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
Thursday, December 17, 2009
Sunday, December 13, 2009
The Illinois Mental Health Treatment Preference Declaration Act
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
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
Friday, December 4, 2009
Mental Health Parity Law Effective 2010
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
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
Monday, November 23, 2009
Drug and Device Info on the Internet
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
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
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
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
Thursday, November 19, 2009
Health Care Reform
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
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
Friday, June 19, 2009
Web Presentation - Working Effectively with Contract Research Organizations - July 30, 2009
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
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
Saturday, April 18, 2009
e-conference May 6, 2009; Working with CROs
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?
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
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
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
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