & Meals (Business Related Travel and Meals)
  • IIR (Investigator-initiated Research)
  • Unknown
  • Educational Items (ie, tchtockes given away by sales reps)
The breakdown is illustrated in the following pie chart (click on it for an enlarged view):


Payments for educational items totaled only $12,275 out of a total of $35,436,797. This is too small to be picked up in this chart, which round to the nearest whole percent. Keep in mind that Pfizer is only reporting items with a value of $25 or greater and that the new PhRMA physician marketing code limits "gifts" to physicians (ie, the code prohibits distribution of non-educational items such as pens, mugs and other “reminder” objects typically adorned with a company or product logo). "Educational" items are supposed to be for the education of patients or healthcare professionals and should not exceed a value of $100. Such items include anatomical models that physicians may use to show patients what their insides look like.

It could be that Pfizer is giving away lots of educational items worth less than $25 and therefore not reporting this expense, but I doubt it. The physician gift (educational item) industry is essentially dead.

How much is spent on marketing vs research activities? "Consulting" fees may be paid for either type of activity, but most often physician consultants are paid by the marketing department to help it position the product with physicians. Let's say 75% of Pfizer's consulting fees were for marketing purposes.  Investigator-initiated research (IIR) is also often just a marketing ploy designed to get key physicians to prescribe more of the product. Let's put 50% of that into the marketing bucket. Travel and meals is a substantial category. Let's also say 50% of that goes to the physician marketing consultants. Pfizer has an "unknown" category that totals $899,688. Let's say 25% of that should be in the marketing bucket. And all of the $12,275 worth of "educational" items I consider marketing related.

The total amount of payments Pfizer made to physicians for marketing purposes in the 2nd half of 2009 was $17,390,969 or 49.1% of the total ($35,436,797). This is the first time I have been able to analyze how much a pharmaceutical company pays for physician marketing versus research. Of course, this does not include direct-to-consumer marketing expenses or research that is done in Pfizer's own labs or by research contract organizations. The latter could be a huge research expense.

The other analysis I did was a state-by-state breakdown, which is shown in the following bubble chart (click on it for an enlarged view):


Each bubble's size is proportional to the amount of money physicians/institutions in that state received (for a comparison with GSK and Merck, see "Why Does GSK Prefer New York Physicians & Will Governor Patterson Ruin It for Them?").

The five states receiving the most money from Pfizer are represented by red bubbles. North Carolina (NC) is one of the top five states receiving money from Pfizer. This was primarily because Duke University received over $1 million for research. That represents about 44% of all the money Pfizer paid physicians and other institutions in that state.