
- AP story
- today's en banc ruling (including Judge Rogers' dissent)
- original 3-judge panel ruling
- Lyle Denniston's same-day analysis at SCOTUSBlog
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Worth reading (as is the rest of this news-filled issue) . . . .Several incidents since the attacks of 9/11 have highlighted this risk. Consider
the following:
- November 2002: The Federal Bureau of Investigation (FBI) issued an alert to hospitals in San Francisco, Houston, Chicago, and Washington, D.C., warning of a vague, uncorroborated terrorist threat.
- August 2004: The FBI and U.S Department of Homeland Security (DHS) issued a nationwide terrorism bulletin that al-Qaeda may attempt to attack Veterans Affairs Hospitals as an alternative to more heavily guarded U.S. military institutions. The bulletin indicated that there had been persistent reports of suspicious activity at medical facilities throughout the United States.
- November 2005: Police in London, England arrest two suspected terrorists accused of plotting a bomb attack. One of the suspected terrorists was found to have a piece of paper with the words in Arabic, “Hospital = Target.”
- April 2005: FBI and DHS investigated incidents of imposters posing as hospital accreditation surveyors. The Joint Commission sent security alerts to the 5,000 medical institutions it accredits and warned them to be on the lookout for suspicious activity.
- July 2007: Eight individuals, all of them either physicians or other medical professionals associated with Britain’s National Health Service, were taken into custody in relation to attempted car-bomb attacks in London and a car-bomb attack at Glasgow Airport in Scotland. The FBI reported that two of the suspects contacted the Philadelphia-based Educational Commission for Foreign Medical Graduates to inquire about working in the United States as physicians.
Washington pharmacists sue state over requirement of morning-after pill. The AP (7/28) reported, "Pharmacists have sued Washington state over a new regulation that requires them to sell emergency contraception, also known as the 'morning-after pill.' In a lawsuit filed in federal court Wednesday, a pharmacy owner and two pharmacists say the rule that took effect Thursday violates their civil rights by forcing them into choosing between 'their livelihoods and their deeply held religious and moral beliefs.'" The state of Washington "ruled earlier this year that druggists who believe emergency contraceptives are tantamount to abortion cannot stand in the way of a patient's right to the drugs." However, the "state's Roman Catholic bishops and other opponents predicted a court challenge after the rule was adopted, saying the state was wrongly forcing pharmacists to administer medical treatments they consider immoral."
This article addresses the unique legal, policy, and ethical questions that arise when patients travel to foreign jurisdictions for medical care. A growing number of patients are leaving the United States, and employers, insurers, and even government payors are beginning to explore whether they can reduce spending by utilizing hospitals and physicians in developing countries. Because this is a dramatic leap, it has generated countless media stories, and has drawn attention from the WHO, WTO, World Bank, and U.S. Senate - many of which believe so-called medical tourism may transform health care here and abroad.
Despite this attention, the market is developing independently of lawmakers and regulators. This is troubling because patients are effectively waiving their rights and benefits in the U.S. to seek medical care in countries that may not grant them remotely similar protections.
This article assesses the risk-benefit calculus for patients and payors entering the global patient market by examining how the market may affect health care costs, quality, and access - the three canonical themes of health care. Using this framework, I consider several policy responses, such as regulating patient travel, regulating referral networks, and regulating employers and insurers. Relying on previous regulatory efforts in analogous areas, I criticize some responses as either impractical or foreclosed by current constitutional doctrine governing the rights to travel and free speech. Instead, I propose that we build on existing consumer protection laws, expand licensing regimes, and recalibrate existing schemes that may unfairly allocate the risks and benefits. I also analyze the feasibility of public and quasi-public multilateral responses.
The underlying goal of this article is to examine how globalization is fundamentally changing health care. Medical tourism is both a symptom and a solution to what ails the U.S. health care system, and the issues it presents may portend future challenges.
I am not quite sure exactly how this is going to work, but I am considering using the Commonwealth Fund site for the first-day reading assignment in Health Law this fall, with period visits back to the site as we make our way through the themes of cost, quality, and access in the course.
Table of Contents © AHLA, 2007. Reprinted by permission.Top Stories
- OIG Finds Sale Of Part Of Physician-Owned ASC To Hospital Could Trigger Sanctions. The sale of part of an ambulatory surgery center (ASC) to a nonprofit hospital could potentially generate prohibited remuneration under the Anti-Kickback Statute and could lead to the imposition of administrative sanctions, according to Department of Health and Human Services Office of Inspector General (OIG) Advisory Opinion No. 07-05 posted June 19. Full Story
- President Bush Vetoes Stem Cell Bill, Calls For Expanding Alternative Research. President Bush vetoed June 20 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells. The measure cleared by a vote of 247-176 in the House and 63-34 in the Senate, short of the two-thirds majorities needed to override the veto. Full Story
Articles & Analyses
- Impact Of IRS’s Draft Redesigned Form 990 On Tax-Exempt Healthcare Organizations, By James R. King and Gerald M. Griffith, Jones Day
- Physician Quality Reporting Initiative Begins July 1, 2007, By Timothy J. Cahill, Porter Wright Morris & Arthur, LLP
Current Topics
- Antitrust
1. DOJ Reaches Settlement With Federation Of Physicians And Dentists Resolving Allegations Of Antitrust Violations
2. Illinois AG Alleges Clinics Conspired To Turn Away Medicaid Patients In Effort To Increase Reimbursement Rates- Criminal Law
Sixth Circuit Upholds Medicare Fraud Convictions, But Remands For Evidentiary Hearing On Documents Withheld By Government- ERISA
U.S. Court In Texas Remands Hospital's Action Against Managed Care Firm To State Tribunal, Finding ERISA Did Not Completely Preempt Claims- Food and Drug Law
1. U.S. Court In New York Upholds Plavix Patent, Enjoins Marketing Of Generic
2. U.S. Court In Minnesota Allows Product Liability Claims Against ICD Device Manufacturer To Proceed To Trial- Fraud and Abuse
1. Update
2. D.C. Circuit Finds Renal Physicians Association Lacks Standing To Bring Lawsuit Challenging Stark Safe Harbor Rule
3. OIG Withdraws Proposed Rule On Exclusion Authority For Entities Submitting Claims Containing Excessive Charges
4. OIG Approves Texas’ False Claims Act- Healthcare Access
Study Finds 689,000 Low-Income Children Eligible For SCHIP, DHHS Says- Healthcare Spending
Senate Budget Panel Considers Options For Controlling Healthcare Costs- Hospitals and Health Systems
1. Grassley Urges CMS To Collect Better Data From Hospitals On Uncompensated Care
2. Baucus Questions CMS About Standards Of Safety And Care At California Hospital- Insurance
Connecticut Appeals Court Finds Liability Insurer Obligated To Cover Claim Made During Required Extension Period- Medicaid
CMS Releases Timeline For Implementing New AMP-Based FULs For Medicaid Prescription Drug Reimbursements- Medical Malpractice
Florida Appeals Court Finds Expert Opinion That Surgery Unnecessary Was Sufficient To Create Triable Issue- Medicare
1. Health Insurers Agree To Suspend Marketing Of Medicare PFFS Plans
2. MedPAC Recommends Ways To Improve Efficiency In Medicare
3. U.S. Court In New Jersey Refuses To Reconsider Its Previous Decision Affirming Finding That Provider Was Overpaid By Medicare
4. Baucus, Grassley Oppose Speculative Cuts In Proposed Medicare Payment Rule
5. Medicare To Expand Testing Of Personal Health Records Tools
6. OIG Finds Medicare Beneficiaries Have Broad Access To Retail Pharmacies That Participate In Medicare Part D Program
7. CMS Extends Timeline For Publication Of Provider Appeals Rule
Study Examines Impact Of Medicare Part D On Nursing Homes And LTCPs- News in Brief
1. CHA Releases Draft "Vision" For Healthcare Reform
2. CMS Enhances Hospital Compare Website
As predicted, Bush made adult-stem-cell research the linchpin of his argument.
Amazing. Or not.
(CNN) -- Two nurses accused in the post-Katrina deaths of four patients at New Orleans' Memorial Medical Center have been offered immunity to testify before a special grand jury, sources close to the investigation tell CNN.
Sources also told CNN the grand jury has been told as many as nine patients may have died after being administered what Louisiana's attorney general called a "lethal cocktail" of medications by hospital staff.
Family members said staffers used the drugs to kill patients so caregivers could flee appalling conditions inside the hospital after the storm.
Dr. Anna Pou and nurses Cheri Landry and Lori Budo were arrested in July 2006 after a 10-month investigation. Louisiana Attorney General Charles C. Foti charged them with second-degree murder.
Sources close to the investigation told CNN the two nurses are expected to testify before the grand jury in the next two weeks, which could signal a possible wrapping up of the case. It could also signal the main target of the investigation is Pou, a physician who was under contract with Memorial Medical Center when Katrina struck.
When Is a Pain Doctor a Drug Pusher?For a variety of reasons, and for a variety of patients (not only patients who have chronic and severe pain) and their doctors, the article includes some important facts, e.g.:
By TINA ROSENBERG
Published: June 17, 2007
Those treating pain make subjective choices about dosage. When a doctor gets it wrong, is it a mistake or a felony?
[F]or many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.
It’s a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction — which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful — occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn’t mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. “Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older,” says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.
The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)
So this well-timed announcement about the switchability of skin cells in mice shouldn't for a minute provide cover for a presidential veto of this bill.
Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.
In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.
And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.
Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.
Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care.
Expensive medicine may, in fact, be poor medicine.
“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.
Some Pennsylvania employers said the state’s findings, based on data from 2005, might put more pressure on insurance carriers and hospitals to start demonstrating the value of care. “It now provides us a tool to have a serious dialogue with our carriers,” said Mark Dever, a benefits consultant for Duquesne Light, a regional utility in Pittsburgh.
“We have to question,” he said. “There’s a big difference in price — why?”
The report by the Pennsylvania Health Care Cost Containment Council, a state agency, provides a rare public glimpse of detailed information about hospital payments and patient outcomes. And the seemingly random nature of the payments is striking.
Although federal Medicare payments are largely fixed, they varied somewhat among the Pennsylvania hospitals surveyed. The far greater disparity involved commercial insurers, which must negotiate their rates hospital by hospital.
And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly
$80,000 in average payments received by the other hospitals, with poorer track records.“It doesn’t make sense,” said Marc P. Volavka, the executive director of the Pennsylvania Health Care Cost Containment Council. “Certain payers are paying an awful lot for poor quality.”
He points to some of the experiments to change how hospitals are paid, like Geisinger Health System in central Pennsylvania, which is trying to demonstrate its commitment to high-quality care by offering a 30-day warranty on its cardiac surgery.
“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive
for a hospital to provide the kind of care that leads to better outcomes and lower payments.
In summary, we hold that disputes involving the Disposition of preembryos produced by in vitro fertilization should be resolved, first, by looking to the preferences of the progenitors. If their wishes cannot be ascertained, or if there is dispute, then their prior agreement concerning Disposition should be carried out. If no prior agreement exists, then the relative interests of the parties in using or not using the preembryos must be weighed. Ordinarily, the party wishing to avoid procreation should prevail,
assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. However, if the party seeking control of the preembryos intends merely to donate them to another couple, the objecting party obviously has the greater interest and should prevail.
Top Stories
- More Questions Surface About FDA's Response To Avandia Risks
The House Oversight and Government Reform Committee held a hearing June 6 to probe the Food and Drug Administration’s (FDA's) role in evaluating the safety of the diabetes drug Avandia. Full Story- House Passes Stem Cell Bill
The House cleared June 7 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells in a 247-176 vote. The Senate cleared the measure in April by a vote of 63-34. Full StoryArticles & Analyses
- The Medicare Competitive Bidding Program For Durable Medical Equipment, Prosthetics, Orthotics, And SuppliesBy Carol Loepere, Elizabeth Carder-Thompson, Bob Hill, and Debra McCurdy, Reed Smith LLP
- Proposed Inpatient PPS Rule To Impact Specialty Hospitals: CMS Continues To Implement Its “Strategic And Implementing Plan For Specialty Hospitals”, By Thomas E. Dowdell and Lara E. Parkin, Fulbright & Jaworski, LLP
Current Topics
- Antitrust
U.S. Court In Tennessee Refuses To Dismiss Nurses’ Claims Alleging Hospitals Conspired To Depress Wages- Arbitration/Mediation
Arkansas High Court Upholds Denial Of Medical Corporation’s Motion To Compel Physician To Arbitrate Claims In Employment Dispute- EMTALA
U.S. Court In Virginia Holds State Hospital's Agreement To Comply With EMTALA Did Not Waive Virginia's Sovereign Immunity- ERISA
1. U.S. Court In Missouri Finds ERISA Preempts Plan Beneficiaries' Suit Against HMO For Charging Copays In Violation Of State Law
2. Eighth Circuit Reverses Lower Court Decision Upholding Health Plan Insurer’s Retroactive Rescission Of Plan Participant’s Coverage- Food and Drug Law
1. FDA Creates Communications Advisory Committee
2. Health Subcommittee Will Mark Up Pharmaceutical, Device Bills Next Week- Fraud and Abuse
1. Eleven Arrested In Alleged $5 Million Billing Scheme For HIV Infusion Treatments
2. Update
3. U.S., Texas Reach $15 Million Settlement With Hospital District To Resolve FCA Claims- Health Information Technology
New Coalition Will Lobby For Immediate Deployment Of Health Information Technology- Health Policy
Business Roundtable Releases Principles For Healthcare Reform- Healthcare Spending
NGA-NASBO Reports Stable Fiscal Conditions For States In FY 2007, But Projects Increasing Strain On Budgets In FY 2008- Hospitals and Health Systems
Texas Supreme Court Finds Hospital May Not Maintain Lien Against Patient For Charges Not Covered By Workers Comp- Individual/Patient Rights
Sixth Circuit Strikes Down Michigan Abortion Law- Insurance
Maine High Court Rejects Payors’ Challenge To Calculation Of “Cost Savings” From Health Program Used To Set Offset Payments- Medicaid
OIG Finds AMPs For Most Drugs Remained Fairly Stable In Quarterly Comparison- Medicare
U.S. Court In District Of Columbia Stays Hospitals’ Action Seeking Reopening Of Medicare Cost Reports- News in Brief
AMA Consortium Approves 10 New Physician Quality Measures- Physicians
1. Physician Survey Finds Medicare Payment Cuts Will Affect Access, Care, AMA Says
2. Oklahoma High Court Reinstates Physician’s Suit Against Hospital, Finding Peer Review Statute Does Not Provide Blanket Immunity- Quality of Care
Study Shows Pay-For-Performance Initiative Did Not Result In Significant Improvement For Heart Attack Patients- Tax
1. Ohio High Court Finds Provider Of Hospice And In-Home Nurse Services Entitled To Property Tax Exemption
2. Indiana Tax Court Finds Taxpayer Failed To Show Medical Facility Was Used Predominantly For Charity, Denies Property Tax ExemptionTable of Contents © AHLA, 2007. Reprinted by permission.