Providing patients with promising experimental therapy or ruining clinical trials?
Posted on: October 31, 2009 |
Author: Jessica
Filed Under: Bioethics, Drug & Device |
Leave a Comment
Ninety percent of clinicians in a recent online survey believed that ignoring certain entry criteria for clinical trials was acceptable if the clinician believes that the patient will benefit from the trial. A number of clinicians described under what circumstances they would bend the rules. Downplaying a substance abuse history, altering medical records, and artificially improving an otherwise poor kidney function test are all examples of protocol violations that some clinicians found acceptable under the right circumstances.
All of the protocol violations were presumably made because the doctors felt that they were acting in the best interests of their individual patients. However, the purpose of clinical trials is not to improve the outcomes of individual patients, they are to determine the safety and effectiveness of an experimental drug or treatment. (To learn more about clinical trials see clinicaltrials.gov)
What does this mean for clinical trials? Do researchers need to focus on improving clinical trial designs so that clinicians do not feel conflicted between their commitment to their patient and the research? If so many clinicians seem willing to break protocol, can the results of the trials even be trusted?
The New York Times, October 29, 2009.
Health Reform: Opportunities for People with Disabilities and Chronic Illness
Posted on: October 22, 2009 |
Author: Sidney Watson
Filed Under: Access to Care, Bioethics, Disability, HMOs & Health Plans, Healthcare Reform, Medicaid, Medicare, Other, Tax & Finance |
Leave a Comment
Despite the noisy demonstrations during the August town hall meetings and a great deal of misinformation spread through email, the internet, talk radio and other media, there is wide scale agreement that the U.S.’s private health insurance system is broken: Private insurers refuse to cover individuals who need medical care; even middle-income families are priced out of private insurance; and businesses, already reeling in the economic downturn, are straddled by skyrocketing health insurance premiums.
There is also significant consensus in Congress on the framework for health reform legislation. Daily headlines that focus on differences in opinion on specific provisions of the reform bills suggest that bipartisan and even Democratic Party agreement is elusive. However, all the bills moving through Congress use the same framework:
(1) reforming private health insurance, (2) guaranteed affordable health insurance for all; (3) using a Health Insurance Exchange to reduce the cost of insurance in the individual and small group markets, (4) increased choices, and (5) shared responsibility.
All the proposals under consideration by Congress build on what works in today’s health care system, fixing the parts that are broken. They protect current coverage-allowing individuals and employers to keep the insurance they have it they like it-and preserve choice of doctors, hospitals and health plans.
The bills also do what the ADA did not: They change the way private health insurance is priced and structured. No longer will private insurers be able to refuse to cover people with disabilities and chronic illness. No longer will they be able to price out those who need medical care or design insurance packages that fail to cover important services that people need to live and work in the community. All the proposals offer people with disabilities increased options for health insurance and health care.
Overview of Process in Congress So Far: Three House Committees have acted: Education and Workforce, Ways and Means, and Energy and Commerce. Two Senate Committees have acted: The Senate Health, Education, Labor and Pensions (HELP) version is the most ambitious and far-reaching bill among the drafts. The Senate Finance Committee passed its version on October 13. It is the least costly and least ambitious of the five bills.
What Comes Next: The three House Committee versions will be combined into one bill that will be voted on by the House of Representatives. On the Senate side, the Senate Finance Committee and the Senate HELP hope to have a merged version of their two bills this week. Their one bill will go to the Senate Floor for a vote.
FRAMEWORK FOR REFORM
Private Health Insurance Reforms
All the proposals change how private insurance companies do business to guarantee access to health insurance, prohibit discrimination based on health status. They all:
- Prohibit private insurance companies from turning down individuals because of pre-existing medical conditions or rescinding policies.
- Stop insurance companies from charging higher premiums because of pre-existing conditions, health status, medical care needs or gender. They also limit the extent to which insurance companies can charge higher premiums because of age or where we live.
- All plans would have to cover an essential benefit package that includes among other benefits hospital, physician, prescription drugs, preventive care, mental health, substance use, services, equipment and supplies incident to the delivery of care in the home or other settings, rehabilitative and habilitative services, and other services with the details to be developed by those responsible for implementing the legislation.
- Prohibit annual or lifetime limits on coverage and require annual out of pocket spending caps for consumers.
- Require insurance companies to report the percentage of premium dollars spent on administrative overhead and profits rather than medical care. (Senate versions). The House version would require insurers to spend at least 85% of premiums for medical care.
Guaranteed Affordable Health Insurance
All the proposals provide for sliding scale premium subsidies for people purchasing insurance through the Exchange to make insurance affordable for lower and middle income families.
- Premium subsidies would be available to families up to 400% of poverty level guaranteeing that they will have to spend no more than 12% of their income for health insurance premium costs.
- Lower income working families will get help so their premium costs are no more than 1-2% of their income.
- Subsidies will also be available to reduce out of pocket costs.
- Each proposal has slightly different subsidy levels, but all the bills recognize that, with premiums now exceeding $13,000 a year for family coverage, even average-income families cannot afford health insurance on their own.
All expand Medicaid to cover all low income individuals and families under age 65 with incomes up to 133% of Federal Poverty Level. This will cover an estimated 11-14 million uninsured.
- No asset test for this new mandatory category or Exchange subsidies.
- Enhanced federal match means that federal government will pick up as much as 95%-100% of the cost for those who are newly eligible.
- States must maintain Medicaid coverage for people above the new federal floor until the Exchange is up and running.
- SCHIP continues until the Exchange is up and running.
- Better Medicare coverage for seniors and people with disabilities. Prescription drug coverage would be more affordable. House proposals would eliminate or significantly reduce the Part D “doughnut hole” while the Senate Finance version provides a 50% discount during the “hole.”
- Preventive services would no longer be subject to co-pays or deductibles.
Creation of a “Health Insurance Exchange”
An Exchange is a new entity that will allow for one-stop shopping for health insurance so individuals can compare options and enroll in the plan that best meets their needs, at the best price. Health insurers offering plans through the exchange will be required to comply with the new health insurance reform rules for issuing and pricing policies.
- An Exchange will make health insurance more affordable by pooling costs across larger numbers of people and reducing the costs of marketing health insurance in the individual and small group markets, where overhead costs typically run as high as 30-40 percent.
- The House bills propose one large national Exchange, the Senate bills provide for 50 state-based Exchanges.
- Individuals will be able to choose among a variety of types of plans, with individuals making their own trade-offs between lower premiums and higher out of pocket costs.
- The Exchange will be for individuals who are not covered by their employers and will not replace employer-sponsored benefits.
- Small businesses may opt to use the Exchange, giving their employees access to all plans offered by the Exchange. The House and Senate Finance versions phase in an option for larger employers to use the Exchange.
Increased Choices
The most contentious issue is whether individuals and small businesses purchasing health insurance through the Exchange should have the option to enroll in a new health insurance plan, not controlled by private health insurance companies.
- There is agreement in Congress that the private insurance market needs to change and that change can be accomplished by offering new affordable choices to compete with private insurance companies. The disagreement is over the form that these new plans should take.
- The House would include a health insurance option, similar to the Federal Employees Heath Benefits Plan.
- The Senate HELP proposal includes a community health insurance plan offered by the government but with claims administered by private entity, much like traditional Medicare.
- The Senate Finance Committee includes a non-profit, consumer-controlled private plan, a consumer co-op.
- Whatever form these new plans take, they will be another option-no one will be required to enroll in them-to those Americans who use the Exchange to purchase health insurance.
Shared Responsibility
Everyone is worried about who will pay for health reform, but the key to making coverage affordable is for everyone to do their part.
- Those without coverage will be asked to pay health insurance premiums on an affordable sliding-scale based on income, whether they are young and healthy or older with complex medical needs. Younger adults will pay lower premiums than older adults and some proposals add options for young adults to continue coverage under their parents’ plans up to age 26.
- All the proposals impose a financial penalty on those who choose not to get coverage with exemptions for those with “hardships.” Both Senate versions authorize a penalty only if “affordable” coverage is available.
- Employers are also expected to do their part, which will level the playing field between those companies that provide coverage and those that do not.
- The Senate HELP and House bills assess an annual fee on larger employers who do not contribute toward their employee’s health insurance. The Senate Finance bill only assesses a penalty against larger employers when their employees receive insurance premium subsidies.
- Assistance to small businesses. All the proposals exempt small employers from the employer contribution.
- The House and Senate HELP versions provide tax credits to small employers to help them pay for the cost of employee health insurance.
- In addition, small businesses will also benefit from the more affordable coverage available in the Exchange, regardless of health status of employees.
- One-third of the uninsured, 13 million people, work for businesses with fewer than 100 workers.
Paying for Reform
While the federal budget price tag for expanded health coverage seems staggering–$829 to $1 trillion over 10 years-this amounts to only about 2-3% of total health care spending. Overall-counting private as well as public spending-it will cost us more to do nothing.
- Congressional rules require that the bills be federal budget neutral. The CBO must certify that the bills will not increase the federal deficit.
- About half the cost of health reform will be financed by slowing the growth of Medicare provider payments by about 1% a year-an amount which hospitals and other providers have agreed is reasonable and possible given savings that result from reform.
- Other savings will come from cuts in the prices of brand name drugs sold to seniors and eliminating overpayments to Medicare managed care plans.
- The House bill would generate revenue to pay for reform by reversing some of the tax cuts enacted over the last 30 years for the wealthiest households. The Senate Finance Committee proposes taxing non-essential insurance benefits and some health industry suppliers.
Delivery System Improvements
All the plans provide, in different ways, for a variety of delivery system reforms aimed at creating real systems of care that are patient centered including
- Accountable care organizations, that might be like the Mayo Clinic or Grand Junction, Colorado
- Medical homes
- Better care co-ordination for dual Medicaid and Medicare eligibles
- Comparative effectiveness research
Provisions providing support for more Community Based Services in some but not all the bills….
New Medicaid Community First Choice Option creates a new state plan option to provide community-based attendant services. (Senate Finance)
- Services include assisting individuals with activities of daily living (ADLs), instrumental activities of daily living (IADLs), health related tasks through hands-on assistance, supervision or cueing.
- To encourage states, the federal match is increased by 6% points.
Medicaid Community services as alternative to nursing home care FMAP increase to states that make Medicaid structural changes than have proven to increased nursing home diversion and expand use of HCBS. (Senate Finance)
Improved Medicaid spousal impoverishment protection requiring states to apply protections for nursing home residents to HCBS. (Senate Finance)
Community Living Assistance and Support (CLASS) Act would create a national insurance program to help pay for community living services and supports. (Senate HELP & House)
- Paid for through voluntary payroll deductions and administered by the federal government.
- Working adults would be automatically enrolled in the program, unless they opt out (with exceptions for Medicaid beneficiaries).
- To qualify for benefits must contribute for at least five years.
- Benefits are based upon being unable to perform two or more activities of daily living like eating, bathing, dressing, or having an equivalent cognitive disability that requires supervision or hands-on assistance that is expected to last for more than 90 days.
- Cash benefit of at least $50 per day with the amount to be determined by HHS
- CBO estimates are based on a monthly premium of $123 and a daily cash benefit of $75 for life. Those with income below poverty and full-time students would pay nominal premiums.
- There is no lifetime limit.
Australian Supreme Court Upholds Patient’s Right to “Pull the Plug”
Posted on: August 17, 2009 |
Author: Scott
Filed Under: Bioethics, Disability, Elder Law, Liability & Litigation, Other |
Leave a Comment
On Friday, August 14, 2009 the highest court in Perth, Australia heard a landmark case brought by a nursing home seeking guidance on whether it can remove the feeding tube keeping a quadriplegic man alive. Chief Justice Wayne Martin of the Western Australia Supreme Court issued the ruling that would prevent Christian Rossiter’s nursing facility from facing criminal liability for complying with his wishes to remove his feeding tube.
Rossiter, 49, was admitted to the Brightwater Care Group nursing facility after a fall at his mother’s home caused his spastic quadriplegia. Rossiger’s mobility is severely limited to only partial movement in his feet and one finger. He is completely dependent upon the Brightwater staff for all aspects of his care; including administering a tube inserted directly into his stomach which provides the nutrition and hydration necessary to sustain his life.
Rossiter continuously asked Brightwater to remove his feeding tube and allow him die. “I am a prisoner in my own body,” Rossiter declared. “I can’t move. I can’t even wipe the tears from my eyes. I have no fear of death—just pain.”
Although Australian law gives patients the right to refuse life-saving treatment, assisting an individual to commit suicide constitutes a crime punishable up to life in prison. While Brightwater did not have a particular view on whether it should or should not comply with Rossiter’s requests, it did not want to be held criminally responsible for removing his feeding tube and providing palliative care.
Chief Justice Martin noted a key distinction in his order stating, “this is a case in which a person with full mental capacity and the ability to communicate his wishes has indicated that he wishes to direct those who have assumed responsibility for his care to discontinue the provision of treatment which maintains his existence.” Chief Justice Martin concluded that as long as Rossiter was given medical advice and understood the consequences of his decision to stop receiving nutrition, Brightwater would not be criminally responsible for providing palliative care or for his death.
Commentary: The plight of the severely injured and disabled can run deep in a world where life can be artificially maintained beyond its “natural” state. With this plight brings complex and controversial issues of law, ethics, and morality. Deeply ingrained therein is the paradox of the health care provider’s duty to provide care and the individual’s right to self-determination. Chief Justice Martin carefully articulated, albeit in his draft opinion, that it is not the place of another to dictate the outcome of an individual fully capable of determining his own course of action. This decision sparks a unique opportunity to explore the end-of-life dynamic within our own country and should be closely watched for further evolution.
CNN.com, August 14, 2009.
-
Search
-
Related Links
-
About the Blog
The Saint Louis University Journal of Health Law & Policy Health Law Blog is an online forum where those interested in discussing current health law and policy developments can collaborate, discuss, and advance solutions to a variety of healthcare issues. Encompassing topics spanning the spectrum of the healthcare industry and dedicated solely to the most timely and relevant health care matters, the JHLP Blog is an innovative and comprehensive tool for those interested in engaging in dialogue with some of the most well-respected health law students and faculty in the nation.
-
Contributing to the Blog
To become a contributor to the JHLP Blog, please email a request for a personal user name and a password to jhlpcomments@gmail.com. If you have any questions or encounter technical difficulties, contact the editors at (314) 977-3351. The JHLP editorial board believes your contributions are important and thanks you in advance for your participation! As a reminder, while all users are welcome to post and comment upon any of the blogs, the JHLP editorial board reserves the right to filter such posts for language and appropriateness.
-
Admin
RSS
