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.

Medicare Actuary Gives Wanted Data to Congress.

The NY Times reports today that on Friday Richard Foster turned over the data that shows the actual projected costs of the Medicare reform law signed into law last fall by Pres. Bush, months after it had been requested by Congress, after being ordered (Foster claims) not to give Congress the data before it voted. An inquiry is planned into Tom Scully's alleged role in plying Congress with incomplete (i.e., incorrect) data. Other inquiries are pending concerning the Bush Administration's phony ad campaign, which may have violated federal law, and allegations that lawmakers were bribed to vote for the reform package. Links to earlier stories are here and here.

"F"-word illegal on broadcast airwaves (can cable be far behind?) . . .

. . . or, "Farewell, Tony Soprano. It was fun while it lasted."

WARNING: Mature Content Follows. Read at your own risk.

The FCC handed down its decision Thursday in the case of the NBC stations' broadcast of the Golden Globes Awards in January 2003, at which Bono (lead singer for U2) accepted his award with the immortal words, "This is really, really, fucking brilliant. Really, really great." The Enforcement Bureau dismissed the numerous complaints filed against this broadcast because, the Bureau reasoned, "the material was not obscene or indecent, finding in particular with respect to indecency that the language used by Bono did not describe, in context, sexual or excretory organs or activities and that the utterance was fleeting and isolated." The FCC reversed, holding that fuck is always indecent or obscene:

"use of the phrase at issue is within the scope of our indecency definition because it does depict or describe sexual activities. We recognize NBC’s argument that the 'FWord' here was used 'as an intensifier.' Nevertheless, we believe that, given the core meaning of the 'F-Word,' any use of that word or a variation, in any context, inherently has a sexual connotation, and therefore falls within the first prong of our indecency definition. This conclusion is consistent with the Commission’s original Pacifica decision, affirmed by the Supreme Court, in which the Commission held that the 'F-Word' does depict or describe sexual activities."

The Commission also found fuck to be profane:

We also find, as an independent ground, that the use of the phrase at issue here in the context and at the time of day here constitutes “profane” language under 18 U.S.C. § 1464. The term “profanity” is commonly defined as “vulgar, irreverent, or coarse language.”34 The Seventh Circuit, in its most recent decision defining “profane” under section 1464, stated that the term is “construable as denoting certain of those personally reviling epithets naturally tending to provoke violent resentment or denoting language so grossly offensive to members of the public who actually hear it as to amount to a nuisance.”35 We find that the broadcast of the phrase at issue here in the context and at the time of day qualifies as “profane” under the Seventh Circuit nuisance rationale.36 Use of the “F-Word” in the context at issue here is also clearly the kind of vulgar and coarse language that is commonly understood to fall within the definition of “profanity.”

Can this definition of "profane" can survive First Amendment scrutiny?

I have a hard time arguing that Bono should be able to say fuck whenever and wherever he wants. It doesn't bother me terribly that the FCC wants to keep the broadcast airwaves free of such crudity. But the FCC's reasoning is off: the Enforcement Bureau was right to focus on the lack of any sexual context and the fleeting, inadvertent, unscripted nature of Bono's use. And where does this end? With 7-second delays on all football games and tennis matches so that the excited utterances of linemen and McEnroe wannabe's will be cleansed from our ears? For the time being, cable is exempt from this ruling, but there appears to be no reason in law why cable franchises can't be held to the same standard as broadcasters. That would seem to be the message from the Court in Denver Area Educational Telecommunications Consortium, Inc., et al. v. Federal Communications Commission et al. ("Cable television broadcasting, including access channel broadcasting, is as 'ccessible to children' as over the air broadcasting, if not more so. Cable television systems, including access channels, 'have established a uniquely pervasive presence in the lives of all Americans.' 'Patently offensive' material from these stations can 'confron[t] the citizen' in the 'privacy of the home with little or no prior warning.'")

Cleaning up the airwaves so that those who want to avoid crude speech and images is a fine goal. But it should be done in a manner that does not throw out the baby with the bathwater. The FCC's opinion in this case has no limiting principal and no handrail for the slippery slope to censorship of all artistic expression (yes, including the artistic use of fuck).

Scalia responds to recusal motion: fuggeddaboudit!

His 21-pg. memorandum explaining why he won't recuse is here. Instant pundits can be expected to opine that any recusal suggestion (or motion, as this was styled) that takes 21 pages to be denied is a recusal suggestion that should be granted. No fan of Justice Scalia's legal positions, I have to concede that he makes a very good argument for staying in the case. Not only are many of the media's facts wrong, but many institutional considerations counsel more strongly against recusal than for it. Not that it should matter to anyone, but I'm satisfied.

For my Con Law students, there is an interesting passage in Scalia's memo about two previous, well-known occasions when a Justice accepted the hospitality of the President while a case that was important to the President was pending before the Court. One example was "Whizzer" White's ski vacation in Colorado with Attorney General Bobby Kennedy's family at a time when two cases were pending in which Kennedy was a named party and a third case was pending in which the AG argued the case himself. (White didn't recuse himself.) The second occasion involved Wickard v. Filburn, a seminal Commerce Clause case that we will be discussing in class on Monday:

Justice Jackson and Franklin Roosevelt

The second example pertains to a Justice who was one of the most distinguished occupants of the seat to which I was appointed, Robert Jackson. Justice Jackson took the recusal obligation particularly seriously. See, e.g., Jewell Ridge Coal Corp. v. United Mine Workers, 325 U. S. 897 (1945) (Jackson, J., concurring in denial of rehearing) (oblique criticism of Justice Black’s decision not to recuse himself from a case argued by his former law partner). Nonetheless, he saw nothing wrong with maintaining a close personal relationship, and engaging in “quite fre-quen[t]” socializing with the President whose administra-tion’s acts came before him regularly. R. Jackson, That Man: An Insider’s Portrait of Franklin D. Roosevelt 74 (J. Barrett ed. 2003). In April 1942, the two “spent a weekend on a very delightful house party down at General Watson’s in Charlottesville, Virginia. I had been invited to ride down with the President and to ride back with him.” Id., at 106 (footnote omitted). Pending at the time, and argued the next month, was one of the most important cases concerning the scope of permissible federal action under the Commerce Clause, Wickard v. Filburn, 317 U. S. 111 (1942). Justice Jackson wrote the opinion for the Court. Roosevelt’s Secretary of Agriculture, rather than Roosevelt himself, was the named federal officer in the case, but there is no doubt that it was important to the President.

I see nothing wrong about Justice White’s and Justice Jackson’s socializing—including vacationing and accepting rides—with their friends. Nor, seemingly, did anyone else at the time. (The Denver Post, which has been critical of me, reported the White-Kennedy-McNamara skiing vacation with nothing but enthusiasm.) If friendship is basis for recusal (as it assuredly is when friends are sued personally) then activity which suggests close friendship must be avoided. But if friendship is no basis for recusal (as it is not in official-capacity suits) social contacts that do no more than evidence that friendship suggest no impropriety whatever. Of course it can be claimed (as some editorials have claimed) that “times have changed,” and what was once considered proper—even as recently as Byron White’s day—is no longer so. That may be true with regard to the earlier rare phenomenon of a Supreme Court Justice’s serving as advisor and confidant to the President—though that activity, so incompatible with the separation of powers, was not widely known when it was occurring, and can hardly be said to have been generally approved before it was properly abandoned. But the well-known and constant practice of Justices’ enjoying friendship and social intercourse with Members of Congress and officers of the Executive Branch has not been abandoned, and ought not to be.

Volunteers in Medicine Institute

A former student is working (pro bono, of course) to help set up a free medical clinic in a Dallas suburb. The hope is that by creating a clinic that can deal with the primary-care needs of the uninsured, they can take some of the pressure (and expense) off local emergency rooms, which are struggling to meet their EMTALA (anti-dumping) obligation to provide a appropriate medical screening for all who come to their emergency departments seeking emergency care and still have the resources needed to treat the true emergencies who come through the door. Their model is the Volunteers in Medicine Institute that sprang up on Hilton Head Island a few years back. The idea is that retired medical, nursing, and dental professionals could be organized into a free community clinic. According to their web page:

Volunteers in Medicine (VIM) began in Hilton Head, South Carolina. In 1992, one out of three people who lived on Hilton Head Island had no access to health care. At the same time, a number of retired medical personnel (physicians, nurses, dentists) began expressing an interest in finding a way to continue practicing their profession on a voluntary, part-time basis to help those without access to care.
So in 1993, we brought these two groups together and created the Volunteers in Medicine Clinic, a 501 (c)(3) free health clinic utilizing retired health care professionals.

The response from the medical community was extraordinary: 55 physicians, 64 nurses, and 15 dentists were recruited, all of whom were retired. They tell us this is what they always wanted to do: to be able to practice their professions in a "hassle-free" environment.

Presently in the U.S., there are 160,000 retired physicians, 350,000 nurses, and 40,000 dentists. Most are looking for a meaningful way to spend their retirement. Not only do many retired medical professionals still want to practice, they need to practice. Serving those in need is as therapeutic for the caregiver as it is for the care recipient.

There are undoubtedly legal issues out the wazoo that would need to be addressed before such a clinic could be launched, but it's certainly a win-win-win solution for the patients, the retired professionals, and their community.

DOD funds Swedish stem cell study.

Reuters and others reported Wednesday that the Department of Defense was awarding $240,000 in research grant money to Swedish researchers looking for a treatment for Parkinson's and similar illnesses. As long as the stem cell lines involved in the study were in existence before the Pres. Bush's August 2001 announcement of federal stem-cell funding policy, nothing would appear to be amiss in this grant. None of the reports have anything on this angle, but I'll keep monitoring the stories . . .

Lots of new stuff on the political intrigue surrounding the Medicare reform bill.

The Times is really working this story. Here's what is in Thursday's issue:

A story by Sheryl Gay Stolberg and Robert Pear on "a mysterious fax" received a House Democratic health policy aide (Cybele Bjorklund) that showed the CMS chief actuary's (Richard Foster's) real cost estimate for the reform bill:

Dated June 11, 2003, the document put the cost at $551.5 billion over 10 years. It appeared to confirm what Ms. Bjorklund and her bosses on the House Ways and Means Committee had long suspected: the actuary, Richard S. Foster, had concluded the legislation would be far more expensive than Congress's $400 billion estimate — and had kept quiet while lawmakers voted on the bill and President Bush signed it into law.

Ms. Bjorklund had been pressing Mr. Foster for his numbers since June. When he refused, telling her he could be fired, she said, she confronted his boss, Thomas A. Scully, then the Medicare administrator. "If Rick Foster gives that to you," Ms. Bjorklund remembered Mr. Scully telling her, "I'll fire him so fast his head will spin." Mr. Scully denies making such threats.

The Wall Street Journal reported on Wednesday that the White House supported an inquiry into whether Tom Scully pressured Foster to keep mum, which Scott McClellan described as "[o]bviously . . . a serious allegation."

Another story by Ms. Stolberg reporting that "[t]he House ethics committee voted on Wednesday to start a formal investigation into accusations of bribery surrounding last November's vote on the Medicare prescription drug law, signaling that an initial fact-finding inquiry might have produced evidence of wrongdoing":

The panel, formally known as the Committee on Standards of Official Conduct, met behind closed doors. Afterward, it issued a statement saying it had established an investigative subcommittee to conduct "a full and complete inquiry" into the bribery claims. The accusations were made by Representative Nick Smith, Republican of Michigan, described in the Washington Post on Thursday as "a relatively obscure sixth-term House member who will retire this year, [and who] was the subject of intense lobbying on the House floor in the predawn hours of Nov. 22, as GOP leaders sought the last few votes they needed to pass a bill adding prescription drug coverage to Medicare."

Beyond Human (President' Council on Bioethics).

In his recent article for Slate, Carl Elliott notes:

Leon Kass, the University of Chicago social theorist and bioethicist, has had the misfortune to chair the President's Council on Bioethics under a man who inspires more revulsion among academics than any president since Richard Nixon. Last week, 170 academic bioethicists sent a petition to President Bush protesting the dismissal of two members of the council, the cell biologist Elizabeth Blackburn and the ethicist William May. . . . Blackburn had told the press she was dismissed because she clashed with Kass, and ethicists have been quick to assume that the two members were dismissed for ideological reasons. Perhaps it is a sign of our strange, politically charged times that the composition of the council can generate protests and petitions from bioethicists while its actual work has been largely ignored.

This is a shame. The council, which was formed in 2001 to advise the president on ethical issues surrounding medicine and biotechnology, has recently published the findings of a two-year project in a report titled Beyond Therapy: Biotechnology and the Pursuit of Happiness. As the title suggests, the report concerns the use of drugs and surgery that not only make sick people well but make well people better than well. Americans take Paxil for shyness, Provigil for sleepiness, Adderall for poor concentration, Ativan for anxiety, Humatrope for short stature, Propecia for baldness, Xenical for obesity, beta blockers for stage fright, designer steroids for poor athletic performance, and Viagra for poor sexual performance—and that's not even counting the possible future technologies on the table, from memory managers to genetic enhancement to longevity drugs. Beyond Therapy asks not whether it is right or wrong to use such technologies, but rather, what are the implications of these technologies, what will they mean for us "as individuals, as members of American society, and as human beings eager to live well in an age of biotechnology"? . . . .

The truly striking thing about Beyond Therapy is how just radically at odds it is with mainstream American culture, right and left alike. The report is skeptical of America's faith in technology, worried about America's radical individualism, alarmed at the transformation of medicine from a profession into a business, and deeply concerned about the role of the market in driving the demand for new medical technologies. Beyond Therapy may not please many bioethicists, but neither will it please the libertarian or the business-conservative wings of the Republican Party. When was the last time you heard a Republican complain, as the council does, that the pharmaceutical industry is expanding diagnostic categories as a way of selling drugs or express concern that it "can manufacture desire as readily as it can manufacture pills"? As much as it pains me to admit that anything worthwhile could come from a council appointed by the Bush administration, Beyond Therapy is a remarkable document: gracefully written, thoroughly researched, ideologically balanced, and philosophically astute. It will be a benchmark for all future work on the topic.

Elliott has a valid point. It is hard to pidgeonhole the Commission and its work. As I wrote the other day about Being Human (now out of print because of extremely high demand and copyright limitations that prevent the Council from ordering more copies), the Commission's work can be ambitious and subtle.