humani nil a me alienum puto

random rants about news, the law, healthcare law, economics and anything I find amusing

Podcasts I’m Listening to, Week of 3/22/2009

Name Album
Unger Report: Advice For Potential Cabinet Appointees NPR: Satire from The Unger Report Podcast
Military Contractor Blackwater Changes Its Name NPR: Satire from The Unger Report Podcast
A Night At The Oscars NPR: Satire from The Unger Report Podcast
#350: Human Resources This American Life
Exploring The Darker Side Of Tweets And Twitter NPR: Satire from The Unger Report Podcast
#376: Wrong Side of History This American Life
Thanks To Fans And Critics Alike NPR: Satire from The Unger Report Podcast
NYT: Science Times for 3/24/2009 Science Times
#209: Didn’t Ask to Be Born This American Life
It’s All Politics March 26 2009 NPR: It’s All Politics Podcast
What Shape Is Your Galaxy? Scientific American Podcast
Does ‘Watchmen’ Hold Hidden Physics Lessons? NPR: Science Friday Podcast
Afghanistan Strategy, Budget Pitch Top Week’s News Shields and Brooks | NewsHour with Jim Lehrer Podcast | PBS
Who’s To Blame For The Financial Crisis? NPR: Intelligence Squared Podcast
Thinning Brain Cortex May Signal Depression NPR: Science Friday Podcast
Researchers Monitor Eruptions At Mt. Redoubt NPR: Science Friday Podcast
Alaska’s Coast Disappearing At Record Rates NPR: Science Friday Podcast
NOAA Head Jane Lubchenco On Ocean Policy NPR: Science Friday Podcast
20 Years Since Exxon Valdez, New Ocean Threats? NPR: Science Friday Podcast
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Filed under: Personal Posts, ,

A Lesson on Health Care From Massachusetts – NYTimes.com

In the March 28th NYT:

In any effort to restructure American health care, two interconnected goals inevitably compete for primacy. One is providing health coverage to the uninsured…The other is slowing the relentless and unsustainable growth of health costs…President Obama[‘s] …positioning suggests he has put cost first…. Mr. Obama’s strategy is to sell the expansion of access — largely through public insurance programs — as inseparable from serious efforts at innovation and restraint…[T]he lawmakers and strategists behind the Massachusetts plan strongly defend their incremental approach. Only by deferring the big decisions on cost containment, they said in recent interviews, was it possible to build a consensus among doctors, hospitals, insurers, consumers, employers and workers for the requirement that all residents have health insurance.

“The [Massechusetts] concept,” Mr. Kingsdale said, “[was] to sequence reform in some way to do the really hard thing, which is expanding access, before we do the nearly impossible thing, which is containing costs. [For the US] don’t want to end up holding 50 million uninsured hostage to cost containment.” ***Massachusetts did not create [a government sponsored] plan [such as being floated by the Obama administration], choosing instead to offer subsidies that make commercial policies more affordable. Diane Archer, co-director of the Health Care for All Project at the left-leaning Institute for America’s Future, questioned whether that put enough competitive pressure on insurers. “If we want to bend that cost curve down, it’s through the public option that we’re going to do it,” she said. …. Although health reformers in Massachusetts acknowledge that the fiscal and political landscape in Washington is profoundly different, there is broad agreement among them about the importance of mandating coverage for adults. The insurance lobby has said that if Washington required coverage for all, it would end the practice of denying coverage to those with pre-existing health conditions. …If history is a guide, the success of health reform may depend on whether the White House and Congress can give interest groups enough to keep them on board.

via A Lesson on Health Care From Massachusetts – NYTimes.com.

Filed under: Health Law, Reform, , ,

Physician Payments Sunshine Act of 2009

Interesting bill introduced in the 111th Congress (SB 301) by Mr. Grassley.  After recent settlements involving Medtronics and then a host of other medical device manufacturers in late 2007 (Johnson & Johnson subsidiary DePuy Orthopaedics, Zimmer, Biomet and Smith & Nephew) who provided lavish trips and sometimes sham consulting and IP royalty payments to physicians allegedly to induce their ordering of the firms’ devices, the Congress is considering forcing pharma and medical device manufacturers to disclose all financial arrangements with physicians and medical groups greater than $100/year.  The financial arrangements would be posted in a manner that would be accessible to the public.  Failure to disclose would subject the companies to up to $150,000 (if innocent) or $1m Civil Monetary Pentalties if knowingly.  It is of note that disclosure was used by the OIG in the deferred prosecution agreements with these companies.   See, for example, Zimmer’s home page at www.zimmer.com.

Search Results – THOMAS (Library of Congress).

Filed under: AKS, CMP, Conflicts of Interest, Health Law, , , , ,

A Trip to the Doctor’s on the Company Jet – DealBook Blog – NYTimes.com

NYT’s Dealwatch Blog reports on the medical device company Stryker’s proxy statement detailing executive perquisites.

What does it say about the local medical community when the chief executive of a large medical technology company has to hop on the corporate jet and fly to another city to get an annual physical? That’s the situation at Stryker, based in Kalamazoo, Mich., which disclosed in its proxy that Stephen P. MacMillan, its chief executive and president, “traveled to a physical exam on the company aircraft.” *** Stryker “believes that its perquisites practices are conservative[.]”

via A Trip to the Doctor’s on the Company Jet – DealBook Blog – NYTimes.com.

Filed under: Conflicts of Interest, Executive Compensation, Health Law, , ,

30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com

The Cleveland Plain Dealer reports on March 27, 2009:

A federal judge on Friday sentenced the founder of a failed health-care financing company to 30 years in prison for his role as “puppet master” in what prosecutors called the biggest fraud on record at a privately held company in the United States.*** National Century offered financing to small hospitals, nursing homes and other health-care providers by purchasing their accounts receivable, usually for 80 or 90 cents on the dollar, so they wouldn’t have to wait for insurance payments. National Century then collected the full amount of the payments. The company raised the money to fund its business by selling bonds to investors. Prosecutors said National Century executives authorized millions in unsecured loans to health-care providers, then misled investors about the loans.  As the money owed to the company mounted, National Century declared bankruptcy in November 2002 after the FBI raided its offices. Since then, at least nine former executives have been convicted of corporate fraud. The government originally alleged proceeds of the fraud topped $1.9 billion, a figure Squires said Friday had been reduced to $1.7 billion. He said investors’ total losses were around $2.8 billion. At its height the company employed more than 300 people, most of them in the Columbus area. Executives made millions, with Poulsen alone earning more than $9.1 million between 1996 and 2002, according to the government.

via 30 years for company founder in $1.7 billion Ohio fraud – Business – cleveland.com.

Filed under: Fraud and Abuse, Health Law, Risk Management, ,

Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ

In its Health Blog, the WSJ reports on March 25, 2009:

GlaxoSmithKline last year promised to publish payments to U.S. docs for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is expanding on its promise.For clinical trials starting in 2010 and after, Glaxo said yesterday it will publicly report the money it pays U.S. doctors and their institutions to carry out the studies*** Disclosing more and more about payments to health-care professionals is a trend du jour in the industry. The list of drug companies and device makers that have said they’ll start reporting payments to docs includes Pfizer, Eli Lilly, Merck and Medtronic. Exactly what payments get reported varies from company to company.  All those self-imposed reporting plans could soon be moot. The Physician Payment Sunshine Act, which has been kicking around for a while, would create national rules for what payments drug and device makers have to publicly disclose.

via Glaxo Expands List of Public Payments to Doctors – Health Blog – WSJ.

Filed under: AKS, Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, , ,

Mass. Department of Public Health report details Beth Israel surgery in which doctor fell asleep – The Boston Globe

Interesting article in the March 25, 2009 Boston Globe concerning a physician at Beth Isreal Deaconess Hospital in Boston.  The physician had a history of drug and alcohol abuse, came into the OR in the morning noticeably tired and “wobbly”, fell asleep during a second surgery and abruptly left prior to finishing another — which took seven hours rather than the estimated 90 minutes.   The surgeon had since been fired and suspended by the board of medicine.  The hospital faced a damaging report by the Department of Public Health.  The scenario shows how difficult it can be in organizations to immediately address impaired and disruptive practitioners.

Mass. Department of Public Health report details Beth Israel surgery in which doctor fell asleep – The Boston Globe.

Filed under: Disruptive Physicians, Health Law, Malpractice, Risk Management, ,

Doctor’s (Gag) Orders : NPR

On the Talk of the Nation, March 24, 2009 (which you can download as a podcast or listen to on the link below), TOTN discusses the emerging trend of consumer driven web reviews of doctors.  Dr. Jeffrey Segal, CEO and founder of Medical Justice, talks about this trend and efforts of some providers of having patient sign waivers agreeing not to participate in them (or otherwise limiting what they say on them).  I had, a few years back, a limited experience with this.  A patient of a physician client of mine had posted an inappropriate post on a general comercial review site.  The site was not focused on reviews of physicians.  After quickly reviewing the post and the terms of service of the site, I emailed the service provider, indicated that the poster was violating its terms of service, and the post was quickly removed.  I hear (but have not researched) that Angies list is now getting into the physician review game.  Wonder where this will lead.  via Doctor’s (Gag) Orders : NPR.

Filed under: Health Law, Quality Reporting, ,

Healthcare Economist · Can Health Care Reform Save the Economy?

In his Healthcare Economist blog, Jason Shafrin discusses the problems with the current healthcare insurance model in the United States.  By tying health insurance to employment, individuals may lack the mobility to take on new opportunities, including starting their own business.  I think that this is interesting.  We’re probably getting a double whammy.  This is a structural problem that has been with us for a long time.  But now, with real estate housing market deflation, people are a locked to a geography.  If they seek another employment opportunity out of their area they then have to sell their house, realizing the new post-market clearing price.  Link to a paper writtne by Jason Safrin and an Economist article.  Interesting reading.  (Yuck.)

via Healthcare Economist · Can Health Care Reform Save the Economy?.

Filed under: Health Law, Reform, ,

Insurers Offer to Soften a Key Rate-Setting Policy – NYTimes.com

In  the March 24, 2009 NYT:

In effect, insurers said they were willing to discard an element of their longstanding business model — pricing insurance policies, in part, on the basis of a person’s medical condition or history.

In the past, insurers have warned that if they could not consider a person’s health status in setting premiums, the rates charged to young, healthy people would need to soar. But they said Tuesday that they were exploring ideas to prevent such sharp increases by spreading the risk and costs broadly across a larger population, including the healthy and the unhealthy.

Insurers said they could accept more aggressive regulation not just of their premiums, but also of their benefits, underwriting practices and other activities. Such strict regulation, they said, would make it unnecessary to create a new public insurance program offered through the federal government.

via Insurers Offer to Soften a Key Rate-Setting Policy – NYTimes.com.

Filed under: Health Law, Reform, , ,

Many Concerns About Health Insurance for All – NYTimes.com

The March 24, 2009 NYT reports:

[The Obama administration has been floating the possibility of a F]ederal, Medicare-like insurance plan to anyone, at any age…And let commercial insurers offer their private health plans alongside it. ***[T]he insurance industry and others wary of too much government intervention vehemently oppose the idea. They say the heavy hand of the government will eventually push out the private insurers, leaving the government option as the only option. *** [T]he details of a federal insurance plan remain vague, a central question is whether it would function like Medicare — wielding the government’s size and clout t to essentially dictate the prices it pays for medical care.  The main selling point for a government-run program would be its low cost.  It would have a much lower overhead than private plans, with no need to make a profit or spend money on marketing or brokers’ commissions. And, if allowed to flex its muscle, the government would buy medical care at much lower prices. *** Karen Davis, the president of the Commonwealth Fund,…estimates the average premium for a family of four would run around $9,000 a year under a public plan, in contrast to nearly $11,000 for a typical private alternative.***[M]any hospital executives object strenuously to the idea of a new program that would behave like Medicare. “Medicare has systematically been underpaying for services,” said Dr. Denis A. Cortese, the chief executive of the Mayo Clinic, the highly regarded health system in Minnesota. If more patients are enrolled in a Medicare-like program, he predicted, “your very best providers will go out of business” or stop seeing patients covered by the government plan.***Some policy experts say a compromise can be struck. They advocate a public plan that would be required to negotiate with doctors and hospitals on a level playing field with commercial insurers, rather than have the government set prices à la Medicare.

via Many Concerns About Health Insurance for All – NYTimes.com.

Filed under: Health Law, Reform, , ,

Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com

The March 25, 2009 NYT reports:

[T]he American Psychiatric Association announced on Wednesday that it would end industry-financed medical seminars at its annual meeting. ***The association, the field’s premier organization, said it would also phase out meals at the meeting paid for with industry money. ***The association has been reviewing the income it received from industry sources since early 2008, Dr. Stotland said, looking for potential conflicts. Since then, Congressional investigators, led by Senator Charles E. Grassley, Republican of Iowa, have found that several prominent psychiatrists who received hundreds of thousands to more than $1 million from drug makers did not report that income to their employers, as required by federal and most academic rules. ***The psychiatric association said it had no plans to eliminate drug advertisements in its journals, commercial exhibits at meetings, or industry-sponsored fellowships for doctors.

via Psychiatric Group Ends Industry-Sponsored Seminars – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Health Law, , , ,

An Overseer of Medical Trials Comes Under Fire – NYTimes.com

The NYT reports:

“The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist. *** The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast. ***Over a five-year period, Coast reviewed 356 study proposals and rejected only one[.] *** In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation.***In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O. ***In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

via An Overseer of Medical Trials Comes Under Fire – NYTimes.com.

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Coming Soon: Comparative Effectiveness Research for Biotech – Health Blog – WSJ

WSJ Health Blog reports:

[T]he NIH has published a list of high-priority projects it wants to fund, providing a clearer picture of just how that money may be spent. The list — online here — suggests scrutiny for some of the best-selling drugs for heart conditions and asthma, among others. The NIH would fund research laying the groundwork “to study clinical and cost-effectiveness of biologics to determine the best therapy for individual patients.” This could include reviewing existing research or computer-based modeling of clinical trials to predict outcomes. Spokespeople for some of the manufacturers told Dow Jones Newswires they believe the drugs are cost-effective, citing the severity of the diseases and the drugs’ effectiveness at treating them***The NIH plans to give out about $400 million of the comparative-effectiveness funding to researchers at academic and other institutions over the next two years. That’s not nearly enough to support multiple large-scale clinical trials, but it could add a therapy to an ongoing trial, an NIH spokeswoman said, or support other methods of research like analyses of past trials.

Wonder how quickly the Stimulus money for Comparative Effectiveness Research will spend out?

See also an earlier WSJ article prior to passage of the Stimulus law.

via Coming Soon: Comparative Effectiveness Research for Biotech – Health Blog – WSJ.

Filed under: Comparative Effectiveness Rearch, Health Law, Reform, ,

Health Reform Dialogue Issues Recommendations – Health Blog – WSJ

The WSJ reports the publication of a “Health Reform Dialogue” issued a set of recommendations today aimed at governing the debate over restructuring health care.  The WSJ observed it was generally consistent with the “direction the Democrats are heading.”  Reviewing the short report, I find the following notable:

The ultimate public policy goal is to increase value for America’s health care consumers and the system as a whole, that is, the highest quality of care delivered in the most efficient manner possible: significantly improving treatment of chronic disease; researching the effectiveness of comparative treatments; paying for quality care, not quantity of care; providing relief for patients, clinicians, and providers caught up in the web of medical liability processes; encouraging public reporting of information that clarifies the performance of individual clinicians and providers; creating a robust health information technology infrastructure; and beginning to significantly transform the health care delivery system through some much-needed payment reforms.

They then discuss some of the efforts that can be undertaken to do this including advocating clinical effectiveness research studies, quality measures and strong HIT infrastructure support by the federal government.

As the WSJ blog notes, while this shows some common agreement and coordination among an impressive cadre of provider, business, hospital, insurance and other interest groups, the agreement ends at, and punts on some of the more difficult policy questions, such as insurance mandates.   I found the language subject to wide interpretation even on the areas of agreement.

In any event, these groups will all have a significant and important seat at the table when the scope, provisions and cost of healthcare reform is debated.

Health Reform Dialogue Issues Recommendations – Health Blog – WSJ.

Filed under: Reform, , , ,

Who’s To Blame For The Financial Crisis? : NPR

I, for one, am beginning to loathe that I waste any of my time watching cable TV news and opinion programs.  The quality of the talking heads on MSNBC, Fox and CNN is (perhaps always was) in free fall.  I can, perhaps, tolerate Chris Mathews a bit; I terribly miss Tim Russert — but he mainly did his Meet the Press show rather than much specific to cable.  But I don’t realize most of the cable programs are just so much cotton candy until I hear real debate.

I most realize it when I actually listen to real, substantive, witty, thoughtful, hard, and fact laden debate.   Like the difference between a quality hard-wood cabinet maker and a rough carpenter.  Yeah, they both work with wood, but one’s a craftsman and the other, well, a day laborer.

Listen to this recent debate on NPR’s program Intelligence Squared.  I’ve not heard the full podcast quite yet.  I caught the last half of it airing this evening on my way home from work (far too late).   The debate – the proposition – “Blame Washington More Than Wall Street for the Financial Crisis” – was timely and really made me think.   The panel exchanged polite barbs (distinct from the often thoughtless vitriol of left/right pundits on cable programs), pushed their position with both factual support as well as comical retorts.  There’s a few great lines in this — the best that I heard was from John Steele Gordon who stated that

While Wall Street constantly needs reform…it does not need reform as much as Congress…Institutions tend to evolve in ways that benefit their elites … the poster child for this is [not Wall Street but] Congress…People lament that Wall Street took its checkbook down to Washington to get the regulation it wanted rather than have stricter regulation.  But Wall Street was not [in Washington] debauching a virgin, it was paying a harlot.

In the end, the position taken by Mr. Gordon and Niall Ferguson (for the proposition) won more of the audience’s change over vote.  They convinced me.  While there’s plenty of blame to go around, when systemic risks crashes down the house, those holding the reigns of the regulatory structure are ultimately accountable.   In any event, if you are following the debate concerning the financial crisis, you’ll want to hear this and see who convinces you.

via Who’s To Blame For The Financial Crisis? : NPR.

Filed under: Personal Posts, , , , , ,

AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News

In the March 23, 2009 AMA News, a consulting firm reports that the heyday of the pharma detailer may have already peaked and is headed into decline:  “At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates’ U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.”

According the article and the survey, fewer physicians are spending less time with the detailers.  More types of providers are requiring advance appointments.

The article and survey reports that “[p]hysicians’ openness toward visits by pharmaceutical company detailers varies by practice ownership and size.

Refuse
to see
Require
appointments
Practice size
1 to 2 doctors 14.3% 32.5%
3 to 5 16.7% 36.1%
6 to 10 23.1% 45.0%
More than 10 44.0% 45.5%
Practice ownership
Non-hospital 22.1% 37.8%
Non-health system 22.3% 37.5%
Hospital 31.2% 44.6%
Health system 34.7% 52.0%

Source: “Physician Access: U.S. Physicians’ Availability to See Drug and Device Sales Reps,” SK&A Information Services Inc., released February”

The article also reports significant decreases in detailing staff.  “Experts estimate the U.S. pharmaceutical sales rep force eventually will be cut 25% from its 2007 peak of more than 100,000. Here are some of the biggest layoffs announced in the last year.

Drugmaker Sales rep cuts
GlaxoSmithKline plc 1,800
Merck & Co. Inc. 1,200
Wyeth 1,200
Schering-Plough Corp. 1,000
Sanofi-Aventis 650

Source: News accounts”

via AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News.

Filed under: Conflicts of Interest, Health Law, , , , , ,

Facebook And Kids: Are Their Brains Ready for Social Networking?

Kari Henley in the March 22, 2009 Huffington Post writes:

For over 25 million youth, Facebook is replacing email as “the” way to communicate, and parents are often left in the dust and wondering is it safe? What age can kids safely have a Facebook page? Should they insist to be their “Friend” and monitor their endless chatter? *** One day, a call came from the principal informing Jill and her husband, their middle daughter was being given in-school suspension for creating a Facebook group used to make fun of another student. Called something like, “Eric is a Hairy Beast,” the group quickly filled with loads of kids making fun of a quiet Armenian boy, uploading cell phone pictures of him and becoming more brazen by the day.  These kids are “A” students, and far from brats; but most are not cognitively developed enough to recognize their behavior is hurtful to others.  *** Kids get into trouble with sites like Facebook and MySpace because they are too self-centered in their overall development to understand the impact of what they are doing… Middle school age children are the most susceptible to cyber bullying, and high school students most likely to use poor judgment in giving out information.  *** I set about interviewing scores of parents with children from elementary to high school, asking their opinions about Facebook and kids. While most felt it was a relatively safe place for kids to connect to each other, many expressed concern over the obsessive nature of these sites.  Designed to be “sticky;” a site is deemed successful the longer it entices you to stay on, yet these hours are replacing other activities critical for healthy development. *** The cyber playground has replaced the physical one, for better or worse. It is our job as parents to make sure their developing brains know how to do more than move a mouse around a keyboard and encourage more face to face social time.

via Kari Henley: Facebook And Kids: Are Their Brains Ready for Social Networking?.

Filed under: Personal Posts, , , , , ,

Running a hospital: Final budget decisions

Running a hospital: Final budget decisions.

Running a hospital: Good progress in budget deliberations.

In his “Running a Hospital” blog, Paul Levy, CEO of Beth Israel Deaconess Medical Center in Boston, writes two particularly remarkable posts concerning the decision-making process leading to budgetary cuts in these lean times for his hospital.  The posts are note-worthy due to the steps taken, the transparency through which the cuts are communicated (effectively to the world), and what appears to be the level of buy-in generated by the hospital management, personnel and medical staff.

Mr. Levy also posts that the accolades he is receiving are misplaced.  The process and the values demonstrated by the budgetary cuts, according to him, are more a reflection of the hospital’s community, then necessarily, his leadership.  Of interest to me, he references, in current events, a quote (that I also took) from Thomas Friedman’s recent op-ed, although focuses this, again, more on the institution’s own values as merely reflected by leadership, rather than leadership instilling the leader’s values on the organization.  Truth is probably somewhere in between.  Very much worth a read.

Filed under: Health Law, Personal Posts, , , ,

Strip-Search Case Tests How Far Schools Can Go – NYTimes.com

As reported on March 23, 2009 in the New York Times, the Supreme Court will shortly address a case concerning the scope of student searches.   In the case, an assistant principal, enforcing the school’s antidrug policies, suspected a thirteen year old student of having brought prescription-strength ibuprofen pills to school. One of the pills is as strong as two Advils.  After being strip searched to the her underwear, they conducted further intimate searches.   The student, who was an honor student, had no pills.

At issue will be how much leeway school officials should have in policing zero-tolerance policies for drugs and violence.  The court is likely to provide important guidance to schools around the nation.  The Ninth Circuit, in San Francisco, found a Fourth Amendment violation by the school, ruling that such a search should be bannned as unreasonable.  This was not without dissent by Judge Hawkins who concluded, “I do not think it was unreasonable for school officials, acting in good faith, to conduct the search in an effort to obviate a potential threat to the health and safety of their students.”

The Supreme Court’s last major decision on school searches based on individual suspicion — as opposed to systematic drug testing programs — was in 1985, when it allowed school officials to search a student’s purse without a warrant or probable cause as long their suspicions were reasonable. It did not address intimate searches.

In his The Health Care Blog of March 24, 2009,  Matthew Holt argues that this case, together with the current drug cartel unrest in Mexico and the previous administration’s prosecution of medical marijuana growers distributors shows the “lunacy” of our current drug laws.  No comment here, but interesting discussion.

via Strip-Search Case Tests How Far Schools Can Go – NYTimes.com.

Filed under: Drug Policy, Health Law, Personal Posts, ,

HHS OIG Open Letter March 24, 2009 – SDP Guidance

OpenLetter3-24-09.pdf (application/pdf Object).

Today, March 24, 2009, the HHS OIG published and Open Letter informing us that providers can no longer used the Self-Disclosure Protocol (SPD) for the physician self-referal (“Stark”) law and will limit SPD submissions to those with a minimum $50,000 settlement.

OIG will no longer accept disclosure of a matter that involves only liability under the physician self-referral law in the absence of a colorable anti-kickback statute violation. We will continue to accept providers into the SDP when the disclosed conduct involves colorable violations of the anti-kickback statute, whether or not it also involves colorable violations of the physician self-referral law… To better allocate provider and OIG resources in addressing kickback issues through the SDP, we are also establishing a minimum settlement amount. For kickback-related submissions accepted into the SDP following the date of this letter, we will require a minimum $50,000 settlement amount to resolve the matter.

The Open Letter casts this as necessary to ensure resources are focused on antikickback violations.  These  “remain[] a high priority for OIG.”  OIG does caution that providers should not read this decision to “draw any inferences about the Government’s approach to enforcement of the physician self-referral law.”

This is a rather remarkable position given the challenges that health systems face with technical (and sometimes  potentially costly) Stark violations without any antikickback component.   And, notwithstanding the OIG’s caution, it is clear that the OIG, recognizing resource limitations, wants to focus on anti-kickback violations rather than purely Stark law violations.   And what about civil monetary penalties SDPs associated with inducement of patients?  One must conclude that if there is not a significant antikickback component, it is not now appropriate for the SDP due to limitations with OIG resources.   Probably more to come.

Filed under: AKS, CMP, Fraud and Abuse, Health Law, Physician Self Referral/Stark

ACLU challenges Cleveland Heights-University Heights schools over removal of magazine from library – Metro – cleveland.com

The Cleveland Plain Dealer on March 23, 2009 reports a dispute in Cleveland Heights-University Heights over the removal of a magazine at the library.  According to the ACLU’s Christine Link: “Literature should not be removed from a school library simply because one person may find it inappropriate.  Ms. Link called for the board to “immediately order that the magazine be reinstated.”  The literature: Nitendo Magazine.  The principal’s objection.  Violence on the cover.  The librarian objected because the principal did not follow the rules — object, take it to the School Board for a determination.  I found this entirely amusing.  I also find it delightful that we are arguing over a Nitendo Magazine, and not Huck Fin, Tropic of Cancer, etc.

Filed under: Personal Posts, , , ,

Goose droppings might be raising bacteria levels in Northeast Ohio waterways – Metro – cleveland.com

Geese are pooping machines.  According to this article in the Cleveland Plain Dealer on March 24, 2009, there is no threat to bacterial levels in our water (Cleveland gets its water from far out in Lake Erie), but these little Canadian guests may contribute to higher bacteria in our lakes and streams.

Weird wildlife fact for the day: A Canada goose can poop up to 10 times an hour — a remarkable rapid-fire effort that can add up to a pound of waste by day’s end.  Second fact: There are at least 100,000 of the loose-boweled migratory birds living near Ohio marshes and waterways. That’s not counting any of the thousands more living in cities, where their nests often are hidden from government researchers. Finally, we all know that both water and waste eventually run downhill — especially when spring rains accelerate the flow.

via Goose droppings might be raising bacteria levels in Northeast Ohio waterways – Metro – cleveland.com.

Filed under: Uncategorized

CVS Resolution Agreement with HHS Office for Civil Rights for HIPAA Violations

CVS Pharmacy, Inc. recently entered into a “Resolution Agreement” with the DHS Office of Civil Rights for a variety of business practices that were reported in the media concerning disclosure of protected health information (“PHI”).   There was a similar agreement with Providence Health System last year for a $100,000 amount and corrective action plan.

Of note is the size of the settlement – $2.25M.  I also took a look at the Resolution Agreement and the Corrective Action Plan (“CAP”) to note similarities/differences from Corporate Integrity Agreements from OIG.  I saw many similar parallel items from my experience with the CIA front.   Now that the bubble has burst on actual enforcement actions with significant settlement payment amounts, and with the recent HIPAA changes in the Stimulus law, you can bet that there will be both more plaintiff litigation on this front (i.e., HIPAA privacy regulations as the “standard of care” and state tort law as the actual suit mechanism) as well as enforcement action by the Office for Civil Rights.   It is also notable that the “trigger” here was media reports.  Perhaps no accident that the proposed HIPAA changes require media outlet reporting once a threshold of PHI is released.  You can check out the press release and the resolution agreement/CAP at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/cvsresolutionagreement.html

Filed under: CMP, Health Law, HIPAA, , , ,

CMS Summarizes Final Revisions To EMTALA Including Community Call Plan

As reported in the March 13, 2009 BNA Health Law Reporter, CMS has published a memorandum that provides a summary of its final 2009 revisions to EMTALA, and the memorandum contains information discussing the community call plan provisions of the Final Regulations. The memorandum and the interpretative guidelines in the State Operations Manual discussing the changes are available at http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09-26.pdf.

Filed under: EMTALA, Health Law, ,

New York Medicaid Provider Self-Disclosure Process

As reported in the March 13, 2009 BNA Health Law Reporter, The New York State Office of the Medicaid Inspector General (OMIG) on March 12 announced the release of the Provider Self-Disclosure Guidance.  According to the the OMIG, this will “enabling health care providers to identify, reveal, and return to the OMIG overpayments they have received from the Medicaid program.”  BNA reports that the guidance is significantly more expansive in scope than the Department of Health and Human Services Office of the Inspector General’s Self-Disclosure Protocol.   OMIG reports that it hopes to save up to $820 million in Medicaid costs in the 2009-2010 fiscal year.  The OMIG also “highly discourages” providers from attempting to avoid the self-disclosure process when circumstances warrant its use and it will not accept full and final payments for self-disclosed violations before the investigatory process is finalized. See  http://www.omig.state.ny.us/data/images/stories/self_disclosure/omig_provider_self_disclosure_guidance.pdf for the new guidelines and http://www.omig.state.ny.us/data/images/stories/self_disclosure/voluntary_disclosure_form.pdf for the disclosure form.

Filed under: AKS, Fraud and Abuse, Health Law, Medicaid, , , , ,

Heimlicher v. Steele, N.D. Iowa, No. C05-4054-PAZ

Health Law Reporter.  The March 13, 2009 Health Law Reporter reports Heimlicher v. Steele, N.D. Iowa, No. C05-4054-PAZ, 3/11/09, where a hospital and physician are found to violate EMTALA for the transfer of a woman in labor nearly 100 miles to another hospital in poor weather rather than perform an emergency c-section.  Award of $1.7 million

Filed under: EMTALA, Health Law, , ,

OIG Finds No Grounds for Penalties on SNF’s Transportation Proposal for Residents’ Family

Health Law Reporter.  As reported in 3/19/2009 BNA Health Law reporter and published by the OIG on 3/13/2009, the OIG granted a favorable advisory regarding transportation program for friends and families of SNF residents, where the SNF is located in a geography difficult for such individuals to reach.  According to the OIG, “[m]any arrangements involving free transportation have important and beneficial effects on patient care, especially where such arrangements are narrowly tailored to address issues of financial need, limited transportation resources, treatment compliance, or safety.”  But the OIG cautions that transportation programs may also be “schemes” to lead to “inappropriate steering of patients, overutilization, and provision of medically unnecessary” services.  The OIG lists some examples:

• Providers offering out-of-state patients free transportation to receive services at their facilities;
• Van drivers soliciting, and offering free transportation services to, Medicaid patients for health care providers who compensate the drivers on a per patient or per service basis;
• Providers offering residents of nursing facilities and other congregate care facilities free transportation services to and from their offices for services of questionable necessity;
• Providers offering patients free limousine services;
• Hospitals or other providers offering patients free ambulance services without making individual determinations of financial need; and
• Hospitals or other providers inducing referrals from physicians by offering the physicians’ patients free transportation to the physicians’ offices or to a facility where the physician furnishes services.

The OIG indicated that it will look at factors such as (i) whether transportation is offered in a manner related to referrals; (ii) the type of transportation and if it is luxury or specialized; (iii) whether the transportation is within or outside of the primary service area of the provider; (iv) the availability of other forms of transportation; (v) how the program is marketed or advertised; (vi) who bears the cost of the transportation — whether the provider itself or beneficiaries or the federal healthcare programs through cost reporting; (vii) whether the destination is to the primary provider or if the transportation is to other providers of care; (viii) whether there is a healthcare provision nexus between the provider and those receiving the transportation — particularly in this case where it is not the patient, but family and friends receiving it.

It goes without saying, but the gating issue also is if the transportation can fit into the other unofficial safe harbor that the OIG has set out — that is, services at less than $10/instance, $50/annually.  Here the program would likely exceed at least the $50/annual guideline.

What the OIG liked about the program:

(A) It was not for or related directly to the patient receiving care and it was not about the patient going to another healthcare provider;

(B) The program is open to all friends and family members of patients, regardless of payor source, means or other potentially problematic factors.

(C) Transportation is reasonable – a van running between public pick-up locations – not a limo or specialized transit.

(D) Marketing is local, limited to local papers and patient/family/friends themselves.

(E) There truly is limited public transportation and the cost to access the facility is hampered by a large “toll-bridge” toll.

(F) It’s good for patients to have the companionship of friends and family and, therefor, supports the SNF’s mission.

(G) The costs will not be on the provider’s cost report.

This is a reasonable and good opinion on a practice that I have a feeling is widespread in the industry and that can be structured in a manner that is good for the patients and the care that they receive and structured in a way that does not increase risks to the Medicare program.

Filed under: AKS, CMP, Health Law, Transportation, , , , ,

Clifton Boulevard to get upgraded bus service and 30 curbside stations

My old neighborhood is getting a bus-line face lift.  Makes me (almost) want to move back and get a job downtown again. Ah, the days walking to Clifton dinner and having brunch with friends.

Sixty-foot long articulated buses, similar to those on the Euclid Avenue HealthLine, are expected to be on the street this fall. RTA will spend $700,000 in federal stimulus money to plan and design a four-mile line extending from the West Shoreway in Cleveland to the Lakewood/Rocky River border. The project, which would include 30 new curbside stations and dedicated bus lanes during rush hours, is expected to cost $14 million. Those funds have yet to be acquired but officials are hoping to seek more federal dollars for the project, said Joe Calabrese, general manager of the Greater Cleveland Regional Transit Authority.

Lakewood grew in the 1900s because of its streetcar system, with lines on Detroit Avenue, Clifton Boulevard and Madison Avenue, according to a history of the city by the Lakewood Heritage Advisory Board.

via Clifton Boulevard to get upgraded bus service and 30 curbside stations – Metro – cleveland.com.

Filed under: Personal Posts, ,

Podcasts I’m Listening to, Week of 3/16/2009

Name Artist Album
NYT: Science Times for 1/6/2009 David Corcoran of The New York Times Science Times
The Evolution of Evolution Scientific American Science Talk: The Podcast of Scientific American
NYT: Science Times for 1/13/2009 David Corcoran of The New York Times Science Times
NYT: Science Times for 1/20/2009 David Corcoran of The New York Times Science Times
Phrasing a Coyne: Jerry Coyne on Why Evolution Is True Scientific American Scientific American Podcast
Appeals Judge Posner Says U.S. Is in a Depression Bloomberg News Bloomberg Law
Buckyball Discoverer Explores Nanotech Frontier NPR NPR: Science Friday Podcast
In Search of Time Scientific American Scientific American Podcast
AIG Bonus Outrage, Soaring Deficit Complicate Obama Agenda NewsHour with Jim Lehrer Shields and Brooks | NewsHour with Jim Lehrer Podcast | PBS
It’s All Politics March 19 2009 NPR NPR: It’s All Politics Podcast
How Do You Amputate A Phantom Limb? NPR NPR: Hmmm…. Krulwich on Science Podcast
The Search For Hidden Dimensions In The Universe NPR NPR: Science Friday Podcast
‘Remarkable Creatures’ Behind Darwin’s Discoveries NPR NPR: Science Friday Podcast

Filed under: Personal Posts, , ,

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