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

In today's New York Times online Dee Gill writes about the resurgence of physician house-calls. One California company, Care Level Management, employs about one hundred physicians and offers services to more than 13,000 chronically ill patients. Apparently, according to the article, it's a money-saver:

Care Level says that its house calls save insurers money by drastically reducing emergency room visits and hospitalizations. In fact, it guarantees savings.

For example, in a three-year trial Care Level is conducting with the federal government’s Centers for Medicare and Medicaid Services, Medicare pays Care Level a monthly case rate and a fee per visit to care for up to 25,000 patients in Texas, California and Florida. But Care Level must return the money unless net costs for its patients are at least 5 percent lower than the costs for patients in a control group. The company splits any saving above 5 percent with Medicare.

The company has used a similar payment structure to charge private insurers, although most of its private customers have switched to flat fees. Care Level says that independent audits show that it has reduced hospital admissions for private-insurer patients by 60 percent on average, for a net cost saving to clients of about 30 percent.

The article gives passing mention to another house-call operation closer to home, with a slightly different take on the financial opportunities:

Dr. Roberta Miller has run a home-visit practice for about 500 patients in the Albany area with her husband and another partner since 1998. She sees little chance for profits under Medicare’s payment plan. Overhead costs are kept low, she said, “but we can’t see a patient every 15 minutes.”

AMSTERDAM NURSING HOME CORP. v. LANG, 601821/05 (9-13-2007)
2007 NY Slip Op 51727(Unpublished)
Supreme Court of the State of New York,
New York County.
Decided on September 13, 2007.

The issue before the Court is whether defendant Ronald Lang can be held liable for the cost of care his grandmother received at a nursing home, based on his signature on the admission agreement.

[Held,] Amsterdam's complaint must be dismissed on the merits, as it is not entitled to hold Lang liable for any portion of his grandmother's outstanding charges, based upon the language of the Admission Agreement he signed, the applicable provisions of the Social Security Act, the
federal and state regulations, or the relevant case law.

From the DOH website:

The New York State Department of Health has awarded $800,000 to 16 nursing homes to support implementation of an evidence-based best practice shown to significantly reduce pressure ulcers.

Read the full press release, including a list of recipient facilities, here.

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 [antiretroviral treatment] 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

May 22, 2008, HHS Secretary Mike Leavitt announced new FDA/CMS efforts that will complement each other to improve patient safety and the quality of medical care.(1) Read more about the big picture and how CBO sees the Federal government's Activities fit in at CBO's Report, pp24-27(2) and Supra Paul Gillan's post of yesterday on CBO below.

This [FDA] initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market...moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.(1)

A new FDA white paper describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it.(3) The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems. FDA Commissioner Andrew C. von Eschenbach, M.D. explains:

With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people...The era of 'wait and see' is going to become the era of 'tell me right now.' By harnessing the world's most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product's performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.

CMS Acting Administrator Kerry Weems states:

There's a clear nexus between the data collected through Medicare's prescription drug program and the FDA's role in protecting the public from adverse events.

For example:CMS's most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality.(4) Medicare beneficiaries' high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA's new Sentinel Initiative.
(1)http://www.hhs.gov/news/press/2008pres/05/20080522a.html
(2)http://www.cbo.gov/ftpdocs/91xx/doc9168/05-20-HealthIT.pdf
(3) FDA's report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html.
"The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety"
(4)http://www.ahrq.gov/news/nn/nn051607.htm
(5)The press release notes that a CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis. Read the Fact Sheet athttp://www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/PartDClaimsDataFactSheet.pdf

The UNAIDS report clearly shows that stronger measures are needed to turn the epidemic around and that ‘knowing your local epidemic’ remains critical to an effective response.(1)

The 2008 Report on global AIDS epidemic is a report from the Joint UN Programme on HIV/AIDS (UNAIDS) and includes contributions from 10 UN system organizations brought together in the AIDS response effort of UNAIDS.(2) The Report: -confirms that the world is making some real in its response to AIDS, but 27 years into the efforts AIDS continues to challenge all efforts. Today for every 2 people who start taking the antiretroviral drugs, another 5 become newly infected. This 2008 Report: -is the most comprehensive ever, reflecting input from countries about what works and why. -asks whether the right actions are being taken, are the right actions being undertaken in the right manner, and have these actions been sufficiently scaled to make a difference. To answer these q’s, the Report relies heavily on data reported to UNAIDS by 147 UN Member States in early 2008-- on 25 core UNGASS indicators, using evidence to assess progress.

P19 shows a useful table of national indicators for the implementation of the Declaration of Commitment on HIV/AIDs referring to programmes, knowledge and behavior and impact of the indicators. Civil society monitors progress. Since HIV was first recognized, approaches and methodologies to monitor the epidemic and the response have continuously improved and as a result the world is better equipped than ever to estimate HIV prevalence, rate of new infections, to determine the extent of programme coverage, to characterize and evaluate national responses and to gauge the level of funding available for HIV programmes in low/middle income countries.Key weaknesses include countries that monitor/evaluate but have no HIV database and 1 in 4 countries with monitoring/evaluating have not calculated budgetary req’ts. The number of monitoring/evaluating countries continues to grow but they must ensure that they actually use the info generated to improve decionmaking.

P67-68 HIV is a biological entity that is responsive to medical interventions, but the epidemic has continued to expand largely due to failures to tackle societal conditions that increase HIV risk and vulnerability. 2 sets of societal factors that have not been effectively addressed in most countries: -gender equality and empowerment of women and girls, and -discrimination, stigma and social marginalizations. A human rights approach to HIV ensures that matters that are often considered discretionary are recognized as legitimate entitlements of all individuals, it empowers people to know and claim their rights and it helps stakeholders to address power imbalances that exist at household, community and national levels.

P132 The impact of retroviral drugs on the management of HIV infection has been startling, with improvements in health proving to be far more marked and enduring than anticipated when the combination antiretroviral therapy first emerged in the 1990’s. Recent studies in Denmark suggest that a young man diagnosed with HIV is likely to live an additional 35 years with available medications, a tripling of life expectancy of people with HIV. (Lohse 2007). The best time to initiate antiretroviral therapy remains a subject of debate.

P155 Focused efforts are required to ensure that all people needing treatment have equal access civil society-- surveys confirm that many people living with HIV face considerable obstacles to accessing HIV treatment (Human Rights Watch). For example several countries stipulate the young people living with HIV must obtain parental consent before receiving antiretroviral drugs. One report indicates that names of people who appear on the Russian Federation’s national registry of drug users often results in discrimination in service access for HIV positive people.

See also an ‘Evidence for action’ table on p160. (1)http://www.un-ngls.org/site/article.php3?id_article=548 (2) http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp 7 chapters, 212 pp plus annex,supplementry errata sheet. Contributors: UN Office of High Commissioner for Refugees, UN Children’s Fund, World Food Programme, UN Development Programme, UN’s Population Fund, UN Office on Drugs and Crime, International Labor Organization, UN Educational, Scientific and Cultural Organization, WHO,World Bank, Global Fund to Fight TB+Malaria, UNGASS Civil Society Steering Committee

From a DOH press release yesterday:

Thirty-seven long-term care providers will share in $1.5 million in grants to improve the quality of the nursing home experience, State Health Commissioner Richard F. Daines, M.D., announced today. The Long-Term Care Quality Improvement Initiative supports projects that demonstrate sustainable improvements that benefit nursing home residents.

Read the press release here.

From today's NY Times:

For 20 years, federal law has protected married couples from having to choose between divorcing or becoming impoverished when one spouse needs expensive nursing home care, allowing the healthier spouse to retain assets and income while the sicker one’s care is covered by Medicaid.

New York State has routinely extended the same benefits to people with illnesses like Alzheimer's disease or cancer who receive care at home, which is both less expensive and less disruptive to relationships.

Now, the federal government has ruled that New York has been too generous in applying the income protections to people at home, forcing several thousand couples to make a stark choice by March.

Get the rest here.

Governor Paterson has signed a bill, Ian's Law, that addresses the discontinuance of a class of health insurance policies when such action is based on claims experience or a health status-related factor. Although such an action is prohibited by current law, the new law strenghtens notice and enforcement provisions and creates a new process to provide certain insureds relief when they are negatively affected by a discontinuance, even when such action is entirely proper. Senator Schneiderman, the lead Senate sponsor of the bill and current attorney general candidate, achieved national press coverage on the issue.

Paterson also signed a bill making changes to the False Claims Act that will give OMIG increased jurisdiction and another allowing direct admission into "Enhanced Assisted Living Residences" - fixing what was largely seen as a technical flaw in the original 2005 Assisted Living Reform Act.

The Governor's press release indicating all bills recently acted upon is here