By Jennifer P. Viegas*
October 23, 2009
Feds Turn Over New Leaf on Medical Marijuana
The U.S. Department of Justice announced to federal prosecutors in the fourteen states that permit the medical use of marijuana that they generally should overlook that activity and spend their time and money on busting the big-time manufacturers and traffickers of marijuana and other drugs.
The new memorandum gives the U.S. attorneys discretion to choose whether to investigate and prosecute users and distributors of medical marijuana, but it is viewed as a departure from the government's antagonistic stance during the Bush administration.
The Department of Justice believes prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen consistent with state law, or those caregivers in clear and unambiguous compliance with existing state law who provide such individuals with marijuana, is unlikely to be an efficient use of limited federal resources.
The memo notes, compliance with state laws, however, will not be accepted as a defense when the government does choose to prosecute, and prosecutors will not be expected to show violations of state laws to prove a violation of the federal Controlled Substances Act. The memo emphasizes that U.S. law continues to view marijuana as a dangerous drug and that the distribution of it is a major source of money for criminal enterprises, in particular accounting for the largest revenue source for violent Mexican cartels.
Gregg Blesch, Feds Turn Over New Leaf on Medical Marijuana, Modern Healthcare's Daily Dose (Oct. 19, 2009) (note: registration is required to view this content).
Hand Hygiene Model Pinpoints 'Superspreaders'
Good hand hygiene among healthcare workers is an important factor in preventing the spread of disease, but exactly how important depends on an individual's job, researchers said.
In a mathematical model, so-called "peripatetic" workers--such as therapists or radiologists--were most likely to spread pathogens if they neglected hand hygiene. In contrast, so-called "assigned" workers--typically nurses and doctors--were less likely to spread pathogens.
In many nosocomial disease outbreaks, a single individual transmits the pathogen to a large number of patients--so-called "superspreading events."
Researchers tried to pin down which types of healthcare workers were most likely to contribute to such events. They modeled the effects of neglecting hand hygiene by three different types of healthcare workers:
- Those who had frequent contact with a few patients, such as nurses;
- Those with less frequent contact, but who saw more patients, such as doctors; and
- Those who typically saw all patients once a day, such as therapists.
The first two types were classified as "assigned" in that they had responsibility for a specific set of patients; those in the last category were "peripatetic" and saw all patients.
The model tracked what would happen over a month if a single colonized patient were introduced into an eighteen-bed ward, under various assumptions about noncompliance with hand hygiene rules.
When all healthcare workers were compliant, the researchers said, the model predicted between 1.5 and 5.8 new cases over the month, depending on how transmissible the pathogen was.
The size of the outbreak increased from 13% to 17% if a single worker neglected hand hygiene--to between 1.7 and 6.8 cases on average over the month. But the results were highly dependent on which workers neglected their hygiene.
For a worker such as a doctor, who saw many patients but infrequently, the increase ranged from 2% to 7%. But for a noncompliant peripatetic worker, the increase ranged from 73% to 238%.
Indeed, a completely noncompliant peripatetic worker produced disease spread similar to what was predicted if all staff neglected hand hygiene after 23% of patient contacts, the model showed.
One implication of the finding is that measuring average compliance with hand hygiene rules, such as by overall use of hand rub products, may not be a good indicator of the real risk of spreading disease. Peripatetic workers can play a "disproportionate role in disseminating pathogens in a hospital ward," making them "potential superspreaders."
Michael Smith, Hand Hygiene Model Pinpoints 'Superspreaders,' MedPage Today (Oct. 19, 2009).
Experts Say Benefits and Risks of Cancer Screening Are Not Always Clear
Studies suggest that some patients are enduring aggressive treatments for cancers that could have gone undetected for a lifetime without hurting them. At the same time, some cancers found through screening and treated in the earliest stages still end up being deadly.
As a result, the chief medical officer for the American Cancer Society now says that the benefits of early detection are often overstated. The American Cancer Society says it will continue to revise its public messages about cancer screening as new information becomes available.
While the limits of cancer screening have long been known in the prevention community, the debate is new and confusing to many patients who have been told repeatedly to undergo screening mammograms or annual blood tests to gauge prostate cancer risk.
Some say the health professions have played a role in oversimplifying and creating the stage for confusion. No one is suggesting that women stop getting mammograms or that men stop discussing prostate cancer screening with their doctor. Instead, the goal is to update public health messages to better reflect the benefits, risks, and limits of various forms of cancer screening.
The American Cancer Society affirmed its current guidelines recommending annual mammography screening for women ages forty and older, and the group advises men to discuss the risks and benefits of prostate cancer screening with their doctors. But understanding the limitations of screening, the statement said, will help researchers develop better screening tests.
Overdiagnosis and overtreatment as a result of cancer screening are a major concern. It is estimated that for every 100 women who are told they have breast cancer, as many as thirty have cancers that are so slow-growing they are unlikely to be life-threatening.
In the case of prostate cancer, for every 100 men with diagnoses, as many as seventy have cancers that if left untreated would never have harmed them. Even for men with aggressive prostate cancer, whether screening improves the odds of survival remains a matter of debate.
One goal of the screening community is to communicate cancer statistics better. It is a commonly cited fact that mammography screening for breast cancer lowers a woman's risk of dying from the disease by 20%, compared with women who do not get screened. That sounds like a big benefit, but it does not fully communicate the extent to which an individual woman is helped by screening.
For men screening for prostate cancer, the data are less clear. An American study showed no statistical difference in prostate cancer death rates among men who were screened, compared with men who were not. A European study showed that screening reduced the risk of dying from prostate cancer by about 20%. But in terms of individual risk, that is not a huge benefit. It means that a man who is not screened has about a 3% average risk of dying from prostate cancer. If that man undergoes annual screenings, his risk drops to about 2.4%.
Many patients do not understand why screening for cancer might be risky. But for every 1,000 healthy women who undergo annual mammograms, about half will have a stressful false positive within ten years, and 180 of them will undergo a biopsy.
For men undergoing prostate cancer screening, the downside is even greater. Most prostate cancers occur in older men and are so slow-growing that the patient would die from something else before the cancer became a problem. Yet about 30,000 men do die each year of the disease.
It is impossible to distinguish between harmless prostate cancers and deadly ones. As a result, many of the 200,000 men who receive prostate cancer diagnoses annually are subjected to aggressive treatments that render them incontinent and impotent.
Tara Parker-Pope, Benefits and Risks of Cancer Screening Are Not Always Clear, Experts Say, N.Y. TIMES (Oct. 21, 2009).
HHS Secretary Properly Denied Payment to Hospital for Losses Due to Consolidation
A federal district court recently upheld the Health and Human Services (HHS) Secretary's denial of about $4.5 million in Medicare reimbursement for depreciation-related losses arising from a consolidation of three Illinois hospital systems (Provena Hospitals v. Sebelius, D.D.C., No. 1:08-cv-01054-WMN, 10/13/09).
The U.S. District Court for the District of Columbia affirmed the HHS Secretary's denial of the claim for Medicare reimbursement by Provena Hospitals after finding that the consolidation was not between unrelated parties. The court found no evidence in the record showing that the purchase price had any relation to the actual value of the property and thus declined to determine that the transaction was bona fide.
According to the court, and contrary to Provena's contentions, there simply has not been a definitive interpretive statement declaring that the bona fide sale and reasonable consideration requirement would not apply to the recognition of gains or losses on depreciable assets in a consolidation. Further, there is no evidence in the record that the purchase price bore any relation to the actual value of the property. Without such evidence, no determination of the transaction's being bona fide is appropriate.
Until November 1997, the sole corporate member of Mercy Center, which operated a hospital in Aurora, IL, was Mercy Health Corp., sponsored by the sisters of Mercy of the Americas. In early 1997, the Sisters of Mercy and two other Catholic orders determined that it would be advantageous for the three orders to consolidate their acute-care hospital facilities.
In November 1997, a new entity, Provena, was formed when the three entities merged. When Provena submitted a cost report, the fiscal intermediary denied the loss on disposal of depreciated assets, and the Provider Reimbursement Review Board affirmed the denial.
The CMS administrator reviewed the decision and also affirmed the denial, disallowing the claim on the ground that the consolidation was a related party transaction and that Mercy Center's transfer of assets to Provena did not satisfy the bona fide sale requirement. In addition to the absence of an arm's length negotiation between unrelated parties, the administrator found that there was no "reasonable consideration" transferred for the depreciable assets.
On appeal, the court found that all of the arguments Provena advanced--that the Secretary retroactively applied to the 1997 consolidation an interpretation of the regulations that was not announced until the issuance of 2000 program memorandum (PM)--regarding the Secretary's alleged "about face" were flatly rejected by every court that considered them. The 2000 PM clarified that nonprofit organizations may engage in mergers and consolidations for reasons that may differ from for-profit mergers and consolidations and "do not always involve engaging in a bona fide sale or seeking fair market value for the assets given."
No Evidence of Arm's Length Transaction
The court also found that, as the 2000 PM said, an arm's length transaction is a transaction negotiated by unrelated parties, each acting in its own self interest in which objective value is defined after selfish bargaining. While Provena argued that the three Catholic healthcare systems were unrelated before the consolidation, the court found no evidence that they bargained or negotiated over the sales price for Mercy Center's assets.
In their agreement, Mercy Center and the other two consolidating hospital systems stated that their goal was to effect a commonality of ownership and control into a single, Catholic-identified integrated health care and human services delivery system. The court found that, given the nature of the institutions involved, those were certainly appropriate reasons for entering into the transaction and were worthy goals.
The court concluded that the Secretary's denial of Provena's claim should be upheld and granted the Secretary's motion for summary judgment, but denied Provena's motion for summary judgment.
HHS Secretary Properly Denied Payment To Hospital for Losses Due to Consolidation, BNA'S HEALTH L. REP. (Oct. 22, 2009) (note: registration is required to view this content).
Medical School Enrollment Numbers Continue to Rise
Four new institutions helped lead to a 2% increase--to 18,390 from 18,036--in enrollment at U.S. medical schools this fall, according to figures released by the Association of American Medical Colleges.
The four new medical schools are Commonwealth Medical College, Scranton, PA; Florida International University Herbert Wertheim College of Medicine, Miami, FL; Texas Tech University Health Sciences Center Paul L. Foster School of Medicine, El Paso, TX; and the University of Central Florida College of Medicine, Orlando, FL. In addition, twelve existing schools expanded their 2009 class size by 7% or more, a news release said. With the exception of a 1.6% increase last year, enrollment increases have been 2% or higher since 2005.
The first-year class is made up of 9,573 men and 8,817 women for a 52.1%-47.9% split. There are 12,045 white students (up from 11,928 in 2008); 4,114 Asian students (up from 3,941); 1,412 Latino students (down from 1,416); and 1,312 black students (up from 1,293).
Total medical school applications were up only 0.1% to 42,269 from 42,231; and included 22,014 men and 20,252 women to equal the 52.1%-47.9% split found in first-year students.
Andis Robeznieks, Medical School Enrollment Numbers Continue To Rise, Modern Healthcare's Daily Dose (Oct. 20, 2009) (note: registration is required to view this content).
*We would like to thank Jennifer P. Viegas, Esquire (Hall Render Killian Health & Lyman PC, Troy, MI), for providing this week's update.
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.