HealthLawProf Blog

Conciege Doctors

The New York Times reports on a recent trend in health care - the conciege doctor.  It seems a far cry from universal health care and doesn't seem to be the medical profession at its best.  According to the Times,

Last October, Barbara L. Allan, 57, received a letter from her family physician, Dr. David Rosenberg, asking her for $1,500 annually to remain a patient. He would be offering longer appointments, with no waiting, and giving out his cellphone number for after-hours calls. Ms. Allan would be one of just 400 patients, the letter said, and she would have his help navigating the local health care system. Dr. Rosenberg said he was switching to a concierge practice to maintain the highest quality of patient care.

Barbara L. Allan, president of a research company in Florida, tried using a concierge doctor to save time, but switched because he didn't offer some routine services.

To her, it was an attractive pitch. "I was tired of going in for routine things and waiting an hour and a half," said Ms. Allan, who is president and chief executive of SRA Research Group Inc. in Jupiter, Fla. She recalled walking out of the doctor's office two or three times when he made her late for a meeting.

[bm]

Sicko

No, not a rude name for those you find in some ways troubling - its the name of a propose new Michael Moore film.  According to Yahoo News,

Michael Moore says his next documentary already has HMOs quaking in their boots. Moore has not yet begun shooting the film, "Sicko," but his planned critique of the nation's health care system, he says, is making "freaked-out" HMOs warn employees what to do if approached by the filmmaker.

"At this point we haven't shot anything yet and they're totally discombobulated," Moore said at the inaugural Traverse City Film Festival. Moore, who lives near Traverse City, founded the film festival with local movie buffs to showcase excellent films.

I cannot imagine why health care officials would be nervous  . . . I am sure that film will be popular.  [bm]

Medical Malpractice Update - Wisconsin

The ABA Journal reports that the Wisconsin Supreme Court struck down a cap on medical malpractice damages.  The Journal reports,

The 4-3 ruling came in the case of Matthew Ferdon, now 8, of Abrams, about 20 miles north of Green Bay. The boy has a deformed and partially paralyzed right arm caused by an injury at birth. Jurors awarded Ferdon $403,000 for future medical expenses and another $700,000 for pain and suffering, twice the state limit.

The case made it to the state high court after the trial judge reduced the pain-and-suffering award. Chief Justice Shirley S. Abrahamson didn’t have to look far for an equal protection problem.

"Indeed, the burden of the cap falls entirely on the most seriously injured victims of medical malpractice," Abrahamson wrote for the majority. "Those who suffer the most severe injuries will not be fully compensated for their noneconomic damages, while those who suffer relatively minor injuries with lower noneconomic damages will be fully compensated. The greater the injury, the smaller the fraction of noneconomic damages the victim will receive."

Because doctors didn’t discriminate against Ferdon on account of his race, religion or similar characteristics, and because they didn’t violate a fundamental right, such as free speech, his case was ineligible for much tougher levels of scrutiny constitutionally required in such situations. Ferdon also had to defeat the statute’s heavy presumption of constitutionality beyond a reasonable doubt.

Instead of taking legislators at their word, which regularly occurs in cases using rational basis review, the Wisconsin court employed what academics sometimes call "rational basis review with teeth," and deeply delved into the law’s history and performance.

"The legislature enjoys a wide latitude in economic regulation," Abrahamson wrote. "But when the legislature shifts the economic burden of medical malpractice from insurance companies and negligent health care providers to a small group of vulnerable, injured patients, the legislative action does not appear rational."

Citing figures from the state insurance commissioner and the U.S. General Accounting Office, the court was unable to conclude that the cap had any measurable effect on insurance premiums. Few Wisconsin pain-and-suffering awards have exceeded the cap, and overall the state has not encountered the mammoth jury verdicts reported in other states. The court also suggested the blame for premium hikes lies more with the cost of defending huge numbers of baseless claims—perhaps up to 70 percent of those filed—rather than with the handful of cases that do end in large awards.

The court followed similar analyses in rejecting arguments about keeping the state insurance pool in the black, lowering patient costs and keeping doctors from fleeing the state.

[bm]

President Signs Medical Error Reporting Bill

President Bush wasted no time signing S. 544 (previously discussed here) into law.  Today's signing statement is here.  [tm]

House Votes to Cap Medical Mal Practice Awards in the "HEALTH" Bill

The AP reports that the House has passed legislation (230-94, with 2 voting "Present") that would limit damages for medical malpractice for the third consecutive year.  The "Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH)" bill (a/k/a HR 5) would cap awards for pain and suffering at $250,000, with no limit on economic damages. It would also cap punitive damages at $250,000 in many circumstances, although punitive damages could total twice the amount of economic damages awarded.  In addition, it limits lawyers' fees on a sliding scale based on the size of the award, imposes a 3-year statute of limitations in most cases, and provides a higher threshold for awarding punitive damages.   Supporters of this bill say it will stabilize malpractice insurance premiums, improve access to quality care, reduce the cost of health care, and ensure a more timely, predictable and fair liability system. Republicans, doctors, hospitals, insurers, and pharmaceutical manufacturers backed this bill.  President Bush said that "the nation's medical liability system is badly broken, as frivolous lawsuits are threatening access to the quality health care and raising health care costs for all Americans...The medical liability crisis is driving up health care costs through higher insurance premiums, higher medical bills, and the practice of defensive medicine."  The Bush Administration and House Republicans blame frivolous lawsuits and multimillion dollar awards for increasingly high premiums. 

Democrats, attorneys, and some consumer advocacy groups oppose this bill since it would prevent victims of malpractice form obtaining fair compensation for injuries.  These groups say supporters of the bill are protecting influential interest groups at the expense of the average citizen.  They predict it will help the insurance business become even more profitable and will not bring doctors any economic relief while posing potential harm to patients in the long run.  Rep. Marion Berry, D- Arkansas, asked "Are you so in bed with the drug companies and insurance companies that you just can't pass up another opportunity to give them money?"  Rep. Phil Gingrey, R-Georgia responded  by citing 15 of Georgia's 20 largest insurance companies have stopped issuing medical malpractice insurance since the business was hardly profitable.  He says that "without this insurance coverage, emergency medicine specialists, neurosurgeons, Ob-Gyn physicians ]are] being chased out of their profession, leaving ordinary people without their specialty doctor."  Rep. Dave Weldon, R-Florida, said "the real issue here i the incredible cost of defensive medicine.  I practiced it every day.  I confess. I ordered extra tests to keep myself from being sued." 

Another controversial provision was the "Vioxx" provision which would protect drug companies and medical device makers from having to pay punitive damages as long as the product had FDA approval. Republican supporters argued the Democrats were exaggerating the protections offered to drug and device makers, noting that they could still be held fully liable if they had not disclosed all data to the FDA. 

Lindley Bain helped with this post.  [twm]

Plan B and Mitt Romney

Massachuetts Governor Mitt Romney vetoed legislation to expand access to Plan B, the so-called morning after" pill.   According to the Boston Globe,

The bill that Romney vetoed would allow trained pharmacists to dispense the morning-after pill without a prescription and would require hospitals to offer it to rape victims. It almost certainly will become law despite Romney's rejection; both the House and Senate approved it by veto-proof margins, and legislative leaders said they plan to override his veto.

Seems like a purely political move on Governor Romney's part.  Here is the New York Times piece from earlier this week about his reasoning. 

On Monday, Mr. Romney said that his veto of the bill - which would allow some pharmacists to dispense the pill without a prescription and require hospitals to offer it to rape victims - was consistent with his past statements and that he continued to support contraception.

But, he said, in consulting with several doctors about the morning-after pill, he learned that it could not only prevent the formation of an embryo, as birth control pills do, but also prevent an embryo already formed from being implanted in the womb.

Mr. Romney said he believed that life began at conception.

"If it only dealt with contraception, I wouldn't have a problem with it," he said of the morning-after pill. "But it also in some cases terminates life after conception, and therefore it ceases to be a contraceptive pill. It becomes an abortion pill."

[bm]

 

Bill Frist and Stem Cells

The New York Times reports that Senator Bill Frist has decided to support legislation that expands federal financing for embryonic stem cell research.   According to the Times, Senator Frist stated,

"While human embryonic stem cell research is still at a very early stage, the limitations put in place in 2001 will, over time, slow our ability to bring potential new treatments for certain diseases," Mr. Frist says, according to a text of the speech provided by his office Thursday evening. "Therefore, I believe the president's policy should be modified."

Mr. Frist's move will undoubtedly change the political landscape in the debate over embryonic stem cell research, one of the thorniest moral issues to come before Congress. The chief House sponsor of the bill, Representative Michael N. Castle, Republican of Delaware, said, "His support is of huge significance."

The Castle-Degrette bill is here.  Before Senator Frist's announcement, the President has threatened to veto the bill.  [bm]

Medicare + Medicaid at 40

The Kaiser Family Foundation has a slick website to commemorate the 40th anniversary of the passage of Titles XVIII and XIX of the Social Security Act - the Medicare and Medicaid laws.  What caught my eye were video documentaries on the political history of the two programs, from the 1930s to the mid-1960s.  The documentaries (one on Medicare, one on Medicaid, one on both) are quite well done, partly because of some compelling excerpts of interviews with some of the principal players in 1965.  Of course, Wilbur Mills and LBJ are long gone, but there are still some terrific interviews with the president of the AMA at that time, Edward Annis; Joe Califano, a White House staffer at the time; LBJ's chief of staff, Jim Jones, and others.  Best of all, longer (7- to 9-minute) interviews with each of these fellows are available on the same page. 

I like the way these videos really makethe federal health care programs come alive.  I plan to link to the videos in my web-based syllabus so that students can click on them at their leisure when we get to Medicare and Medicaid in my health law survey course.  [twm]

Medicare Revisited

First, apologies to everyone for the dulpicate posting - I am sure that you are aware of all the news about Medicare being a mess.  Here are some further comments by Erza Klein about some of the information about Medicare that the press has been covering.  He states,

So when you talk about Medicare, realize you're not talking about government-run health insurance, you're talking about government-funded health insurance. It's a big difference. It's a big difference because Medicare's failures and flaws are still part and parcel of the fractionalization and perverse incentives of private health delivery. It's not that the government side of things is perfect, but folks like Ken Baer and the Times should be clear that the fault isn't solely the government's because the program isn't solely the government's.

[bm]

Medical Error Reporting Bill Passes in Congress

According to AP/Yahoo, a bill intended to encourage the reporting of medical errors is on its way to the president for his signature:

Under the legislation approved overwhelmingly by the House, health care officials would voluntarily report medical errors to patient safety organizations, which would use a network of computer databases to analyze the information and make recommendations on ways to improve health care. The information would be treated as privileged and confidential.

The Patient Safety and Quality Improvement Act of 2005 (S. 544) cleared the House Wednesday by a 428-3 vote.  The bill is aimed at "providers," defined to include --

`(A) an individual or entity licensed or otherwise authorized under State law to provide health care services, including--

`(i) a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner's office, long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or

`(ii) a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or

`(B) any other individual or entity specified in regulations promulgated by the Secretary.

Of course, providers will be most interested in the scope of the privilege and confidentiality provisions and their exceptions.  Interested? HealthLawProfBlog is happy to oblige:

`SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.

`(a) Privilege- Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), patient safety work product shall be privileged and shall not be--

`(1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;

`(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;

`(3) subject to disclosure pursuant to section 552 of title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;

`(4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or

`(5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.

`(b) CONFIDENTIALITY OF PATIENT SAFETY WORK PRODUCT- Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), patient safety work product shall be confidential and shall not be disclosed.

`(c) Exceptions- Except as provided in subsection (g)(3)--

`(1) EXCEPTIONS FROM PRIVILEGE AND CONFIDENTIALITY- Subsections (a) and (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:

`(A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after a court makes an in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source.

`(B) Disclosure of patient safety work product to the extent required to carry out subsection (f)(4)(A).

`(C) Disclosure of identifiable patient safety work product if authorized by each provider identified in such work product.

`(2) EXCEPTIONS FROM CONFIDENTIALITY- Subsection (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:

`(A) Disclosure of patient safety work product to carry out patient safety activities.

`(B) Disclosure of nonidentifiable patient safety work product.

`(C) Disclosure of patient safety work product to grantees, contractors, or other entities carrying out research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations.

`(D) Disclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration.

`(E) Voluntary disclosure of patient safety work product by a provider to an accrediting body that accredits that provider.

`(F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part.

`(G) Disclosure of patient safety work product to law enforcement authorities relating to the commission of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes.

`(H) With respect to a person other than a patient safety organization, the disclosure of patient safety work product that does not include materials that--

`(i) assess the quality of care of an identifiable provider; or

`(ii) describe or pertain to one or more actions or failures to act by an identifiable provider.

`(3) EXCEPTION FROM PRIVILEGE- Subsection (a) shall not apply to (and shall not be construed to prohibit) voluntary disclosure of nonidentifiable patient safety work product.

`(d) Continued Protection of Information After Disclosure-

`(1) IN GENERAL- Patient safety work product that is disclosed under subsection (c) shall continue to be privileged and confidential as provided for in subsections (a) and (b), and such disclosure shall not be treated as a waiver of privilege or confidentiality, and the privileged and confidential nature of such work product shall also apply to such work product in the possession or control of a person to whom such work product was disclosed.

`(2) EXCEPTION- Notwithstanding paragraph (1), and subject to paragraph (3)--

`(A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections provided for in subsection (b) shall no longer apply to the work product so disclosed; and

`(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B) (relating to disclosure of nonidentifiable patient safety work product), the privilege and confidentiality protections provided for in subsections (a) and (b) shall no longer apply to such work product.

`(3) CONSTRUCTION- Paragraph (2) shall not be construed as terminating or limiting the privilege or confidentiality protections provided for in subsection (a) or (b) with respect to patient safety work product other than the specific patient safety work product disclosed as provided for in subsection (c).

`(4) LIMITATIONS ON ACTIONS-

`(A) PATIENT SAFETY ORGANIZATIONS-

`(i) IN GENERAL- A patient safety organization shall not be compelled to disclose information collected or developed under this part whether or not such information is patient safety work product unless such information is identified, is not patient safety work product, and is not reasonably available from another source.

`(ii) NONAPPLICATION- The limitation contained in clause (i) shall not apply in an action against a patient safety organization or with respect to disclosures pursuant to subsection (c)(1).

`(B) PROVIDERS- An accrediting body shall not take an accrediting action against a provider based on the good faith participation of the provider in the collection, development, reporting, or maintenance of patient safety work product in accordance with this part. An accrediting body may not require a provider to reveal its communications with any patient safety organization established in accordance with this part.

`(e) Reporter Protection-

`(1) IN GENERAL- A provider may not take an adverse employment action, as described in paragraph (2), against an individual based upon the fact that the individual in good faith reported information--

`(A) to the provider with the intention of having the information reported to a patient safety organization; or

`(B) directly to a patient safety organization.

`(2) ADVERSE EMPLOYMENT ACTION- For purposes of this subsection, an `adverse employment action' includes--

`(A) loss of employment, the failure to promote an individual, or the failure to provide any other employment-related benefit for which the individual would otherwise be eligible; or

`(B) an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of the individual.

`(f) Enforcement-

`(1) CIVIL MONETARY PENALTY- Subject to paragraphs (2) and (3), a person who discloses identifiable patient safety work product in knowing or reckless violation of subsection (b) shall be subject to a civil monetary penalty of not more than $10,000 for each act constituting such violation.

`(2) PROCEDURE- The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b) and the first sentence of subsection (c)(1), shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.

`(3) RELATION TO HIPAA- Penalties shall not be imposed both under this subsection and under the regulations issued pursuant to section 264(c)(1) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note) for a single act or omission.

`(4) EQUITABLE RELIEF-

`(A) IN GENERAL- Without limiting remedies available to other parties, a civil action may be brought by any aggrieved individual to enjoin any act or practice that violates subsection (e) and to obtain other appropriate equitable relief (including reinstatement, back pay, and restoration of benefits) to redress such violation.

`(B) AGAINST STATE EMPLOYEES- An entity that is a State or an agency of a State government may not assert the privilege described in subsection (a) unless before the time of the assertion, the entity or, in the case of and with respect to an agency, the State has consented to be subject to an action described in subparagraph (A), and that consent has remained in effect.

`(g) Rule of Construction- Nothing in this section shall be construed--

`(1) to limit the application of other Federal, State, or local laws that provide greater privilege or confidentiality protections than the privilege and confidentiality protections provided for in this section;

`(2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to information that is not privileged or confidential under this section;

`(3) except as provided in subsection (i), to alter or affect the implementation of any provision of the HIPAA confidentiality regulations or section 1176 of the Social Security Act (or regulations promulgated under such section);

`(4) to limit the authority of any provider, patient safety organization, or other entity to enter into a contract requiring greater confidentiality or delegating authority to make a disclosure or use in accordance with this section;

`(5) as preempting or otherwise affecting any State law requiring a provider to report information that is not patient safety work product; or

`(6) to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.

It will be fascinating to see if this voluntary-reporting scheme gets off the ground. [twm]

Housecleaning, Part V: First Licensed DNA Vaccine

The U.S. Department of Agriculture has licensed the first DNA vaccine.  According to a news release, the Centers for Disease Control and Prevention and Fort Dodge Animal Health, an animal biologics and pharmaceutical company, have developed the vaccine to protect horses from West Nile virus.  However, this is the first step in the future development of human DNA vaccines.  Dr. Julie Gerberding, CDC Director, stated that "this science will allow for the development of safer and more effective human and animal vaccines more quickly."  Unlike traditional vaccines, DNA vaccines use carefully selected small pieces of the virus's genetic material that stimulate the vaccine recipient's body to develop protective immunity.  Traditional vaccines use a weakened or killed virus to stimulate immunity development.   

DNA vaccines have several important advantages over traditional vaccines:

1. a DNA vaccine can be adapted easily for a similar organism, which would allow for a quick turnaround time during an emerging epidemic;
2. DNA vaccines are less vulnerable to temperature changes, which would greatly benefit developing areas such as Africa;
3. multiple DNA vaccine candidates can be combined into a single DNA vaccination which would allow vaccination against multiple viruses at the same time; and
4. those vaccinated with the DNA vaccine can be differentiated form those that have been naturally infected (which would be a huge help to public health disease monitoring). 

If more information would be useful, you could do worse than to start at University of Kansas microbiology prof Jack Brown's page, "What the Heck Is DNA Vaccine?," which builds upon his infamous essays, "What the Heck Is a Gene?," "What the Heck is an Antibody?," and the unforgettable "What the Heck is an MHC Molecule?".

Lindley Bain provided help on this story.  [twm]

Housecleaning, Part IV: Oregon House Votes to Require Prescriptions for Pseudoephedrine Products

With a 55-4 vote, the Oregon House of Representatives has sent HB 2485, requiring prescriptions for cold and allergy medicines containing an ingredient used to make methamphetamine, to the Senate for passage.  The Oregonian reported that the bill is expected to quickly pass in the Senate and be signed into law.  (As reported in the Salem Statesman Journal, the bill passed out of committee on Monday, July 26, by a 5-0 vote and is now on its way to the full Senate.)

Many legislators voted for this bill despite the inconvenience and expense to constituents this law would create.  It would force a person to obtain a prescription for common over the counter drugs such as Sudafed and Claritin-D.  The law currently allows the purchase of these types of pills and drugs after a consumer shows identification and signs a log.  Rep. Brian Boquist, R-Dallas, comments that "Could I lose my seat for doing the right thing?  Absolutely, and if necessary, I will."  Rep. Jeff Kropf, R-Sublimity, opposed the bill, saying that voters would not understand the complexities of the meth issue.  He argues that this new requirement "goes too far beyond common sense... What they're [the consituents] going to understand is: I'm being punished for something I didn't do."  He also argued that this bill would not be very effective in cutting down the number of meth labs since most of the meth in Oregon is imported from Mexican superlabs.  He says a better solution is prevention through education and treatment.  Another Representative, Tom Butler, R-Ontario, expressed concern over tourists to Oregon being arrested for carrying pseudo-ephedrine not purchased with a prescription.   Others dismiss that argument since someone carrying medicine for personal use would not be arrested and the need for tougher enforcement since most supplies come from out of state. 

As for the hardship issue, Rep. Bill Garrard, R-Klamath Falls says that drug companies are producing an increasing number of alternatives.  Pfizer, which makes Sudafed, sells an alternative that uses another decongestant and is planning to develope pseudo-ephedrine-free formulas of other brands.  Doctors would also be allowed to give prescriptions over the phone, and consumers could get up to 5 refills per 6-month period. 

Despite passing a companion bill which would provide money for drug treatment ($7.1 million), Rep. Gary Hansen, D-Portland, said the measures do "pathetically little for drug treatment... particularly in light of $28 million in cuts to treatment programs paid for through the Oregon Health Plan. " 

Lindley Bain contributed to this post. [twm]

Housecleaning Part III: Drug Companies Propose Advertising Guidelines

In an effort to stem movements against consumer drug advertising, the pharmaceutical industry (via Pharmaceutical Researchers and Manufacturers Association) released draft guidelines as a self-policing initiative (press release).  The N.Y. Times reports that the guidelines endorse a period of informing doctors about new drugs before running ads for them but without setting a time span between a drug's release and the beginning of ads.   The guidelines say that drug makers should have "conversations with physicians" before advertising new products.  The guidelines also require age and audience appropriate ads, ads that promote disease awareness, and ads that notify patients about low-cost drugs for the uninsured. 

The N.Y. Times reports that many critics of the drug industry have called for a set time period, arguing that doctors need time to understand drugs before patients start asking for them.    Ken Johnson, senior vice president of PhRMA, counters that "there's a clear recognition by our companies that there should be an appropriate period of time to educate physicians before any new ad campaign begins."  Rob Schneider of Consumers Union, a large consumer group, said that "It appears the pharmaceutical industry has produced a placebo rather than supporting real reform of drug advertising."  Johnson adds that details of the proposal will be released next month at a news conference and that they are working on a notice and comment process to receive information and comments from the public and other healthcare professionals. 

Last month Bristol-Myers Squibb adopted its own voluntary 12-month delay between introducing a product into the market and advertising it (Direct-to-Consumer Communications Code, June 13, 2005, PDF).

Research assistant Lindley Bain was on this story. [tm]

Housecleaning, Part II: Johnson & Johnson Being Investigated by Justice Department

According to the N.Y. Times, the Justice Department is looking into Johnson & Johnson's aggressive marketing of Natrecor, a heart-failure treatment.  The US attorney in Massachusetts, Michael J. Sullivan, issued a subpoena requesting information about the sales and marketing of Natrecor.  His office is known for prosecuting health care fraud cases.  In 2003 Johnson & Johnson acquired the maker of Natrecor, Scios, for $2.4 billion.  Sales of Natrecor are projected to be $700 million for 2005, nearly double what they were last year. 

The article reports that Johnson & Johnson has been "criticized by some prominent cardiologists for encouraging widespread and frequent use of intravenous Natrecor therapy in outpatient clinics, one or more times a weeks for some patients, even though the FDA has approved the drug only for acutely ill hospitalized patients."  It is illegal for companies to promote and market off-label or non-approved uses of a drug even though it is legal for doctors to administer drugs for off label uses.  Johnson & Johnson has been accused of violating this rule by actively promoting the outpatient use of Natrecor.  Due partially to outpatient use, Natrecor has been very profitable to Johnson & Johnson and cardiologists (who bill hundreds of dollars for each infusion).   The N.Y. Times reports that 80 percent of the patients receiving Natrecor are covered by Medicare. 

An editorial in the New England Journal of Medicine by Dr. Eric Topol, the chairman of the cardiovascular medicine at the Cleveland Clinic, accuses the Scios unit of actively encouraging physicians to open their own infusion centers to bill Medicare for this treatment.  He says that company documents instructed doctors to bill Medicare $408 for eight hours of observation during the infusion, above and beyond the actual cost of the drug, which is around $500 per vial.  He claims that other heart-failure drugs, which cost less than $10 a dose, are equally as effective.   There are also concerns about the safety of Natrecor and how it's used.  According to an article in HealthDay, Dr. Topol states that Johnson & Johnson continues to aggressively market Natrecor even though it is being linked to kidney failure and death.  He says:

It's a pattern.  We saw it with Vioxx and some of the cox-2 inhibitor drugs, and we're seeing it now with Natrecor. . . . The twist here is that the aggressive marketing is through the medical community.  With other drugs, it's direct-to-consumer advertising.  We have the themes of manuscripts published in prestigious journals with key omissions f data, the FDA approving drugs without mandating key trials, and companies aggressively pursuing sales and marketing of their drugs. 

The article claims that Scios is encouraging physicians to start their own infusion centers which would be billed to Medicare.  In addition, it has set up a toll-free telephone hotline for "Natrecor Reimbursement Support" and published a 46-page reimbursement and billing guide that provides doctors with specific Medicare billing codes. 

Mark Wolfe, Scios spokesman, argues that "the reimbursement guide was developed to provide hospitals and other medical staff with comprehensive information, not selective information, to accurately code a patient's condition under Medicare requirements." 

One of the problems cited in the article is the lack of enforcement capability by the FDA. 

Lindley Bain was instrumental in pulling this post together.  [tm]

Housecleaning, Part I: New Organ Donor Law In Illinois

Going back through some odds and ends that got drafted but never posted, yet days or weeks later seem just as interesting as when I first encountered them. . . .

Let's start with an AP story reporting on a new Illinois law recently signed by Governor Blagojevich makes a person's decision to become an organ donor binding, even if family members object (Public Act 94-0075).  Before this law, a donor's next of kin had to give consent before the organ or tissue was harvested.  Last year 30 families overruled a relative's decision to donate an organ or tissue, according to the Elmhurst-based Gift of Hope Organ and Tissue Donor Network.   Currently, Illinois has more than 6 million names on the organ donor registry, the largest in the country.  [tm]

Federal Judge Rules That Union Pacific Discriminated Against Women By Not Providing Coverage for Contraceptives

Following up on Betsy's post earlier today, the class-action lawsuit is styled In re Union Pacific R.R. Employment Practices Litigation, No. MDL 1597, 803CV437. The opinion by U.S. District Judge Laurie Smith Camp is unavailable (so far) through PACER and Westlaw.  [twm]

Medicare Concerns

This week, the Washington Post has an excellent series examining some of the problematic issues that exist within the Medicare program and efforts to ensure that it provides quality care. 

The first article concerned wasteful spending that occurs when Medicare fails to hold accountable those health care organizations that provide poor care.

For a year, The Washington Post crisscrossed the country to examine the economics of Medicare and how it monitors the quality of its services -- reviewing thousands of documents and interviewing hundreds of researchers, regulators and patients. Medicare is highly valued by 42 million elderly and disabled members, but it wastes an enormous amount of money on inefficient medicine, the examination found.

The second article concerns JCAHO's role in accediting various health care facilities. 

. . . . the joint commission's practices raise questions about potential conflicts of interest and the rigor of its hospital surveys. It operates a thriving subsidiary that charges hospitals thousands of dollars for coaching on how to pass its reviews. About 99 percent of the hospitals reviewed by the joint commission win accreditation, and in recent years it has missed glaring examples of poor care in which patients have been injured or killed . . . .

The third article examines problems with the close relationship that Quality Improvement Organizations (QIOs) have established with a number of those health care organizations that it should be monitoring.

By law, QIOs, which are dominated by doctors and health executives, operate in secrecy with little oversight or accountability. Consumers say they are difficult to contact and rarely uphold complaints. At the same time, the number of sanctions QIOs recommend against doctors each year has dwindled from hundreds to a few.

All three articles provide a good overview with some of the problematic issues facing Medicare and attempts to reform some of its practices. [bm]

Coverage for Birth Control

A Nebraska federal district judge ruled that Union Pacific Corp. engaged in illegal  sex discrimination when it barred coverage for prescription contraceptives from its health plans.  The L.A. Times reports,

In a sharply critical ruling, a Nebraska federal district judge said Union Pacific Corp. illegally discriminated against female employees by barring prescription contraceptive coverage from its health plans — even as it underwrote the cost of Viagra and drugs for male-pattern baldness.

. . . . In its briefs, the railroad justified its decision to exclude birth control coverage by arguing that "because fertility is 'normal,' contraception is not 'medically necessary.' " Company health plans do cover contraceptives if prescribed for a "non-contraceptive purpose," such as the treatment of skin diseases or menstrual disorders.

The judge will be issuing additional rullings discussing precisely what the railroad needs to do to come into compliance with the law.  If you are interested in the employer's coverage of prescription birth control, Professor Elizabeth Pendo has a recent article in the Connecticut Insurance Law Journal. [bm]

The Costs of Nonbeneficial Treatment in the Intensive Care Setting

Health Affairs' July/August issue has an important article on the cost of "nonbeneficial treatment" in the ICU.  It's written by Todd Gilmer, Lawrence J. Schneiderman, Holly Teetzel, Jeffrey Blustein, Kathleen Briggs, Felicia Cohn, Ronald Cranford, Daniel Dugan, Glen Komatsu and Ernlé Young; here's the abstract:

Ethics consultations have been shown to reduce the use of "nonbeneficial treatments," defined as life-sustaining treatments delivered to patients who ultimately did not survive to hospital discharge, when treatment conflicts occurred in the adult intensive care unit (ICU). In this paper we estimated the costs of nonbeneficial treatment using the results from a randomized trial of ethics consultations. We found that ethics consultations were associated with reductions in hospital days and treatment costs among patients who did not survive to hospital discharge. We conclude that consultations resolved conflicts that would have inappropriately prolonged nonbeneficial or unwanted treatments in the ICU instead of focusing on more appropriate comfort care.

The journal is also running two "Perspectives" commentaries on the lead article:

• The Prognosis For Changes In End-Of-Life Care After The Schiavo Case (abstract) by Lindsay A. Hampson and Ezekiel J. Emanuel:
  • Americans have reached consensus that (1) people have a right to refuse life-sustaining medical interventions, and (2) interventions that can be terminated include artificial nutrition and hydration. The one unresolved issue is how to decide for mentally incompetent patients. Only about 20 percent of Americans have completed living wills, and data show that family members are poor at predicting patients’ wishes for life-sustaining care. But despite court cases and national consensus that these are private and not legislative matters, the Schiavo case is unlikely to change practices except to increase the number of Americans who complete living wills.
• Terri Schiavo, Son Hudson, And ‘Nonbeneficial’ Medical Treatments (abstract) by Robert M. Veatch:
  • Two disputed cases about withholding life support (Terri Schiavo and Son Hudson) call for greater public discussion. Confusion arises from intermixing three kinds of cases: those (1) in which demanded treatment is physiologically futile, (2) involving competition for scarce resources, and (3) in which the treatment would likely achieve the patient’s goals although the clinician perceives those goals to be valueless. This Perspective argues that clinicians should unilaterally refuse the first but do not have legitimate roles in blocking access to the second and third. Absent scarcity, patients should have access to effective life-prolonging treatments even if clinicians see no value in them. 

Although the principal study chose a fairly conservative definition for "nonbeneficial treatment" (patient failed to survive to discharge from hospital), Professor Veatch in particular provides an important caution against using the term as a basis for overriding families' choices simply because the treating physician rejects their goals for treatment.  These articles are important contributions to the literature.  [tm]

John Roberts and Disability Law

Sam Bagenstos of the Disability Law Blog (a very informative and interesting blog) found a brief discussion on Judge John Roberts and his views on disability law.  Professor Bagenstos quotes the important part of that article as saying,

President Bush's nomination of John G. Roberts Jr. to the Supreme Court should concern people who care about disability rights. If he is confirmed, Roberts is likely to cast the swing vote against the ADA and disability rights.

Professor Bagenstos is not sure that this statement is correct given our limited knowledge of Judge John Roberts.  I must admit, I am becoming a little concerned about the Judge's nomination based on this Jonathan Turley L.A. Times piece and this flap over Federalist society membership.  [bm]