This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.

Wednesday, November 21, 2012

Obamacare Regulations

Three key sets of regulations needed to implement the Affordable Care Act have been issued. Insurers, consumer groups and the public have 30 days to weigh in with comments on two of the proposed rules {essential benefits and premiums) and will have until Jan. 25 for the third, which outlines how employers can structure wellness programs that offer discounts to workers who participate. The contents of the laws which authorize these regulations are summarized in my October 23, 2012 blog "Contents of Obamacare - Part 2". Here is a good article from Kaiser that summarizes the proposed regs:

Thursday, November 8, 2012

Contents of Obamacare - Part 11- Elders

The Elder Justice Act.This law, among other things, establishes forensic centers to determine elder abuse, neglect and exploitation. “Elder” is defined “an individual who is 60 years old or older!”. The law offers grants to the states to promote “adult protective services.” There will be a study on the usefulness of a “nurses aide registry”. (Each year, 5000,000 to 5,000,000 elders are abused, neglgected, or explited. Last year, financial exploitation robbed seniors of $2.9 billion dollars, per a MetLife Mature Market Institute study. 77 million baby boomers are now approaching retirment and old age. In Illinois, Financial exploitation is the most common type of elder abuse in Illinois. Improving Access to Innovative Medical Therapies. The law allows for FDA approval of “biosimilar” biologics, which are analogous to generic drugs, which are less expensive than proprietary drugs. The US Food and Drug Administration (FDA) is charged with implementing an abbreviated pathway to the market for biosimilars. A “biologic” is a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” NEXT: FUNDING FOR OBAMACARE

Sunday, November 4, 2012

Contents of Obamacare -Part 10 - Fast Food and Dental Care

Prevention of Chronic Disease and Promotion of Public Health: The law authorizes a “National Prevention, Health Promotion and Public Health Council, headed by the Surgeon General. The committee includes the Secretaries of Health and Human Services, Agriculture and Education, Federal Trade Commission, Transportation, Labor, Homeland Security, environmental Protection Agency, Office of National Drug Control Policy, and others. The purpose of the committee is to promote coordination among the federal agencies for the promotion of health-care related goals. The law also creates an “Advisory Group on Prevention, Health Promotion, and Integrative and Public Health.” The purpose of the committee is to establish policy and program recommendations on life-style based chronic disease and management. School-based health centers. The law provides grants to schools to establish these centers. Oral care. Not much is said about oral disease (dental care) in regards to health reform. The beloved state of Illinois recently cut adult dental care for Medicaid recipients, except for tooth extractions and emergency care. Indiana provides adult dental services under Medicaid under limited circumstances. The federal Affordable Health Care Act (”Obamacare”) doesn’t say much about dental care either. It approves a few grants to study the problem and intends to publish related studies. The New “Wellness” visit under Medicare includes the following: determination of medical history, a list of current health care providers and medications, determination of cognitive impairments, determination of a screening schedule, a list of personal risk factors for disease, and counseling as how to reduce the risk. The law then goes into particular details as to how funding under Medicare for mammograms, and immunizations. Fast-Food Restaurants: There is now a federal definition of a “food restaurant chain”: it is one that is part of a chain “with 20 or more locations doing business under the same name… and offering for sale substantially the same menu items”. These “chains” must now include caloric information on their menus. Federal regulations shall ensue as to standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children’s combination meals. The law goes on to strengthens public health surveillance systems through grants, including pain management and research and childhood obesity.

Wednesday, October 31, 2012

Contents of Obamacare - Part 9 - Women and Obamacare

Women and The Affordable Care Act (“Obamacare”). Erin Weir, the Manager of Health Care Access at “AgeOptions” an Oak Park, Illinois based Not-for-profit, says there are many reasons that women should be excited about Obamacare. Erin says that women visit the doctor more often than men and are usually the primary health care decision-makers in families. Women are less likely to get insurance from their jobs because they are often working part time or serving as family caregivers. They currently pay more for insurance premiums than men, and a greater share of their income is consumed by out-of-pocket health care costs. Women are more likely to lose their health insurance due to changes in marital status. Finally, access to health care is especially difficult for women of color, young women, and women in rural areas. Women’s Protections Against Pre-existing Conditions: Starting 2014, insurance companies can no longer deny coverage due to pre-existing conditions such as pregnancy, C-sections, cancers, domestic violence, or sexual assault. Prior law allowed them to do so. Consumer Protections for Women. Starting in 2014, insurance plans will no longer be able to discriminate against women by charging higher premiums due to gender. Women will also enjoy the immediate benefits of no lifetime limits on coverage and the upcoming benefit of no annual limits starting in 2014. Preventive Services for Women. Effective August 1, 2012, the law requires coverage of the following preventive services without a co-pay or deductible: annual well-women’s visits, gestational diabetes screening for women who are 24-48 weeks pregnant and high risk, HPV DNA testing (women 30 and over), sexually transmitted infection screening and counseling, including HIV, contraception and contraceptive counseling (excluding abortions), breastfeeding support and equipment, and interpersonal and domestic violence screening and counseling. Source: Erin Weir, “The ACA and Women”, Presentation at Chicago Bar Association, October 30, 2012. Agencies and Websites:Obamacare maintains an “Office of Women’s Health” within the federal Department of Health and Human Services, which is led by the “Deputy Assistant Secretary for Women’s Health”. In addition, the law maintains a “National Women’s Health Information Center”. Nancy C. Lee, MD, initially from the Center for Disease Control, is the Director, and the information center is at The law also maintains an “Office of Women’s Health” within the Center for Disease Control (CDC). This office’s website is at

Tuesday, October 30, 2012

Contents of Obamacare - Part 8 - The Donught Hole

Improving Medicare for Patients and Providers. New rules allow Physician Assistants to order post-hospital testing, allow funding for complex diagnostic testing such as genetic testing or cancer chemotherapy sensitivity assays, improved access for certified nurse mid-wife services, and extension of “hold harmless” provisions and other protections for small rural hospitals. Improving Payment Accuracy. This section includes adjustments to payment for Home Health Care, more modifications for rural care, hospice care payment modifications, procedures for reevaluation and modification of misvalued codes under the physician fee schedule, adjustments to payments for “power-driven wheel chairs”, payment rates for ambulatory cancer centers, and payment for biosimilar products (generic versions of biologicals). Medicare Advantage Payment (Part C): Covering someone on a Medicare Advantage plan used to cost 14% more than covering someone on the original Medicare. These payments are being reduced under the law which accounts for the savings in Medicare that are often referred to as “cuts” by Mitt Romney and his advocates. These savings to the government are actually being put back into the Medicare program. Medicare Part D (Prescription Drugs): The law phases out the “donut hole” by 2020. The “donut hole” was a coverage level in the original plan (signed into law by President George W. Bush) where seniors had to pay 100% of their costs for pharmaceuticals until their annual costs became so severe that they qualified for “catastrophic coverage”. Pharmaceutical manufacturers will now be paying 50% of the costs for brand name drugs purchased while the beneficiary is “in the donut hole”, and generic drugs will be offered with a 14% discount. Obamacare offers better prescription drug coverage for people with low incomes. Health Care System Delivery Research: The law directs the “Center for Quality Improvement and Patient Safety”, which is part of the” Agency for Healthcare Research and Quality”, to conduct studies and determine workable best practices for health care that can be promoted across the board to all providers. The center may identify certain health care programs that are particularly astute and successful in their delivery of services and develop methods for dissemination of such techniques nationwide. Grants are offered to conduct pilot projects for various health care delivery systems to determine the effectiveness and feasibility. The law promotes the availability of trauma care centers for all local areas. The law promotes grants to develop “patient decision aids” where patients, based upon their value system, provide input into the proper path for their own care; this includes the summaries of the risks and benefits of prescription drugs in a standardized format. NEXT: WOMEN AND OBAMACARE!

Monday, October 29, 2012

Contents of Obamacare - Part 7 - Linking Payment to Quality Outcomes

Improvements to Medicaid System: These include coverage for freestanding birth centers, more home health care, increased rebates for pharmaceuticals, coverage of drugs for smoking cessation, refusal to pay hospitals for treatment of hospital-acquired infections. Special Rules for Native Americans: Native Americans and Alaskans have no cost-sharing if they enrolled in a qualified state exchange and their income is less than 300% of the Federal poverty level. Maternal and Child Health Services: The states are to provide reports and the Federal government is to offer grants to enhance home visitation treatments for disadvantaged communities with higher than average levels of premature birth, child abuse, and other social problems. Postpartem Conditions: The act provides funding for the study and treatment of postpartum depression and psychosis. Personal Responsibility Education Programs: The act provides grants for innovative programs to promote individual responsibility in regards to sexual abstinence and birth control for the prevention of sexually transmitted diseases. Improving the Quality and Efficiency of Health Care: The preceding statement is the name of Title III of the Act. Subtitle A is called “Transforming the Health Care Delivery System” Linking Payment to Quality Outcomes Under the Medicare Program: This program pertains to five medical events: heart attacks, heart failure, pneumonia, surgical infections and hospital-acquired infections. Hospitals shall be given pay incentives for Medicare patients if they successfully treat and discharge the subject without a readmission. Likewise, payment to physicians will be based upon quality outcomes moreso that the number and cost of procedures that the MD performs. Hospitals shall be penalized in their payment amounts if their patients suffer from hospital-acquired infections. Intragency Working Group in Health Care Quality: The group contains senior executives from the Department of Health and Human Services , the Center for Medicare and Medicaid Services, the National Institutes of Health, the Center for Disease Control, Food and Drug Administration, Health Resources and Services Administration, Agency for Healthcare Research and Quality, Office of the Nation Coordinator for Health Information Technology, Substance Abuse and Mental Health Services Administration, Administration for Children and Families, Department of Commerce, Office of Management and Budget, Bureau of Federal Prisons, United States Coast Guard, National Highway Traffic Safety Administration, Federal Trade Commission, Social Security Administration, Department of Labor, United States Office of Personnel Management, Department of Defense, Department of Education, Department of Veterans Affairs, Veterans Health Administration, and “any other appropriate federal agency”. This “Justice League” of representatives from Federal agencies is supposed to coordinate activities to avoid duplication and maximize results for national health care priorities.

Saturday, October 27, 2012

Contents of Obamacare - Part 6 - Individual Mandate

Individual Responsibility: Subtitle F, Part I, is ironically entitled “Individual Responsibility”. I say “ironically entitled” because Mitt Romney, who believes 47% of the US population takes no individual responsibility, wants to repeal this provision. This is the provision that was upheld by the United States Supreme Court. Under this provision, individuals are fined $750 on their personal tax return if they do not purchase minimal essential health care coverage during a calendar year. This is phased in at a rate of $95 for 2014 and $315 for 2015. If an individual goes one month without minimal coverage the fee is 1/12 of this amount. “Minimal Essential Coverage” includes Medicare, Medicaid, CHIP, Tricare, Veteran’s plans, and plans for Peace Corp volunteers. It also includes employer-sponsored plans, individual plans and grandfathered plans. Although the penalty is collected on your income tax form, the law expressly prohibits the Federal government from filing criminal charges against you if you don’t pay the penalty and also prohibits the IRS from filing liens and levies against your property to collect the fee. The US Supreme Court debated as to whether it was constitutional for the government to require you to purchase health insurance, and this provision was upheld under Congress’s taxing power. Beginning in 2014, your insurer will send you a formal notice of your coverage for tax purposes. Employers shall also be required to file a return regarding coverage of their employees and also to provide notice to their employees. Assisted Suicide: The law continues on with a prohibition of discrimination against individuals or health care entities on the basis that they refuse to implement assisted suicide, mercy killings or euthanasia. Expansion of Medicaid. The law initially required the states to expand Medicaid by offering it to anyone with an income of %133 of the federal poverty line but the United States Supreme Court struck down this requirement. It is now optional for the states. Children’s Health Insurance Plan (CHIPs): The law enhances funding for this federal program to assist the states in providing health insurance for Children.

Friday, October 26, 2012

Contents of Obamacare - Part 5 - Congress and Immigrants

The Federal Government may offer ONLY health care plans governed by Obamacare to the members of the US House of Representatives, the members of the US Senate, and their staff. ( I always thought such a provision, more than any other, would guarantee high quality health care plans in the system.) Can Illegal Immigrants enroll in an Obamacare plan? No, such plans are available only for lawful residents, i.e., citizens or lawful immigrants. Can prisoners enroll in an Obamacare plan? No. Does the False Claims Act apply to activities under Obamacare? Yes, this is the law that makes it a crime and imposes civil and criminal penalties for those who make false statements to the federal government or submit false claims. States May Opt Out of the Health Insurance Exchanges. If they do, the Federal government will establish the exchanges for them. Non-Profit Health Insurers. The law offers grants to encourage the formation of non-profit health insurers within the states and puts restrictions on what type of entities may operate as such. Multiple State Insurance Plans. States may agree to operate multistate plans. The law of the state where the plan is written shall control. Nationwide Insurance Plans. Nationwide plans are permitted under the law of the state when the plan was written. NEXT: THE HIGHLY CONTESTED INDIVIDUAL MANDATE MINIMAL ESSENTIAL COVERAGE (AS UPHELD BY THE UNITED STATES SUPREME COURT).

Thursday, October 25, 2012

Contents of Obamacare - Part 4- Mental Health

Mental Health Parity. The Mental Health Parity Act (see my December 4, 1209 blog) applies to health care plans that are qualified under this law. This requires health plans that are governed by to offer equivalent levels of coverage for mental health and physical ailments. As stated in my October 23, 2012 blog (Contents of Obamacare - Part 2), one of the 10 essential benefits required of plans is described as "“mental health and substance use disorder services, including behavorial health treatment”. Not only do plans have to cover these services, the have to do so in a manner that is actuarially equivalent to coverage for physical ailments. Definitions: The law goes on to define various terms, such as group markets, individual markets, large employers and small employers. A large employer is one with 100 or more employees. A small employer is one with at least one employee and less than 100. The state can chose to define a small employer as 50 or less employees. Federal Grants to States for Health Benefit Exchanges. The law goes further to create Federal grants to the States to establish Health Benefit Changes in 2013. The Health Benefit Changes are to become self-funded in 2015 via user fees. Rewarding Quality Through Market-Based Incentives: The law’s strategy is to improve health care through quality reporting, effective case management, care coordination, chronic disease management, medication and care compliance initiatives, including the medical home model. It also includes the prevention of re-admission to the hospital for a prior condition through patient education and planning, discharge counseling and post-discharge enforcement. The law is designed to promote activities to improve patient safety and reduce medical errors through the appropriate us of “best clinical practice”, evidence based medicine, and health information technology. Finally, the law promotes the implementation of wellness and health promotion activities. Requirements for Hospitals. Hospitals are required to operate a patient safety evaluation system. Hospital discharge must include education and planning, a comprehensive discharge plan, and post-discharge enforcement of the plan. NEXT: DO THE PROVISIONS OF OBAMACARE APPLY TO THE MEMBERS OF THE HOUSE AND THE SENATE, and CAN ILLEGAL ALIENS BENEFIT FROM THE LAW?????

Wednesday, October 24, 2012

Contents of Obamacare - Part 3 - Abortion

Abortion: Obamacare is neutral on abortions in the sense that it adds no new federal requirements to cover abortions but does not disallow the coverage of abortions if no federal funds or federal risk is required for the coverage. However, it leans towards abortion in that it requires at least one plan in a state exchange to cover abortions and also requires at least one plan in a state exchange to refrain from covering abortions. Obamacare divides abortions into two subgroups: 1.) those for which federal funding is illegal as of 6 months prior to the start of the calendar year for the insurance plan, and 2.) those for which federal funding is allowed per the law as of 6 months prior to the start of the calendar year for the insurance plan. The states may cover abortions from the first subgroup (no federal funds allowed) but the law prohibits the federal government from providing any funding or accepting any insurance risk for such coverage. Effect of Obamacare of State and Federal Abortion Laws: The law attempts to have no indirect effect of its own on other abortion laws. In regards to the states, the law declares “Nothing in this Act shall be construed to preempt or otherwise have any effect on State laws regarding the prohibition of (or requirement of) coverage, funding, or procedural requirements on abortions, including parental notification or consent for the performance of abortion on a minor.” In regards to federal law, the statue declares, “Nothing in this Act shall be construed to have any effect on Federal laws regarding conscience protection, willingness or refusal to provide abortions, or discrimination on the basis of the willingness or refusal to provide, pay for, cover or refer for abortion or to provide or participate in training to provide abortion." In regards to Civil Rights law, the statute declares “Nothing…shall alter the rights and obligations of employees and employers under title VII of the Civil Rights Act of 1964."

Tuesday, October 23, 2012

FDA's List of Clinics Utilizing Source of Meningitis Outbreak

Contents of "Obamacare" - Part 2 - Essential Health Benefits/Wellness Programs/Nondiscrimination

Administrative Simplification. Pages 60 through 80 of the Act, arguably entitled “Administrative Simplifications” make revisions to the Health Insurance Portability and Accountability Act (HIPAA) to set up operating rules for electronic and other health care transactions. The section requires the filing of numerous reports by health plans and government agencies by specific deadlines. Health Insurance Market Reforms. Part I of Subtitle C of the Act deals with reforms such as the prohibition of pre-existing exclusions, the effects of age and tobacco use on the rating of an insurance plan, regulations for open enrollment periods, and guaranteed renewability of coverage for participants. Prohibition of Discrimination against Individual Participants and Beneficiaries. Section 2705 of the law prohibits discrimination due to health status, a physical medical condition, a mental medical condition, claims experience, receipt of health care, medical history, genetic information, evidence of insurability, disability, etc. Wellness programs. The law allows employers to offer lower rates to employees that participate in wellness programs . The Secretary of Health and Human Services is to establish a “demonstration” wellness program in ten states. Prohibition of Waiting Periods: No insurer may install a waiting period of greater than 90 days per the law. Preservation of the Right to Maintain Existing Coverage. The law expressly allows everyone to keep their existing coverage in place at the time the law was enacted and allows any health plans in place under union negotiations to remain in place until their natural expiration. Establishment of Covered Health Plans. Subtitle D of the law, entitled “Available Coverage Choices for All Americans”, calls for the establishment of “covered health plans” under the law and provides a detailed definition of such. Essential Health Benefits. A qualified health plan must provide the following: ambulatory (“one-day”) patient services, emergency services, hospitalization, maternity and newborn care, “mental health and substance use disorder services, including behavioral health treatment”, prescription drugs, rehabilitative and habilitative services and devices, laboratory services, preventive and wellness and chronic disease management, and pediatric services including oral and vision care. The Department of Labor will conduct a survey and provide the results to the Secretary of Health and Human Services (HHS) and HHS shall issue a proposed list of covered benefits for public review and comment. Limitation of Deductibles. The law puts a ceiling on the deductible at $2,000 for a single individual plan and $4,000 for all others. Four levels of plans: The law defines four levels of plans based upon the percentage of actual health care costs that they cover: bronze (60%), silver (70%), gold (80%) and platinum (90%). WE ARE NOW TO PAGE 118 OF THIS 2,409 PAGE ACT. NEXT: DOES THE LAW MANDATE THE COVERAGE OF ABORTIONS?

Saturday, October 20, 2012

Contents of "Obamacare" - Part I

CONTENTS OF THE AFFORDABLE CARE ACT From now until the election, I will be briefly summarizing the content of the Affordable Care Act (aka “Obamacare”) so that you may be informed about the act when you vote in November. The law is lengthy and complex so I shall be simplifying. Title I, Subpart A, of the act starts with improvements that were to take effect immediately upon the signing of the act. These include the removal of annual or lifetime limits for benefits; a prohibition disallowing insurers to rescind (“take back” or “cancel”) an existing health insurance policy unless the applicant has committed fraud in the application process; coverage of appropriate immunizations; preventive care for infants, children and adolescents; preventive care and screening for women such as mammograms and breast cancer screening; extension of coverage for dependents up to 26 years of age. Changes in wording and definitions: The act provides for standardization of wording and format for coverage documents and benefits plans to make them easier to understand and easier to cross-compare; the development of standard definitions for insurance related terms such as “deductibles’ “copayments”, “preferred provider”, “out-of-pocket” , etc.; the development of standard definitions for medical terms that are utilized in insurance plans, such as “durable medical equipment”, “hospitalization”, “hospice” so that individuals may more easily cross-compare and understand various plans; Equality of benefits. The act includes prohibitions preventing employers from discriminating against lower-paid full-time employers or providing better insurance for higher-paid full-time employees. Changes in health care delivery: the act provides incentives to encourage hospitals to avoid re-admissions for the same condition rather than putting a Band-Aid on the problem, stabilizing the patient, and discharging them; steps to reduce medical errors through “best clinical practices”; and incentives to include wellness and preventive care. <Wellness and preventive care: These are “smoking cessation”, “weight management”, “stress management”, “physical fitness”, “nutrition”, “heart disease prevention”, “health lifestyle support”, and “diabetes prevention.” Reporting by insurance plans: Insurers will be provided to report on a website the percentage of their premiums that they actually spend on health care and provide a refund to the insured if this is less than 80%. Standardization and reporting of charges for medical procedures: The act requires hospitals to publish in advance their standardize costs for procedures so that individuals may cross-compare. Minimal requirements for an appeals process: These include and internal appeals process, an understandable notice to individuals receiving denials about their rights and appeals, and the patient’s right to review their record and provide testimony. Health insurance consumer information: The law provides grants to the states, if they provide certain information in return, to establish contacts for consumer assistance in regards to health care insurance. Funding: The act funded all of the above activities for the first year with 30 million dollars. <b>Justification and Disclosure for Premium Increases: The state is required to monitor and review premium increases, and the law offers federal grants to states to achieve this. Immediate Actions to Preserve and Expand Coverage (Title 1, Subpart B): The law creates temporary high-risk pools to provide insurance for those with pre-existing conditions (this has already been done) and adds sanctions for the dumping of sick patients. Five billion dollars was appropriated each year for these claims. In 2014, the patients will be transferred to other plans. The act also provides funds to cover re-insurance for early retirees (those over 55 years of age), their spouses, their surviving spouses and dependents. Establishment of websites to allow patients to find coverage. HOLD YOUR BREATH. I AM ONLY THROUGH PAGE 60 OF A 2,409 PAGE ACT! MORE TO COME.

Wednesday, August 8, 2012

Recent Federal Court Decisions Re: FDA

Two Federal Courts have released decisions that affect the extent of authority of the FDA. The first case deals with FDA's capability to debar corporate executives of companies that engage in illegal conduct. The second case deals with the agency's authority to regulate stem cell treatments. In the first case, called Friedman v. Sebelius, No. 11 5028, July 27, 2012, the United States Court of Appeals for the DC Circuit upheld a lower court's ruling allowing the FDA to personally bar executives of the Purdue Frederick Company ("Purdue") from participating in Federal programs such as Medicare and Medicaid. The CORPORATION had pleaded guilty to felony charges for misbranding and the fradulent promotion of the painkiller OxyContin. The INDIVIDUAL EXECUTIVES of Purdue had pleaded guilty to misdeamor violations in which the Purdue exectutives did not admit, and the government did not allege, any fraudulent conduct on the part of the executives. Soon after the plea, the United States Department of Health and Human Services Office of Inspector General ("OIG") determined that the executives should be individually debarred from participating in the federal health programs for 20 years. After several administrative rulings, the case came up before the Court of Appeals. The federal statute at play says that individuals can be excludied from participating in federal health care plans if they have been convicted "of a criminal offense consisting of a misdemeanor relating to fraud." 42 U.S.C.Sec.1320a-7(b)(1)(A). The executives had pleaded guilty to a misdeamenor which did not include fraud. The Court held that the government can exclude an individual under this provision based on a conviction which was for conduct factually related to fraud, even thought the offense to which the person pleaded guilty did not require a showing of fraud. The significance of the above case is that pleading guilty to a non-fraudulent misdemeanor may not longer save the defendent from disbarment. In the second case, a US District Court, which is the lowest court level in the federal system, held that the harvesting of a patient's own mesencymal stem cells from his/her own bone marrow and then re-injecting the stem cells into the same patient for treatment of bone and joint pain constitutes the manufacture of a drug or biological product rather than the practice of medicine. If the procedure was the practice of medicine, it would be regulated by state, i.e., in this case, Colorado. If the procedure was manufacturing, it would regulated by the FDA. If the stem cells are only “minimally manipulated”, they should only be regulated under FDA regulations for HCT/Ps, which would not require FDA approval. However, the court found that this particular procedure exceeded mere “processing” of cells in that the procedure changed their relevant biological and physiological characteristics. This is in part because the procedure added the antibiotic doxycycline into the removed stem cells to avoid infection. The Court went on to find the stem cells "adulterated" because they were not manufactured according to FDA regulations and "misbranded" because the syringe label did not have the required federal wording. United States v. Regenerative Sciences, LLC (Civil Action No. 10-1327 (RMC) (U.S.D.C. July 23, 2012).

Thursday, May 17, 2012

Do We Need the Insurance Mandate of the Affordable Care Act?

The Affordable Care Act requires individuals to purchase health insurance or face penalties from the IRS beginning 2014. The US Supreme Court recently heard arguments as to whether this requirement was constitutional. Regardless of it is constitutionality, the purchase mandate is necessary to the success of the bill in order make health insurance more affordable. Rates will not go down unless more younger, healthier individuals are included in the insurance pool. For example, Blue Cross Blue Shield just raised my personal premium rates by 20%, yet at my last annual physical, I had no new diagnoses, no hospitalizations and no outpatient surgery. Why did they raise my rates? Because I turn 55 years old before the next premium payment is due. Yet the policiticians on both sides say that it is the small business owners such as myself that will hire people and get the ecomony going again. This is not going to happen if we are burderned by increasing health care costs just to maintain the status quo. This country will go bankrupt if health care costs are not put under control. For that reason, the insurance purchase mandate is necessary.

Friday, April 20, 2012

Illinois governer Quinn's proposals to cut Medicaid

From Crain's Chicago business. AS the federal government tries to expland health care for the poor, the state proposes to cut it.

Tuesday, February 28, 2012

Alarming planned closure of Chicago's Mental Health Clinics

At a time when the economy is bad, Chicago plans to close some of the city's neighborhood mental health clinics. Below is a link to a WGN interview of Bechar Choucair of the Chicago Department of Public Health trying to rationalize the closings. Cook County Sheriff Dart has said this will result in making Cook County Jail the largest mental health care "provider" in the state, because if the mentally ill cannot receive treatment, they will ultimately be arrested and incarcerated at a greater expense to the city. Dart is right.

Sherrif Dart's prediction: