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34 posts from October 2014

October 31, 2014

California’s Controversial “Prop 46” Would Quadruple Dollar Limits for Med Mal Pain and Suffering; Require Doctor Drug Testing

Prop 46

California’s Proposition 46 is an initiative that combines a number of controversial policies into one ballot. In broad terms, the Proposition would more than quadruple the cap on “pain and suffering” that could be awarded in a medical malpractice suit from $250,000 to $1.1 million. Second, it would require doctors and pharmacists to check California’s drug database before prescribing certain drugs. Third, it would make California the first state to require mandatory drug testing for doctors.

The media surrounding this proposition has dubbed it “lawyers vs. doctors.” Much of the funding on the “pro” side—about $10 million—has come from personal injury attorneys. Insurance companies, doctors, and hospitals have put in about 5 times as much to defeat the measure.

Malpractice Limit for Pain and Suffering

As a background, California's current "malpractice cap" limits compensation for pain and suffering due to medical negligence at $250,000. This cap was part of the Medical Injury Compensation Reform Act of 1975, which was a response to skyrocketing medical insurance premiums for doctors and hospitals. California currently has the lowest non-economic cap in the country—most are in the $500,000 range or not capped at all. There are no limits on economic losses resulting from injuries—such as medical bills or lost wages.

While plaintiffs’ attorneys have been running ads to raise this cap for many years, Prop. 46 itself began tragically when a driver killed two young children while heavily medicated with prescription drugs. The children’s father, Bob Pack, found that no attorney would help him sue the doctor and hospital that Pack believed had wrongfully prescribed thousands of drugs to the driver. Attorneys have been reluctant to take such cases because of the high cost of litigation and the $250,000 cap. Because Pack’s children were dependents, his family had lost no wages; furthermore, because they had died, there were no medical expenses.

However, opponents of Prop. 46 say the measure will do more harm than good. The initiative has the potential to greatly increase healthcare costs, create more lawsuits, and perhaps cause physicians to seek states with different laws. 

Jason Kinney, spokesman for “no” on Prop 46, believes the initiative's "greatest weak spot is its price tag.” He notes that "under Prop 46, trial lawyers stand to make a lot of money and everyone else is going to be stuck footing the bill." Critics of the proposal note that increasing the potential malpractice recoveries will cause a spike in medical malpractice coverage. When health care insurance companies raise their rates, tax payers and patients all pay more in health care premiums.

The estimated state and local government costs from raising the cap on medical malpractice damages ranges from the low end of tens of millions to the high end of several hundred million dollars annually. These costs could be offset somewhat by savings from requirements on health care providers that may limit spending on prescription drugs. 

Mandatory Drug Testing

The initiative would place a lot of scrutiny on practicing doctors, especially after they make a mistake. Specially, Prop 46 requires:

  • Hospitals to administer random drug and alcohol tests to doctors affiliated with the facility.
  • Drug and alcohol tests if a doctor saw a patient within 24 hours of an “adverse event” or if a doctor is reported for possible use of drugs or alcohol while on duty or failing to follow an appropriate standard of care.
  • The state medical board to take specific disciplinary action, including license suspension, if a doctor is found to have been using drugs or alcohol on duty or refuses to follow the drug and alcohol testing protocol.
  • Doctors to report to the board any doctor believed to be impaired while on duty.

Sam Brodey of Mother Jones sums up the response from both sides of this aspect of the proposal:

Those in favor of Prop. 46 argue that doctor drug abuse in California is at "epidemic levels"—leading to devastating medical malpractice that kills millions per year. That claim doesn't quite hold up to scrutiny: Backers cite a 14-year-old report stating that 18 percent of California doctors abused drugs or alcohol. But from 2003 to 2013, only 62 doctors had their licenses revoked for that reason. Estimates put the total number of practicing California physicians at about 100,000. It's worth noting that the majority of Californians support testing—making this provision the "sweetener" to the other provision: raising the $250,000 award cap.

Kinney, too, believes this provision is a "sweetener" added to the proposal "to make increasing the cap palatable to voters.” While drug testing seems like good policy in theory, as written, the outcome would be virtually unworkable, notes Dr. Martin Fishman:

[Prop 46] would create the first statewide drug- and-alcohol-testing program in history -- for any profession -- that would require testing when the employees are off duty, including on personal vacation.

Proposition 46 would require doctors to submit to drug and alcohol testing up to 12 hours after the occurrence of certain events in a treatment setting.

However, because it can take days or weeks for infections, for example, to develop after medical care, drug and alcohol testing at that point would be meaningless. Doctors who missed a test for any reason would be reported to state authorities and have their medical license suspended.

Other critics simply point to the practical issues that would creep up on a daily basis if the Proposition was made law:

Imagine if the MD performed surgery that morning and was completely sober, yet a complication occurs 12 hours later and that evening after the doctor is at home enjoying a glass of Napa Valley wine, he/she would be required to report for testing and could be accused of being under the influence even though the doctor was not drinking at the time of the surgery.

Others note that while drug testing is mandatory in a number of industries, "adverse events" in medical treatment can take weeks or months before they become known. Doctors potentially could get suspended for not getting tested after an unknown error. 

CURES database

Finally, the proposition requires health professionals, including pharmacists, to check the statewide drug database before dispensing potentially abusive drugs to a patient for the first time to determine if the patient already has an active prescription. 

Many have argued that such a database would be susceptible to data breaches, however, the system has been up and running for several years now. The CURES database actually stems back to Mr. Pack’s initial efforts to curtail the over-prescription of certain prescription medication. His efforts paved the way for CURES, a statewide database that contains patient prescription records that doctors can check before prescribing medications. Prop. 46 would make these checks a requirement. 

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Voting on Proposition 46 will take place in the November 4, 2014 General Election. 

October 30, 2014

Physician Payments Sunshine Act: CMS Returns Payment Records, Corrections Due March 31, 2015; Agency Releases New Physician "Matching Support Resource" To Address Mismatched Physicians

Policy and Medicine

The Centers for Medicare and Medicaid Services today made a number of announcements related to their Open Payments system, mostly aimed at correcting mismatched physician payments that were withheld or de-identified in the initial data release.

CMS Returns Payment Records for Review and Correction

Starting today, manufacturers have the opportunity to review and correct 2013 payment records returned from the intermingled data fix that went into effect in August. To get started, log-in to the Open Payments system to download a "Removed Records Report" which will show which records across all three payment types (general, research, and ownership/investment interests) were removed from the published identified data, and why each individual record was removed.

After reviewing this report, you can re-submit corrected records to the Open Payments system. Step-by-step instructions on this process, and a detailed explanation of the reasons for record removal, are included in the Quick Reference Guide: Applicable Manufacturer and GPO Removed Records Report. CMS notes that once the records are re-submitted and re-attested (at a later date), physicians and teaching hospitals will then be able to review and dispute that information, and the information can be publicly posted.

Reporting entities will be required to submit corrected records into the Open Payments system no later than the end of the 2014 data submission and attestation periodMarch 30, 2015—and be published in the data release projected for June 30, 2015.

 

CMS Webinar

CMS is also hosting a webinar for applicable manufacturers and group purchasing organizations with a returned record report on Thursday, November 13, 2014;  1:00 p.m. – 3:00 p.m. EST.

  • Registration link: https://event.webcasts.com/starthere.jsp?ei=1047138; to register, enter your name and email address into the box titled “Complete this form to enter the webinar.”
  • Dial-in information: Please use the link you receive after you register for the session to access the online portion of the webinar, and use this phone bridge line to listen to the audio portion: 
    1-877-267-1577
  • Meeting Number: 996 876 705 (a password is not required)

 

Data Matching Support Resource: Validated Physician List

We noted earlier this year that a source of the problems with Open Payments had to do with how physician information was matched from what companies provided on the one hand to CMS's own data on the other. Today, CMS stated: “[m]any of the inconsistencies identified in the returned records are a result of physician identifiers not exactly matching against CMS or external data sources.” They state that to “proactively assist with data matching, and in an effort to be fully transparent about the method and data sources used to validate submitted data, CMS is publishing a downloadable list of physician data in CSV format, which contains variations of physician first/last name, NPI and state license number, for physicians who were reported in the Open Payments system.”

This Validated Physician List is accessible in the Open Payments system via the CMS Enterprise Portal. CMS encourages applicable manufacturers and GPOs to utilize the provided physician list to avoid further inconsistencies in data reporting.

CMS states:

Each individual record in the Removed Record Report includes a “Reason for Deletion.” If the reason for deletion is because the physician data you originally provided did not match what is contained within CMS sources, simply update your submitted data to match what is shown in the Validated Physician List. If you cannot find the physician on the Validated Physician List, review the information in the National Plan & Provider Enumeration System (NPPES)(https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do).

 

Last Chance: Correct Disputed 2013 Data by Friday, October 31

Finally, CMS states that manufacturers and GPOs have until Friday, October 31 to make data corrections to any 2013 Open Payments disputed records for publication in the data refresh on or before December 31, 2014. "Please note that these disputes were initiated by physicians and teaching hospitals during the review and dispute period held earlier this year," states CMS. 

 

Physician Payments Sunshine Act: One Month After the Data Release, What Are People Writing About Open Payments?

Newspapers

The Sunshine database was released one month ago, and it has been interesting to see the range of media coverage that has surrounded the release. On October 3, we looked at the first few days of Open Payments articles. These focused primarily on the deficiencies in the roll-out of the Open Payments System. Many early articles also highlighted the importance of context in looking at the database. Other journalists looked for evidence of wrongdoing in the database, but often noted that the system made proper analysis difficult.

One month later, news outlets have had a better chance to analyze some of the numbers. While approximately 40-50% of the records are not connected to a specific doctor or teaching hospital, researchers (including Policy and Medicine) have analyzed certain breakdowns of the data that provide interesting information. In this article, we have provided a number of stories that run the gamut of coverage—some offer an objective breakdown of the payment data, some call out the highest paid doctors and hospitals, others point to the fact that Open Payments may chill important collaborations between industry and physicians.

CMS Releases Search Tool:

When Open Payments launched on September 30th, articles targeted the system’s lack of usability. “Another Government Website Rollout That Is Found Wanting,” wrote the New York Times. On October 17, CMS released a more patient-friendly search tool that allows users to enter the name of their physician and have all of the transactions come up at once. During the first weeks, Open Payments required users to search through a list of thousands of names in alphabetical order and manually add up the payments for a particular doctor.

Resources Analyzing the Open Payments Data:

Brookings Institute breaks down the identifiable payment categories in a number of interesting ways. One graphic that is telling is the physicians who received royalties, which constitute payments for inventions, dominated the highest paid on the list. Also notable, two prominently placing hospitals--the City of Hope National Medical Center (top of the list of general grants) and the Dana Farber Cancer Institute (top of the list of research grants)--are two of the top ranking hospitals for cancer care in the country. 

Note that this payment data does not take into account de-identified payments. Thus, for the research category, the article is missing approximately 90% of the data.  

Medical Money: See What Drug and Device Companies Paid Doctors: Ed Silverman offers a nice interactive pie chart of Open Payments data.

Breakdown of Research Payments by Top Manufacturer and State, Policy and Medicine. We broke down the research payment category, and looked at both identified and de-identified data to get a macro-picture of how and where industry was spending its research dollars.

What sort of information can I get from the new Open Payments data? Quora took many interesting cuts of the data as well. 

Dollars for Dudes: Almost No Women Among Medical Industry’s Top-Paid Speakers, Consultants: ProPublica finds that few of the top paid consultants and speakers are women. Women are attending medical school now at the same rate as men, so we hope these payments even out over time. 

Many Articles Were Critical of the "Witch Hunt" Aspect of Open Payments

Open Payments: Detailing the media’s witch hunt:

Perhaps the most entertaining and also insightful take on the Open Payments release came from Kevin MD writer Margalit Gur-Arie. The whole article is worth a read, but here is a choice excerpt:

The big money went to a fraction of a percent at the top, mostly for royalties and licensing of things they designed or invented. I randomly picked a couple of these folks and looked them up on Google. The first one turned out to be a world famous vascular surgeon who invented multiple devices to fix aneurysms, pioneered various types of surgeries, and even got himself a medal from the Society for Vascular Surgery.

The second fellow is an orthopedic surgeon, also world famous who specializes in acute trauma and post-traumatic reconstruction of feet and ankles, and is the inventor of all sorts of plating and nailing systems for his specialty. He has more credentials than you can count and some very prestigious awards to go with that. At this point I stopped searching.

The author is also critical how certain outlets covered the release:

The third New York Times article was cleverly titled “Detailing Financial Links of Doctors and Drug Makers,” a title as innocent as the 1987 Miami Herald story “Miami woman is linked to Hart.” Linkage implies secretive impropriety about to be exposed. You don’t often see headlines saying, “Fireman linked to saving baby from burning building.” The article itself is fraught with equally innocent language such as “doctors reaping over half a million dollars each,” “murky financial ties between physicians and the health care industry,” “lucrative arrangements are just some of the findings,” and a surreal tale of the doomed, in which a righteous Cleveland Clinic physician is contesting his own listing because “he had spoken at the event but deliberately skipped the lunch.”

Without context, Sunshine Act’s health care ‘transparency’ is useless:

Peter J. Pitts, a former FDA associate commissioner, and current president of the Center for Medicine in the Public Interest was strongly opposed to the “gotcha” aspect of the Sunshine Act, intended to embarrass the pharmaceutical industry and healthcare professionals. He notes that research, which made up $1.5 billion in payments, "are merely reimbursing doctors for their professional services."

Biopharmaceutical companies and doctors bring separate skill sets and knowledge bases to the research table. Doctors working in the field have a better sense of what types of treatments patients need. And those in the biopharmaceutical industry are better versed in the drug development process. According to a recent survey, 94 percent of physicians say that the role of pharmaceutical and biotech firms in sponsoring clinical trials for new treatments is useful. 

Thanks to these partnerships, there are currently 3,400 drugs being developed in the United States. These are drugs that will combat diseases like diabetes, heart disease and Parkinson's. 

...[C]ollaborations are especially critical considering that federal research dollars are quickly drying up. In fiscal year 2013, burdened with the sequestration and budget cuts, the National Institutes of Health (NIH) - the country's main source of biomedical research funding - awarded 722 fewer grants than the previous year.

If the data released under the Sunshine Act continues to present the financial relationship between physicians and industry without this crucial background information, these collaborations could be in jeopardy. Doctors may end up resisting them in order to avoid sensationalist claims that their medical judgment is for sale to the highest bidder. Patients will be the real losers.

Sunshine Act Shouldn't Start Chill, argues Steven Kalkanis, M.D. chairman of the Department of Neurosurgery at Henry Ford Health System.

Sunshine Act Update: First Data Set Published: JD Supra breaks down "Why Sunshine Act Reporting Data Matters," including the legal and reputational implications of the Open Payments database, including False Claims Act considerations. 

New data disclosures highlight doctor-payment relationships. The Star Tribune interviews Dr. Richard Lindstrom, inventor of a solution that preserves eye tissue for surgery. He "has given sight to legions of people worldwide and become highly sought after for speeches and consulting deals," the article notes. And "He has been handsomely rewarded for his work."

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Some Docs Get Big Payments From Drug Firms. The Augusta Chronicle writes: "One Augusta physician got more than $150,000 in payments, food and travel from drug and medical device manufacturers, and a dozen others got at least $12,000, according to records released under the Affordable Care Act. But the top earning physician said that reimbursement for a number of trips on behalf of diabetes drugs is a necessary part of educating colleagues and is 'highly regulated' by federal agencies."

The Federal Report on Financial Relationships Between Pharma Industry and Prescribing Physicians, But Shadows Remain on the Controversial ADHD Drug Market. Michael Corrigan, a noted critique of ADHD drug over-prescribing, went through the database with a fine tooth comb to find companies spending a lot marketing ADHD drugs. Corrigan is thoughtful in his approach to scoping out Open Payments, but believes the disclosures may not be enough.  "I do not believe the pharmaceutical companies selling ADHD drugs are being open when it comes to what has been reported. And if the ADHD subsample of the pharmaceutical population is not being forthcoming, the possibility exists the practices are being repeated throughout the industry." 

Public gets first look at health industry payments to doctors: A Connecticut outlet goes through the highest paid physicians in the state. 

Alabama doctors who receive the most money from drug, device companies explain why.

 

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