Elder Law, Drug and Device Laws and Insurance Laws

New Illinois Insurance Plan for Those with Pre-existing Medical Conditions is Now Accepting Applications Effective August 20, 2010

2010-08-20T13:32:00.000-07:00

The federal health reform law, known as the "Patient Protection and Affordable Care Act", establishes a federally-funded temporary high risk pool to provide affordable health insurance coverage to people who have been denied insurance because of pre-existing conditions. In Illinois, this plan is call the Illinois Pre-Existing Condition Insurance Plan (IPXP). Urbana-based Health Alliance Medical Plans Inc. was awarded the contract for this plan. The plan began accepting applications at 10:00 am August 20, 2010.

To qualify for the plan you must be a U.S. Citizen, national, or legal resident, be uninsured for at least 6 months, and have a pre-existing condition.

You can establish that you have a pre-existing condition by: 1.) providing documentation from a health insurance company stating that you are ineligible for comprehensive coverage due to a medical condition; 2.) providing documentation from a health insurance company offering you health coverage with a rider that excludes coverage for your medical condition; or 3.) provide a written statement from a physician stating that you have an existing medical condition that may result in denial of comprehensive coverage by a health insurance company. The plan has provided me with a "Qualifying Pre-existing Medical Condition Certification Form" that you may provide to your doctor to certify your current health status.

You can find out more information at htt://www.insurance.illinois.gov/HealthInsurance/highriskpools.asp.

I would recommend that any interested persons apply asap because the project has limited funding.

Steve

Urgent: New Government Funding For Biomedical Research

2010-05-24T12:32:00.000-07:00

On May 21, 1010, the U.S. Treasury Department announced the procedures for requesting a tax credit of up to $5 million per firm to be utilized for the development of new biomedical therapies (Therapeutic Discovery Credit). The purpose of the credit is to provide an immediate boost to U.S. biomedical research and the small businesses that conduct it. The credit is effective for investments made in 2009 and 2010. Only smaller firms with 250 employees or less can participate.

The application period for the credit opens on June 21, 2010 and closes on July 21, 2010. The Department of Health and Human Services (HHS) will evaluate each project for its potential to produce new therapies, address unmet medical needs, reduce health care costs or advance the goal of curing cancer. Meeting any one of the pre-stated criteria could result in qualification. Applicants will receive a determination no later than October 29, 2010.

The credit can apply to up to 50% of a company's "qualified investment" which is defined as the "aggregate amount of the costs paid or incurred in the taxable year for expenses necessary for and directly related to the conduct of a qualify therapeutic discovery project". The credit can be applied to the taxable years of 2009 and 2010. The qualfied investment does not include costs for remuneration for executives, interest expenses or facility maintenance expenses during those taxable years. Qualified investments may include expenses for wages, supplies and lab costs, depreciable property, contractor costs, etc.

There are three types of projects that can qualify for the credit: 1.) those to treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials, and clinical studies, or carrying out research protocols, for the purpose of securing FDA approval; 2.) those to diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions; and 3.) those to develop a product, process, or technology to further the delivery or administration of therapeutics.

A separate application for certification must be submitted to each project for which an eligible taxpaying entity is seeking certification of a qualified investment. An application consists of the following:

1. New Tax Form 8942 (this new tax form will be released no later than June 21, 2010)

2. Penalty of Perjuries Statement

3. Project Information Memorandum

4. Consent to Public Disclosure of Certain Qualifying Therapeutic Discovery Project Program Application Information (optional).

Brochures and other presentations are not permitted as part of the application and will not be considered.

The application must disclose the number of full-time and part-time employees whose work is directly billed to the project and their average salaries. It must also disclose the number of contractors in the US that were paid for work on the project.

The application must also disclose whether the project is active, terminated, or suspended. If the project has been terminated or suspended because the project failed a clinical trial, failed a pre-clinical research milestone, or failed to secure FDA licensure, it would be ineligible for the credit. Termination or suspension of the project due to lack of funds does not disqualify the project for consideration.

The application must assert whether the project will produce new or significantly improved technology as compared to commercial technologies currently in service and whether the project is expected to lead to the construction or use of a contract production facility in the US within the next five years.

The Project Information Memorandum, to be included in the application, must meet a specified format and meet certain stated number of word limitations in response to the required questions. The applicant can take certain steps to protect confidential trade secrets and information. The memorandum will describe the scientific rationale, research and developent plan, and the scientific evidence relied upon by the applicant, including citations. The memorandum will address the FDA regulatory status of the project. The memorandum will also explain the resources, management experience and organizational capacity of the applicant. The memorandum will finally address in 250 words or less per item the likelihood that the project will: 1.) produce new therapies; 2.) address unmet medical needs; 3.) reduce health care costs; or 4.) advance the goal of curing cancer.

I recommend that interested applicants start preparing their Project Information Memorandum immediately so they can stand at the beginning of the line when their application is filed on June 21, 2010.

Steve

Steve Schurr

Immediate Benefits to Health Care Reform

2010-04-09T08:23:00.001-07:00

According to President Obama, below are some of the immediate effects of the new health care bill:

Beginning this year, small businesses can receive tax credits to help cover the cost of employee health insurance, if they choose to do so. Eligible employers will receive credits worth up to 35% of employees' premiums.

This year, a high risk pool provides access to affordable coverage to individuals who are uninsured because of a pre-existing condition.

This year, the law begins to close the Medicare Prescription Drug "Donut Hole" by providing a $250 rebate for seniors who fall in the coverage gap.

This year, the law helps early retirees by creating a temporary re-insurance program to help offset the expensive costs of premiums for those aged 55 to 64.

Next year, seniors will have access to free preventive care under Medicare, such as annual check-ups, mammograms and colonoscopies.

Next year, seniors will receive a 50% discount on proscription drugs in the Medicare "Donut Hole."

This year, health insureres are banned from discrimination against children with pre-existing conditions.

This year, insurers are required to give parents enrolled in new plans the ability to select their child's pediatrician from among any participating provider.

Steve

COBRA Extension to 15 Months

2009-12-17T13:49:00.000-08:00

House Lawmakers Approve COBRA Subsidy Extension

December 16, 2009 (PLANSPONSOR.com) – The U.S. House of Representatives on Wednesday approved a bill that would extend federal COBRA health coverage cost subsidies for involuntarily terminated employees.

http://www.plansponsor.com/House_Lawmakers_Approve_COBRA_Subsidy_Extension.aspx

The Illinois Mental Health Treatment Preference Declaration Act

2009-12-13T11:39:00.000-08:00

In Illinois, an individual of sound mind may make an advance declaration of preferences or instructions regarding mental health treatment. See the Mental Health Treatment Preference Declaration Act, 755 ILCS 43. If you suffer from a recurring mental illness, I recommend that you implement such a directive on your behalf when you are of sound mind. This will help you maintain control over your situation if you later become incapacitated.

Applicability

In the declaration, the individual may designate a competent individual to be an agent to make decisions about mental health treatment if the principal is incapable. The individual may also designate an alternative mental health care agent. 755 ILCS 43/15. Under the law, the treating physician must continue to obtain the individual’s informed consent to all mental health treatment decisions if the individual is capable of providing informed consent or refusal. 755 ILCS 43/25. The designated agent has no authority to make mental health treatment decisions unless the individual is incapable. 755 ILCS 43/30(a). In addition, the treating physician or health care provider and the owner, operator or employee of the health care facility cannot act as the designated agent. 755 ILCS 43/60.

Issues Addressed

In the declaration, the individual may address the following issues:

1.) Consent or refusal to the administration of psychotropic medications;

2.) Consent or refusal to electroconvulsive therapy;

3.) Consent or refusal to admission and retention in a mental health facility;

4.) Selection of a treating physician; and

5.) Any other pertinent matters (for example, medications that you react more favorably to versus others, who may visit you while you are institutionalized, etc.)

Duration of Effectiveness

Such a declaration remains valid for three years, and continues past the three-year period if the individual is mentally incapacitated at the time of expiration of the three year period. 755 ILCS 43/10(2). Under the statute, a person is “incapable” if, in the opinion of two physicians or a court, the individual’s ability to receive and evaluate information effectively or communicate decisions is impaired to such an extent that the individual currently lacks the capacity to make mental health treatment decisions. 755 ILCS 43/5(5). The individual may revoke the declaration in writing, but only if he/she is capable. 755 ILCS 43/50.

Duties of Treating Provider

Once a declaration is implemented, the physician or health care provider must comply with the declaration unless: 1.) a court order contradicts the declaration or 2.) an emergency endangering life or health arises. The declaration does not limit the provider’s rights to implement commitment proceedings under Illinois law. 755 ILCS 43/45.

Confidentiality of Mental Health Records

The agent may obtain and consent to disclosure of mental health records, but this right of access does not waive any pre-existing legal privilege regarding the confidentiality of the mental health records. 755 ILCS 43/30(3).

Liability of Designated Agent

The designated agent is not personally liable for the resulting costs of the mental health treatment that he/she directs. 755 ILCS 43/30(2).

Proper Execution

A declaration is effective only if it is signed by the individual and witnessed by two competent adults who must attest that the principal is known to them, signed the declaration in their presence and appears to be of sound mind and not under duress, fraud or undue influence. 755 ILCS 43/20. The following people may not serve as witnesses: 1.) a family member related to the individual by blood, marriage or adoption, 2.) the treating physician or health care provider, and 3.) the owner, operator or employee of the health care facility.

Contact the Schurr Health Care Legal Clinic at 312-560-4202 if you desire such a directive.

Thanks.

Steve

Mental Health Parity Law Effective 2010

2009-12-04T13:35:00.000-08:00

Because I've had some questions, I thought I would repost a blog that I posted previously in 2008 in regards to the Mental Health Parity Law.

Steve

Previously posted:

At least one good thing came out of the recent financial troubles that our country has been experiencing. After more than 10 years of trying, Congress has passed a law that requires employer-sponsored health care plans to treat mental health disorders to the same level and degree as they do physical ailments.

The new requirements are included in the Emergency Economic Stabilization Act (H.R. 1424), which is the "economic bailout" bill that President Bush signed into law on October 3, 2008. For years, plans have generally been less generous in their coverage of treatment for mental illness. The new law becomes effective in 2010 and generally applies to employers with more than 50 workers, with certain exceptions.

Under the new law, plan participants cannot be required to pay more in deductibles, copayments, coinsurance and out-of-pocket expenses for mental health and substance use disorder benefits than they are required to pay for the plan's most common or frequent types of medical/surgical benefit. The new law prevents plans from limiting the frequency of treatment, the number of visits, the days of coverage, etc. for mental health/substance use treatment moreso than they do for medical/surgical benefits. In addition, "out-of-network" mental health services must be covered under the law if they are covered for medical/surgical benefits.

A plan must provide a legally acceptable definition of "mental health" and "substance use disorder" and is permitted to use utilization review and/or pre-authorization to determine medical necessity and appropriateness. The plan administrator must disclose any medical necessity determination criteria to any participant upon request. Also, the reason for any denial of reimbursement or payment also must be provided.

The law provides a penalty of up to $100/day for non-compliance and allows plan participants to file civil lawsuits to obtain inappropriately denied benefits. Steve

Drug and Device Info on the Internet

2009-11-23T09:56:00.000-08:00

On November 12 and 13 the US Food and Drug Administration (FDA) held a "Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." If you would like to view a video of the public meeting on this topic, you may do so at the following link: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm.

Tony Blank of Boston Scientific speaks on behalf of AdvaMed in the first morning session of the first day. Jeffrey Francer speaks on behalf of PhRMA during this same session. In addition, representatives from Eli Lilly, sanofi-aventis, Johnson and Johnson and Pifzer also give short presentations on behalf of manufacturers.

Comments on the hearing are due by February 28, 2010.

Some of the issues that arise seem to be: 1.) how to distinguish between reliable FDA- approved information and unreliable information on the web, 2.) what should, if anything, a manufacturer do if someone posts inaccurate information about their product on the internet; should they police this and respond?; if so, are they assuming responsibility for all the content of the blog that they are responding to? and 3.) what are the responsibilities of a manufacturer if they post reliable information and a third-party modifies it. Some problems that I have experienced: What do you do when study patients or clinical investigators communicate on a blog and mention potential adverse events that have not been reported on the study case report forms? Should someone at the sponsor be monitoring these blogs?

Steve

Medicare Part D - Prescription Drug Plans - Enrollment and Health Care Reform

2009-11-23T09:20:00.000-08:00

Once again, it is the open enrollment period for the Medicare prescription drug plan known as Medicare Part D. The enrollment period runs from November 15, 2009 to December 31, 2009. It is time to evaulate your current plan to see if it best meets your needs. Did you purchase enough medications this year so that you reached the "donut hole", that is, the part of the plan that requires you to pay 100% of your costs for medication? If so, can you afford to buy insurance coverage for drug costs within the donut hole? Are you already purchasing insurance to cover the donut hole costs, but your drug expenditures were so few that you probably do not need the coverage? Does you current plan allow you to purchase the medications that you truly need?

While I am on the topic, I would like to comment on the effect on Medicare Part D of the two proposed health care plans. The plan proposed by the House of Representatives (HR 3962)promptly reduces the amount of the donut hole by $500 and then requires gradual phase-out of the donut hole over the next several years. The plan proposed by the Senate (The Patient Protection Affordable Care Act) promptly reduces the donut hole by $500 but proposes no further reductions.

This would suggest that the final bill, if passed, would include some sort of relief, either short-term or long-term, in regards to this infamous donut hole.

Steve

Health Care Reform

2009-11-19T19:24:00.000-08:00

When I first heard that the proposed health care bill from Congress (HR 3962) essentially would not take effect until 2013, I became discouraged, because many people will suffer from now until then due to lack of health insurance. However, there are some provisions in the proposed bill that would take effect immediately on passage, as explained below by the Speaker of the House:

TOP 14 PROVISIONS THAT TAKE EFFECT IMMEDIATELY

1. BEGINS TO CLOSE THE MEDICARE PART D DONUT HOLE — Reduces the donut hole by $500 and institutes a 50%discount on brand-name drugs, effective January 1, 2010.

2. IMMEDIATE HELP FOR THE UNINSURED UNTIL EXCHANGE IS AVAILABLE (INTERIM HIGH-RISK POOL) — Creates atemporary insurance program until the Exchange is available for individuals who have been uninsured for severalmonths or have been denied a policy because of pre-existing conditions.

3. BANS LIFETIME LIMITS ON COVERAGE—Prohibits health insurance companies from placing lifetime caps on coverage.

4. ENDS RESCISSIONS—Prohibits insurers from nullifying or rescinding a patient’s policy when they file a claim forbenefits, except in the case of fraud.

5. EXTENDS COVERAGE FOR YOUNG PEOPLE UP TO 27TH BIRTHDAY THROUGH PARENTS’ INSURANCE— Requires healthplans to allow young people through age 26 to remain on their parents’ insurance policy, at the parents’ choice.

6. ELIMINATES COST-SHARING FOR PREVENTIVE SERVICES IN MEDICARE—Eliminates co-payments for preventiveservices and exempts preventive services from deductibles under the Medicare program.

7. IMPROVES HELP FOR LOW-INCOME MEDICARE BENEFICIARIES—Improves the low-income protection programs inMedicare to assure more individuals are able to access this vital help.

8. PROVIDES NEW CONSUMER PROTECTIONS IN MEDICARE ADVANTAGE— Prohibits Medicare Advantage plans fromcharging enrollees higher cost-sharing for services in their private plan than what is charged in traditional Medicare.

9. IMMEDIATE SUNSHINE ON PRICE GOUGING—Discourages excessive price increases by insurance companies throughreview and disclosure of insurance rate increases.

10. CONTINUITY FOR DISPLACED WORKERS—Allows Americans to keep their COBRA coverage until the Exchange is inplace and they can access affordable coverage.

11. CREATES NEW, VOLUNTARY, PUBLIC LONG-TERM CARE INSURANCE PROGRAM—Creates a long-term care insuranceprogram to be financed by voluntary payroll deductions to provide benefits to adults who become functionally disabled.

12. HELP FOR EARLY RETIREES—Creates a $10 billon fund to finance a temporary reinsurance program to help offset thecosts of expensive health claims for employers that provide health benefits for retirees age 55-64.

13. COMMUNITY HEALTH CENTERS—Increases funding for Community Health Centers to allow for a doubling of thenumber of patients seen by the centers over the next 5 years.

14. INCREASING NUMBER OF PRIMARY CARE DOCTORS — Provides new investment in training programs to increase thenumber of primary care doctors, nurses, and public health professionals.

PREPARED BY OFFICE OF SPEAKER PELOSI – OCTOBER 29, 2009

Web Presentation - Working Effectively with Contract Research Organizations - July 30, 2009

2009-06-19T09:19:00.000-07:00

I will be giving a web presentation on July 30, 2009 at 1 pm CST to discuss my experiences and recommendations for the utilization of Contract Research Organizations (CROs) by pharmacuetical, biologics and medical device companys who engage in clinical research. Please join us by registering at http://www.q1productions.com/store/product_info.php/cPath/30_42/products_id/80

Thanks. Hope to "see" you there. If you have any specific issues of concern that you would like me to cover, please contact me.

Steve Schurr

e-conference May 6, 2009; Working with CROs

2009-04-18T05:28:00.000-07:00

On May 6, 2009, I will be presenting an e-conference over the web in conjuction with Clinical Device Group of Chicago, IL on how to work effectively with Contract Research Organizations (CROs) on a clinical research project. For more information on the e-conference, use the link below:

https://www.clinicaldevice.com/mall/eConferences.asp

I welcome any questions or issues in advance from the audience. Please feel free to contact me if you have a question or issue you would like to have discussed. Please see below for more information about the upcoming e-conference.

Thanks.

Steve Schurr

Common Mistakes with CROsOver and over again sponsors make the same mistake when choosing a Contract Research Organization. They base the choice on cost rather than reputation, capability, demonstrated knowledge, contribution to the industry, and a match in size, philosophy, and attitude. Then, after having chosen poorly, they fail to manage the CRO or stay in close contact.
Learning ObjectiveYou will learn the regulatory, legal and financial pitfalls in the use of a CRO for a research project and how to protect your organization from such pitfalls.
Step by StepSteven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will cover:[x] The risks involved in utilizing a CRO versus hiring in-house employees to perform the tasks. [x] The best ways for a sponsor to solicit and evaluate potential CRO vendors. [x] Once the sponsor chooses a CRO vendor, how to structure the budget and contract.[x] How to monitor and evaluate the performance of the CRO during the project.[x] What happens if the project needs to be expanded beyond its original scope after the original contract is finalized. [x] What the sponsor should do if they choose to terminate the contract with the CRO while the project is ongoing.
Case StudiesMr. Schurr will use case studies of precarious situations to demonstrate what can go wrong, explanations of what caused the situations, and recommendations on how to avoid them.
Are You A CRO?For the CROs in the audience, Mr. Schurr will have a few words about choosing a client. Vendors should go through a selection process too, as was vividly demonstrated in the recent GAO sting operation against independent IRBs. You should ask questions like:[x] Is the client honest?[x] Do they want an ethical research study with data that have proven integrity?[x] Can they pay you?

2009 Clinical Research Educational Conference

2009-04-18T05:16:00.000-07:00

I will be presenting at the 2009 Clinical Research Educational Conference on Friday, May 15, 2009 at Northwestern University in Chicago. I will be giving two one hour presentations on what I believe to be the "10 Most Important Documents in Implementing a Clinical Trial". I will be speaking from a legal, regulatory and practical perspective. It is my hope that this topic will generate much debate and opinion from the audience.

Please join us in the discussion. You may learn more about the conference at the following link:

http://www.nucats.northwestern.edu/education/CRPT/CREC/index.html

Thanks and I hope to see you there.

Steve

Enrollment for Medicare Drug Plan Begins November 15, 2008

2008-11-15T06:56:00.000-08:00

Starting today, seniors can enroll in a new or different Medicare drug plan for 2009.

Even if you are already enrolled, please review your options since several popular plans are raising monthly premiums or changing benefits. Do not assume that your plan will be the same in the following year. By now, you should have received an "annual notice of change" package of materials telling you the changes in your plan that go into effect in the next year.

To be on safe side, the Medicare Rights Center advises seniors to call their plans and check if their medications are covered. Be sure to make a list of all your drugs and the dosages prescribed in advance.

Also, you'll want to ask about drug co-payments, the pharmacies in the plan network, and if the plan has placed any restrictions on the medications you use.

For an overview of the Medicare drug benefit, the different types of plans available and questions you might want to consider, go to http://www.medicareinteractive.org/. You can compare how your plan stacks up against others by going to the Medicare Drug Plan finder at http://www.medicare.gov/ or calling 1-800-Medicare (1-800-633-4227).

Remember, if you don't have much money, you might qualify for financial subsidies from the government to cover drug expenses.

Please contact me if I can help or if you have any questions.

Steve

Update on Enforcement of HIPAA Privacy Rule

2008-10-23T06:59:00.000-07:00

CCH has published a summary of enforcement data for privacy violations under HIPAA since enforcement of the law began in April 2003:

http://www.hr.cch.com/news/benefits/092208.asp

There is no individual private cause of action for HIPAA violations. A complaint must be filed with the Office of Civil Rights in the case of an alleged violation.

Steve

New Mental Health Parity Law

2008-10-23T06:35:00.000-07:00

At least one good thing came out of the recent financial troubles that our country has been experiencing. After more than 10 years of trying, Congress has passed a law that requires employer-sponsored health care plans to treat mental health disorders to the same level and degree as they do physical ailments.

The new requirements are included in the Emergency Economic Stabilization Act (H.R. 1424), which is the "economic bailout" bill that President Bush signed into law on October 3, 2008. For years, plans have generally been less generous in their coverage of treatment for mental illness. The new law becomes effective in 2010 and generally applies to employers with more than 50 workers, with certain exceptions.

Under the new law, plan participants cannot be required to pay more in deductibles, copayments, coinsurance and out-of-pocket expenses for mental health and substance use disorder benefits than they are required to pay for the plan's most common or frequent types of medical/surgical benefit.

The new law prevents plans from limiting the frequency of treatment, the number of visits, the days of coverage, etc. for mental health/substance use treatment moreso than they do for medical/surgical benefits.

In addition, "out-of-network" mental health services must be covered under the law if they are covered for medical/surgical benefits.

A plan must provide a legally acceptable definition of "mental health" and "substance use disorder" and is permitted to use utilization review and/or pre-authorization to determine medical necessity and appropriateness. The plan administrator must disclose any medical necessity determination criteria to any participant upon request. Also, the reason for any denial of reimbursement or payment also must be provided.

The law provides a penalty of up to $100/day for non-compliance and allows plan participants to file civil lawsuits to obtain inappropriately denied benefits.

Steve

Importation of Medicines via the Internet

2008-08-28T10:00:00.000-07:00

Is it legal to order prescription pharmaceuticals over the internet? If not, your shipment could be seized at the border by US Customs and you could receive an alarming letter.

In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.

FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.

Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.

Can an individual legally order drugs using the internet without seeing a doctor? No.

Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.

Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.

A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.

In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).

Steve to Participate in MEDI Conference

2008-08-28T09:51:00.000-07:00

I will be attending a round table at the MEDI medical device conference at the Marriott in Hartford, CT on September 9, 2008. I was asked to review what I consider to be the 10 most important documents for the conduct of a successful investigational medical device clinical trial.

My topics will include the clinical trial agreement, investigator agreement/FDA form 1572, indemnification, reimbursement for adverse events, the informed consent form, delegation of responsibilities, etc. The presentation will be useful to clinical monitors, sponsor and site management, and clinical trial vendors.

For more information, go to MEDI2008.com.

Thanks!

Steve

Increase in personal medical costs

2008-08-25T10:53:00.000-07:00

There was an article in the Washington Post last week reporting that more than 2 in 5 adults in the 19-64 age group reported problems paying medical bills or had accumulated medical debt in 2007, compared to 1 in 3 in 2005. We all know about the plight of the uninsured. What is alarming about this new statistic is that 61% of those with medical debt or bill problems in this survey had health insurance.

I've recently seen an increase in the rise of individuals coming to me with problems having their insurance cover major medical bills that, IMO, are unquestionable as to the medical necessity. This is occurring among clients who are insured by the most reputable insurance companies. It is difficult to pay health insurance premiums AND out of pocket expenses at the same time.

You can review this survey at http://www.commonwealthfund.org/. The survey defines four problems with access to health care due to money or poor coverage: 1.) failure to fill a prescription, 2.) not seeing a specialist when needed, 3.) skipping a medical test, treatment or follow-up, and/or 4.) refraining from seeing a practitioner when a problem exists.

These problems are no longer relegated to the poor and the uninsured. The percentage of people with the above problems has approximately doubled among those with middle income ($40.000-59,999/year) and those with incomes of more than 60K per year.

Steve

Welcome to my health care blog

2008-05-08T07:11:00.000-07:00

Greetings, everyone. I will be posting information soon regarding the plight of the uninsured and the legal problems associated with purchasing prescription pharmaceuticals on line.

Regards,

Steve