Godsend Institute.

If you want to see a movie promotion site that is over the top, but fascinating, check out the site for the new DeNiro move, Godsend.

Infectious disease . . . and the duty to treat: what are the limits?

I recently did a piece for the Pediatric Infectious Disease Journal on the duty (and the limits to that duty) of health care professionals to respond to an infectious disease even at a considerable risk to the responder. Today's N.Y. Times Magazine has an article that does a nice job of the epidemiology and the ethics issues related to it.

Health care and IT.

Steve Pearlstein has a good piece in today's Washington Post on the failure, so far, of the health care sector to jump on the information-technology bandwagon (resulting in much waste and worse: avoidable death and injury). His analysis of the problem seems right on the money:

So why has health care almost uniquely failed to invest in IT? First, the industry remains fragmented, with few entities big enough to make the necessary sizable upfront investment. Even in cases where hospitals or doctors' practices might be large enough, the economic incentives are pretty weak. In an industry in which service providers are still paid largely on the basis of how much they do, investing in systems that would help reduce the number of tests and procedures isn't the most obvious way to boost incomes.

The networked quality of the health care industry, with independent doctors, hospitals, labs and pharmacies all providing services to the same patient, also discourages IT investment. Any economic gains wouldn't be fully captured by the entity making the investment, but would be likely to leak out to other providers or the insurer. And because the big payoff from such investments comes only after lots of other enterprises install the same system and make it possible for information to be easily shared, there's little incentive to be first.

Finally, there are the doctors, who still pretty much control the health care system and, up to now, have resisted anything that threatens to increase their workload, change the way they practice or limit their medical discretion. It is no coincidence that some of the earliest successes have come at Veterans Affairs hospitals, where doctors are salaried employees.

All of this raises an obvious question: what can the government do, through Medicare conditions of participation and through changes in reimbursement, to encourage the transition to a safer and more efficient system?

HR 3108 signed into law

As stated by the White House Press Secretary, the President signed into law the pension law discussed here earlier today and yesterday, which includes the provision that purports to -- but may not quite -- kill the antitrust challenge to the resident match program.

April 10, 2004
STATEMENT BY THE PRESS SECRETARY

On Saturday, April 10, 2004, the President signed into law:
H.R. 3108, the 'Pension Funding Equity Act of 2004,' which establishes a two-year temporary replacement of the benchmark interest rate for determining funding liabilities of private sector pension plans; establishes temporary alternative minimum funding requirements for certain underfunded pension plans; and allows certain multiemployer plans to temporarily delay the amortization of specified losses.

Parkland's not the only one . . . .

According to a story in today's N.Y. Times, the Westchester County government has created a committee to monitor the public county hospital's weak finances. Though the losses appear to be much greater in Westchester than in Dallas, the political rhetoric is familiar:

The new "financial improvement committee" will give county officials greater power and control over the beleaguered medical center, which was once operated by the county but was spun off into a public-benefit corporation in 1997. Though Westchester has little direct control over the hospital corporation, the county is ultimately liable for its debts.

After the corporation posted two straight years of deficits totaling nearly $140 million, Westchester officials told hospital officials to set up the oversight committee or risk losing county financing.

"It gives us an ability to watch what goes on," said Bill Ryan, the chairman of the Westchester Legislature and a member of the committee. "We can't accept business as usual. There's been a tremendous failure over there over six years."

More on the pension bill that may kill the antitrust challenge to The Match.

AP has picked up the story that first appeared yesterday in Modern Healthcare. There seems to be some confusion as to whether the about-to-become-public-law would actually apply to the pending lawsuit, in light of its statement that "Nothing in this section shall be construed to exempt from the antitrust laws any agreement on the part of 2 or more graduate medical education programs to fix the amount of the stipend or other benefits received by students participating in such programs." Predictably, plaintiffs' counsel alleges that his complaint states just that: a price-fixing claim. You be the judge and read the complaint. There certainly are allegations that the participants in the match "fixed" resident compensation, and www.savetheresidents.com believes their complaint will survive:

First, the legislation contains an explicit exception stating that it does not apply to price-fixing claims and Judge Paul Friedman noted in a recent ruling that plaintiffs have brought such a claim. Senators Bingaman and Feingold both noted on the Senate floor that the legislation does not apply to the residents' lawsuit.

Second, any legislation depriving tens of thousands of medical residents of the same antitrust protections enjoyed by all other Americans would be unconstitutional. At stake are not only the constitutional rights of medical residents, but the rights of workers in all other industries where employers have the political clout to force unfair wages through price-fixing and cover it up with secretive, insulating legislation.

Despite the experience of Sen. Bingaman's wife, Anne, in heading the Antitrust Division of DOJ during the Clinton Administration, Bingaman's and Feingold's comments may not amount to much, considering their opposition to the inclusion of this provision in the pension bill. But they do have a point . . . .

In the district court's opinion (undated, but handed down Feb. 21, 2004), the court noted (beginning at p. 60) that "Plaintiffs raise one claim of price-fixing against all defendants under Section 1 of the Sherman Act." In response to motions to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim, the court wrote that it "concludes that plaintiffs adequately have alleged a common agreement to displace competition in the recruitment, hiring, employment and compensation of resident physicians and to impose a scheme of restraints, which have the purpose and effect of fixing, artificially depressing, standardizing and stabilizing resident physician compensation and other terms of employment among a number of the named organizational defendants and those institutional defendants that participated in the Match Program."

Antitrust challenge to the residency match may be about to bite the dust.

Modern Healthcare is reporting that a Conference Committee-added provision of "the Pension Funding Equity Act [H.R. 3108] could end a 2-year-old antitrust challenge of the National Resident Matching Program. . . . President Bush is expected to sign the bill into law next week."

The law was passed by Congress on Thursday. The last-minute provision -- Section 207 -- exempts residency matching programs and sponsors from antitrust laws, other than for price-fixing claims:

SEC. 207. CONFIRMATION OF ANTITRUST STATUS OF GRADUATE MEDICAL RESIDENT MATCHING PROGRAMS.
(a) FINDINGS AND PURPOSES-

(1) FINDINGS- Congress makes the following findings:

(A) For over 50 years, most United States medical school seniors and the large majority of graduate medical education programs (popularly known as `residency programs') have chosen to use a matching program to match medical students with residency programs to which they have applied. These matching programs have been an integral part of an educational system that has produced the finest physicians and medical researchers in the world.

(B) Before such matching programs were instituted, medical students often felt pressure, at an unreasonably early stage of their medical education, to seek admission to, and accept offers from, residency programs. As a result, medical students often made binding commitments before they were in a position to make an informed decision about a medical specialty or a residency program and before residency programs could make an informed assessment of students' qualifications. This situation was inefficient, chaotic, and unfair and it often led to placements that did not serve the interests of either medical students or residency programs.

(C) The original matching program, now operated by the independent non-profit National Resident Matching Program and popularly known as `the Match', was developed and implemented more than 50 years ago in response to widespread student complaints about the prior process. This Program includes on its board of directors individuals nominated by medical student organizations as well as by major medical education and hospital associations.

(D) The Match uses a computerized mathematical algorithm, as students had recommended, to analyze the preferences of students and residency programs and match students with their highest preferences from among the available positions in residency programs that listed them. Students thus obtain a residency position in the most highly ranked program on their list that has ranked them sufficiently high among its preferences. Each year, about 85 percent of participating United States medical students secure a place in one of their top 3 residency program choices.

(E) Antitrust lawsuits challenging the matching process, regardless of their merit or lack thereof, have the potential to undermine this highly efficient, pro-competitive, and long-standing process. The costs of defending such litigation would divert the scarce resources of our country's teaching hospitals and medical schools from their crucial missions of patient care, physician training, and medical research. In addition, such costs may lead to abandonment of the matching process, which has effectively served the interests of medical students, teaching hospitals, and patients for over half a century.

(2) PURPOSES- It is the purpose of this section to--

(A) confirm that the antitrust laws do not prohibit sponsoring, conducting, or participating in a graduate medical education residency matching program, or agreeing to do so; and

(B) ensure that those who sponsor, conduct or participate in such matching programs are not subjected to the burden and expense of defending against litigation that challenges such matching programs under the antitrust laws.

(b) APPLICATION OF ANTITRUST LAWS TO GRADUATE MEDICAL EDUCATION RESIDENCY MATCHING PROGRAMS-

(1) DEFINITIONS- In this subsection:

(A) ANTITRUST LAWS- The term `antitrust laws'--

(i) has the meaning given such term in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12(a)), except that such term includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent such section 5 applies to unfair methods of competition; and

(ii) includes any State law similar to the laws referred to in clause (i).

(B) GRADUATE MEDICAL EDUCATION PROGRAM- The term `graduate medical education program' means--

(i) a residency program for the medical education and training of individuals following graduation from medical school;

(ii) a program, known as a specialty or subspecialty fellowship program, that provides more advanced training; and

(iii) an institution or organization that operates, sponsors or participates in such a program.

(C) GRADUATE MEDICAL EDUCATION RESIDENCY MATCHING PROGRAM- The term `graduate medical education residency matching program' means a program (such as those conducted by the National Resident Matching Program) that, in connection with the admission of students to graduate medical education programs, uses an algorithm and matching rules to match students in accordance with the preferences of students and the preferences of graduate medical education programs.

(D) STUDENT- The term `student' means any individual who seeks to be admitted to a graduate medical education program.

(2) CONFIRMATION OF ANTITRUST STATUS- It shall not be unlawful under the antitrust laws to sponsor, conduct, or participate in a graduate medical education residency matching program, or to agree to sponsor, conduct, or participate in such a program. Evidence of any of the conduct described in the preceding sentence shall not be admissible in Federal court to support any claim or action alleging a violation of the antitrust laws.

(3) APPLICABILITY- Nothing in this section shall be construed to exempt from the antitrust laws any agreement on the part of 2 or more graduate medical education programs to fix the amount of the stipend or other benefits received by students participating in such programs.

(c) EFFECTIVE DATE- This section shall take effect on the date of enactment of this Act, shall apply to conduct whether it occurs prior to, on, or after such date of enactment, and shall apply to all judicial and administrative actions or other proceedings pending on such date of enactment.

More on drugs: Reimportation.

Chuck Grassley can be a royal pain sometimes, but this time the Republican Senator from Iowa, may have done something useful. Yesterday, he introduced S. 2307, a bill entitled, "Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004." I thought this title confirmed that weird bill names have hit an all-time high (or low) until I read his press release on this and saw the bill title's acronym: REMEDIES. Cute. The printed bill hasn't made it to Thomas yet, but you should be able to click here in a couple of days and get it. Meanwhile, AHLA has a copy on their web site. Here's Grassley's description of the key provisions:

Overview of Key Elements of the REMEDIES Act of 2004

Legalizes reimportation (or importation) of prescription drugs from FDA approved exporters. To be approved, registered exporters must agree to meet safety requirements and to permit FDA inspectors on their premises full time to ensure compliance.

Creates a "fast-track" regulatory process for FDA to implement the importation system quickly.

Importation of qualified prescription drugs from Canada is immediately legalized while the new importation system is developed and implemented by FDA.

Under the new system, individuals, pharmacies, and drug wholesalers are permitted to legally import prescription drugs from registered foreign exporters:

o Individuals may order drugs from a registered exporter pursuant to a valid prescription issued by a U.S. doctor and filled by a pharmacist whose licensing requirements are equivalent to those required in the U.S. or by a dispensing pharmacist duly licensed by a state.
o Commercial shipments are permitted only to licensed pharmacists for resale directly to consumers and by drug wholesalers who can sell to pharmacies as they do today.

Drugs imported to U.S. pharmacies and drug wholesalers must be FDA approved drugs produced in the United States or in FDA inspected manufacturing facilities in other counties. FDA is required to provide the proper labeling for drugs for importation.

The FDA through its inspectors is responsible for tracing all drugs exported to the US back to their original manufacturing plant and ensuring that they have been stored and transported safely from that plant.

Individuals may also purchase drugs that are bioequivalent to FDA-approved brand name drugs that are produced by the same brand-name manufacturer.

o These drugs are drugs not technically approved by the FDA but the foreign government has approved the drug and that drug has the same active ingredient or ingredients as the FDA-approved drug and the same route of administration, dosage form, and strength.
o If a drug manufacturer believes, however, that the non-FDA approved drug is not bioequivalent to the FDA approved drug, then it must submit a petition to the FDA to show that (a) the differences result in a product that is not bioequivalent to the drug approved in the U.S., and (b) that such differences are due to scientifically and legally valid differences in the regulatory requirements of the U.S. and the country(ies) in which the apparently similar drug is marketed. The manufacturer is required to pay a user fee sufficient to cover the cost of the FDA's review of the petition and supporting documentation.

A User Fee charged to registered exporters provides the financing to provide the resources to FDA to ensure the safety of imported drugs.

o User fees charged to registered exporters would be sufficient to cover all costs including those incurred for inspection and verification within the United States, at the exporter's premises and any other location where the drugs have been stored prior to entry into the U.S.
o The FDA would be required to verify the source and inspect the intermediate handlers of all drugs intended for export into the United States.
o FDA would also be required to determine by a statistically significant sample that the recipients held valid prescriptions (individuals ordering 90-day supply or less) or verify that recipient was a licensed pharmacy that only dispensed drugs to individuals.

The FDA would also be required to supply valid U.S. labeling upon request of the registered exporter and affix or supervise the affixing of seals, markings or tracking technology that would inform border personnel that such imports were lawful to be entered as labeled.

Drugs not permitted for importation include controlled substances and certain other drugs not appropriate for importation because of storage, significant safety concerns, or drugs that are more likely to be counterfeited.

Provisions to Protect Safety of the Public:

Unauthorized imports would be treated as contraband and would be seized and destroyed upon entry without notice.

For the first two years, importation would be limited to Canada. The Department of Health and Human Services would submit a report to Congress in the second year, and unless Congress changed the law, countries from which importation is permitted would be expanded to include, the European Union, the European Free Trade Association, Japan, Australia, and New Zealand. Other countries meeting statutory criteria could also be added to the list by the Secretary.

The legislation continues to prohibit the import or reimport of drugs supplied free or at nominal cost to charitable or humanitarian organizations including the United Nations or a government of a foreign country.

Requires pedigrees from the manufacturer to the dispensing pharmacist for all prescription drugs sold within the U.S. or to an exporter authorized to export drugs into the U.S.

Requires the automatic suspension of an exporter's registration for any attempted entry of non-qualified or unsafe drugs with restricted ability to seek re-instatement in the future.

Requires that registered exporters submit to the jurisdiction of the U.S. federal court system and provides a mechanism for civil actions against the property of persons that import non-qualified drugs.

Repeals the provision in the Controlled Substances Act that permits the personal import of scheduled drugs, which is a significant source of illegal drug trade in the U.S. Tax Incentives for Manufacturers to Facilitate Reimportation

Incentive To Not Prevent Reimportation: Manufacturers that do not take any action, directly or indirectly, to prevent reimportation receive a 20% increase in R&D tax credit for that year.

Penalty For Preventing Reimportation: Manufacturers that take any action, directly or indirectly, to prevent authorized reimportation lose the business expense deduction for advertising expenses.

Drug costs redux.

Who knows? Maybe drug costs will be the leading edge of a health-care reform movement that drags the country, kicking and screaming, into universal coverage (maybe single-payer, but probably not). Lord knows we are working overtime trying to figure out how to make drugs affordable, or it least make it look as though we are trying to make drugs affordable.

The Medicare reform law last fall [Pub. L. No. 108-173] falls into that latter category: many Medicare beneficiaries will pay more out of pocket for their drugs than before this so-called reform, and their ability to lay off the risk through third-party insurance is restricted by the law. But the political message was, "Hi, we're Congress and we're here to help you with your staggering drug bills," and AARP and others bought it. (Tip: When the drug companies support a drug reform bill, hold on to your wallet.)

Maine has been experimenting with a plan to keep drug costs low for Medicaid beneficiaries, and despite being fought tooth and nail by the drug companies' representative, they had their law upheld in the Supreme Court last Term [PhRMA v. Walsh].

In addition, the on-going controversy over reimportation of drugs from Canada is a symptom of the lengths to which employers will go in order to lower sky-high drug costs, as well as the absurd lengths to which the FDA will sometimes go to promote the interests of Big Pharm. (Thankfully, this policy is currently under review, though nothing is expected to come of the review anytime soon.)

More recently, the Detroit Free Press reports in yesterday's paper that Michigan's drug price control law was upheld by the D.C. Circuit last week. The case, PhRMA v. Thompson, No. 02-5117 (D.C. Cir. April 2, 2004), affirmed summary judgment for DHHS, which had been sued by PhRMA for approving the Michigan plan ("the Initiative")"

Under the Initiative, if a drug manufacturer does not sign each of two specified rebate agreements with Michigan—one to provide rebates for drugs the state purchases for Medicaid recipients and the other to provide identical rebates for drugs the state purchases for the two non-Medicaid state health programs—the drug will be covered under the programs subject to ‘‘prior authorization.’’. . .

The court concluded that the resulting plan adequately promotes the best interests of patients and provides for a suitable appeal mechanism is a physician believes a nonlisted drug would be better for the patient than one of the discounted listed drugs.

Been down so long, it looks like up to me.

I'm not sure where the time goes sometimes, and it comes as a bit of shock that I haven't posted to this space in well over a week. The fact is, these puppies take some time to put together, and the last few weeks have been chockablock with writing and speechifying. Not that I expect any sympathy . . .

Since I've been gone:

DHHS' OIG has issued its long (long, long) awaited final Stark II, Phase 2 rule (albeit as an "interim final rule with comment period," which allows for the possibility of a final final rule), a mere 3 years and 3 months after the publication of the final Stark II, Phase 1 rule (available in three parts: 1, 2, 3) -- which allows for the possibility that the final final rule might appear in, say, June 2007. By the way, two omitted sections of the preamble were published in Tuesday's Federal Register.

DHHS also published an "OIG Alert" entitled "OIG ALERTS PHYSICIANS ABOUT ADDED CHARGES FOR COVERED SERVICES." This is a somewhat unhelpful title, but upon closer inspection, the alert addresses the situation of participating physicians (that is, physicians who agree to accept assignment for all Medicare patients) who charge their patients additional amounts for covered services. (The same problem would arise on a case-by-case basis if a physician charged extra for services provided to a patient for whom the physician agreed to accept assignment.) Everyone knows (or ought to know) that a physician who accepts assignment cannot "balance bill," but the alert seems to address a slightly different problem:

For example, the OIG recently alleged that a physician violated his assignment agreement when he presented to his patients -- including Medicare beneficiaries – a “Personal Health Care Medical Care Contract” asking patients to pay an annual fee of $600. While the physician characterized the services to be provided under the contract as “not covered” by Medicare, the OIG alleged that at least some of these contracted services were already covered and reimbursable by Medicare. Among other services offered under this contract were the “coordination of care with other providers,” “a comprehensive assessment and plan for optimum health,” and “extra time” spent on patient care. OIG alleged that based on the specific facts and circumstances of this case, at least some of these contracted services were already covered and reimbursable by Medicare. Therefore, OIG alleged that each contract presented to this physician’s Medicare patients constituted a request for payment for already covered services, other than the coinsurance and deductible, and was therefore a violation of the physician’s assignment agreement.

As I read it, this was a somewhat inept attempt to create a "boutique" or "concierge" practice with Medicare patients -- a topic I've addressed before, here and here.

It's nice to be back . . .

Medicare: belly up or double down?

The scary news out of DC last week was from the Medicare Board of Trustees, whose 2004 Annual Report predicted that the middle-class health insurance benefit for retirees and others would go belly-up by 2019. Ellen Beck of UPI did a nice job of analyzing the dire predictions, which are less dire than the Administration would like to have you believe. Paul Krugman of the N.Y. Times added a political perspective on why the Administration is pushing the insolvency button:

The trustees' report does, however, give one more reason to hate the prescription drug bill the administration rammed through Congress last year. If deception, intimidation, abuse of power and giveaways to drug companies aren't enough, it turns out that the bill also squanders taxpayer money on H.M.O.'s. . . .

But whether because of ideology or because of H.M.O. campaign contributions, the people now running the country refuse to learn that lesson. As part of last year's prescription drug bill, they tried again, offering an even bigger subsidy to private plans.

And that turns out to be an important reason for the deterioration in Medicare's prospects: of the seven years lopped off the life of the trust fund, two are the result of increased subsidies mandated by last year's law, mainly in the form of higher payments to H.M.O.'s.

So what did we learn this week? Social Security is in decent shape. Medicare has problems, but ill-conceived "reform" has only made those problems worse. And let's rip up that awful prescription drug bill and start over.

I hate to say 'I told you so,' but the consistent line from this blogger since last July has been that the R_x benefit was too expensive and not a sufficient benefit to those who need the help with their medications. Subsequent analysis and news have borne this out: (1) the true cost of the bill was intentionally underestimated by 25 percent and (2) the true beneficiaries of the bill are the pharmaceutical companies and the HMOs.

When (and how) will the Administration's chicaneries catch up to Dubya? Time will tell . . . . Speaking of chicaneries, check out this report: "United States House of Representatives, Committee on Government Reform -- Minority Staff Special Investigations Division (March 16, 2004): Iraq on the Record -- The Bush Administration's Public Statements on Iraq, prepared for Rep. Henry A. Waxman."

Seventh Circuit Court of Appeals Backs Privacy of Hospital Abortion Records

As reported by the N.Y. Times today, the US Court of Appeals for the Seventh Circuit (in Chicago) became the first appellate court to uphold the right of hospitals to refuse to turn over abortion information to the Bush Administration's Justice Department. The opinion is here. The district court quashed the government's subpoena for Northwestern's abortion records on the ground that HIPAA does not preempt state laws that provide greater privacy protection than does HIPAA. Since Illinois law is very restrictive about turning over medical records, even after identifying personal information has been redacted, the district court reasoned that state law survived HIPAA preemption and controlled the evidentiary question posed by the DOJ subpoena. The Court of Appeals affirmed the district court's order but disagreed with the lower court's reasoning. State privacy laws such as Illinois' do not provide evidentiary privileges in suits to enforce federal law (in this instance, DOJ claims that it needs the abortion information in order to enforce the federal law against partial-birth abortions). The Court of Appeals also rejected the district court's separate and independent basis for quashing the subpoena: a brand new, common-law privilege for abortion records:

He based this ruling on their sensitivity, which he compared to that of psychotherapists’ treatment records, held privileged in Jaffee v. Redmond, 518 U.S. 1 (1996). The creation of new common law evidentiary privileges is authorized by Fed. R. Evid. 501, and Jaffee is not the only recent case in which the authority was exercised. Goodyear Tire & Rubber Co. v. Chiles Power Supply, Inc., 332 F.3d 976, 979–81 (6th Cir. 2003); In re Air Crash Near Cali, Colombia, 959 F. Supp. 1529, 1533–35 (S.D. Fla. 1997), and United States v. Lowe, 948 F. Supp. 97, 99–100 (D. Mass. 1996), all created new privileges on the authority of Jaffee. But none relates to medical records and we are reluctant to embark on a case-by-case determination of the relative sensitivity of medical records of different ailments or procedures. Most medical records are sensitive, and many are as sensitive as late-term abortion records, such as the records of AIDS patients. Proceeding down the path taken by the district court would inevitably result in either arbitrary line drawing or the creation of an Illinois-type comprehensive privilege for medical records. Northwestern Memorial Hospital concedes that there is no federal common law physician-patient privilege. It is not for us—especially in so summary a proceeding as this litigation to quash the government’s subpoena—to create one, whether all at once or by a process of slow but inevitable additions to the sole category recognized by Jaffee.

The government wants abortion records on patients of doctors who are challenging the constitutionality of the Partial-Birth Abortion Ban Act of 2003, Pub. L. No. 108–105, 117 Stat. 1201, 18 U.S.C. § 1531, presumably to impeach them when they testify as medical experts in their own case. The Court of Appeals ultimately decided the burdens of production outweighed the benefits to the government:

What is true is that the administrative hardship of compliance would be modest. But it is not the only or the main hardship. The natural sensitivity that people feel about the disclosure of their medical records—the sensitivity that lies behind HIPAA—is amplified when the records are of a procedure that Congress has now declared to be a crime. Even if all the women whose records the government seeks know what “redacted” means, they are bound to be skeptical that redaction will conceal their identity from the world.

This is hardly a typical case in which medical records get drawn into a lawsuit. Reflecting the fierce emotions that thelong-running controversy over the morality and legality of abortion has made combustible, the Partial-Birth Abortion Ban Act and the litigation challenging its constitutionality—and even more so the rash of suits around the country in which the Department of Justice has been seeking the hospital records of abortion patients—have generated enormous publicity. These women must know that, and doubtless they are also aware that hostility to abortion has at times erupted into violence, including criminal obstruction of entry into abortion clinics, the firebombing of clinics, and the assassination of physicians who perform abortions. Some of these women will be afraid that when their redacted records are made a part of the trial record in New York, persons of their acquaintance, or skillful “Googlers,” sifting the information contained in the medical records concerning each patient’s medical and sex history, will put two and two together, “out” the 45 women, and thereby expose them to threats, humiliation, and obloquy. . . .

Even if there were no possibility that a patient’s identity might be learned from a redacted medical record, there would be an invasion of privacy. Imagine if nude pictures of a woman, uploaded to the Internet without her consent though without identifying her by name, were downloaded in a foreign country by people who will never meet her. She would still feel that her privacy had been invaded. The revelation of the intimate details contained in the record of a late-term abortion may inflict a similar wound.

If Northwestern Memorial Hospital cannot shield its abortion patients’ records from disclosure in judicial proceedings, moreover, the hospital will lose the confidence of its patients, and persons with sensitive medical conditions may be inclined to turn elsewhere for medical treatment. It is not as if the government were seeking medical records from every hospital and clinic that performs late-term abortions, in which event women wanting assurance against the disclosure of their records would have nowhere to turn. It is Dr. Hammond’s presence in the New York suit as plaintiff and expert that has resulted in the government’s subpoenaing Northwestern Memorial Hospital. . . .

The merits of the dispute are for determination at trial. The only issue for us is whether, given that there is a potential psychological cost to the hospital’s patients, and a potential lost in lost goodwill to the hospital itself, from the involuntary production of the medical records even as redacted, the cost is offset by the probative value of the records. The district judge presiding at the trial has said that the records are “relevant,” and no doubt they are—in the attenuated sense in which nonprivileged materials may be sought in discovery. “Relevant information need not be admissible at the trial if the discovery appears reasonably calculated to lead to the discovery of admissible evidence.” Fed. R. Civ. P. 26(b)(1); see Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 350–52 (1978); CSC Holdings, Inc. v. Redisi, 309 F.3d 988, 995–96 (7th Cir. 2002). The trial judge has not opined on the probative value of the records, which appears to be meager. . . .

The Partial-Birth Abortion Ban Act was passed, as we said, in response to the Supreme Court’s decision in the Stenberg case. Stenberg was one of a number of “first generation” partial-birth cases. . . .

Were the government sincerely interested in whether D & X abortions are ever medically indicated, one would have expected it to seek from Northwestern Memorial Hospital statistics summarizing the hospital’s experience with late-term abortions. Suppose the patients who undergo D & X abortions are identical in all material respects (age, health, number of weeks pregnant, and so on) to those who undergo procedures not forbidden by the Partial-Birth Abortion Ban Act. That would be potent evidence that the D & X procedure does not have a compelling health rationale. No such evidence has been sought, in contrast to the Planned Parenthood case, supra, at Transcript 26 (Mar. 5, 2004). A variant of the suggested approach would be to obtain a random sample of late-term abortion records from various sources and then determine, through good statistical analysis, whether the patient characteristics that lead Dr. Hammond to perform a D & X lead other physicians to perform a conventional D & E instead, and whether there are differences in the health consequences for these two groups of women. If there are no differences, the government might have a good defense of the Act. Gathering records from Hammond’s patients alone will not be useful; but if the government has other records (say, from VA hospitals) already in its files, then records of Hammond’s procedures might enable a useful comparison. The government hasn’t suggested doing anything like that either. Its motives in seeking individuals’ medical records remain thoroughly obscure.

The question whether the D & X procedure is ever medically indicated will be resolved as a matter of legislative fact not requiring the taking of trial-type testimony at all (see Hope Clinic v. Ryan, supra, 195 F.3d at 885 (dissenting opinion)), or will pivot on the clash of expert witnesses at the New York trial, or perhaps, as suggested in Stenberg, will be answered by some combination of these two approaches to determining facts. The medical records of expert witnesses are irrelevant to the first inquiry; and, so far as we can determine after having listened to the government’s arguments at length, those records will not figure significantly in the resolution of experts’ disagreements either.

The fact that quashing the subpoena comports with Illinois’ medical-records privilege is a final factor in favor of the district order’s action. As we held in Memorial Hospital for McHenry County v. Shadur, 664 F.2d 1058, 1061 (7th Cir. 1981), comity “impels federal courts to recognize state privileges where this can be accomplished at no substantial cost to federal substantive and procedural policy.” See also United States v. One Parcel of Property Located at 31–33 York Street, 930 F.2d 139, 141 (2d Cir. 1991) (per curiam). Patients, physicians, and hospitals in Illinois rely on Illinois’ strong policy of privacy of medical records. They cannot rely completely, for they are not entitled to count on the state privilege’s being applied in federal court. But in a case such as this in which, so far as we can determine, applying the privilege would not interfere significantly with federal proceedings, comity has required us not to apply the Illinois privilege, but to consider with special care the arguments for quashing the subpoena on the basis of relative hardship under Fed. R. Civ. P. 45(c).

The full opinion contains the suggestion -- hinted at rather than explicitly stated -- that the government's true motivation in seeking these records from hospitals across the country is harrassment -- of physicians and patients alike. The Court of Appeals may not have created a new common-law privilege, but it did the next best thing.

SCOTUS heard oral arguments in the Texas HMO case today.

As previously discussed here (Nov. 3 and Nov. 6), SCOTUS has two taken two Texas cases, both decided (with two others) in a single Fifth Circuit opinion. The cases involve tort claims under the Texas health care liability statute, which the HMOs argue is completely preempted by ERISA. Oral argument was today. My short piece in Mealey's Managed Care Liability Report is here (requires Lexis/Nexis account). The early report from Bloomberg News indicates that a majority of the Court appeared, in their comments and questions, to be leaning toward Aetna and Cigna and in favor of striking down Texas' health care liability law. The Associate Press' Anne Gearan agrees. I will post more news reports tomorrow and a link to the transcript as soon as it becomes available.

One Crucial Issue in Pledge Case: What Does "Under God" Mean?

In addition to this key question -- which Linda Greenhouse's article in today's NY Times summarizes nicely -- there is a tricky little standing question as well. Seems Michael Newdow, the plaintiff, isn't married to the student's mother and isn't the custodial parent, either. So does he have standing to sue the school district to stop the pledge? The briefs make fascinating reading (for students of standing law): petitioner school district, United States, Mike Newdow.

Law profs weigh in on Scalia's recusal decision.

Interesting piece in today's NY Times: 6 law profs grade Scalia's 21-page memorandum opinion denying the motion of the Sierra Club to recuse himself from the Cheney case. Ther's no actual grade or even conclusion, but reading between the lines, three seem to give a passing grade (Ed White, David Lubet, Ron Rotunda) and three give him an "F" (Monroe Freedman, Stephen Gillers, James Moliterno). Just like real law school . . .

More on Scalia's recusal refusal.

Much has been made in the days following Scalia's memorandum opinion denying Sierra Club's motion to recuse about "the appearance of impropriety or bias." I agree that appearances matter, and that Supreme Court justices should strive mightily to avoid even the appearance of impropriety or bias. But if "appearance" is what a well-oiled publicity machine can get a dozen editorial-page writers to agree with, then we've created a kind of "heckler's veto," and we will all reap the whirlwind if that becomes the standard for recusal.

It would have been better for us all, especially for Scalia and the Court, if he hadn't gone duck hunting with the Veep three weeks after the Court granted cert. in Cheney's case. If Scalia truly believes in his heart that this is not true, he has as tin an ear for appearances as he has been accused of having. But it did happen. And he explained it in as direct and forceful a manner as one could wish. Is there still an appearance of impropriety? Do you really believe that Scalia has left the impression that he might throw the case for Cheney?

A generation ago, conservatives mounted a witch hunt to get William O. Douglas off the Court. Liberals howled, even though Douglas probably gave his opponents more impeachment fodder to work with than Scalia ever will. Going after the scalps of justices whose positions we oppose may seem like sport, but it can be turned against justices whose positions we support in a heartbeat. And, regardless of whose ox is getting gored, the Court and the rest of us are the losers at the end of this game.

More on the "F-word"

The FCC can't have the last word, now, can it?

CMS issues guidance for exceptions to specialty-hospital moratorium.

The Centers for Medicare and Medicaid Services (CMS) announced Friday that it had issued a clarification of its "moratorium on physician investment in and referrals to certain specialty hospitals. Under the moratorium, a physician may not refer a patient to a specialty hospital in which he has an ownership or investment interest, and the hospital may not bill Medicare or any other entity for services provided as a result of a prohibited referral." The moratorium was required by last fall's Medicare reform act, "Medicare Prescription Drug, Improvement and Modernization Act of 2003" (MMA). (The moratorium provision begins on p. 230, sec. 507.)

For most transactional lawyers, the guidance probably comes a little too late to do their clients any real good, since the race was on last fall to get specialty hospitals "grandfathered" before the moratorium took effect on November 18, 2003. According to the press release, "The MMA also excludes from the moratorium (or grandfathers), hospitals that were in operation before or under development as of November 18, 2003. In determining whether a hospital was under development as of that date, the law instructs CMS to consider whether architectural plans were completed, funding was received, zoning requirements were met, and necessary approvals from appropriate State agencies were received. CMS can also consider additional evidence that would indicate whether a specialty hospital was under development."

Bush Medicare Reform Bill Become a Nightmare for GOP.

Excellent summary of the Medicare reform-law mess in today's Miami Herald. Up-to-date details on all pending investigations, and this observation:

But less than four months after he signed it into law on Dec. 8, Bush's Medicare-reform dream has turned into a nightmare and a potential drag on his bid for re-election.

-- The Bush administration deliberately didn't tell Congress that the measure could cost more than $100 billion more than advertised.

-- House Republican leaders abused House rules to push the measure to a narrow victory. There are also allegations of threats and bribes that are under investigation.

-- The Bush administration spent millions of taxpayer dollars on public service TV ads touting the Medicare reform law that look suspiciously like Bush campaign commercials. Those, too, are now under investigation.

-- Polls show that a majority of Americans don't like the Medicare reforms.

"It's something that's eating away at the credibility of the administration in an election year on a bill that he (Bush) thought was a building block for his re-election," said Stephen Hess, a political analyst for the Brookings Institution, a centrist think tank, and a former aide to President Eisenhower.

You can say that again. In fact, the NY Times did, in today's editorial: "Credibility is indeed at the heart of the matter — not only for the media, but also for an administration intent on spinning its way toward November."

Times editorial on administration's phony TV ads.

The Times ran an editorial today to make a point you would have thought did not to be made: that it's wrong for the government to create fake news clips -- replete with fake reporters ending their fake news stories with the fake signoff, "In Washington, I'm Karen Ryan reporting" -- so that gullible local news directors will run the tapes on the nightly news programs without realizing they are political ads masquerading as the real deal. Sure, there's a prankish air to the whole thing, but the GAO is reopening its investigation of the fraud to see if federal laws were violated by the perps in the Administration. This is less Dick Tuck-ish and a little more Orwellian than any of us should feel comfortable with.