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H.R. 3962:
Affordable Health Care for America Act
111th Congress

This is a bill in the U.S. Congress originating in the House of Representatives ("H.R."). A bill must be passed by both the House and Senate and then be signed by the President before it becomes law.

Bill numbers restart from 1 every two years. Each two-year cycle is called a session of Congress. This bill was created in the 111th Congress, in 2009-2010.

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Congressional Research Service Summary

The following summary was written by the Congressional Research Service, a well-respected nonpartisan arm of the Library of Congress. GovTrack did not write and has no control over these summaries.

11/7/2009--Passed House amended. Affordable Health Care for America Act -
Division A - Affordable Health Care Choices
Title I - Immediate Reforms
Section 101 -
Requires the Secretary of Health and Human Services (HHS) to establish a temporary, national high-risk pool program to provide health benefits to eligible individuals beginning on January 1, 2010, and ending on the date on which the Health Insurance Exchange is established. Sets forth eligibility requirements for such program, including: (1) specifying that such program is available to uninsured individuals with eligible medical conditions; and (2) limiting eligibility to individuals who are citizens or nationals of the United States or who are lawfully present in the United States. Requires the Secretary to establish criteria for determining whether health insurance issuers and employment-based health plans have discouraged an individual from remaining enrolled in prior coverage based on that individual's health status. Requires reimbursement to the program for medical expenses for such actions. Sets forth provisions for the establishment and governance of the program. Terminates such program on the date on which the Health Insurance Exchange is established.
Section 102 -
Amends the Public Health Service Act (PHSA) to provide rebates to enrollees of a group health plan for any year in which the plan's medical loss ratio (a ratio of medical expenses paid to premiums received) is below 85%. Terminates such provision on the date that health insurance is offered through the Health Insurance Exchange. Applies such provisions to coverage offered in the individual market.
Section 103 -
Allows a health insurance issuer to rescind group health coverage only upon clear and convincing evidence of fraud.
Section 104 -
Requires the Secretary to establish a process for the annual review of increases in premiums for health insurance coverage.
Section 105 -
Amends the PHSA, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code (IRC) to require a group health plan that provides coverage for dependent children to make available such coverage, at the option of the participant, for dependent children under 27 years of age. Applies such requirement to coverage offered in the individual market. Allows a health plan to impose a preexisting condition exclusion only for: (1) a condition for which medical advice, diagnosis, care, or treatment was recommended or received within 30 days of the enrollment date; and (2) three months after the enrollment date (nine months for a late enrollee). Terminates such provision as of the date that such plan becomes subject to the requirements for qualified health benefit plans.
Section 107 -
Prohibits a health plan from imposing any preexisting conditions exclusion on the basis of domestic violence.
Section 108 -
Requires a health plan that provides coverage for surgical benefits to provide coverage for outpatient and inpatient diagnosis and treatment of a minor child's congenital or developmental deformity, disease, or injury.
Section 109 -
Prohibits a health plan from imposing any aggregate dollar lifetime limit with respect to benefits payable under the plan.
Section 110 -
Limits the ability of a group health plan to reduce benefits for a retired participant.
Section 111 -
Requires the Secretary to establish a temporary reinsurance program to assist participating employment-based plans with the cost of providing health benefits to retirees and to eligible spouses, surviving spouses, and dependents of such retirees. Establishes a Retiree Reserve Trust Fund.
Section 112 -
Requires the Secretaries of HHS and Labor to jointly award wellness grants to small employers for 50% of the costs paid or incurred by such employers in connection with a qualified wellness program.
Section 113 -
Extends COBRA coverage (health insurance continuation benefits) until the date on which an individual becomes eligible for acceptable coverage or eligible for health insurance coverage through the Health Insurance Exchange.
Section 114 -
Requires the HHS Secretary to provide grants to states to establish programs to expand access to affordable health care coverage for the uninsured populations in the state.
Section 115 -
Amends title XI (General Provisions, Peer Review, and Administrative Simplification) of the Social Security Act (SSA) to require the Secretary to adopt and regularly update standards for financial and administrative transactions consistent with specified goals. Sets forth requirements for such standards, including requiring: (1) timely and transparent claim and denial management processing; and (2) the use of a standard electronic transaction for health care providers to quickly and efficiently enroll with a health plan to conduct electronic transactions.
Title II - Protections and Standards for Qualified Health Benefits Plans
Subtitle A - General Standards
Section 201 -
Requires qualified health benefits plans to meet requirements under this division related to affordable coverage, essential benefits, and consumer protection. Authorizes the Health Choices Commissioner (established under subtitle E) to permit a qualified health benefits plan to provide coverage through a qualified direct primary care medical home plan so long as the plan meets all requirements that are otherwise applicable and the services covered by the medical home plan are coordinated with the QHBP offering entity (an entity offering a qualified health benefits plan).
Section 202 -
Sets forth provisions governing grandfathered health insurance coverage.
Subtitle B - Standards Guaranteeing Access to Affordable Coverage
Section 211 -
Prohibits a qualified health benefits plan from imposing any limit or condition on coverage under the plan based on health status, medical condition, claims experience, receipt of health care, medical history, genetic information, evidence of insurability, disability, source of injury (including conditions arising out of acts of domestic violence), or any similar factors.
Section 212 -
Applies provisions relating to guaranteed availability and renewability of health insurance coverage to individuals and employers in all individual and group health insurance coverage. Prohibits rescission of coverage except in cases of fraud.
Section 213 -
Prohibits premium rate variances in a qualified health benefits plan. Sets forth exceptions that include variances by age, premium rating area, and family enrollment. Requires the Commissioner to conduct a study of the large-group-insured market and self-employer health care markets to examine issues such as: (1) the similarities and differences between typical insured and self-insured health plans; (2) the financial solvency and capital reserve levels of employers that self-insure by employer size; and (3) the extent to which rating rules are likely to cause adverse selection in the large group market or to encourage small and midsize employers to self-insure.
Section 214 -
Requires a qualified health benefits plan to comply with standards established by the Commissioner to prohibit discrimination in health benefits or benefit structures. Applies mental health parity provisions to such plans.
Section 215 -
Requires a qualified health benefits plan that uses a provider network for items and services to meet standards that may be established by the Commissioner to ensure the adequacy of the provider network.
Section 216 -
Requires a qualified health benefits plan to make available, at the option of the principal enrollee, coverage for dependent children under 27 years of age.
Section 217 -
Requires the issuer of coverage under a qualified health benefits plan to provide notice to enrollees at least 90 days before any decrease in coverage or increase in cost-sharing.
Subtitle C - Standards Guaranteeing Access to Essential Benefits
Section 221 -
Requires a qualified health benefits plan to meet the benefit standards adopted for the essential benefits package. Allows a qualified health benefits plan not participating in the Exchange to offer additional coverage. Requires Exchange-participating plans to provide specified levels of benefits and, in the case of a plan offering a premium-plus level of benefits, to provide additional benefits.
Section 222 -
Defines an "essential benefits package" as health benefits coverage that: (1) provides payment for covered items and services in accordance with generally accepted standards of medical or other appropriate clinical or professional practice; (2) limits cost-sharing for covered health care items and services in accordance with benefit standards; (3) does not impose any annual or lifetime limit on the coverage of covered health care items and services; (4) complies with requirements for provider network adequacy; and (5) is equivalent in its scope of benefits to the average prevailing employer-sponsored coverage in 2013. Directs the Secretary of Labor to conduct a survey of employer-sponsored coverage to determine the benefits typically covered by employers. Sets forth the items and services to be covered under the essential benefits package, including: (1) hospitalization; (2) outpatient hospital and clinic services, including emergency department services; (3) professional services of physicians and other health professionals; (4) prescription drugs; (5) rehabilitative and habilitative services; (6) mental health and substance use disorder services; (7) preventive services; (8) maternity care; (9) well-baby and well-child care and oral health, vision, and hearing services, equipment, and supplies for children under 21 years of age; and (10) durable medical equipment, prosthetics, orthotics, and related supplies. Prohibits cost-sharing under the essential benefits package for certain preventive items and services and vaccines recommended by the Centers for Disease Control and Prevention (CDC) or for well-baby and well-child care. Sets forth provisions governing the allowable level of cost-sharing under the essential benefits package. Requires the HHS Secretary to support the need for an assessment and brief counseling for domestic violence as part of a behavioral health assessment or primary care visit and to determine the appropriate coverage for such assessment and counseling. Prohibits the Health Benefits Advisory Committee from recommending, and the Secretary from adopting, standards for the essential benefits package that include abortion services. Prohibits the Commissioner from requiring abortion services for qualified health benefits plans to participate in the Health Insurance Exchange. Provides that a qualified health benefits plan is not required or prohibited from providing coverage of such services. Requires the Secretary to report to Congress the results of a study determining the need and cost of providing accessible and affordable oral health care to adults as part of the essential benefits package.
Section 223 -
Establishes the Health Benefits Advisory Committee to recommend covered benefits and essential, enhanced, and premium plans.
Section 224 -
Sets forth a process for the Secretary to review and adopt recommended standards.
Subtitle D - Additional Consumer Protections
Section 231 -
Requires the Commissioner to establish uniform marketing standards for all QHBP offering entities with respect to qualified health benefits plans that are health insurance coverage.
Section 232 -
Requires a QHBP offering entity to provide for timely grievance and appeals mechanisms.
Section 233 -
Requires a QHBP offering entity offering an Exchange-participating health benefits plan to comply with standards established by the Commissioner for the accurate and timely disclosure of plan documents, plan terms and conditions, and other appropriate information. Requires a pharmacy benefit manager that manages prescription drug coverage or otherwise controls prescription drug costs under a qualified health benefits plan to provide at least annually to the Commissioner and the QHBP offering entity information on the cost of prescriptions, payments, and other required information.
Section 234 -
Applies requirements of this subtitle to qualified health benefits plans that are not being offered through the Health Insurance Exchange only to the extent specified by the Commissioner.
Section 235 -
Requires qualified health benefits plans to comply with provisions requiring prompt payment for services and supplies applicable to Medicare+Choice organizations.
Section 236 -
Requires the Commissioner to establish standards for the coordination and subrogation of benefits and reimbursement of payments for qualified health benefits plans.
Section 237 -
Requires a QHBP offering entity to comply with specified administrative simplification provisions under the SSA with respect to qualified health benefits plans it offers.
Section 238 -
Declares that this Act does not supersede state and local laws designed to prohibit a qualified health benefits plan from discriminating against a health care provider that is acting within the scope of that provider's license or certification under applicable state law.
Section 239 -
Requires the Secretary to study the use of physician prescriber information in sales and marketing practices of pharmaceutical manufacturers and to report to Congress on actions needed to be taken by Congress or the Secretary to protect providers from biased marketing and sales practices.
Section 240 -
Requires a QHBP offering entity to provide for the dissemination of information related to end-of-life planning that meets certain requirements.
Subtitle E - Governance
Section 241 -
Establishes the Health Choices Administration as an independent agency in the executive branch. Requires the Administration to be headed by a Health Choices Commissioner appointed by the President, by and with the advice and consent of the Senate.
Section 242 -
Sets forth the duties of the Commissioner, including: (1) the establishment of qualified health benefits plan standards under this title; (2) the establishment and operation of the Health Insurance Exchange; and (3) administration of individual affordability credits. Requires the Commissioner to: (1) undertake activities to promote accountability of QHBP offering entities in meeting federal health insurance requirements; and (2) collect data for purposes of carrying out the Commissioner's duties. Authorizes the Commissioner to provide for specified remedies when a QHBP offering entity violates a requirement of this title, including civil money penalties, suspension of enrollment of individuals under the plan, suspension of payment to Exchange-participating health benefit plans, and working with state insurance regulators to terminate plans for repeated failures to meet the requirements of this title.
Section 244 -
Requires the Secretary to appoint a Qualified Health Benefits Plan Ombudsman to: (1) receive and provide assistance with respect to complaints, grievances, and requests for information submitted by individuals; and (2) submit annual reports and recommendations for improvement to Congress and the Commissioner.
Subtitle F - Relation to Other Requirements; Miscellaneous
Section 252 -
Requires that all health care and related services covered by this Act be provided without regard to personal characteristics extraneous to the provision of high quality health care or related services.
Section 253 -
Prohibits an employer from discharging or discriminating against any employee because the employee provided information relating to any violation of this Act.
Section 257 -
Allows a state attorney general to bring a civil action to secure monetary or equitable relief for violations of any provision of this title.
Section 258 -
Declares that this Act does not preempt state laws related to abortion or federal laws regarding conscience protection.
Section 259 -
Prohibits a federal agency or program or any state or local government that receives federal financial assistance under this Act from discriminating against any individual or institutional health care entity on the basis that the entity does not provide, pay for, provide coverage of, or refer for abortions. Defines "health care entity" to include an individual health care professional, a hospital, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.
Section 260 -
Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to share certain information relating to insurance.
Section 261 -
Declares that the development, recognition, or implementation of any guideline or other standard related to health care under specified provisions shall not be construed to establish the standard of care or duty of care owed by health care providers to their patients in any medical malpractice action or claim.
Section 262 -
Declares that the McCarran-Ferguson Act antitrust exemptions do not apply to persons engaged in the business of health insurance or the business of medical malpractice insurance, with specified exceptions, including for: (1) collecting, compiling, classifying, or disseminating historical loss data; (2) determining a loss development factor applicable to historical loss data; or (3) performing actuarial services if doing so does not involve a restraint of trade.
Section 263 -
Requires the Secretary to study and report to Congress on potential methods to increase the use of qualified electronic health records by small health care providers.
Section 264 -
Extends federal agency reporting requirements to executive agencies established by this Act.
Section 265 -
Prohibits funds authorized or appropriated by this Act from being used to pay for any abortion or to cover any part of the costs of any health plan that includes coverage of abortion, except where: (1) a woman suffers from a physical disorder, physical injury, or physical illness that would place the woman in danger of death unless an abortion is performed; or (2) the pregnancy is the result of an act of rape or incest.
Title III - Health Insurance Exchange and Related Provisions
Subtitle A - Health Insurance Exchange
Section 301 -
Establishes within the Health Choices Administration a Health Insurance Exchange in order to facilitate access of individuals and employers to a variety of choices of affordable, quality health insurance coverage, including a public health insurance option. Requires the Commissioner to: (1) establish standards for, accept bids from, and negotiate and enter into contracts with QHBP offering entities for the offering of health benefit plans through the Exchange; and (2) facilitate outreach and enrollment in such plans of Exchange-eligible individuals and employers.
Section 302 -
Declares that all individuals are eligible to obtain coverage through enrollment in an Exchange-participating health benefits plan offered through the Exchange unless such individuals are enrolled in another qualified health benefits plan or certain other acceptable coverage. Sets forth a three-year transition schedule for when individuals and employers are eligible to enroll or participate in the Exchange, beginning in 2013. Allows an Exchange-eligible employer to meet employer responsibility requirements by offering employees the option of enrolling with an Exchange-participating health benefits plan. Gives the Commissioner authority to establish rules to deal with special situations with regard to uninsured individuals and employers participating as Exchange-eligible individuals and employers. Requires the Commissioner to engage in information-gathering activities regarding the Exchange, including periodic surveys and a study of access to the Exchange for individuals and employers.
Section 303 -
Directs the Commissioner to: (1) specify the benefits to be made available under Exchange-participating health benefits plans during each plan year; and (2) establish standards for Exchange-participating health benefits plans for basic, enhanced, and premium plans. Sets forth specific requirements for each plan tier.
Section 304 -
Requires the Commissioner to: (1) solicit bids from, negotiate with, and contract with QHBP offering entities for the offering of Exchange-participating health benefits plans; and (2) deny excessive premiums and premium increases. Sets forth standards for a QHBP offering entity to offer an Exchange-participating health benefits plan, including related to state licensing, reporting to the Commissioner, providing for affordable premiums, accepting all enrollments, and participating in a risk pooling mechanism.
Section 305 -
Requires the Commissioner to: (1) conduct activities to inform and educate individuals and employers about the Exchange and Exchange-participating health benefits plan options; (2) make timely eligibility determinations; (3) establish a process for enrollments in Exchange-participating health benefits plan; (4) coordinate the distribution of affordability premium and cost-sharing credits; and (5) establish a mechanism for risk-sharing among Exchange-participating health benefits plans.
Section 307 -
Creates the Health Insurance Exchange Trust Fund from which payments shall be made to operate the Exchange and for which amounts shall be appropriated equal to receipts from a tax on individuals not obtaining acceptable coverage and on employers not providing health benefits to employees.
Section 308 -
Authorizes state-based Health Insurance Exchanges if approved by the Commissioner to be operated instead of the Health Insurance Exchange. Sets forth requirements for state-based Exchanges.
Section 309 -
Allows two or more states to form Health Care Choice Compacts to facilitate the purchase of individual health insurance coverage across state lines. Requires the Secretary to consult with the National Association of Insurance Commissioners to develop model guidelines for the creation of such compacts.
Section 310 -
Requires the Secretary to establish a Consumer Operated and Oriented Plan program (CO-OP program) under which the Commissioner may make grants and loans for the establishment and initial operation of not-for-profit, member-run health insurance cooperatives that provide insurance through the Health Insurance Exchange or through a state-based Exchange.
Subtitle B - Public Health Insurance Option
Section 321 -
Requires the Secretary to provide for the offering of the public health insurance option that: (1) is only available through the Health Insurance Exchange; and (2) complies with all requirements applicable to Exchange-participating health benefits plans.
Section 322 -
Requires the Secretary to establish geographically-adjusted premium rates for such option at a level sufficient to fully finance health benefits and administrative costs. Provides for startup costs. Prohibits any bailout of the such option.
Section 323 -
Requires the Secretary to negotiate rates for items and services in a manner that results in payment rates that are not lower than Medicare rates and not higher than rates paid by other QHBP offering entities. Declares that health care providers participating in Medicare are participating providers in the public health insurance option unless they opt out.
Section 324 -
Authorizes the Secretary to utilize innovative payment mechanisms and policies to determine payments for items and services under such option. Requires the Secretary to establish conditions of participation for health care providers under such option.
Section 326 -
Applies to such option: (1) the False Claims Act; (2) health insurance requirements under PHSA in the same manner as they apply to coverage offered by a health insurance issuer in the individual market; and (3) health information security provisions.
Section 329 -
Declares that enrollment in such option is voluntary. Authorizes members of Congress to enroll in such option. Provides for reimbursement for non-service connected care or services provided by the Secretary of Veterans Affairs to an individual covered under such option.
Subtitle C - Individual Affordability Credits
Section 341 -
Sets forth provisions providing for affordability credits consisting of affordability premium credits and affordability cost-sharing credits to be paid by the Commissioner to the QHBP offering entity for eligible individuals enrolled in an Exchange-participating health benefits plan. Limits eligibility for such credits to U.S. citizens or individuals otherwise lawfully present in the United States. Sets forth a verification process.
Section 342 -
Establishes eligibility requirements for affordability credits based on income.
Section 343 -
Sets forth provisions for determining the amount of the affordability premium credit and the amount of the affordability cost-sharing credit.
Section 346 -
Establishes special rules for applicability of this Act to territories.
Title IV - Shared Responsibility
Subtitle A - Individual Responsibility
Section 401 -
References individual responsibility requirements set forth under title V of this Act.
Subtitle B - Employer Responsibility
Part 1 - Health Coverage Participation Requirements
Section 411 -
Requires employers to: (1) offer each employee individual and family coverage under a qualified health benefits plan (or under a current employment-based health plan) and make contributions towards such coverage; or (2) make contributions to the Health Insurance Exchange for employees declining such coverage and obtaining coverage in an Exchange-participating health benefits plan.
Section 412 -
Requires employers to auto-enroll employees in employment-based health benefit plans. Provides for an opt-out for employees.
Section 413 -
Requires employers not offering coverage to contribute 8% of average wages paid by the employer during the period of enrollment to the Health Choices Commissioner for deposit into the Health Insurance Exchange Trust Fund, but not to be applied against the premiums of the employee under the Exchange-participating health benefits plan. Establishes special rules for small employers with tiered contribution rates, including no required contribution for employers with an annual payroll that does not exceed $500,000.
Section 414 -
Authorizes the Commissioner to set standards for determining whether employers or insurers are undertaking any actions to affect the risk pool within the Health Insurance Exchange by inducing individuals to decline coverage under a qualified health benefits plan offered by the employer and instead to enroll in an Exchange-participating health benefits plan.
Section 415 -
Requires the Secretary of Labor to study the effect of small employer exemptions and employer responsibility requirements on employment-based health plan sponsorship, generally and within specific industries.
Section 416 -
Requires the Secretaries of Labor, Treasury, and HHS and the Commissioner to study the impact of employer responsibility requirements and make a recommendation to Congress about whether an employer hardship exemption would be appropriate.
Part 2 - Satisfaction of Health Coverage Participation Requirements
(Sec 421) Amends ERISA and the PHSA to authorize an employer to make an election to be subject to the health coverage participation requirements. Treats such an election as the establishment and maintenance of a group health plan. Authorizes termination of such election for substantial noncompliance. Provides for civil penalties for failure to satisfy the health care participation requirements.
Title V - Amendments to Internal Revenue Code of 1986
Subtitle A - Provisions Relating to Health Care Reform
Part 1 - Shared Responsibility
Subpart A: Individual Responsibility -
Section 501 -
Amends the IRC to impose an additional tax on individuals who do not obtain health care coverage deemed acceptable by this Act. Makes such tax equal to 2.5% of a specified portion of individual modified adjusted gross income, but not more than the national average health care premium for the taxable year. Allows exemptions from such tax for dependents, nonresident aliens, certain individuals residing outside the United States and in possessions of the United States, and individuals objecting on religious grounds. Makes such tax effective after 2012. Directs the Secretary of the Treasury to prescribe regulations for imposing such tax and for granting waivers in cases of de minimis lapses of acceptable coverage and hardship. Sets forth reporting requirements for health insurance providers with respect to such tax. Subpart B: Employer Responsibility -
Section 511 -
- Requires employers to make an election to provide health care coverage for their employees or pay an additional 8% payroll tax. Allows a graduated reduction in such tax for employers whose annual payroll does not exceed $750,000.
Part 2 - Credit For Small Business Employee Health Coverage Expenses
Section 521 -
- Allows qualified small employers to elect, during a two-year period, a tax credit for 50% of their employee health care coverage expenses. Defines "qualified small employer" as an employer who has no more than 25 employees with average annual compensation levels less than $40,000. Requires a phaseout of such credit based on employer size and employee compensation.
Part 3 - Limitations on Health Care Related Expenditures
Section 531 -
Restricts payments for medications from health savings accounts, medical savings accounts, and heath flexible spending arrangements to prescription drugs or insulin.
Section 532 -
Limits annual salary reduction contributions by an employee to a health flexible spending arrangement under a cafeteria plan to $2,500.
Section 533 -
Increases to 20% the penalty for distributions from a health savings account not used for qualified medical expenses.
Section 534 -
Denies a tax deduction for subsidy payments received under the SSA for prescription drug plans that are excludable from gross income.
Part 4 - Other Provisions to Carry Out Health Insurance Reform
Section 541 -
Requires the Treasury Secretary to disclose certain tax return information to the Health Choices Administration or state-based health insurance exchanges to determine eligibility for health insurance subsidies under this Act.
Section 542 -
Allows employees participating in a tax-exempt cafeteria plan to chose health insurance coverage from an exchange-participating health benefit plan.
Section 543 -
Allows a tax exclusion of payments to reinsurance programs for retiree health benefits.
Section 544 -
Requires the PHSA CLASS program to be treated for tax purposes in the same manner as a qualified long-term care insurance contract.
Section 545 -
Excludes from gross income the value of certain health benefits provided to members of Indian tribes, including: (1) health services or benefits provided or purchased by the Indian Health Service; (2) medical care provided by an Indian tribe or tribal organization to a member of an Indian tribe; (3) accident or health plan coverage provided by an Indian tribe or tribal organization for medical care to a member of an Indian tribe and dependents; and (4) any other medical care provided by an Indian tribe that supplements, replaces, or substitutes for federal programs.
Subtitle B - Other Revenue Provisions
Part 1 - General Provisions
Section 551 -
Imposes a 5.4% surtax on individuals whose modified adjusted gross income exceeds $500,000 ($1 million in the case of married individuals filing jointly).
Section 552 -
Imposes a 2.5% excise tax on the first taxable sale of any medical device. Defines "first taxable sale" as the first sale, for a purpose other than for resale, after production, manufacture, or importation. Exempts medical devices sold to the public at a retail establishment or sold for further use in manufacturing.
Section 553 -
Expands reporting requirements for payments of $600 or more to corporations (other than tax-exempt corporations).
Section 554 -
Repeals special tax rules for the worldwide allocation of interest for purposes of computing the limitation on the foreign tax credit.
Section 555 -
Amends the definition of "cellulosic biofuel" for purposes of the tax credit for alcohol used as fuel to exclude any fuel if more than 4% of such fuel is any combination of water and sediment or if the ash content of such fuel is more than 1%.
Part 2 - Prevention of Tax Avoidance
Section 561 -
Prohibits any reduction of tax withholding for payments made by a U.S. subsidiary of a foreign parent corporation to a related subsidiary in any country that has a tax treaty with the United States, except for payments made directly to the foreign parent corporation.
Section 562 -
Sets forth rules for the application of the economic substance doctrine to transactions affecting taxpayer liability. Treats a transaction as having economic substance if: (1) the transaction changes in a meaningful way the taxpayer's economic position; and (2) the taxpayer has a substantial purpose, other than tax avoidance, for entering into a transaction. Increases penalties for underpayments resulting from transactions lacking economic substance. Disallows waivers of penalties based on reasonable cause for underpayments resulting from transactions lacking economic substance.
Section 563 -
Modifies the reasonable cause and good faith requirement for waiving penalties for underpayment of tax with respect to certain publicly traded entities and corporations with gross receipts in excess of $100 million to require a reasonable belief on the part of such entity or corporation that its tax treatment of an item creating an underpayment is more likely than not the proper tax treatment.
Part 3 - Parity in Health Benefits
Section 571 -
Extends the tax exclusion for employer-provided accident and health plan spousal and dependent benefits to any other beneficiary of an employee who is eligible to receive benefits or coverage under an employer plan.
Division B - Medicare and Medicaid Improvements -Title I: Improving Health Care Value
Subtitle A - Provisions Relating to Medicare Part A
Part 1 - Market Basket Updates
Section 1101 -
Amends title XVIII (Medicare) of the SSA with respect to: (1) market basket updates for skilled nursing facility (SNF) payments and inpatient rehabilitation facility payments; and (2) other specified Medicare part A (Hospital Insurance) requirements, including a productivity adjustment in the update factors for inpatient acute hospitals, psychiatric hospitals, and certain providers.
Part 2 - Other Medicare Part A Provisions
Section 1111 -
Directs the HHS Secretary to adjust the case mix indexes in the recalibration factor with respect to payments to SNFs.
Section 1114 -
Authorizes physician assistants to order post-hospital extended care services for Medicare payment purposes. Recognizes attending physician assistants as attending physicians to serve hospice patients.
Subtitle B - Provisions Related to Part B
Part 1 - Physician Services
Section 1121 -
Revises requirements related to Medicare part B (Supplementary Medical Insurance) and physicians' services including those concerning: (1) the resource-based feedback program for physicians in Medicare; (2) potentially misvalued codes under the physician fee schedule; and (3) modifications to the physician quality reporting initiative).
Part 2 - Market Basket Updates
Section 1131 -
Incorporates certain productivity adjustments into market basket updates that do not already incorporate such adjustments.
Part 3 - Other Provisions
Section 1141 -
Sets forth provisions concerning a miscellany of subjects, including: (1) rental and purchase of power-driven wheelchairs; (2) treatment of certain cancer hospitals; and (3) payment for imaging services and biosimilar biological products. (Sec. 1149B) Directs the Comptroller General to study and report to Congress on the potential establishment of a program under Medicare to acquire durable medical equipment and supplies through a competitive bidding process among manufacturers.
Subtitle C - Provisions Related to Medicare parts A and B
Section 1151 -
Amends requirements under Medicare parts A and B to prescribe adjustments to hospital payments for excess readmissions.
Section 1152 -
Directs the Secretary to: (1) develop a detailed plan to reform payment for post acute services under Medicare; and (2) convert the acute care episode demonstration program to a pilot program and expand it as so converted to include post acute services and other appropriate services.
Section 1154 -
Prescribes Medicare payment adjustments for home health care. (Sec. 1155A) Directs the Medicare Payment Advisory Commission to study and report to Congress regarding variation in performance of home health agencies in an effort to explain variation in Medicare margins for such agencies.
Section 1156 -
Prescribes requirements to qualify for rural provider and hospital ownership exceptions to the physician self-referral prohibition.
Section 1157 -
Directs the Secretary to contract with the Institute of Medicine (IOM) of the National Academy of Sciences to study and report to Congress on the accuracy of Medicare geographic adjustment factors.
Section 1158 -
Directs the Secretary to revise the geographic adjustment factors in the Medicare physician services and inpatient hospital services.
Section 1159 -
Directs the Secretary to enter into an agreement with the IOM to study and report to Congress on geographic variation and growth in volume and intensity of services in per capita health care spending among the Medicare, Medicaid, and privately insured and uninsured populations.
Section 1160 -
Requires the Secretary to submit to Congress a final implementation plan proposing changes in payments for services under Medicare parts A and B which are designed to promote high value health care.
Subtitle D - Medicare Advantage Reforms
Part 1 - Payment and Administration
Section 1161 -
Modifies the calculation of Medicare Advantage (MA) area-specific non-drug monthly benchmarks for payments to Medicare+Choice organizations. Establishes a formula for a blended benchmark amount, phased-in during 2011 and following years.
Section 1162 -
Revises requirements with respect to the MA program and: (1) extension of the Secretarial coding intensity adjustment authority; (2) restriction of the annual beneficiary election period to November 1-December 15, and elimination of the three-month additional open enrollment period; (3) extension of reasonable cost contracts; (4) a limitation of the waiver authority for employer group plans; (5) risk adjustment for payments; and (6) elimination of the MA Regional Plan Stabilization Fund.
Section 1168 -
Requires the Administrator of the Centers for Medicare and Medicaid Services (CMS) to study and report to Congress on the potential effects of calculating MA payment rates on a more aggregated geographic basis rather than using county boundaries.
Part 2 - Beneficiary Protections and Anti-Fraud
Section 1171 -
Limits cost-sharing for individual health services, including for those eligible for both Medicare and Medicaid (dual eligibles) and qualified Medicare beneficiaries.
Section 1172 -
Allows plan disenrollment for enrollees in MA plans with enrollment suspension because of failure to meet certain requirements.
Section 1173 -
Requires the Secretary to publish administrative cost information, including the medical loss ratio for MA plans.
Section 1174 -
Authorizes the Secretary to take necessary action, including the pursuit of financial recoveries, to address deficiencies identified during an annual audit.
Section 1175 -
Declares that the Secretary is not required to accept any or every bid submitted by an MA organization. (Sec. 1175A) Declares that nothing shall be construed to prohibit states from conducting market examinations or imposing civil monetary penalties against MA organizations, prescription drug plan (PDP) sponsors, or their agents or brokers for violating federal marketing requirements.
Part 3 - Treatment of Special Needs Plans
Section 1176 -
Revises requirements for special needs plans, including: (1) a limitation on enrollment outside of the open enrollment period of individuals with severe or disabling chronic conditions; (2) extension of authority of special needs plans to restrict enrollment; and (3) extension of special rules for MA senior housing plans.
Subtitle E - Improvements in Medicare Part D
Section 1181 -
Amends Medicare part D (Voluntary Prescription Drug Benefit Program) to phase out between 2011 and 2018 the standard prescription drug coverage gap (doughnut hole) during which enrollees, who are not eligible for the low-income subsidy, are responsible for paying 100% of the cost of their prescription drugs until it is completely eliminated in 2019. Requires drug manufacturers to pay the Secretary drug rebates for rebate eligible individuals.
Section 1182 -
Requires drug manufacturers to provide PDP sponsors or MA organizations discounts for brand-name drugs used by Medicare part D enrollees in the coverage gap.
Section 1183 -
Repeals certain provisions relating to submission of claims by pharmacies located in or contracting with long-term care facilities.
Section 1184 -
Counts toward the annual out-of-pocket threshold under part D any costs incurred by AIDS drug assistance programs and Indian health services in providing prescription drugs.
Section 1185 -
Prohibits midyear formulary changes. Allows such changes no later than the start of plan marketing activities for the plan year.
Section 1186 -
Repeals the prohibition against: (1) interference by the Secretary with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and (2) institution by the Secretary of a price structure for the reimbursement of covered part D drugs. Requires the Secretary, instead, to negotiate prescription drug prices (including discounts, rebates, and other price concessions) that may be charged to PDP sponsors and MA organizations; but still allows PDPs to obtain discounts or price reductions below those negotiated by the Secretary. Maintains the prohibition against the establishment of a formulary by the Secretary.
Section 1187 -
Requires PDP sponsors to employ certain utilization management techniques, such as weekly, daily, or automated dose dispensing, to reduce the quantities of covered part D drugs dispensed to beneficiaries who reside in long-term care facilities in order to reduce waste associated with unused medications.
Section 1188 -
Excludes from the definition of (illegal) remuneration a reduction in or waiver of the copayment amount (under a PDP offered by a PDP sponsor or an MA-PDP offered by an MA organization) that is given to an individual to induce the individual to switch to a generic, bioequivalent drug, or biosimilar.
Section 1189 -
Permits the Secretary to grant a waiver of the requirement that an entity seeking to offer a PDP in a state be licensed in the state only if the Secretary has received a certification from the State Insurance Commissioner that the PDP has a substantially complete application pending in that state. Excepts PACE programs from this condition. Allows revocation of the waiver under certain conditions.
Subtitle F - Medicare Rural Access Protections
Section 1191 -
Includes a renal dialysis facility as a covered originating site for telehealth services. Requires the Secretary to appoint a Telehealth Advisory Committee.
Section 1192 -
Revises requirements for the prospective payment system for hospital outpatient department services to extend through 2011 hold harmless provisions specifying temporary payment increases for certain rural hospitals.
Section 1193 -
Extends certain requirements for: (1) section 508 hospital reclassifications; (2) the increase to 1.0 of the work geographic index floor in the formula for physician payments; (3) payments for the technical component of certain physician pathology services; and (4) the temporary increase in payment rates for ground as well as rural area air ambulance services.
Title II - Medicare Beneficiary Improvements
Subtitle A - Improving and Simplifying Financial Assistance for Low Income Medicare Beneficiaries
Section 1201 -
Increases the asset test used to determine eligibility for the low income subsidy and Medicare Savings programs.
Section 1202 -
Eliminates Medicare part D cost-sharing for certain individuals who are full-benefit dual eligible individuals who receive home and community based care.
Section 1203 -
Allows individuals applying for the low-income subsidy under the prescription drug program to qualify on the basis of self-certification of income and resources.
Section 1204 -
Entitles to automatic reimbursements, without being required to file further information, certain retroactive low-income subsidy enrollment beneficiaries.
Section 1205 -
Gives the Secretary the option of using an intelligent assignment process as an alternative to the random assignment process with respect to enrollment under Medicare part D for a full-benefit dual eligible individual who has failed to enroll in a PDP or an MA-PDP.
Section 1206 -
Creates a special enrollment period and automatic enrollment process for subsidy eligible individuals who are also full-benefit dual eligible.
Section 1207 -
Excludes the MA rebate amounts and MA quality bonus payments from the MA-PDP premium bids when calculating the low-income regional benchmark for subsidy determinations for a subsidy eligible individual.
Subtitle B - Reducing Health Disparities
Section 1221 -
Directs the Secretary to study and report to Congress on: (1) the extent to which Medicare service providers utilize, offer, or make available language services for beneficiaries who are limited English proficient; and (2) ways that Medicare should develop payment systems for language services.
Section 1222 -
Directs the Secretary, acting through the CMS and the Center for Medicare and Medicaid Innovation, to carry out a demonstration program under which the Secretary shall award grants to eligible Medicare service providers to improve effective communication between them and Medicare beneficiaries who are living in communities where racial and ethnic minorities are underserved with respect to such services.
Section 1223 -
Directs the Secretary to enter into an arrangement with the IOM under which the IOM will report on the impact of language access services on the health and health care of limited English proficient populations.
Subtitle C - Miscellaneous Improvements
Section 1231 -
Sets forth provisions with respect to: (1) extension of the therapy caps exceptions process; (2) extended months of coverage of immunosuppressive drugs for kidney transplant patients and other renal dialysis provisions; (3) voluntary advanced care planning consultation; (4) Medicare part B special enrollment period and waiver of limited enrollment penalty for Tricare beneficiaries; (5) gains from the sale of a primary residence in computing Medicare part B income related premium; and (6) a demonstration program on the use of patient decisions aids.
Title III - Promoting Primary Care, Mental Health Services, and Coordinated Care
Section 1301 -
Amends SSA title XVIII (Medicare) to direct the Secretary to conduct a pilot program to test different payment incentive models designed to reduce the growth of expenditures and improve health outcomes in the provision of items and services to applicable beneficiaries by qualifying accountable care organizations.
Section 1302 -
Requires the Secretary to establish a medical home pilot program to evaluate the feasibility and advisability of reimbursing qualified patient-centered medical homes for furnishing medical home services to beneficiaries and to targeted high need beneficiaries. Requires payments under both independent and community-based patient-centered medical home models.
Section 1303 -
Establishes payment incentives for selected primary care services.
Section 1304 -
Increases the reimbursement rate for certified nurse-midwives.
Section 1305 -
Extends Medicare coverage to specified preventive services, and waives cost-sharing for them.
Section 1306 -
Waives the deductible for colorectal cancer screening tests regardless of coding, subsequent diagnosis, or ancillary tissue removal.
Section 1307 -
Excludes clinical social worker services from coverage under the Medicare SNF prospective payment system and consolidated payment.
Section 1308 -
Extends Medicare coverage to marriage and family therapist services and mental health counselor services.
Section 1309 -
Amends the Medicare Improvements for Patients and Providers Act of 2008 to extend the increased payments for psychotherapy services for an additional two years through December 31, 2011.
Section 1310 -
Extends Medicare part B coverage to all federally recommended vaccines.
Section 1311 -
Expands the Medicare-covered preventive services at federally-qualified health centers.
Section 1312 -
Directs the Secretary to conduct a demonstration program to test a payment incentive and service delivery model that utilizes physician and nurse practitioner directed home-based primary care teams designed to reduce expenditures and improve health outcomes in the provision of Medicare items and services to applicable beneficiaries.
Section 1313 -
Recognizes certified diabetes educators as certified providers for purposes of Medicare diabetes outpatient self-management training services.
Title IV - Quality
Subtitle A - Comparative Effectiveness Research
Section 1401 -
Amends SSA title XI to direct the Secretary to establish within the Agency for Health care. Research and Quality a Center for Comparative Effectiveness Research to conduct, support, and synthesize research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically. Establishes an independent Comparative Effectiveness Research Commission to advise the Center.
Subtitle B - Nursing Home Transparency
Part 1 - Improving Transparency of Information on Skilled Nursing Facilities, Nursing Facilities, and Other Long-Term Care Facilities
Section 1411 -
Amends SSA title XI to require disclosure of ownership and additional disclosable parties with respect to SNFs and nursing facilities.
Section 1412 -
Details accountability requirements with respect to compliance and ethics programs relating to SNFs and nursing facilities. Directs the Secretary to establish and implement a quality assurance and performance improvement program for SNFs.
Section 1413 -
Directs the Secretary to ensure that HHS includes specified additional information on the Nursing Home Compare Medicare Website.
Section 1414 -
Requires SNFs to report expenditures for wages and benefits for direct care staff separately from other costs.
Section 1415 -
Directs the Secretary to develop a standardized complaint form for SNFs and nursing facilities.
Section 1416 -
Directs the Secretary to require a SNF to submit electronically all direct care staffing information to ensure staffing accountability.
Section 1417 -
Directs the Secretary to establish a program to identify efficient, effective, and economical procedures for long-term care facilities or providers to conduct background checks on prospective direct patient access employees on a nationwide basis.
Part 2 - Targeting Enforcement
Section 1421 -
Specifies civil money penalties for various deficiencies related to SNFs and nursing facilities.
Section 1422 -
Requires the Secretary to establish a pilot program to develop, test, and implement use of an independent monitor to oversee interstate and large intrastate chains of SNFs and nursing facilities.
Section 1423 -
Requires SNFs and nursing facilities to provide notification of facility closure to the Secretary, facility residents, and other specified parties.
Part 3 - Improving Staff Training
Section 1431 -
Requires dementia management and resident abuse prevention training of SNF and nursing facility staff.
Section 1432 -
Directs the Secretary to study and report to Congress on the content of training for certified nurse aids and supervisory staff of SNFs and nursing facilities.
Section 1433 -
Requires the Director of Food Services of a SNF or nursing facility to be a Certified Dietary Manager.
Subtitle C - Quality Measurements
Section 1441 -
Amends SSA title XI to direct the Secretary to: (1) establish and periodically update national priorities for performance improvement; and (2) enter into agreements with qualified entities to develop quality measures for the delivery of health care services in the United States.
Section 1443 -
Requires multi-stakeholder pre-rulemaking input into the selection of such quality measures.
Section 1446 -
Directs the Secretary to develop quality indicators for the provision of medical services to people with Alzheimer's disease and other dementias and a plan for implementing the indicators to measure the quality of care provided for people with these conditions by physicians, hospitals, and other appropriate providers of services and suppliers.
Subtitle D - Physician Payments Sunshine Provision
Section 1451 -
Requires financial reports to the Secretary on physicians' financial relationships with manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, SSA title XIX (Medicaid), or SSA title XXI (Children's Health Insurance Program) (CHIP, formerly known as SCHIP) and with entities that bill for services under Medicare. Requires the Comptroller General to study and report to Congress on this requirement.
Subtitle F - Public Reporting on Health Care-Associated Infections
Section 1461 -
Amends SSA title XI to direct the Secretary to provide that a hospital or ambulatory surgical center meeting Medicare or Medicaid requirements may participate in such programs only if it reports such information on health care associated infections that develop in the hospital or center, as appropriate. Requires the Secretary to post the reported information on the official public HHS Internet site the information reported.
Title V - Medicare Graduate Medical Education
Section 1501 -
Prescribes requirements for additional redistributions of unused residency positions with respect to payments to hospitals for the direct graduate medical education (GME) costs of inpatient hospital services.
Section 1502 -
Revises requirements for rules for the computation, for direct GME payment purposes, of the number of full-time-equivalent residents in an approved medical residency training program. Requires such rules after July 1, 2009, to cover all the time so spent by a resident in nonprovider settings. Revises requirements for an additional payment amount for subsection (d) hospitals with indirect costs of medical education. Requires such rules after July 1, 2009, to cover all the time spent by an intern or resident in patient care activities at an entity in a nonprovider setting. (Generally, a subsection (d) hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system when providing covered inpatient services to eligible beneficiaries.) Directs the HHS Inspector General to analyze and report to Congress on the data collected from certain records in order to assess the extent to which there is an increase in time spent by residents in training in nonprovider settings as a result of the amendments made by this title. Directs the Secretary to conduct a demonstration project under which an approved teaching health center would be eligible for repayment of amounts of its own direct costs of GME activities for primary case residents, as well as for the direct costs of GME activities of its contracting hospital for such residents, in a manner similar to the manner in which such payments would be made to a hospital if the hospital were to operate such a program.
Section 1503 -
Requires both direct GME and indirect costs of medical education rules for the computation of full-time-equivalent residents to include all time spent by an intern or resident in a nonprovider setting in nonpatient care activities, such as didactic conferences and seminars. Counts toward the full-time-equivalent determination, as well, all the time spent by an intern or resident on vacation, sick leave, or other approved leave which does not prolong the total time the resident is participating in the approved program.
Section 1504 -
Directs the Secretary to establish a process for redistribution of residency slots after a hospital closes.
Section 1505 -
Prescribes goals for medical residency training programs. Requires the Comptroller General to evaluate and report to Congress on the extent to which such programs meet such goals.
Title VI - Program Integrity
Subtitle A - Increased Funding to Fight Waste, Fraud, and Abuse
Section 1601 -
Amends SSA title XVIII (Medicare) to increase funding for the Health Care Fraud and Abuse Control (HCFAC) account of the Federal Hospital Insurance Trust Fund to fight waste, fraud, and abuse.
Subtitle B - Enhanced Penalties for Fraud and Abuse
Section 1611 -
Amends SSA to prescribe enhanced penalties for: (1) false statements on provider or supplier enrollment applications; (2) delayed inspections; (3) individuals excluded from program participation; (4) false information by MA and Medicare part D plans; (5) MA and Medicare part D marketing violations; and (6) obstruction of program audits.
Section 1614 -
Amends Medicare part A to require the Secretary to develop and implement intermediate sanctions and appeals procedures for hospices that fail to meet federal health and safety standards. Applies such requirement to hospices under Medicaid and CHIP.
Section 1619 -
States that, subject to certain exceptions, payment is prohibited from any federal health care program with respect to an item or service furnished: (1) by an excluded individual or entity; or (2) at the medical direction or on the prescription of a physician or other authorized individual when the person submitting a claim for the item or service knew or had reason to know of an individual's exclusion.
Section 1621 -
Directs the Secretary to establish a protocol to enable health care service providers and suppliers to disclose an actual or potential violation of the Stark law pursuant to a self-referral disclosure protocol. Gives the Secretary the authority to reduce the amount due and owing for a violation of the Stark law.
Subtitle C - Enhanced Program and Provider Protections
Section 1631 -
Amends SSA title XI to add: (1) enhanced program and provider protections in the Medicare, Medicaid, and CHIP programs; and (2) enhanced Medicare, Medicaid, and CHIP program disclosure requirements.
Section 1633 -
Amends SSA title XVIII to direct the Secretary to establish a payment modifier under the Medicare physicians' fee schedule for evaluation and management services that result in the ordering of additional services (such as lab tests), the prescription of drugs, the furnishing or ordering of durable medical equipment in order to enable better monitoring of claims, or the ordering, furnishing, or prescribing of other items and services determined by the Secretary to be at high risk of waste, fraud, and abuse.
Section 1634 -
Requires Medicare Integrity Program contractors to assure the Secretary that they will conduct periodic evaluations of the effectiveness of their activities and submit annual reports.
Section 1635 -
Prohibits the Secretary from enrolling any service providers and suppliers that fail to adopt compliance programs to reduce waste, fraud, and abuse.
Section 1636 -
Reduces the maximum period for submission of Medicare claims from 36 months to 12 months.
Section 1637 -
Requires physicians who order durable medical equipment or home health services to be Medicare-enrolled physicians or eligible professionals.
Section 1638 -
Permits the Secretary to disenroll, for no more than one year, a Medicare-enrolled physician or supplier that fails to maintain and provide access to documentation of written orders or requests for payment for durable medical equipment, home health services, or referrals for other items and services. Extends the Office of Inspector General permissive exclusion authority to include individuals or entities that order, refer, or certify the need for health care services that fail to provide adequate documentation to the Secretary.
Section 1639 -
Requires that physicians have a face-to-face encounter (including through telehealth) with the patient sometime in the preceding six months before issuing a certification or re-certification for home health services or durable medical equipment under Medicare, Medicaid, or CHIP. Gives the Secretary the authority to apply this face-to-face requirement to other Medicare services as well.
Section 1640 -
Extends testimonial subpoena authority to program exclusion investigations.
Section 1641 -
Requires providers and suppliers that know of an overpayment to report and return it within 60 days.
Section 1642 -
Expands the application of hardship waivers for Office of Inspector General program exclusions to beneficiaries of any federal health care program.
Section 1643 -
Directs end state renal disease facilities to provide the Secretary, upon request, with access for audit or evaluation purposes to information relating to any ownership or compensation arrangement between the facility and its medical director or between the facility and any physician.
Section 1644 -
Requires billing agents, clearinghouses, or other alternate payees to register under Medicare.
Section 1645 -
Conforms generally civil monetary penalty provisions to amendments to the False Claims Act made by the Fraud Enforcement and Recovery Act of 2009.
Section 1646 -
Requires Medicare provider and supplier payments to be made through direct deposit or electronic funds transfer at insured depository institutions.
Section 1647 -
Establishes an Office of Inspector General for the Health Choices Administration.
Subtitle D - Access to Information Needed to Prevent Fraud, Waste, and Abuse
Section 1651 -
Conditions Medicare part D payments to a PDP sponsor or MA organization on their providing the Office of Inspector General, the CMS Administrator, and the Attorney General with access to certain information for anti-fraud purposes.
Section 1652 -
Directs the Secretary to: (1) eliminate duplication between the Health Care Integrity and Protection Data Bank (HIPDB) and the National Practitioner Data Bank (NPDB); and (2) cease the operation of the HIPDB and collect all required information in the NPDB.
Section 1653 -
Applies the privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and the Privacy Act of 1974 to all fraud, waste, and abuse requirements of this subtitle.
Section 1654 -
Requires any statement or notice containing an explanation of Medicare benefits distributed after July 1, 2011, to display prominently a separate toll-free Medicare fraud and abuse telephone hotline number.
Title VII - Medicaid and CHIP
Subtitle A - Medicaid and Health Reform
Section 1701 -
Makes individuals over age 65 who are not entitled to Medicare part A hospital benefits, but whose family income is below 150% of the federal poverty level (non-traditional eligible individuals), eligible for full Medicaid benefits. Increases the federal medical assistance percentage (FMAP) with respect to Medicaid expenditures for such nontraditional eligible individuals. Requires a state plan to make Medicaid available for Medicare cost-sharing for individuals under age 65 who would be qualified Medicare beneficiaries but for the fact that their income exceeds the state-established income level but is less than 150% of the official poverty line. Requires a state plan to make Medicaid available to individuals: (1) between ages 18 and 65 who would be Medicaid eligible except for income, but who are in families whose income does not exceed 150% of the income official poverty line; (2) beginning with 2014, who are under age 19, and also would be Medicaid eligible except for income, but who are also in families whose income does not exceed 150% of the income official poverty line; or (3) beginning with 2014, who are under age 19 and who would be CHIP eligible based on a state CHIP plan as in effect as of June 16, 2009. Increases the FMAP with respect to Medicaid expenditures for such individuals.
Section 1702 -
Requires states to accept without further determination the Medicaid enrollment of nontraditional as well as traditional individuals.
Section 1703 -
Adds requirements for CHIP and Medicaid maintenance of state eligibility.
Section 1704 -
Directs the Secretary to report to Congress on the extent to which, based upon the impact of the health care reforms carried out under
Division A of this Act in reducing the number of uninsured individuals, there is a continued role for Medicaid disproportionate share hospital payments. Prescribes a formula for mandatory reductions in such payments for FY2017-FY2019. Subtitle B - Prevention
Section 1711 -
- Revises certain requirements to: (1) extend Medicaid coverage to preventive services; (2) end the permissible exclusion of tobacco cessation agents from covered outpatient drugs (and thus covering them); (3) extend optional Medicaid coverage to nurse home visitation services; and (4) establish a state option to cover family planning services and supplies under Medicaid for specified individuals.
Subtitle C - Access
Section 1721 -
Increases Medicaid payments to primary care practitioners.
Section 1722 -
Directs the Secretary to establish a program under which a state may apply for approval of a medical home pilot project for the application of the medical home concept.
Section 1723 -
Adds as new optional Medicaid benefits: (1) translation or interpretation services for individuals other than families; (2) freestanding birth center services; and (3) therapeutic foster care services for eligible children in out-of-home placements.
Section 1725 -
Includes public health clinics under the Vaccines for Children Program.
Section 1726 -
Requires Medicaid coverage of services of podiatrists and optometrists.
Section 1728 -
Requires a state plan to specify adequate payment levels, subject to the Secretary's approval, for services under Medicaid.
Section 1729 -
Requires a state plan to ensure enrollment in Medicaid coverage for otherwise Medicaid-eligible youths age 18 or younger upon release from public institutions.
Section 1730 -
Directs the Secretary to develop quality measures for maternity and adult health services under Medicaid and CHIP. (Sec. 1730A) Directs the Secretary to establish a program under which a state may apply for approval of a pilot program to apply an accountable care organization concept under Medicaid. (Sec. 1730B) Makes an entity receiving a school-based health clinic program grant under the PHSA a federally-qualified health center.
Subtitle D - Coverage
Section 1731 -
Grants state plans the option to extend Medicaid coverage to low-income HIV infected individuals.
Section 1732 -
Extends transitional Medicaid assistance through December 31, 2012.
Section 1733 -
Requires 12-month continuous coverage under certain CHIP programs.
Section 1734 -
Exempts children meeting specified requirements from application of coverage waiting periods under CHIP.
Section 1735 -
Prohibits the Secretary from withholding or disallowing federal financial assistance, or withdrawing federal approval of a state Medicaid plan, for the provision of adult day health care services, day activity and health services, or adult medical day care services if such services are provided consistent with the plan requirements.
Section 1736 -
Makes citizens of the Freely Associated States eligible for full Medicaid (without regard to the five-year bar) if they are lawfully residing: (1) in the United States in accordance with the Compacts of Free Association between the governments of the United States and the governments of the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau; or (2) in Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa, at the option of the governor of the respective territory.
Section 1737 -
Requires state Medicaid plans to cover nonemergency transportation to medically necessary services.
Section 1738 -
Amends SSA title XIX, as amended by the Children's Health Insurance Program Reauthorization Act of 2009, to give states the option to disregard certain family income requirements in providing continued Medicaid coverage for certain individuals with extremely high prescription costs, including the costs of orphan drugs.
Section 1739 -
Requires state Medicaid plans to provide that the state will comply with regulations regarding the application of primary and secondary payor rules with respect to Medicaid eligible individuals who are also eligible beneficiaries under the community living assistance services and supports (CLASS) program under the PHSA. (Sec. 1739A) Expresses the sense of the Congress that states should be allowed to elect under their Medicaid state plans to implement a Community First Choice Option for coverage of community-based attendant services and supports furnished in homes and communities.
Subtitle E - Financing
Section 1741 -
Requires the Secretary, with respect to Medicaid payment for covered outpatient drugs, to calculate the federal upper reimbursement limit at 130% of the weighted average (determined on the basis of manufacturer utilization) of monthly average manufacturer prices.
Section 1742 -
Revises requirements for the additional rebate for single source and innovator multiple source drugs. Changes the Medicaid rebate for a drug that is a line extension of a single source drug or an innovator multiple source drug in oral solid dosage form. Increases the basic minimum rebate for single source prescription drugs.
Section 1743 -
Conditions payment to a state for services of Medicaid managed care organizations upon regular reports on covered outpatient drugs dispensed to eligible individuals enrolled with the organization and for which the organization is responsible for coverage of such drugs.
Section 1744 -
Authorizes GME payments under Medicaid, regardless of whether the GME occurred in or outside of a hospital.
Section 1745 -
Makes appropriations to the Secretary for FY2010-FY2013 to reimburse dually-certified nursing facilities for furnishing quality care to Medicaid-eligible individuals.
Section 1746 -
Requires a state participating in the Medicaid program to report annually to the CMS Administrator on Medicaid payments.
Section 1747 -
Directs the Comptroller General to study and report to Congress on: (1) federal payments made to state Medicaid programs; and (2) the administration of the Medicaid program by HHS, state Medicaid agencies, and local government agencies.
Section 1748 -
Extends from October 1, 2009, until October 1, 2010, the delay in the elimination of the managed care organization provider tax.
Section 1749 -
Amends the American Recovery and Reinvestment Act of 2009 to extend the increase in the FMAP.
Subtitle F - Waste, Fraud, and Abuse
Section 1751 -
Amends SSA title XIX to set forth provisions for: (1) Medicaid nonpayment for health care acquired conditions; (2) evaluations and reports required under the Medicaid integrity program; (3) a requirement that providers and suppliers adopt programs to reduce, waste, fraud and abuse; (4) extension to one year of the period for state recovery of overpayments due to fraud; (5) a minimum medical loss ratio of at least 85% in managed care organization contracts; (6) termination of provider participation under Medicaid and CHIP if terminated under Medicare or other state plan or child health plan; (7) mandatory exclusion from Medicaid and CHIP participation of individuals or entities with certain ownership, control, and management affiliations; (8) a requirement to report Medicaid claims data elements necessary to detect waste, fraud, and abuse; (9) mandatory registration of billing agents, clearinghouses, or other alternate payees; (10) denial of payments for litigation-related misconduct; and (11) mandatory state use of the National Correct Coding Initiative.
Subtitle G - Payments to the Territories
Section 1771 -
Amends SSA title XI to require increased payments to the territories for FY2011-FY2019.
Subtitle H - Miscellaneous
Section 1781 -
Sets forth provisions: (1) making technical corrections; (2) extending the qualifying individual program: (3) requiring the transparency of hospital price information; (4) concerning outreach and enrollment of Medicaid and CHIP eligible individuals; and (5) creating a demonstration project for the stabilization of emergency medical conditions by institutions for mental diseases.
Title VIII - Revenue-Related Provisions
Section 1801 -
Amends the IRC to authorize the Internal Revenue Service to disclose to the Social Security Administration certain taxpayer return information to assist in identifying individuals likely to be ineligible for the low-income subsidy and help focus outreach to eligible individuals.
Section 1802 -
Establishes in the Treasury the Health Care Comparative Effectiveness Research Trust Fund, consisting in part of fees on insured and self-insured plans.
Title IX - Miscellaneous Provisions
Section 1901 -
Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to repeal requirements for triggering a Medicare funding warning whenever general revenue financing is projected to exceed 45% of total Medicare outlays within the next six years.
Section 1902 -
Amends SSA title XVIII to repeal the Comparative Cost Adjustment Program.
Section 1903 -
Amends the Deficit Reduction Act of 2005 to extend through FY2011 the gainsharing demonstration project to evaluate arrangements between hospitals and physicians designed to improve the quality and the efficiency of care provided to Medicare beneficiaries.
Section 1904 -
Amends part B of SSA title IV to authorize grants to states for quality home visitation programs for families with young children and families expecting children.
Section 1905 -
Directs the Secretary to provide, through an identifiable office or program within the CMS, for improved coordination between Medicare and Medicaid and protection in the case of dual eligibles.
Section 1906 -
Directs the Secretary to conduct an assessment of the diseases and conditions that are the most cost-intensive for the Medicare program and, to the extent possible, assess the diseases and conditions that could become cost-intensive for Medicare in the future.
Section 1907 -
Creates in the CMS the Center for Medicare and Medicaid Innovation.
Section 1908 -
Provides that nothing in this Act shall be construed to relieve any health care provider from providing emergency services as required by state or federal law.
Section 1909 -
Amends SSA title XVI (Supplemental Security Income for the Aged, Blind, and Disabled) (SSI) to exclude from income for SSI eligibility purposes the first $2,000 per year of any compensation for participation in clinical trials for rare diseases or conditions.
Division C - Public Health and Workforce Development
Section 2002 -
Establishes the Public Health Investment Fund for carrying out activities under designated public health provisions.
Title I - Community Health Centers
Section 2101 -
Amends the PHSA to authorize additional appropriations for community health centers.
Title II - Workforce
Subtitle A - Primary Care Workforce
Part 1 - National Health Service Corps
Section 2201 -
Authorizes the Secretary to allow half-time service to satisfy obligated service requirements in the National Health Service Corps Scholarship Program. Increases the maximum loan repayment amount under the National Health Service Corps Loan Repayment Program. Provides for further increases to reflect inflation. Authorizes the Secretary to treat teaching as clinical practice for up to 20% of obligated service.
Section 2202 -
Authorizes appropriations through FY2015 for the National Health Service Corps Program.
Part 2 - Promotion of Primary Care and Dentistry
Section 2211 -
Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to establish the Frontline Health Providers Loan Repayment Program to address unmet health care needs in health professional needs areas through student loan repayment for health professionals.
Section 2212 -
Requires the Secretary to take into account the extent to which an individual is financially independent in determining whether to require or authorize the submission of financial information regarding such individual's family members.
Section 2213 -
Directs the Secretary to establish: (1) a primary care training and capacity building program; (2) a program for the training of medical residents in community-based settings; and (3) a training program for oral health professionals.
Section 2216 -
Authorizes appropriations for primary care and dentistry training programs.
Section 2217 -
Directs the Comptroller General to study the effectiveness of scholarship and loan repayment programs for primary care and primary dental programs.
Subtitle B - Nursing Workforce
Section 2221 -
Makes nurse-managed health centers eligible for grants for nursing workforce programs. Requires the Secretary to give special consideration under the advanced education nursing traineeship program to an eligible entity that agrees to expend the grant to increase diversity among advanced education nurses. Revises the nurse practice grant program and the nurse faculty loan program. Increases the maximum loan amount a school of nursing may give a student and adjusts such amount for inflation. Provides for fulfillment of an individual's service obligation under the nursing loan repayment and scholarship program through service as a nurse at a health care facility with a critical shortage of nurses or as a faculty member at an accredited school of nursing. Terminates the program to develop and issue public service announcements that promote the nursing profession. Reauthorizes appropriations for nursing workforce grant and loan programs through FY2015.
Subtitle C - Public Health Workforce
Section 2231 -
Establishes the Public Health Workforce Corps to ensure an adequate supply of public health professionals throughout the nation by requiring the Secretary to establish the Public Health Workforce Scholarship Program and the Public Health Workforce Loan Repayment Program.
Section 2232 -
Requires the Secretary, acting through the Administrator of HRSA, to establish a public health workforce training and enhancement program.
Section 2233 -
Revises public health training center grant program provisions to define such a center as one that plans, develops, operates, and evaluates projects that are in furtherance of the goals established by the Secretary in the national prevention and wellness strategy.
Section 2234 -
Revises provisions concerning the public health training program for graduate medical residents in preventive medicine specialties.
Section 2235 -
Authorizes appropriations for FY2011-FY2015 for programs to address health care needs in health professional needs areas and training programs for the public health and dental workforce.
Subtitle D - Adapting Workforce to Evolving Health System Needs
Part 1 - Health Professions Training for Diversity
Section 2241 -
Increases the maximum student loan repayment for individuals from disadvantaged backgrounds agreeing to serve as members of the faculties of health professional schools.
Section 2242 -
Makes revisions to a program authorizing grants to increase nursing education opportunities for individuals who are from disadvantaged backgrounds by providing student scholarships or stipends, pre-entry preparation, and retention activities.
Section 2243 -
Requires the Secretary to coordinate health professions education programs and workforce diversity programs to enhance the effectiveness of such activities and avoid duplication of effort.
Part 2 - Interdisciplinary Training Programs
Section 2251 -
Requires the Secretary to establish: (1) a cultural and linguistic competency training program for health professionals; and (2) an innovations in interdisciplinary care training program.
Part 3 - Advisory Committee on Health Workforce Evaluation and Assessment
Section 2261 -
Requires the Secretary, acting through the Assistant Secretary for Health, to establish the Advisory Committee on Health Workforce Evaluation and Assessment to develop and implement an integrated, coordinated, and strategic national workforce policy reflective of current and evolving health workforce needs.
Part 4 - Health Workforce Assessment
Section 2271 -
Requires the Secretary to collect data on the health workforce.
Part 5 - Authorization of Appropriations
Section 2281 -
Authorizes appropriations through FY2015 for various health workforce programs, including diversity programs, training programs, and health workforce assessment.
Title III - Prevention and Wellness
Section 2301 -
Establishes a Prevention and Wellness Trust to be funded out of the Public Health Investment Fund. Provides for the allocation of Fund amounts for FY2011-FY2015. Requires the Secretary to submit to Congress biannually a national strategy designed to improve the nation's health through evidence-based clinical and community prevention and wellness activities. Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to establish the Task Force on Clinical Preventive Services. Requires the Secretary, acting through the Director of CDC, to establish the Task Force on Community Preventive Services. Directs the heads of agencies within HHS to take into account the national strategy and recommendations of the task forces under this title when conducting or supporting research. Requires the Secretary, acting through the Director of CDC, to conduct research in priority areas identified by the Secretary in the national strategy or by the Task Force on Community Preventive Services. Directs the Secretary to: (1) conduct research and demonstration projects on the use of financial and in-kind subsidies and rewards to encourage individuals and communities to promote wellness, adopt healthy behaviors, and use evidence-based preventive health services; and (2) ensure that a subsidy or reward that meets certain Task Forces' standards is included in the essential benefits package under this Act. Requires the Secretary, acting through the Director of CDC, to: (1) establish a program for the delivery of community prevention and wellness services; (2) establish a core public health infrastructure program; (3) develop standards for voluntary accreditation of health departments and public health laboratories; and (4) expand and improve the core public health infrastructure and activities of CDC to address unmet and emerging public health needs.
Title IV - Quality and Surveillance
Section 2401 -
Establishes the Center for Quality Improvement to prioritize areas for the identification, development, evaluation, and implementation of best practices for quality improvement activities in the delivery of health care services.
Section 2402 -
Establishes within HHS an Assistant Secretary for Health Information to ensure the collection and reporting of information on key health indicators regarding the nation's health and health care.
Section 2403 -
Authorizes additional appropriations for FY2011-FY2015 for programs under this title.
Title V - Other Provisions
Subtitle A - Drug Discount for Rural and Other Hospitals; 340B Program Integrity
Section 2501 -
Expands the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees) to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. Prohibits certain covered hospitals from obtaining covered outpatient drugs through a group purchasing arrangement.
Section 2502 -
Requires the Secretary to carry out activities to improve compliance by manufacturers and covered entities with the requirements of the 340B program. Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.
Subtitle B - Programs
Part 1 - Grants for Clinics and Centers
Section 2511 -
Requires the Secretary to establish a school-based health clinic program to support the operation of such clinics.
Section 2512 -
Requires the Secretary, acting through the Administrator of HRSA, to establish a nurse-managed health center program to plan, develop, and operate such centers.
Section 2513 -
Provides for community mental health services to be offered through federally-qualified behavioral health centers.
Part 2 - Other Grant Programs
Section 2521 -
Directs the Secretary of Labor to establish a partnership grant program to provide education to nurses and create a pipeline to nursing for incumbent ancillary health care workers who wish to advance their careers.
Section 2522 -
Requires the HHS Secretary, acting through the Administrator of HRSA, to establish an interdisciplinary mental and behavioral health training program for mental health professionals.
Section 2523 -
Revises provisions of the teleheath network and telehealth resource centers grant programs. Reauthorizes appropriations for such programs for FY2011-FY2015.
Section 2524 -
Requires the Secretary to carry out a program to ensure that children have coverage for all reasonable and customary expenses related to influenza vaccinations.
Section 2525 -
Expands and reauthorizes appropriations for a program to award grants for preventive heath services and referrals for medical treatment for women through entities that are screening women for breast or cervical cancer.
Section 2526 -
Requires the Secretary, acting through the Director of CDC, to provide grants for evidence-based education programs to reduce teen pregnancy or sexually transmitted diseases.
Section 2527 -
Amends the Developmental Disabilities Assistance and Bill of Rights Act of 2000 to require the Secretary to award grants to improve services rendered to children and adults with autism and their families. Requires the Secretary to award grants to establish University Centers for Excellence in Developmental Disabilities Education, Research, and Service.
Section 2528 -
Requires the Secretary, acting through the Director of AHRQ, to award grants to implement medication management services provided by licensed pharmacists to improve the quality of care and reduce overall cost in the treatment of chronic diseases.
Section 2529 -
Encourages the Secretary to expand and intensify activities on postpartum conditions and to continue research to expand the understanding of such conditions. Expresses the sense of Congress that the Director of the National Institute of Mental Health may conduct a nationally representative study on the mental health consequences for women of resolving a pregnancy in various ways.
Section 2530 -
Authorizes the Secretary to award grants to promote positive health behaviors for populations in medically underserved communities through the use of community health workers.
Section 2531 -
Requires the Secretary to make an incentive payment to each state that has an alternative medical liability law that: (1) makes the medical liability system more reliable through prevention of, or prompt and fair resolution of, disputes; (2) encourages the disclosure of health care errors; and (3) maintains access to affordable liability insurance.
Section 2532 -
Requires the Secretary, acting through the Director of CDC, to award grants for infant mortality pilot programs.
Section 2533 -
Authorizes the Secretary, acting through the Administrator of HRSA, to establish a health sciences training program to prepare secondary students for careers in health professions.
Section 2534 -
Authorizes the Secretary to award grants for community-based collaborative care networks. Defines such a network as a consortium of health care providers providing a comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities.
Section 2535 -
Requires the Secretary to establish a community-based overweight and obesity prevention program.
Section 2536 -
Authorizes the Secretary of Education to make demonstration grants to eligible local education agencies for the purpose of reducing the student-to-school nurse ratio in public elementary and secondary schools.
Section 2537 -
Requires the HHS Secretary to establish a nationwide demonstration project consisting of awarding grants to, and entering into contracts with, medical-legal partnerships to assist patients and their families to navigate health-related programs and activities.
Section 2538 -
Requires the Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, to establish a program on mental health and substance abuse screening, brief intervention, referral, and recovery services for individuals in primary health care settings.
Section 2539 -
Authorizes the Secretary to make grants to nonprofit organizations or institutions of higher education to develop medical schools located in health professional shortage areas.
Part 3 - Emergency Care-Related Programs
Section 2551 -
Requires the Secretary to establish a trauma center grant program for new and existing trauma centers.
Section 2552 -
Requires the Secretary to establish an Emergency Care Coordination Center to promote research in emergency medicine and trauma health care, regional partnerships and more effective emergency medical systems, and emergency preparedness. Requires the Secretary, acting through the Director of the Center, to establish a Council of Emergency Care to provide advice and recommendations to the Director on carrying out this section.
Section 2553 -
Requires the Secretary, acting through the Assistant Secretary for Preparedness and Response, to award contracts or grants to support demonstration programs that design, implement, and evaluate innovative models of regionalized, comprehensive, and accountable emergency care systems.
Section 2554 -
Requires the Secretary to establish a program to award grants to states to assist veterans who received and completed military emergency medical training while in the Armed Forces to become, upon their discharge or release from active duty service, state-licensed or certified emergency medical technicians.
Section 2555 -
Includes dental personnel as emergency responders.
Part 4 - Pain Care and Management Programs
Section 2561 -
Requires the Secretary to seek to enter into an agreement with the IOM to convene a Conference on Pain to: (1) increase the recognition of pain as a significant public health problem in the United States; (2) evaluate the adequacy of assessment, diagnosis, treatment, and management of acute and chronic pain in the general population and in identified demographic groups that may be disproportionately affected by inadequacies; (3) identify barriers to appropriate pain care; and (4) establish an agenda for action to reduce such barriers and significantly improve the state of pain care research, education, and clinical care in the United States.
Section 2562 -
Encourages the Director of the National Institutes of Health (NIH) to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain. Requires the Pain Consortium to develop and submit to the Director of NIH recommendations on appropriate pain research initiatives that could be undertaken with available funds. Requires the Secretary to establish the Interagency Pain Research Coordinating Committee.
Section 2563 -
Requires the Secretary to establish and implement a national pain care education outreach and awareness campaign. Authorizes appropriations for FY2011-FY2015.
Subtitle C - Food and Drug Administration
Part 1 - In General
Section 2571 -
Requires the Secretary to establish a national medical device registry to facilitate analysis of postmarket safety and outcomes data on each covered device. Defines "covered device" to include each class III device and may include a class II device that is life-supporting or life-sustaining.
Section 2572 -
Requires the labeling of a food item offered for sale in a retail food establishment that is part of a chain with 20 or more locations under the same name to disclose, in a clear and conspicuous manner on the menu or menu board: (1) in a nutrient content disclosure statement, the number of calories of each standard menu item; (2) a succinct statement concerning suggested daily caloric intake; and (3) a statement regarding the availability in written form on the premises and upon request of specified additional nutrient information. Requires self-service facilities to place adjacent to each food offered a sign that lists calories per displayed food item or per serving. Requires vending machine operators who operate 20 or more vending machines to provide a clear and conspicuous sign disclosing the number of calories contained in each article of food.
Section 2573 -
Amends the Federal Food, Drug, and Cosmetic Act to make it unlawful for any person to be party to an agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the drug involved for any time period. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages.
Part 2 - Biosimilars
Section 2575 -
Allows a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product). Requires the Secretary to license the biological product if it is biosimilar to or interchangeable with the reference product. Prohibits the Secretary from determining that a second or subsequent biological product is interchangeable with a reference product for any condition of use for specified periods based on the marketing of, and the presence or status of litigation involving, the first biosimilar biological product deemed interchangeable with the same reference product. Prohibits the Secretary from making approval of an application under this Act effective until 12 years after the date on which the reference product was first licensed.
Section 2576 -
Revises the definition of human drug application to include licensure of a biological product under this part.
Section 2577 -
Deems as patent infringement the submission of a written statement providing an explanation as to why making or selling the product would not infringe the patent or that the patent is invalid or unenforceable if such statement is provided in connection with an application to obtain a license to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent or the use of which is claimed in a patent before the patent has expired.
Subtitle D - Community Living Assistance Services and Supports
Section 2581 -
Creates a national, voluntary disability insurance program (CLASS program) under which: (1) all employees are automatically enrolled, but are allowed to waive enrollment; (2) payroll deductions pay monthly premiums; and (3) benefits provide individuals with functional limitations with tools that will allow them to maintain their personal and financial dependence and live in the community.
Subtitle E - Miscellaneous
Section 2585 -
Makes a state eligible for federal funds under the PHSA only if the state: (1) agrees to be subject in its capacity as an employer to each obligation under division A of this Act applicable to employers; and (2) assures that all political subdivisions in the state will do the same.
Section 2586 -
Deems volunteer health care practitioners at health centers to be employees of the Public Health Service for purposes of any civil action that may arise due to providing services to patients at such health centers.
Section 2587 -
Requires the Secretary to report to Congress on the epidemiology of, impact of, and appropriate funding required to address neglected diseases of poverty.
Section 2588 -
Establishes an Office of Women's Health within HHS. Requires the Secretary, acting through the Office, to take certain action that includes establishing: (1) goals and objectives within HHS related to women's health; and (2) a National Women's Health Information Center. Establishes: (1) an Office of Women's Health within CDC and within the Food and Drug Administration (FDA); and (2) an Office of Women's Health and Gender-Based Research within AHRQ. Requires the Secretary to establish the Office of Women's Health within HRSA. (Sec. 2588A) Requires the Secretary to establish an Office of Minority Health in each of the following agencies: (1) CDC; (2) Substance Abuse and Mental Health Services Administration; (3) AHRQ; (4) HRSA; and (5) FDA.
Section 2589 -
Amends the Older Americans Act of 1965 to require the Assistant Secretary for Aging to make recommendations to other federal entities regarding appropriate and effective means of: (1) identifying, promoting, and implementing investments in the direct care workforce necessary to meet the growing demand for long-term health services and supports; and (2) assisting states in developing a comprehensive state workforce development plan with respect to such workforce. Requires the Assistant Secretary for Aging to establish a Personal Care Attendant Workforce Advisory Panel to examine and formulate recommendations on workforce issues related to providing long-term services and supports. Authorizes appropriations for family caregiver support.
Section 2590 -
Requires the Secretary of Labor to establish and maintain a website to serve as a comprehensive source of information on the health care labor market and related educational and training opportunities.
Section 2591 -
Amends the Workforce Investment Act of 1998 to require the Secretary of Labor to award National Health Workforce Online Training Grants to train individuals to attain or advance in health care occupations. Authorizes the Secretary of Labor to award one or more grants to postsecondary educational institutions to disseminate data and best practices identified by the National Health Workforce Online Training Grant Program.
Section 2592 -
Amends the Rehabilitation Act of 1973 to require the Architectural and Transportation Barriers Compliance Board to issue guidelines setting forth the minimum technical criteria for new medical equipment for use in medical settings to ensure that such equipment is accessible to, and usable by, individuals with disabilities.
Section 2593 -
Directs the HHS Secretary to conduct a study to determine if any new division C grant program is duplicative of one or more other grant programs of HHS and, if so, to take corrective action.
Section 2594 -
Requires the Secretary to: (1) review uptake and utilization of diabetes screening benefits to identify and address any existing problems; and (2) establish an outreach program to identify existing efforts to increase awareness among seniors and providers of diabetes screening benefits.
Section 2595 -
Requires the Secretary, acting through the Director of CDC, to: (1) promote the education and training of physicians on the importance of birth and death certificate data and on how to properly complete these documents; (2) encourage state adoption of the latest standard revisions of birth and death certificates; and (3) work with states to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data. Authorizes the Secretary to promote improvements to the collection of diabetes mortality data.
Section 2596 -
Authorizes the Secretary to establish a demonstration program under which incentive payments are awarded to members of the National Health Service Corps who are assigned to a health professional shortage area with extreme need.
Division D - Indian Health Care Improvement
Indian Health Care Improvement Act Amendments of 2009 -
Title I - Amendments to Indian Laws
Section 3101 -
Amends the Indian Health Care Improvement Act to revise requirements for health care personnel, facilities, programs, and services for Indians, Indian Tribes, Tribal Organizations, and urban Indian organizations. Requires the Secretary to make grants of not more than $300,000 to each of nine colleges and universities (under current law, grants are authorized for at least three colleges and universities) for the purpose of developing and maintaining Indian psychology career recruitment programs as a means of encouraging Indians to enter the behavioral health field. Allows establishment, through the Indian Health Service (Service), of a national Community Health Aide Program in accordance with an existing program for Alaskan Natives. Excludes dental health aide therapist services. Authorizes funding of demonstration programs, including for Tribal Health Programs to address chronic shortages of health professionals and for development of substance abuse counseling educational curricula. Prohibits removing a member of the National Health Service Corps from an Indian Health Program or urban Indian organization or withdrawing funding used to support such member, unless the Indians receiving services from such member will experience no reduction in services.
Requires that Bureau of Indian Affairs (BIA) staff in specified fields (including education, social services, law enforcement, and alcohol and substance abuse) have training in the identification, prevention, education, referral, or treatment of mental illness or dysfunctional and self-destructive behavior. Expands current provisions relating to diabetes among Indians to include the purchase of dialysis equipment and the provision of necessary staffing. Authorizes providing long-term care in a facility to Indians either directly or through contracts or compacts with Indian Tribes or Tribal Organizations. Requires the provision of: (1) screening mammography for Indian women at a frequency appropriate to such women under accepted and appropriate national standards; and (2) other cancer screening that receives an A or B rating as recommended by the United States Preventive Services Task Force. Authorizes grants to develop comprehensive school health education programs for pre-school through grade 12 in schools for the benefit of Indian children (under current law, in schools located on Indian reservations). Authorizes grants for the prevention, control, and elimination of communicable and infectious diseases (under current law, of tuberculosis). Authorizes funding for hospice care and for assisted living, long-term care, home- and community-based, and convenient care services. Requires the planning and delivery of programs to improve and enhance the treatment models of care for Indian women by the Secretary, acting through the Indian Health Service and Indian Tribes, Tribal Organizations, and urban Indian Organizations. (Current law provides for services to women through the Office of Indian Women's Health Care in the Service.) Establishes an Intergovernmental Task Force to deal with Indian health hazards and problems relating to environmental hazards such as nuclear resource development, petroleum contamination, and contamination of water source and of the food chain. (Current law provisions relate only to safe water and sanitary disposal facilities.) Designates as contract health service delivery areas all or parts of Arizona (for FY1982-FY2025), North Dakota and South Dakota (both beginning in FY2003), and California. Provides for contract health services for members of the Turtle Mountain Band of Chippewa Indians in specified areas of North Dakota and Montana. Defines the term" contract health service" to mean health services provided at the expense of the Service or a Tribal Health Program by public or private medical providers or hospitals, other than the Service Unit or the Tribal Health Program at whose expense the services are provided.
Requires funding for health care programs, services, information technology, and facilities operated by Tribal Health Programs. Requires the Service to respond to a notification of a claim by a provider of a contract care service with either an individual purchase order or a denial of the claim within five working days after the receipt of such notification. Exempts a patient who receives contract health care services are authorized by the Service from liability for the payment of any charges or costs associated with the provision of such services.
Authorizes establishment of the Office of Indian Men's Health. Requires that, whenever practicable and applicable, the construction or renovation of a facility meet the construction standards of any accrediting body recognized by the Secretary for purposes of the Medicare program, the Medicaid program, and CHIP under titles XVIII, XIX, and XXI of the SSA (under current law, the standards of the Joint Commission on Accreditation of Health Care Organizations). Authorizes the BIA and all other agencies and departments of the United States, notwithstanding any other law, to transfer, at no cost, land and improvements to the Service for the provision of health care services. Authorizes the Secretary to enter into leases, contracts, and other agreements with Indian Tribes and Tribal Organizations which hold title to, a leasehold in, or a beneficial interest in facilities used by an Indian Health Program. Defines "Indian Health Program" as any health program administered directly by the Service, any Tribal Health Program, or any Indian Tribe or Tribal Organization to which the Secretary provides funding under specified provisions of the Act commonly known as the Buy Indian Act. Permits a Tribal Health Program to lease permanent structures for the purpose of providing health care services without obtaining advance approval in appropriation Acts. Directs the Secretary to establish joint venture demonstration projects with Indian Tribes and Tribal Organizations under which a Tribe or Tribal Organization expends tribal, private, or other funds, including loan guarantees, for the acquisition or construction of a health facility for a minimum of 10 years in exchange for the Service providing the equipment, supplies, and staffing for the facility's operation and maintenance. Authorizes a Tribal Health Program operating a hospital or other health facility pursuant to a contract or compact under the Indian Self-Determination and Education Assistance Act, notwithstanding any other provision of law, to establish the rental rates charged to the occupants and to collect that rent directly from federal employees who occupy the quarters. Authorizes the Secretary to accept, from any source, funds to plan, design, and construct health care facilities for Indians. Prohibits considering Medicare, Medicaid, and CHIP payments in determining appropriations for the provision of health care and services to Indians. Requires that 100% of payments to which facilities of the Service are entitled under Medicare or Medicaid shall be returned to the facilities. Permits a Tribal Health Program to elect to directly bill for, and receive payment for, health care items and services provided by such Program for which payment is made under Medicare, Medicaid, and CHIP. Allows Indian Tribes, Tribal Organizations, and urban Indian organizations to purchase health benefits coverage using amounts made available to Indian Tribes, Tribal Organizations, and urban Indian organizations for health benefits for Service beneficiaries. Authorizes the Secretary to enter into or expand arrangements for the sharing of medical facilities and services between the Service, Indian Tribes, and Tribal Organizations and the Department of Veterans Affairs (VA) and the Department of Defense (DOD), requiring the VA or DOD to pay reimbursement for services provided to VA- or DOD-eligible Indian beneficiaries. Reaffirms the goals stated in the Memorandum of Understanding Between the VA/Veterans Health Administration And HHS/Indian Health Service dated February 23, 2003. Requires a study to determine the feasibility of treating the Navajo Nation as a State for the purposes of Medicaid. Authorizes the Secretary to make grants to contractors or certain grant recipients for the lease, purchase, renovation, construction, or expansion of (under current law, for minor renovations to) facilities to assist such contractors or recipients in complying with licensure or certification requirements. Replaces the Urban Health Programs Branch with a
Division of Urban Indian Health. Requires that, notwithstanding any other provision of law, the Tulsa Clinic and Oklahoma City Clinic demonstration projects - (1) be permanent programs in the Service's direct care program; (2) continue to be treated as Service Units and Operating Units; and (3) continue to meet the requirements and definitions of an urban Indian organization. Directs the Secretary, through grant or contract, to fund the construction and operation of at least one residential treatment center in each Service Area to demonstrate the provision of alcohol and substance abuse treatment services to urban Indian youth in a culturally competent residential setting. Authorizes the Secretary to make grants to certain urban Indian organizations for the provision of services for the prevention and treatment of, and control of the complications resulting from, diabetes among urban Indians. Authorizes the Secretary to enter into contracts with, and make grants to, urban Indian organizations for the employment of Indians trained as health service providers through the Community Health Representatives Program. Authorizes the Secretary to establish programs, including programs awarding grants, for urban Indian organizations that are identical to any programs established under specified provisions of this title related to behavioral health training, school health education, prevention of communicable diseases, behavioral health prevention and treatment services, and multidrug abuse programs. Authorizes grants to urban Indian organizations for health information technology, telemedicine services development, and related infrastructure. Directs the Secretary to establish an automated management information system for the Service. Authorizes the Secretary to enter into contracts, agreements, or joint ventures to enhance information technology in Indian Health Programs and facilities. Directs the Secretary to review and update a specified existing memoranda of agreement required by the Indian Alcohol and Substance Abuse Prevention and Treatment of 1986 relating to mental health and behavioral health services. Directs the Secretary to provide a program of comprehensive behavioral health, prevention, treatment, and aftercare, including Systems of Care providing: (1) education; (2) detoxification psychiatric hospitalization, residential, and intensive outpatient treatment; (3) specialized residential treatment programs for high-risk populations; and (4) diagnostic services. Directs the Secretary to provide programs of comprehensive continuum of behavioral health for Indians of all ages, including: (1) community-based prevention, intervention, outpatient, and aftercare; (2) detoxification; (3) outpatient and residential treatment; (4) transitional living; (5) emergency shelter; (6) fetal alcohol disorder services; (7) identification and treatment of neglect and physical, mental, and sexual abuse; (8) sex specific treatment for sexual assault and domestic violence; and (9) identification and treatment of dementias regardless of cause. Directs the Secretary to: (1) establish and maintain in the Service a mental health technician program which provides for the training of Indians as mental health technicians; (2) employ such technicians; (3) involve the use and promotion of the traditional health care practices of the Indian Tribes. Directs the Secretary to provide high-standard paraprofessional training in mental health care. Authorizes grants to urban Indian organizations to develop and implement a comprehensive behavioral health program of prevention, intervention, treatment, and relapse prevention services that specifically addresses the cultural, historical, social, and child care needs of Indian women, regardless of age. Directs the Secretary to develop and implement a program for acute detoxification and treatment for Indian youths, including behavioral health services. Requires the Secretary, Indian Tribes, or Tribal Organizations to: (1) develop and implement community-based rehabilitation and follow-up services for Indian youths who are having significant behavioral health problems; and (2) require long-term treatment, community reintegration, and monitoring. Directs the Secretary to provide programs and services to prevent and treat the abuse of multiple forms of substances, including alcohol, drugs, inhalants, and tobacco, among Indian youths and provide appropriate mental health services to address the incidence of mental illness among such youths. Authorizes grants for a demonstration project to provide telemental health services to Indian youth who have expressed suicidal ideas, have attempted suicide, or have mental health conditions that increase or could increase the risk of suicide. Provides for programs to deliver innovative community-based behavioral health services. Requires grants or contracts to research the incidence and prevalence of behavioral health problems among Indians served by the Service, Indian Tribes, or Tribal Organizations and among Indians in urban areas. Deems medical quality assurance records created by or for any Indian Health Program or a health program of an urban Indian organization confidential and privileged and regulates their disclosure. Reauthorizes the Indian Health Care Improvement Act. (Sec. 3102) Amends the Indian Self-Determination and Education Assistance Act to direct the Secretary to establish the Native American Health and Wellness Foundation as a charitable and nonprofit federally chartered corporation that is not an agency or instrumentality of the United States to: (1) encourage, accept, and administer private gifts in support of the Service's mission; and (2) conduct other activities to further the health and wellness of Native Americans. Title II: Improvement of Indian Health Care Provided Under the Social Security Act
Section 3201 -
Amends the SSA to define "Indian Health Program" as any health program administered directly by the Service, any Tribal Health Program, or any Indian Tribe or Tribal Organization to which the Secretary provides funding under specified provisions of the Act commonly known as the Buy Indian Act. Makes an Indian Health Program eligible for payment for medical assistance under title XIX (Medicaid) of the SSA. (Under current law, a facility of the Service is eligible for such payment.) Authorizes the Secretary to enter into agreements with states to reimburse the states for medical assistance by the Indian Health Service, an Indian Tribe, Tribal Organization, or an urban Indian organization. Makes an Indian Health Program eligible for payments under title XVIII (Medicare) of the SSA. (Under current law, a hospital or skilled nursing facility of the Service is eligible for such payments.) Makes an Indian Health Program eligible for payment for medical assistance under SSA title XXI (CHIP).
Section 3202 -
Allows CHIP payments to states under a health care program operated or financed by the Service or by an Indian Tribe, Tribal Organization, or urban Indian organization. (Current law allows CHIP payments under an insurance program operated or financed by the Service.)
Section 3204 -
Requires the Secretary to report annually regarding the enrollment and health status of Indians receiving items or services under SSA health benefit programs.
Section 3205 -
Requires the Secretary to conduct a study concerning improving interstate coordination of Medicaid and CHIP coverage.
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