humani nil a me alienum puto

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

The New Tarasoff? 6th Circuit OKs Hospital Suit Over Ax-Wielding Ex-Patient | ABA Journal – Law News Now

In Moses v. Providence Hospital and Medical Ctrs the Sixth Circuit federal court of appeals finds that the Emergency Medical Treatment and Active Labor Act (“EMTALA”), 42 U.S.C. § 1395dd gives hospitals a duty to third parties concerning patients that are admitted and then not appropriately treated and stabilized for a mental illness who later go on to harm the third party.  In Moses, a husband presents to the hospital emergency room with his wife, having severe headaches, muscle soreness, high blood pressure, vomiting, slurred speech, disorientation, hallucinations and delusions.  According to his wife he is demonstrating threatening behavior.  The man is clearly screened, although there is a dispute as to whether the physician involved concluded that the husband had an emergency medical condition.   He was admitted for testing and observation.  He was discharged four days later.  There is some evidence in the record that he was to be admitted to the psych unit, although other evidence suggest he had medically stabilized and desired to leave, although the wife was still afraid of him.  The husband, ten days after his discharge, killed his wife.

The defendant hospital’s case is dismissed in summary judgment at the district level.  The hospital contends that (1) the defendant lacked standing because only the individual patient who seeks treatment at the hospital has standing under EMTALA; and (2) that EMTALA imposes no further obligation on a hospital once the hospital has admitted a person as an inpatient.

The court, discounting some legislative history as not controling, and other judicial decisions that have held that relatives of individuals do not have standing, says that a plain reading of the statute requires that any individual who suffered an actual personal injury due to the EMTALA violation may bring a claim against the hospital.  Because this is a third party that suffered actual person injury by the hospital’s allged injury, the court did not think that Zeigler v. Elmore County Health Care Auth., 56 F. Supp. 2d 1324 (M.D. Ala. 1999) (looking to the legislative history of EMTALA, holding that a mother cannot maintain an EMTALA action for a violation related to her daughter’s medical condition) was on point.  The court acknowledges that “our interpretation of the civil enforcement provision may have consequences for hospitals that Congress may or may not have considered or intended. However, our duty is only to read the statute as it is written, as we have in our past analysis of EMTALA.”

The court also holds that the hospital’s obligations do not end upon admission of the patient as an inpatient.  This can be a thorny issue for hospital, but most hoped with the Centers for Medicare and Medicaid Services (“CMS”) new rules,  a hospital’s EMTALA obligations upon admitting an individual as an inpatient. 42 C.F.R. § 489.24(d)(2)(i).  The Moses court acknowledges that the rules state that “[i]f a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual.”  But the Moses court finds that this does not support the summary judgement because it was (1) enacted after the cause of action accruing in this case, and, more importantly (2) “[t]he CMS rule appears contrary to EMTALA’s plain language, which requires a hospital to ‘provide . . . for such further medical examination and such treatment as may be required to stabilize the medical condition[.]'”  The court pretty much lays down the gauntlet to hospitals: “a hospital may not release a patient with an emergency medical condition without first determining that the patient has actually stabilized, even if the hospital properly admitted the patient.”

This is a particularly remarkable case.  The allusions to the famous Tarasoff case may be overly broad — but I am sure there will be much more written about it.

Filed under: CMP, EMTALA, Health Law, , , ,

Health Law Reporter – Economy Increases False Claims Risk, Requiring Greater Focus on Compliance

In the most recent BNA Health Law Reporter, Health Law Reporter. 18 HLR 387, there was an article opining that harder economic times increases FCA qui tam and, in general, healthcare compliance risks.  I found the following notable summary of reasons that compliance programs do not work as well as intended (taken from the BNA article, which, in turn takes from a February 11, 2009 presentation to the AHLA by Patrick S. Coffey, Chris J. Mollet, University of Illinois at Chicago, and Linda A. Wawzenski, assistant U.S. attorney for the Northern District of Illinois):

• Compliance is not a business priority;
• Programs do not operate as written and do not focus on heading off claims;
• Employee training is dull and ineffective;
• There is a lack of ongoing and meaningful risk assessment;
• Hotlines are not sufficiently promoted;
• Employees do not trust the compliance commitment so do not report concerns, while managers do not understand why this is so;
• Significant enforcement settlements are ignored or quickly forgotten;
• Organizations are not prepared to handle internal investigations and routinely mishandle internal reports;
• Disgruntled employees are dismissed and whistleblowers are not protected; and
• Difficult economic times are allowed to undercut compliance efforts.

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

Finding a Doctor Who Accepts Medicare Isn’t Easy – NYTimes.com

A New York Times article on April 1, 2009 discusses some trends: (i) a national shortage of internists, (ii) more internists and other primary care physicians refusing to accept Medicare entirely or at least new Medicare patients, and (iii) boutique/concierge  medicine.

On the first two points:

[T]he American College of Physicians, the organization for internists, estimates that by 2025 there will be 35,000 to 45,000 fewer than the population needs — and internists are increasingly unwilling to accept new Medicare patients. In a June 2008 report, the Medicare Payment Advisory Commission, an independent federal panel that advises Congress on Medicare, said that 29 percent of the Medicare beneficiaries it surveyed who were looking for a primary care doctor had a problem finding one to treat them, up from 24 percent the year before. And a 2008 survey by the Texas Medical Association found that while 58 percent of the state’s doctors took new Medicare patients, only 38 percent of primary care doctors did.

On the last point:

Another, more expensive option is concierge or “boutique” care, which comes in two forms. In the most popular kind, doctors accept Medicare and other insurance, but charge patients an annual retainer of $1,600 to $1,800 to get in the door and receive services not covered by Medicare, like annual physicals. Before signing up and paying the retainer, patients should get a written agreement spelling out which services the doctor will bill Medicare for and which the retainer covers. And always check carefully for double-billing…The other form of concierge medicine — doctors who have opted out of Medicare — is more expensive still. Fees range as high as $15,000 a year and cover office visits, access to the doctor when care is needed, referrals to specialists and thorough annual physicals…Dr. Knope, the author of “Concierge Medicine: A New System to Get the Best Healthcare,” has this kind of practice in Tucson. His patients sign a contract agreeing to pay $6,000 a year for individuals and $10,000 a year for couples. The fee covers office visits, physical exams and phone consultations, and Dr. Knope will meet patients in the emergency room, see them in the hospital and occasionally make house calls…A list of about 500 concierge doctors throughout the country is available on Dr. Knope’s Web site, http://www.conciergemedicinemd.com.

via Finding a Doctor Who Accepts Medicare Isn’t Easy – NYTimes.com.

Filed under: CMP, Concierge Medicine, Health Law, Medicare, Payment, Primary Care, Reform, , , ,

The Washington Independent » Rick Scott on His Health Care Record

The NY Times did an article on Mr. Rick Scott recently. Also of note, The Washington Independent interviewed Rick Scott on March 31, 2009.  You’ll recall him as the ousted CEO of Columbia/HCA after their trillion dollar fraud settlement with the federal government.  He’s back in the headlines as a ‘conservative’ voice against a potential Obama healthcare reform initiative.  I note only due to his comments on Columbia/HCA at the time.

RICK SCOTT: There’s no grudge. First off, if you go back and look at what we accomplished at Columbia/HCA, it was the lowest prices and best outcomes. I left and nothing happened to me. I can’t do anything about what people want to complain about. But if you look at what we’re doing, we’re doing the right things.

TWI: What, specifically?

RICK SCOTT: If you go look at Solantic [which Scott co-founded in 2001], we have transparency on prices, we’re dramatically less expensive than everyone else and we have a great service. Or go back and look at Columbia, look at all the objective measures. Go look at joint commission, accommodation, at accreditation. If you look at the top 100 hospitals, we started with less than seven percent of them. My last year, we had 27 percent of those hospitals. If you look at my management team, all of my management team went on and ran hospital companies.

TWI: People can still say, “Look, this was the guy who resigned in the biggest fraud settlement in American history.”

RICK SCOTT: But, you know, we were the biggest company. If you go back and look at the hospital industry, and the whole health care industry since the mid-1990s, it was basically constantly going through investigations. Great institutions, like ours, paid fines. It was too bad.

via The Washington Independent » Rick Scott on His Health Care Record.

Filed under: AKS, CMP, Drug Policy, Executive Compensation, Health Law, Reform, Risk Management, , ,

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, , , , ,

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

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, , , ,

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, , , , ,

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