HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Tuesday, November 23, 2004

Medicare Prescription Drug Plan - More Costly for Some

The Associated Press reports on a new independent analysis by the Kaiser Family Foundation that shows that the  Medicare Prescription Drug plan isn't saving everyone money.   Although approximately 19 million people will benetif from the new Medicare drug benefit, 10 million others will pay the same or more for their medications.

"The biggest winners are low-income Americans who will receive government assistance that is projected to reduce their drug spending by 83 percent when the drug insurance program begins in 2006, said the Kaiser Family Foundation. The poorest of these people would spend an average of $90 for medicines, said the study by Kaiser, a health care think tank.

The signature component of last year’s Medicare law, the prescription drug benefit will vary widely in its impact on the 29 million older and disabled Americans that the Congressional Budget Office projects will enroll, the study said. The CBO said the average savings will be 37 percent in 2006."

In response, the federal Centers for Medicare and Medicaid Services sent a four-page rebuttal of the report, claiming that it is flawed and tends to "understate savings and exaggerate the number of people who would pay more."

http://www.msnbc.msn.com/id/6559717/

November 23, 2004 | Permalink | Comments (4)

Monday, November 22, 2004

JAMA Editors Call for New Agency to Monitor Drugs

As the Vioxx issue continues to concern many Americans, the December 1st issue of JAMA contains six articles concerning the conflicts of interest that exist in the current method of drug approval and the need for better postmarketing  surveillance.  In an editorial entitled, Postmarketing Surveillance--Lack of Vigilance, Lack of Trust, several JAMA editors called for the creation of a new and independent group, separate from the FDA, to monitor drug safety after a drug have been released on the market.  They further call on Congress to provide the necessary funding for such an independent group.

A preview of the December 1st volume may be found at JAMA's website.  The New York Times provides a further brief report on these issues.

If you are interested in learning more about what JAMA might be publishing in the future, you can register at JAMA's website to receive the table of contents of upcoming issues via e-mail. 

November 22, 2004 | Permalink | Comments (0)

Medicinal Marijuana Update

The SCOTUSBLOG reports that the Acting Solicitor General Clement filed the Government's Reply Brief in Raich v. Ashcroft.  Oral argument has been scheduled for November 30th with Acting SG Clement arguing for the government, and Professor Randy Barnett (Boston University School of Law) arguing on behalf of the respondents. 

November 22, 2004 | Permalink | Comments (0)

Textbook Selection

Text For those of you that are trying to decide on a textbook for a Spring Health Law course, you might want to check out the new Health Care Law and Ethics books by Hall, Bobinski and Orentlicher.  Aspen Publishers has divided the longer text book into a three part set of shorter books that may be used for health law seminars and other health law classes that do not require the comprehensive coverage provided by the complete text.  The three texts are:  Bioethics and Public Health Law, Medical Liability and Treatment Relationships and The Law of Health Care Finance and Regulation.  As you are well aware, the Health lLaw:  Cases, Materials and Problems by Furrow, Greaney, Johnson, Jost and Schwartz has been published for a number of years in a series of shorter topical books.  Now, you have more choices in textbooks and can even mix and match your health law text selections.  Of course, there exist a variety of other health law texts on the market and I have tried a number of them in the quest to keep myself fresh and well-educated on a wide variety of health law topics and viewpoints.  Best of luck with your selection!

November 22, 2004 | Permalink | Comments (1)

Antitrust: ALJ Says Physician Group Unlawfully Conspired

Here's an item I meant to include last week, now back in my inbox today in the form of this helpful summary from AHLA's "Health Law Highlights":

In an initial decision announced November 16, an Administrative Law Judge (ALJ) upheld the Federal Trade Commission's (FTC's) complaint against a physicians' group alleging that the group conspired to fix prices in certain contracts its doctors entered into to provide medical services to the patients of health plans. According to the FTC, nearly all of North Texas Specialty Physicians' (NTSPs') participating physicians are parties to some non-risk contracts and that "[w]ith respect to these non-risk contracts, NTSP often has sought to negotiate for, and often has obtained, higher fees and other more advantageous terms than its individual physicians could obtain by negotiating individually with payors." In its decision, the ALJ stated that, "In this case, Complaint Counsel [FTC staff] has proven that Respondent [NTSP] engaged in horizontal price fixing through its negotiation, on behalf of its member physicians, of economic terms of non-risk contracts with health plan services for the provision of physician services."

The full text of the initial decision is here (PDF).  As reported in Modern Healthcare, North Texas Specialty Physicians "has been the only IPA to challenge the FTC in the agency's three-year, industrywide investigation of physician price-fixing, which so far has resulted in 20 consent decrees with physician organizations."  The other cases are summarized, beginning at page 7, in the FTC's publication, "FTC Antitrust Actions In Health Care Services and Products" (PDF).

November 22, 2004 | Permalink | Comments (0)

UNOS Opposes Advertising for Transplants

Not surprisingly, the United Network for Organ Sharing "is asking hospitals to discourage patients from advertising for donors and, if possible, to refuse to perform transplants that arise from these campaigns" (Newsday, Nov. 19).  As UNOS explained in its press release, "Most deceased organ donation takes place anonymously through the national organ distribution system. At times donors or donor families want to donate to a specific person they know, and we support that. But we strongly oppose public or private appeals that effectively put the needs of one candidate above all others and pose concerns of fairness. Transplant candidates rely on the public's trust in the fairness of the allocation system and support of that system through donation. Public appeals may jeopardize that trust."

The UNOS board was responding to news reports that "a Houston man, Todd Krampitz, bought a pair of billboards and gave a series of media interviews soliciting a liver donor. It worked: Someone died, and the person's family had heard about Krampitz and opted to donate directly to him.

"Normally, when people die their organs go to whomever is at the top of the waiting list, determined by many factors including who would obtain the greatest medical benefit from a transplant, who would die soonest without one, the locations of the patient and donor.

"'There's integrity to that. That process is public, it's transparent, it's accountable,' said Dr. Mark Fox, chairman of the network's ethics committee."

November 22, 2004 | Permalink | Comments (0)

Sunday, November 21, 2004

New Book on Anthrax Vaccine and the Military as Alleged Test Subjects

Interested in reading mysteries or possibly even conspiracy theories, Jon Cohen of Slate reviews the new book, Vaccine A:  The Covert Government Experiment That's Killing Our Soldiers - and Why GI's Are Only the First Victims, by Gary Matsumoto.  Mr. Cohen doesn't find the book convincing in its argument that the government deliberately tampered with the anthrax vaccine given to soldiers during the first Gulf War but states that it does provide an overview of some of the problems with the vaccine and the quick decision to use it on those soldiers shipping out to Iraq in the early 1990s. 

According to Mr. Cohen, in Vaccine A, Mr. Matsumoto alleges that the U.S. military's anthrax vaccine causes a constellation of autoimmune diseases and symptoms such as lupus, rashes, hair loss, and aching joints that fall under the rubric known as Gulf War Syndrome.  Mr. Matsumoto argues that the problems result from the military secretly spiking the vaccine with squalene, "a fat naturally found in the body that, when injected as part of a vaccine, supercharges the immune system's ability to make antibodies."  He further  "accuses the Department of Defense of slipping this experimental vaccine past the Food and Drug Administration and involving unwitting troops in a human test" that he "equates with Nazi experimentation and the infamous Tuskegee syphilis study." Mr. Cohen contends that Matsumoto's book fails to answer the question of why the military would subject its soldiers to such an experimental and potentially dangerous vaccine.   He also finds the book rather sloppily researched.  If you have an interest in vaccines and vaccine contamination,  Mr. Cohen recommends a different book on the polio vaccine and its early troubles.  In his conclusion, he states,

"Vaccine accidents do happen, they do get covered up, and they deserve close scrutiny. One of the most famous vaccine accidents is the contamination of the first polio vaccines with a monkey virus, and a new book on the accident by Debbie Bookchin and Jim Schumacher, The Virus and the Vaccine, has many parallels with Vaccine A. But the research in this book is meticulous, and Bookchin and Schumacher's tone is so measured and thoughtful that my mind opens to their controversial thesis (that the monkey virus accidentally injected into people through polio vaccines causes human cancers). I'm not convinced that the monkey virus does, in fact, cause harm, but I am convinced that the question merits serious attention. Matsumoto, in contrast, with his sloppy errors, remote possibilities trumped up as facts, and outright dismissal of evidence that doesn't support his thesis, leaves me groaning."

November 21, 2004 | Permalink | Comments (2)

Abortion Amendment Passes With Budget Bill.

As discussed here yesterday, the omnibus budget bill, H.R. 4818, contains an amendment to federal abortion law that has drawn the ire of 9 women senators and pro-choice advocacy groups.  As expected, the Senate adjourned (at 12:31 a.m. this morning) having taken one record vote, to approve the bill, 65-30.  The House had approved the spending bill (344-51) earlier in the day.

As reported by The Washington Post, "The abortion language remained in the spending bill, but late yesterday, Senate opponents agreed not to block its consideration after Senate Majority Leader Bill Frist (R-Tenn.) promised to schedule a vote in the near future on a bill drafted by Sen. Barbara Boxer (D-Calif.) to repeal the provision."  Even if Sen. Boxer's bill passes in the Senate, no-one gives the repeal effort much of a chance in the more conservative House.

November 21, 2004 | Permalink | Comments (0)

"Good Tissue Practice" Addressed by FDA

On Nov. 18, the FDA announced publication of "a final rule on current good tissue practice (GTP), the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls used to manufacture these products. With this final rule, FDA's efforts to establish a new, comprehensive, and risk-based approach to this promising and innovative field of medicine can be realized. The new approach will be fully implemented on May 25, 2005."  The final rule is here and will be published in the Federal Register soon. 

All tissue-related FDA documents are collected on this web page.  The FDA describes its previous final rules this way: "[T]he agency has published two final rules and one interim final rule to implement aspects of the proposed approach. On January 19, 2001, we issued regulations to create a new, unified system for registering HCT/P establishments and for listing their HCT/Ps (registration final rule, 66 FR 5447).  Part of the definition of 'human cells, tissues, or cellular or tissue-based products' became effective on January 21, 2004. On January 27, 2004 (69 FR 3823), we issued an interim final rule to except human dura mater and human heart valve allografts from the scope of that definition until all of the tissue rules became final. On May 25, 2004, we issued regulations requiring most cell and tissue donors to be tested and screened for relevant communicable diseases (donor-eligibility final rule, 69 FR 29786)."

November 21, 2004 | Permalink | Comments (0)

Saturday, November 20, 2004

Reasonable Accommodation for a Dolphin?

Just for fun, a heartwarming story about a dolphin and an artificial fin designed by Bridgestone.  What will they think of next?

November 20, 2004 | Permalink | Comments (0)

Med-Mal Reform Developments in 8 States

The Kaiser  Daily Health Policy Report recently published its review of recent med-mal reform developments in eight states. Here are the leads:

  • Florida: More than half of rural physicians over the past year have limited medical services, and most cited increasing medical malpractice premiums as a "key reason" for limiting service, according to a 2003 study published Monday in the Archives of Internal Medicine, the St. Petersburg Times reports. . . . Voters on Nov. 2 passed Amendment 7, which will allow patients in the state to review records of medical errors committed by physicians in medical facilities. Voters also approved Amendment 8, which will allow the revocation of the licenses of physicians who lose three malpractice lawsuits. In addition, Florida voters passed Amendment 3, which allows plaintiffs in malpractice lawsuits to retain 70% of the first $250,000 in damages awarded and 90% of damages awarded in excess of that amount.
  • Georgia: About 59% of state residents believe it is "very important" to pass a bill to limit medical malpractice insurance premiums, and 25% said such a bill is "somewhat important," according to a Georgia Hospital Association survey released Monday, the Florida Times-Union reports.
  • Maryland: While Democratic state lawmakers support taxing HMOs to "help defray the costs" for the Medical Mutual Liability Insurance Society of Maryland -- the medical malpractice insurer that covers about 75% of the state's private practice physicians -- Gov. Robert Ehrlich (R) has "vowed" not to raise taxes and said the state should consider drawing from its general funds to help pay malpractice insurers, the Washington Times reports.
  • Missouri: Medical malpractice claims fell to "a record low" in 2003, and total payouts to plaintiffs in malpractice cases dropped about 21%, according to a report released last week by the state Department of Insurance, the St. Louis Post-Dispatch reports.
  • Nevada: Voters in the state last week approved Question 3, a medical liability reform measure on the Nov. 2 statewide ballot, by a 59% to 41% margin, but physicians in the state "now must wait and see" whether the measure will reduce malpractice insurance premiums in the state, the Las Vegas Sun reports (Kanigher, Las Vegas Sun, 11/5).
  • Utah: The Utah Supreme Court on Friday upheld the $250,000 state cap on noneconomic damages in malpractice lawsuits in a case that involved a six-year-old boy with brain damage, the Salt Lake Tribune reports. In the case, a Utah jury awarded $1,250,000 in noneconomic damages to the parents of the boy, who experienced severe brain damage when a physician failed to deliver him with forceps, in addition to $22,735 for medical costs and $1 million for future expenses.  (NOTE: the case is Judd v. Drezga, 11/5/2004.)
  • Virginia: Physicians at the Medical Society of Virginia annual meeting last weekend launched a "White Coats on Call" campaign to promote medical liability reform, the Washington Times reports. According to outgoing MSV President Mitchell Miller, as many as 100 physicians daily will visit Richmond throughout the next session of the state Legislature to highlight the increased costs of malpractice insurance in the state (McElhatton, Washington Times, 11/8).
  • Wyoming: Voters in the state last week passed Amendment C, a medical liability reform measure on the Nov. 2 statewide ballot, but rejected Amendment D, a companion measure, resulting in a "split" that supporters maintain could limit the ability of the state Legislature to address the issue of high malpractice insurance premiums, the AP/Billings Gazette reports (Bohrer, AP/Billings Gazette, 11/4).

November 20, 2004 | Permalink | Comments (0)

Politics of Abortion Snags Spending Bill.

Conference negotiators are close to a deal on the Consolidated Appropriations Bill (H.R. 4818), an omnibus $388 billion spending package that is needed to keep the federal government running after midnight tonight.  One of the last issues to resolve is a rider that, according to the L.A. Times, "would make it easier for healthcare providers to refuse to provide abortions or abortion referrals."  Nine women senators (8 Democrats and Olympia Snowe (R-Me.)) wrote to Sen. Ted Stevens (R-Alaska), chairman of the Senate Appropriations Committee, voicing their opposition to the provision: "Should this provision become law, federal, state or local government may no longer require any institutional or individual healthcare provider to provide, pay for or refer abortion services. This will mean that medical providers in hospitals and clinics across the country will likely be victims of demonstrations and intimidation as this provision allows that they be forbidden from providing abortion care to women who need it, and also to deny women referrals to another provider."  (The full text of the senators' letter is on Sen. Diane Feinstein's web site (PDF).)

The paper also reports NARAL's opposition to the provision: "NARAL Pro-Choice America, an abortion rights group, also assailed the provision, contending that it would bar physicians at health maintenance organizations, for-profit hospitals and others from even talking to their patients about abortion. The group called the provision a 'backdoor gag rule.'"  (NARAL's press release is here.)

The provision itself is variously and confusingly described by parties for and against in a Washington Post article this morning: "Under the provision, sponsored by Rep. David Joseph Weldon (R-Fla.), state governments could lose federal funds if they were found to discriminate against any 'health care entity' that opts not to provide abortion services or referrals. Supporters of the change say it would protect Catholic hospitals and health insurers from 'harassment' by state officials. In a letter yesterday, the nine senators said it would expose abortion providers to more intimidation by antiabortion groups."

According to the ACLU web site, the "Federal Refusal Clause" -- which NARAL says has twice been inserted by the House into bills that have (until now) been rejected by the Senate -- is S.1397, which would amend 42 U.S.C. § 238n to read as follows [changes indicated in boldface]:

§ 238n. Abortion-related discrimination in governmental activities regarding training and licensing of physicians licensing, and practice of physicians and other health care entities

(a) In general
The Federal Government, and any State or local government that receives Federal financial assistance, may not subject any health care entity to discrimination on the basis that—
     (1) the entity refuses to undergo training in the performance of induced abortions, to require or provide such training, to perform such abortions to perform, provide coverage of, or pay for induced abortions, or to provide referrals for such training or such abortions;
     (2) the entity refuses to make arrangements for any of the activities specified in paragraph (1); or
     (3) the entity attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.

(b) Accreditation of postgraduate physician training programs
     (1) In general
In determining whether to grant a legal status to a health care entity (including a license or certificate), or to provide such entity with financial assistance, services or other benefits, the Federal Government, or any State or local government that receives Federal financial assistance, shall deem accredited any postgraduate physician training program that would be accredited but for the accrediting agency’s reliance upon an accreditation standards [1] that requires an entity to perform an induced abortion or require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training, regardless of whether such standard provides exceptions or exemptions. The government involved shall formulate such regulations or other mechanisms, or enter into such agreements with accrediting agencies, as are necessary to comply with this subsection.
     (2) Rules of construction
          (A) In general
With respect to subclauses (I) and (II) of section 292d (a)(2)(B)(i) of this title (relating to a program of insured loans for training in the health professions), the requirements in such subclauses regarding accredited internship or residency programs are subject to paragraph (1) of this subsection.
          (B) Exceptions
This section shall not—
               (i) prevent any health care entity from voluntarily electing to be trained, to train, or to arrange for training in the performance of, to perform, or to make referrals for induced abortions; or
               (ii) prevent an accrediting agency or a Federal, State or local government from establishing standards of medical competency applicable only to those individuals who have voluntarily elected to perform abortions.

(c) Definitions
For purposes of this section:
     (1) The term “financial assistance”, with respect to a government program, includes means governmental payments provided as reimbursement for carrying out health-related activities.
     (2) The term “health care entity” includes an individual physician or other health professional, a postgraduate physician training program, and a participant a participant in a program of training in the health professions , a hospital, a provider sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization or plan.
     (3) The term “postgraduate physician training program” includes a residency training program.

November 20, 2004 | Permalink | Comments (0)

More Nonprofits Sued Over Charity Care

Modern Healthcare reports that "Carolinas HealthCare System, Charlotte, N.C., and Wake Forest University Baptist Medical Center, Winston-Salem, N.C., were named in class-action lawsuits brought by uninsured patients who claim the providers charged them too much for care compared with what publicly and privately insured patients would have paid."  Although the suits are reportedly based on a breach-of-contract theory -- and thus may resemble class-action suits brought this summer by Richard Scruggs and attorneys working with him -- they are not listed on Scruggs' Not-For-Profit Hospital Class Action Litigation site.  Numerous "copycat" lawsuits have been filed since Scruggs' suits first started to appear, of which these may be two more.  (The Modern Healthcare site requires registration.)

November 20, 2004 | Permalink | Comments (0)

Friday, November 19, 2004

Kentucky Governor/Doctor - Problems with the Death Penalty

This is an interesting article about a dilemma that Governor Fletcher of Kentucky may face with respect to keeping his medical license and signing off on death warrants as the Governor of Kentucky.    Thanks for Professor Fred Harris for the article.

According to the Associated Press, Governor Fletcher, also a licensed Doctor, risks potentially losing his medical license.   The article states,
"When Gov. Ernie Fletcher signed a death warrant for a convicted killer this month, he may have done more than start the clock ticking on an execution. Some say Fletcher, a doctor, may have put his medical license at risk.

American Medical Association guidelines bar doctors from taking part, directly or indirectly, in executions. And Kentucky requires doctors to follow AMA ethical guidelines. . . .

A group of doctors is seeking an opinion from the Kentucky Board of Medical Licensure on whether Fletcher can sign death warrants without running the risk of having his medical license revoked. The board is not scheduled to take up the matter until at least January, and would not comment in the meantime."

The New York Times on Saturday November 20th, also has a further update discussing Governor Fletcher's potential problems fulfilling his Governorship duties as well as his duty to remain true to the guidelines controlling his medical license.

November 19, 2004 | Permalink | Comments (1)

Congressional Investigation of the Flu Vaccine Shortage

The following provides some informative links to recently released documents from Rep. Henry Waxman's office about what went wrong this year and in previous years with our flu vaccine supply. 

More than 1,000 pages of documents obtained by Rep. Henry Waxman (D-CA) reveal, in striking detail, "that despite being aware of major problems at the [Chiron] vaccine manufacturing facility as early as June 2003, [the Food and Drug Administration] missed repeated opportunities to correct them." (The Chiron facility was located in Liverpool, England,, but Chiron is a California company whose operations are regulated by the FDA.) Sixteen months later, British regulators shuttered the facility because of contamination problems and the United States was left with a massive flu vaccine shortage. The incident draws focus to bipartisan concerns about the impact of the Bush administration's personal and financial ties to the drug industry. Sen. Charles Grassley (R-IA) said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny. One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern."

Waxman staff summary of FDA docs at http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf

Washington Post story (Nov. 18th) quoting Grassley (above ) http://www.washingtonpost.com/ac2/wp-dyn/A58470-2004Nov17?language=printer

Highlights provided by the American Progress Fund in its Progress Report for

Nov. 18, 2004

. http://www.americanprogressaction.org/site/pp.asp?c=klLWJcP7H&b=83210

FDA VISITED PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION: In June 2003, the FDA inspected the plant and "found high levels of overall bacterial contamination." FDA inspectors, in some instances, "found records of bacteria concentrations that were more than a thousand times higher than inspected." The inspectors also "identified poor sanitary practices that could contaminate sterile parts of the production process." Significantly, the FDA found the company was not doing enough to correct the problems.

TOP OFFICIALS REJECT INSPECTORS' RECOMMENDATION FOR MANDATORY ACTION: The FDA team that visited the facility recommended official enforcement action

against the facility. That means issuing a warning letter to Chiron outlining the problems that must be fixed. If Chiron failed to fix the problems, the FDA could have initiated legal action against the company. Instead, FDA officials overruled the recommendation of inspectors and instead submitted a request for voluntary action by Chiron. 

FDA DELIVERS REPORT TO CHIRON NINE MONTHS LATE: Even when it recommends voluntary action, the FDA is "supposed to send the manufacturer the full inspection report to help the manufacturer understand what corrective actions are needed." The report wasn't sent to Chiron until a year later – June 2004 – nine months after it was supposed to have been sent. The biggest problem: by that time "manufacture of the 2004 vaccine supply was already well underway." Chiron requested a meeting with the FDA after the 2003 inspection, but the agency never granted the request.

FOR 16 MONTHS FDA DOESN'T INSPECT THE PLANT: For 16 months, the FDA failed to send inspectors to the plant to see if Chiron had fixed the problem. FDA Commissioner Lester Crawford "defended the decision not to send inspectors into the plant." Crawford claimed that occasional conference calls with the company were "a form of 're-inspection.'" (For more on the Chiron debacle, check out this column.)

CRAWFORD FALSELY CLAIMS THAT 2003 PROBLEMS WERE UNRELATED: At an Oct. 21 press conference, Lester Crawford claimed, "what happened in 2003 has no relevancy for 2004." That isn't true. When the FDA's own inspectors finally visited the facility last month – after it was shut down – they reported that at least three sources of contamination were "not corrected from [the] previous inspection of 2003."   

CRAWFORD SAID HE WOULD DO VIRTUALLY EVERYTHING THE SAME: The FDA's negligence has put the health of tens of millions of Americans at risk. But appearing before the House Reform Committee Crawford testified, "except for the late delivery of its full report, the FDA has done nothing wrong – and would do nothing differently if given the chance." Sound familiar?

November 19, 2004 | Permalink | Comments (0)

Thursday, November 18, 2004

DEA and the Treatment of Pain.

The DEA published its "Interim Policy Statement on Dispensing of Controlled Substances for the Treatment of Pain" in the Federal Register on Tuesday, November 16, 2004.  The link is here (PDF).

The DEA published a document on its website in August 2004 entitled "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel."  The DEA subsequently withdrew the document because it contained misstatements. This interim policy statement explains how some of the statements in the August 2004 document were erroneous. The DEA plans to address in a future Federal Register document the issue of dispensing controlled substances for the treatment of pain.

The three previous misstatements discussed in the interim policy statement involve the investigation of diversion behaviors, refills of Schedule II prescriptions, and reselling of controlled substances.  The DEA recommends that this interim policy statement be distributed to hospitals' outpatient pain management centers, emergency rooms, and other units of hospitals where controlled substances are ordered for the treatment of pain. It also recommends that an announcement of the interim policy statement should also be made in the next communication to the medical staff from the pharmacy department and generally as physicians in a variety of specialties prescribe controlled substances for the treatment of pain.   Thanks to Lew Lefko, of Haynes and Boone in Dallas, for bringing this notice to our attention.

November 18, 2004 | Permalink | Comments (2)

Tax-exempts and Political Activity.

On Friday, November 12, 2004, the IRS released a National Office Technical Advice Memorandum (TAM 2004-46-033) that addressed a payroll-deduction Politcal Action Committee arrangement established by a tax-exempt healthcare organization. According to the TAM, the entity "began an effort to make all . . . employees aware of their ability to participate in [the PAC] through payroll deduction.  During regularly scheduled meetings, department heads and the management . . . briefly discussed the Plan.  Managers were asked to develop a simple and efficient method of informing employees they had a right to participate . . . through payroll deduction. A video that featured [the Chairman of the Board of Trustees] explaining the impact of political input on the hospital industry was distributed to managers for use in communicating with employees.  Donation cards were made available to employees at the meetings and managers were encouraged to get a signed form from each employee, irrespective of the employee's decision to participate, in order to avoid duplicative efforts.  Employees were told that their participation in the Plan was strictly voluntary. The cards included an option to decline participation in the Plan."

The TAM concluded that the arrangement violates the political activity prohibition and triggers the § 4955 excise tax (10% tax on the amount of the political expenditures; and on the knowing agreement to make political expenditures, a 2-1/2% on the amount thereof).  A copy of this TAM is available on the AHLA website or the IRS website (PDF).

November 18, 2004 | Permalink | Comments (0)

Bills Address End-of-Life Care.

As reported in the Nov. 17 Bend (Ore.) Bugle, Sen. Ron Wyden (D. Ore.) has "introduced  two pieces of legislation Tuesday aimed at providing better care options for dying patients. . . .  The first Wyden bill, the Palliative Care Training Act, recognizes the need for a larger pool of health care professionals who know how to help terminally ill patients to have a better quality of life. The second bill, the Medicare Hospice Demonstration Act, seeks to test ways to improve the Medicare hospice benefit."  Neither bill is yet on Thomas or the senator's web page.  Wyden's press release on the bills is here.

November 18, 2004 | Permalink | Comments (0)

ADA Amendments from the National Council of Disability

On December 1, 2004, the National Council on Disability (NCD) will release its report Righting the ADA.  The report will contain NCD’s legislative proposal, entitled, “ADA Restoration Act.”   The NCD hopes that its proposal will restore the protections of the Americans with Disabilities Act that have been restricted by some of the recent ADA U.S. Supreme Court decisions.

If you cannot wait until December 1st, the NCD asks that you contact contact Mark Quigley or Julie Carroll at 202-272-2004 or 202-272-2074 TTY for further information. 

November 18, 2004 | Permalink | Comments (0)

Goody-Bye to the Employer-Sponsored Health Insurance Tax Deduction?

The Washington Post reports today on some of the President's plans for revising the tax code.   Although these are tentative, it does appear that some drastic changes are in store - including the elimination of the tax deduction for employer-sponsored health insurance.   The Post states,

"The Bush administration is eyeing an overhaul of the tax code that would drastically cut, if not eliminate, taxes on savings and investment, but it is unlikely to try to replace the existing tax code with a single flat income tax rate or a national sales tax, according to several sources familiar with ongoing tax deliberations.

During his reelection campaign, President Bush piqued interest among conservatives and liberals alike when he said replacing the income tax with a national sales tax was "an interesting idea." Just after the election he signaled that tax policy would be a centerpiece of his domestic agenda, reiterating his pledge to name a bipartisan panel to draft a fundamental tax reform proposal. That sent conservatives scurrying into either the flat tax or sales tax camp to muster political momentum.

But before the tax panel is even named, administration officials have begun dialing back expectations that they will move to scrap the current graduated income tax for another system.

Instead the administration plans to push major amendments that would shield interest, dividends and capitals gains from taxation, expand tax breaks for business investment and take other steps intended to simplify the system and encourage economic growth, according to several people who are advising the White House or are familiar with the deliberations.

The changes are meant to be revenue-neutral. To pay for them, the administration is considering eliminating the deduction of state and local taxes on federal income tax returns and scrapping the business tax deduction for employer-provided health insurance, the advisers said. "

I cannot believe that this would be acceptable to Congress but who knows . . . .  I don't seem to be able to predict anything in politics these days.

"To pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documentsTo pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documents."

November 18, 2004 | Permalink | Comments (0)