S U P R A S P I N A T U S

Today's New York Times reports:

New York's public and private hospitals stand to lose more than $1 billion in state and federal funds for the training of doctors because of changes to the Medicaid program backed by the Bush administration, according to an analysis by the city's Independent Budget Office released on Tuesday.

The change would end a revenue stream that the medical residencies have relied on for more than 40 years and that have widespread ramifications, because New York hospitals train a large share of the nation's doctors, many of whom work in poor neighborhoods during their residencies.

Read the full article here.

After losing its bid for approval of its expansion plans, St. Vincent Catholic Medical Centers tries a different tack, as reported today in the New York Times:

On Tuesday --- after the commission rebuffed the hospital's $1.6 billion development proposal --- Henry J. Amoroso, president of St. Vincent Catholic Medical Centers, the entity that includes the hospital, said it would file an application seeking hardship status.

He sought "the demolition of the O'Toole Building," he said, referring to the distinctive white monument on Seventh Avenue between 12th and 13th Streets that the hospital owns.

When it grants hardship status, the commission accepts nonprofit landlords' arguments that maintenance of buildings they own interferes with their ability --- physical or financial --- to carry out their charitable purpose.

Read the full article here.

A recent UK review article entitled, "What impact do prescription drug charges have on efficiency and equity? Evidence from high-income countries" (1) reviews the literature
(173 articles from 15 countries) on user charges for prescription charges in high-income countries with a view to assessing their impact on efficiency and equity. Almost all of the studies reviewed concluded that prescription charges reduce the use of prescription drugs, but they also show that most patients are not particularly sensitive to changes in the out-of-pocket price of prescription drugs; the economic effect is that the demand for prescription drugs is price inelastic.
One of many issues discussed: The authors observe that most studies conclude that user charges reduce the use of prescription drugs and so enhance allocative efficiency as defined by standard welfare economics. However, the authors posit that in assessing the impact of prescription drug charges on efficiency, an interpretation of efficiency more commonly used to evaluate policy is one that focuses on improving health through the provision of effective health care. From this perspective they propose that the cost,health, and distributional consequences of prescription drug charges can be seen to lower efficiency.
They examine various policy implications/options. They provide critiques of the studies they reviewed, also noting what areas have not yet been studied.
The authors also provide tables which incorporate information from the studies, showing the impact of prescription drug charges;
-on the volume of prescriptions obtained,
-on the probability of obtaining a prescription,
-on the use of generic or reference-price drugs,
-on the demand for other health services,
-on patients' out of pocket expenditures.

(1) http://www.equityhealthj.com/content/pdf/1475-9276-7-12.pdf , from Biomed Central (http://www.biomedcentral.com/) a peer reviewed article of The International Journal for Equity in Health 2008, Marin C. Gemmill, Sarah Thomson, Elias Mossialos,all of London School of Economics and Political Science, London, UK , acknowledged support of an educational grant from the Merck Company Foundation program on Pharmaceutical Policy Issues. 19 pp followed by references and tables.Countries include Australia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, New Zealand, Spain, Sweden, UK, US.

From IOM's website-chock full of important projects (1): IOM's Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule- is investigating the effects on health research of the Privacy Rule regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) section on Administrative Simplification. As data and evidence allow, the needs and benefits of patient privacy will be balanced against the needs, risks, and benefits of identifiable health information for various kinds of health research. The committee will formulate recommendations for alterations or retention of the status quo accordingly and prepare a report.
Several helpful powerpoint presentations from the Feb. meeting are archived on the website.
More specifically, this Committee plans to consider/review:
-the range of study types (clinical trials, epidemiologic designs, research using tissue repositories and databases, public health research, and health services research);
-research carried out by a full range of sponsors (government, public/private academic, for-profit sectors, including the pharmaceutical, biotechnology,medical device industries);
-provisions of the Privacy Rule relevant to health research, including those dealing with authorizations and accounting for disclosures of personal health information, de-identification of data, reviews preparatory to research, and others;
-issues of interpretation/implementation of the Privacy Rule and overlapping provisions of the Common Rule/FDA regulations (in existence much longer);
-potential impact of the Rule on: public health research, recruitment of research subjects for studies, conduct of research internationally, research using data and biomaterials in databases and tissue repositories; and
-needs for privacy of identifiable personal health information and the value of such privacy to patients and the public.
Another project underway: IOM's Forum on the Science of Health Care Quality Improvement and Implementation; their goals are to (i)advance the understanding of the value and appropriate role of research philosophies, cultures, and methods and (ii) develop greater awareness and support for appropriate approaches and methods by key stakeholder groups.
Also, an IOM ad hoc committee will undertake a comprehensive review/analysis of the health consequences of lacking health insurance coverage including, for example, the effect on morbidity/mortality for the uninsured population overall and for certain vulnerable groups such as persons with chronic disease and older adults in the years preceding Medicare eligibility (12-month study).
(1) http://www.iom.edu/ Established in 1970 under the charter of the National Academy of Sciences, IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. IOM's mission embraces the health of people everywhere.

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The Empire State Stem Cell Board will hold a regular business meeting on May 13, 2008 in Albany, NY which will include meetings of both the Ethics Committee and the Funding Committee. Agenda topics include: Ethics and the Sources of Stem Cells for Research; Report on Interstate Alliance on Stem Cell Research (IASCR);Consideration of Draft Strategic Plan.(1)

Governor David A. Paterson announced that new state funding of nearly $109 million is being made available to support stem cell research initiatives in New York, representing the second round of available funding from the state’s 11-year, $600 million stem cell research initiative that was approved as part of last year’s state budget. Governor Paterson played a leading role in the development and implementation of the state’s stem cell initiative while he was Lieutenant Governor. 'This new funding will strengthen and revitalize New York’s biomedical research industry and potentially help thousands of New Yorkers who suffer debilitating diseases, including Alzheimer’s, Parkinson’s, diabetes and cancer.'

4 new RFAs seek proposals to broadly stimulate stem cell research through:

-Consortia Planning Grants-to encourage collaborations among new and established stem cell investigators within and between New York State institutions and in partnership with non-New York State investigators and corporations.
-Facilities and Equipment Grants-to support the establishment and operation of multi-institutional core facilities and specialized equipment to maximize the expertise, efficiency, and quality of stem cell research.
-Investigator-Initiated Research Projects and Innovative, Developmental or Exploratory Activities (IDEA) in Stem Cell Research-to support investigations of stem cell biology that will increase understanding of the unique properties of stem cells and allow their use to treat disease; awards for well developed basic, translational or pre-clinical research, or for preliminary testing of novel or high-risk hypotheses.
-Targeted Investigation of Pluripotent Stem Cells-to support the development of improved methods for deriving pluripotent stem cell lines; defining the reprogramming mechanisms, and comparing the utility of induced pluripotent stem (IPS) cells with embryonic and other pluripotent stem cells for use in disease models and potential therapeutic applications.(2)

IASCR is a voluntary body whose mission is to advance stem cell research by fostering effective interstate collaboration, by assisting states in developing research programs, and by promoting efficient and responsible use of public funds.
Support for the IASCR Secretariat at the National Academies has been provided by the Presidents' Committee of the National Research Council.(3)

(1)http://stemcell.ny.gov/events_nystem_full_committee.html To attend the meeting, please provide Ms. Mary Szesnat with advance notice by 12:00 p.m., Monday, May 12, 2008. (518) 474-1151 or mms04@health.state.ny.us. View a webcast of the meeting at
http://www.health.state.ny.us/events/webcasts/(2)http://www.ny.gov/governor/press/press_0508081.html Letters of intent for all the RFAs are due May 28, 2008, with applications due June 30, 2008. The full RFAs can be found on the state Department of Health’s website www.nyhealth.gov/funding and on the NYSTEM website www.stemcell.ny.gov/research_support.html.
(3)http://www.iascr.org/ see below.

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The New York Times reported Wednesday on a striking figure:

More than 2 percent of all doctors practicing in New York last year landed on the state medical board’s watch list because of problems including substance abuse, mental health concerns or their professional conduct.

While many were alarmed at the numbers, which are something like twice the national average, others were not:

Dr. Richard F. Daines, New York’s health commissioner, said "the higher numbers reflect active, good programs, rather than bad physicians."

Read the full story here.

Yet another criminal HIPAA case:

Jane W. Duke, United States Attorney for the Eastern District of Arkansas, along with William C. Temple, Special Agent in Charge of the Little Rock Division of the Federal Bureau of Investigation, announced today the guilty plea of Andrea Smith, age 25, of Trumann, Arkansas. Smith, a licensed practical nurse, pleaded guilty to wrongfully disclosing individually identifiable health information for personal gain, a violation of the health information privacy provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) contained in Title 42, United States Code, Section 1320d-6.

. . .

Duke noted that criminal enforcement of HIPAA is a fairly new concept. In fact, the first Department of Justice HIPAA prosecution was initiated in 2004 in the Western District of Washington. Since then only a handful of such cases have followed.

Read the US Attorney's press release here.

This recent spate of criminal HIPAA prosecutions is interesting to say the least. Recall that in 2005 a memorandum opinion was prepared for the General Counsel of the Department of Health and Human Services and the Senior Counsel to the Deputy Attorney General that described a rather narrow scope under the HIPAA criminal provisions (emphasis is mine):

Specifically, you have asked, first, whether the only persons who may be directly liable under section 1320d-6 are those persons to whom the substantive requirements of the subtitle, as set forth in the regulations promulgated thereunder, apply—i.e., health plans, health care clearinghouses, certain health care providers, and Medicare prescription drug card sponsors—or whether this provision may also render directly liable other persons, particularly those who obtain protected health information in a manner that causes a person to whom the substantive requirements of the subtitle apply to release the information in violation of that law. We conclude that health plans, health care clearinghouses, those health care providers specified in the statute, and Medicare prescription drug card sponsors may be prosecuted for violations of section 1320d-6. In addition, depending on the facts of a given case, certain directors, officers, and employees of these entities may be liable directly under section 1320d-6, in accordance with general principles of corporate criminal liability, as these principles are developed in the course of particular prosecutions. Other persons may not be liable directly under this provision. The liability of persons for conduct that may not be prosecuted directly under section 1320d-6 will be determined by principles of aiding and abetting liability and of conspiracy liability.

The memorandum opinion was notable at the time for defining a much smaller scope of potential criminal liability than what was anticipated in the legal community. The weight of the memo was undoubtedly a factor in the overall small number of HIPAA prosecutions in the years since the regulations went into effect.

That appears to be changing somewhat. Both Dwight McPherson (NewYork-Presbyterian Hospital/Weill Cornell Medical Center) and Lawanda Jackson(UCLA Medical Center) appear to have been low-level clerks whose actions would be difficult to impute to the Covered Entity itself.

An April 29, 2008 article in the Wall Street Journal hinted at more aggressive criminal enforcement of privacy breaches than what has been widely reported. iHealthBeat covered the article for those still waiting for WSJ to move to free content:

HHS said several hundred violations of the HIPAA medical privacy rule have been reported to the U.S. Department of Justice for criminal prosecution.

However, a DOJ spokesperson said that the department has filed about 200 criminal cases since 2003 under a statute that includes HIPAA but that not all cases are necessarily HIPAA-related (Rubenstein, Wall Street Journal, 4/29).

Read the full iHealthBeat article here.

The Health Law Section listserve this afternoon broke a story on a new case filed April 29, 2008 against Ingenix, Inc. and a number of payors in Connecticut U.S. District Court. The additional defendants include UnitedHealth Group Inc, Oxford Health Plans, Aetna Inc, Cigna Corp, Empire BlueCross BlueShield, Humana Inc, Group Health Ins Inc, Health Ins Plan of NY and Health Net Inc.

The district court case number is 3:2008cv00654

Link to the Justia docket information here.

Hat tip: James G.Fouassier, Esq.

Updated (2:04pm) The complaint itself is here.

The complaint alleges three counts:

I - RICO (18 USC 1962(c))
II - Sherman Act (15 USC 1)
III - Connecticut Unfair Trade Practices Act

Paragraphs 50 to 52 of the complaint reference the NY investigation and quote from AG press conferences.

See earlier Supraspinatus coverage on Ingenix matters by clicking the Ingenix tag at the foot of this post.

From the AG's website:

Attorney General Andrew M. Cuomo today released the 2007 Annual Report of the New York State Attorney General’s Medicaid Fraud Control Unit (MFCU), which was submitted to the Secretary of the U.S. Department of Health and Human Services.

The report, which details MFCU’s activities and major cases for the past year, includes data regarding the $112.5 million in court-ordered civil damages and criminal restitution the Attorney General’s Office obtained - nearly double the $59.4 million recovered in 2006.

Read the press release here. The 2007 Annual Report is available online from the AG here (PDF format).

CMS is proposing significant changes to the Stark II, Phase III rules that were promulgated last September. The changes are contained in the 2009 Inpatient Prospective Payment System Proposed Rule that was published in the April 30, 2008 Federal Register. Here are some highlights.

CMS is proposing to narrow the application of the new "stand-In-the-shoes" rule. Under one proposal, the stand-in-the-shoes rule would not apply if the only financial arrangement between the physician and the physician organization is a compensation arrangement that meets the employment exception, personal services exception, or fair market value exception. A physician will continue to stand in the shoes of his/her physician organization if the physician is an owner and receives a share of the profits, receives any compensation protected under the in-office ancillary services exception or has a space or equipment rental arrangement with the group. This means the stand-in-the-shoes concept would continue to apply to agreements with a physician group, unless the physician-owners receive only employment compensation from the group.

CMS is seeking comments on whether it should develop a set of exceptions to the stand-in-the-shoes rules for arrangement that do not pose a risk of program or patient abuse. Examples include mission support payments made by an academic medical center and payments within an integrated healthcare system. These arrangements are currently exempt from the stand-in-the-shoes rule.

CMS is also soliciting comments on an entity stand-in-the-shoes rule, which it originally outlined in the 2008 Medicare Physician Fee Schedule Proposed Rule. Under the current proposal, a DHS entity would stand in the shoes of any wholly-owned organization, not just a wholly-owned DHS entity. CMS is considering whether to apply this rule to partially-owned organizations and organizations which are controlled, but not owned, by a DHS entity (e.g., non-for-profit membership corporations).

Because of the overlaps that could occur when applying both the entity stand-in-the-shoes rule and the physician stand-in-the-shoe rule, CMS is developing conventions for determining which order to apply the rule. This will make applying the Stark regulations to a particular situation almost as much fun as settling a conflicts of law issue.

If an arrangement with a particular physician does not satisfy a Stark exception, how long is that physician prohibited from making referrals to the DHS entity? CMS is proposing to amend the regulations to establish three finite periods of disallowance: (i) for relationships that are non-compliant for reasons unrelated to compensation, the date the relationship becomes compliant; (ii) for relationships that are non-compliant due to payment for excess compensation, the date on which the excess compensation, plus applicable interest, is returned; and (iii) for relationships that are non-compliant due to payment of insufficient compensation, the date on which the additional required compensation, plus applicable interest, is paid. Note: the DHS entity can't wait until the period of disallowance has ended to submit claims for prohibited referrals.

Finally, CMS is also soliciting comments on its (currently suspended) disclosure of financial relationship reporting initiative, gainsharing arrangements, and physician-owned implant and other medical device companies.

Comments on these proposals are due June 13, 2008.

Hard on the heels of the patient data theft at NewYork-Presbyterian Hospital/Weill Cornell Medical Center comes an indictment of an administrative specialist at UCLA Medical Center for snooping in celebrity medical records.

Lawanda Jackson, 49, was indicted April 9 on a charge of obtaining individually identifiable health information for commercial advantage. Actress Farrah Fawcett and her lawyers allege that Jackson leaked personal information about her battle with cancer to the National Enquirer and other tabloids.

Read the full LA Times story here. Jackson joins a short list of HIPAA indictees. The first was Richard Gibson, a Seattle cancer center employee who in 2004 was sentenced to 16 months in prison for stealing one patients' protected health information. The second was Leslie Howell of Oklahoma City, a mental health counselor indicted in August 2007 for selling over one hundred patient files. Dwight McPherson was likely the third, though I'm not completely certain he was charged under HIPAA as I've not seen the charging document, who is alleged to have sold tens of thousands of records. Jackson's indictment is made available by the LA times here.

A recent "Trials" paper (authors from China, UK )

[critically evaluates] RCTs conducted in China based on studies published in 2004... to describe their general characteristics, evaluate the quality of their reporting and evaluate their conduct where adequately reported.(1)

The paper observes that China is a developing country with the largest population in the world, research in China has been rapidly gaining momentum but as yet there is no systematic evaluation of the current standard of trials conducted there.

'Randomized controlled trials' (RCTs) are considered the 'gold standard' for assessing the effectiveness of pharmacological and other interventions in the field of medicine and are widely accepted as the best research design because they distribute both known and unknown prognostic factors between treatment groups by the play of chance thereby minimizing the possibility that any treatment effect is due to bias or confounding and providing the basis for valid statistical comparison. However RCTs vary in their methodology rigor and it is well known that poor quality studies tend to produce systematically different results from larger better quality studies, often erroneously showing larger treatment effects. The conduct of studies cannot be assessed without clear reporting.

RCTs published in 2004 were reviewed--as identified through PubMed database, and on-line versions of main medical journals in China-- about 71 journals.
A 2008 JAMA Editorial discusses requirements for publication of clinical trials in JAMA
-all RCTs to be registered in a public trials registry that is acceptable to the International Committee of Medical Journals and that requires the minimum registration data set as described by the ICMJE,
-authors of clinical trials should follow the CONSORT guidelines for reporting RCT results, and
-for all RCTs data anaylsis must be conducted by an academic statistician.(2)
Authors from the UK, Canada, USA published a recent paper in "Trials" entitled: "Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors' "(3) which indicates that the CONSORT Statement provides recommendations for reporting RCTs, and Journals should be more explicit in their recommendations and expectations for authors regarding the CONSORT Statement and related CONSORT extensions papers.
CONSORT (Consolidated Standards of Reporting Trials)

encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of RCTs. The CONSORT Statement, is an evidence-based, minimum set of recommendations for reporting RCTs. (4) ...It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. The CONSORT Statement comprises a 22-item checklist and a flow diagram, along with some brief descriptive text... The CONSORT Statement is available in 10 different languages other than English.

See also AHRQ 's "Systems to Rate the Strength of Scientific Evidence" (5)- a description of systems used to rate the strength of scientific evidence. Valuable information gleaned from 1602 articles, reports,... indicates that overall many systems covered most of the domains that are considered generally informative for assessing study quality.
Some background: From a 2000 JAMA article "Meta-analysis of Observational Studies in Epidemiology-a Proposal for Reporting", by the MOOSE group

,...because of pressure for timely and informed decisions in public health and medicine and the explosion of information in scientific literature, research results must be synthesized to answer urgent questions. Principles of evidence-based methods to assess the effectiveness of health care interventions, set policy, are cited increasingly

.(6)
(1) http://www.trialsjournal.com/content/pdf/1745-6215-9-22.pdf
"Trials" via BIOMED Central on line: "An Assessment of the quality of randomized controlled trials (RCTs) conducted in China" by authors from China and the UK" D. Zhang, P. Yin, N. Freemantle, R. Jordan, N. Zhong,l K. Cheng
(2) http://jama.ama-assn.org/cgi/reprint/299/1/95?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=JAMA+Instructions+for+Authors+2006&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
http://jama.ama-assn.org/cgi/reprint/295/1/103?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=JAMA+Instructions+for+Authors+2006&searchid=1&FIRSTINDEX=0&resourcetype=HWCITJAMA Jan 4 2006 vol 295 no 1 instructions to authors
(3)http://www.trialsjournal.com/content/pdf/1745-6215-9-20.pdf authors S. Hopewell, D. Altman, D. Moher, K.Schulz
(4) http://www.consort-statement.org/index.aspx?o=1056 who is
(5)http://www.fda.gov/ohrms/dockets/dockets/04q0083/04q-0083-pdn0001-03-Tab-01-AHRQ-vol9.pdf
(6) http://jama.ama-assn.org/cgi/reprint/283/15/2008? JAMA Vol 283, No 15

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As part of the ongoing evolution of Supraspinatus we have added a "tag cloud" to the right-hand column. The tag cloud includes all of the tags that Suprapspinatus contributors have applied to their posts. The more items bearing a certain tag, the larger the tag appears in the tag cloud. (In the current cloud, "hospitals" is very big, while "marijuana" is very small.) By clicking a tag in the tag cloud, a reader can see all of the articles that have been tagged in that way.

The tag cloud appears towards the bottom of the right-hand column, below the feed from the CBO director's blog.

Feedback on the tag cloud, positive or negative, is welcome.

Published April 23, 2008 in "Trials" (1) an open access article shares a study protocol entitled: "Streamlining tasks and roles to expand treatment and care for HIV: [randomized] controlled trial protocol" Fairal, l, et al.

The South Africa Free State health department has decided to support this trial and to decide whether to implement nurse-led ART based on the trials' results. Despite national guidelines, its Provincial Pharmaceutical and Therapeutics committee is legally [authorized] to permit nurses to prescribe Schedule 4 drugs such as antiretrovirals and has done so for intervention clinics in this trial. The National Department of Health and the main patient advocacy group in South Africa, the Treatment Action Campaign also support the trial and are keenly interested in the results. The timing of this trial is thus critical for policy making....

The aim of the trial is to compare the effectiveness of a primary care system based on nurse-led ART with the current system based on doctor -led ART. It is still widely assumed that ART is too difficult and risky to be entrusted to nurses because of drug side effects and resistance. But many eligible patients continue to die because of delays in starting ART. It is likely that with appropriate training and support, nurses can manage most patients effectively, leaving doctors to manage the minority at high risk or with complications....

Background: South African government health services started in 2004 to provide free ART to HIV-infected patients with certain CD4 counts but by 2007 only 1/3 of patients who need ART were receiving it. The major bottleneck is due to reliance on doctors to prescribe ART including starting treatment. Doctors are generally only available in hospitals and large urban health centers whereas most public sector primary care clinics are staffed by nurses.

... a better use of nurses is a compelling way to expand access and avoid delays in starting treatment. If most patients with HIV/AIDS can start and continue ART without doctors' involvement , they could start treatment earlier and thus avoid disease progressing and death.
At present in South Africa, only doctors may prescribe ART in keeping with national guidelines.

(1) http://www.trialsjournal.com/content/pdf/1745-6215-9-21.pdf

Today's Wall Street Journal online profiles Peter Orszag, the Director of the Congressional Budget Office, and shows how prominently Orszag figures in the debate over health care reform.

As the presidential candidates and Congress rev up the debate over the future of health care, Peter Orszag is already playing one of the toughest positions: referee.

Mr. Orszag, a 39-year-old economist, is the director of the Congressional Budget Office, the influential agency charged with toting up congressional bills' impact on the federal budget. Such scoring can sink bills that can't offset their costs with savings -- a serious risk for proposals that aim to expand federal health programs to cover more citizens.

Mr. Orszag increasingly is focusing on health issues, taking an unusually high profile for his nonpartisan office. He has become a prominent speaker at health conferences and co-wrote two pieces in the New England Journal of Medicine. He has launched a blog, cboblog.cbo.gov/, boosted the number of staffers who work on health to 47 from 31 and is seeking to add more. The agency has 235 employees.

Read the full article here. Regular Supraspinatus readers are already on to Orszag; we added a component to our right-hand column a couple of months ago that pulls in the most recent five posts from Orszag's blog.