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?????

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."

FDA's List of Clinics Utilizing Source of Meningitis Outbreak

http://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf

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?

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.

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).

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.