Bases teóricas sobre faenado de animales de abasto

Sec. 6121. Dementia and abuse prevention training.

Requires facilities to include dementia management and patient abuse prevention training as part of pre-employment initial training for permanent and contract or agency staff, and if the Secretary determines appropriate, as part of ongoing in-service training. Effective 3/23/2010.

Subtitle C—Nationwide Program for National and State Background Checks on Direct Patient Access Employees of Long-term Care Facilities and Providers Sec. 6201. Nationwide program for National and State background checks on direct patient access employees of long-term care facilities and providers.

Requires the Secretary to establish a nationwide program for national and State background checks on direct patient access employees of certain long-term supports and services facilities or providers. This program is based on the background check pilot program in the Medicare Modernization Act.

Subtitle D—Patient-Centered Outcomes Research

Sec. 6301. Patient-Centered Outcomes Research (as modified by sec. 10602).

Mandates a new Patient-Centered Outcomes Research Institute as a private, non-profit corporation to assist patients, clinicians, purchasers, and policy makers in making informed health decisions by advancing the quality and relevance of clinical evidence through research and evidence synthesis. The research will compare the health

outcomes and clinical effectiveness, risks, and benefits of 2 or more medical treatments, services or items.

Mandates a Board of Governors, which is responsible for carrying out the duties of the Institute. The Board may not delegate certain tasks, including identifying national

research priorities, and adopting methodological standards. Board members include the Director of AHRQ and the Director of NIH (or their designees), 3 members representing each of the following groups: (1) patients and health care consumers, (2) private payers, and (3) pharmaceutical, device, and diagnostics manufacturers or developers; 7

members representing physicians and providers, including 4 members representing physicians (at least 1 of whom is a surgeon), 1 nurse, 1 State-licensed integrative health care practitioner, and 1 representative of a hospital; 1 member representing quality improvement or independent health service researchers, and 2 members representing the Federal Government or the states.

The Institute must identify research priorities, establish a research project agenda, adopt methodological standards, provide for a peer-review process for primary research, and

provide for a public comment period of not less than 45 days and not more than 60 days prior to adopting (by majority vote) such priorities, agenda, methodological standards, and peer-review process.

The Institute may appoint permanent or ad hoc expert advisory panels, and must appoint such panels in carrying out randomized clinical trials and in the case of a research study for rare disease. The Institute may include a technical expert of each manufacturer or each medical technology that is included under the relevant topic, project or category for which an expert advisory panel is established. The Institute must also establish a standing methodology committee of not more than 15 members appointed by the Comptroller General (which must also include the Directors of the National Institutes of Health and the Agency for Healthcare Research and Quality or their designees). The Comptroller General must consider and disclose any conflicts of interest of potential Board appointees and in appointing members of the methodology committee. The Institute must disclose any conflicts of interest of other participants in its processes. The Institute may not mandate coverage, reimbursement, or other policies for any public or private payer. The reports or research findings may not include practice guidelines, coverage recommendations, payment or policy recommendations. The Secretary of HHS is prohibited from denying Medicare coverage based solely on a study conducted by the Institute, and the Secretary may only use evidence and findings from Institute research to make a Medicare coverage decision if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.

The Secretary is also prohibited from using the Institute’s research in determining coverage, or creating reimbursement or incentive programs for a treatment in ways that (1) treat extending the life of an elderly, disabled, or terminally ill patient of lower value than extending the life of others or (2) preclude or discourage an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability. The Institute is prohibited from developing or using a dollars-per-quality-adjusted-life-year or other similar methodology. All of the above notwithstanding, the Secretary is not prohibited from using comparative clinical effectiveness research in determining coverage, reimbursement or incentive programs under Medicare based upon comparing

differences in the effectiveness of alternative treatments in extending a patient’s life due to the patient’s age, disability, or terminal illness. The Institute may not allow the

subsequent use of data from original research by individuals, entities or instrumentalities that have a financial interest in the results unless approved under a data use agreement with the Institute, and original research may be published in peer-reviewed publications as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research.

Includes provisions intended to ensure transparency and opportunities for stakeholder input. The Institute is expected to work with users of health information technology focused on clinical decision support to promote the timely incorporation of research findings into clinical practice.

The Office of Communication and Knowledge Transfer of AHRQ must broadly disseminate the research findings published by the Institute and other like research.

AHRQ is directed to build capacity for comparative clinical effectiveness research by establishing a grant program. The Secretary is directed to provide for the coordination of relevant Federal health programs to build data capacity for comparative clinical

effectiveness research, including the development and use of clinical registries and health outcomes research data networks.

Creates a Patient-Centered Outcomes Research Trust Fund (PCORTF), with contributions from Medicare, private health insurers and self-insured health plans

beginning at $1 per capita for FY 2013, rising to $2 per capita for FY 2014 (then indexed by the percentage increase in the projected per capita amount of National Health

Expenditures for FY 2015 through FY 2019). Additional financing is provided through appropriations, beginning with $10 million for FY 2010, rising to $150 million per year for FY 2012 through FY 2019.

Sec. 6302. Federal coordinating council for comparative effectiveness research.

Terminates the Coordinating Council on enactment (3/23/2010).

Subtitle E—Medicare, Medicaid, and CHIP Program Integrity Provisions

Sec. 6401. Provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP (as modified by sec. 10603 and sec. 1304 of HCERA).

Not later than 9/19/2010, mandates screening of all providers and suppliers before the granting of Medicare, Medicaid or CHIP billing privileges, including criminal background checks (screening will apply to those already enrolled in these programs on 3/23/2012). A $500 application fee per institutional provider (in FY 2010) is imposed to cover

screening costs (the fee is indexed by CPI-U). No application fee applies to individual providers. Authorizes a provisional period of enhanced oversight for new providers and suppliers (30-365 days long), such as prepayment review and payment caps, as the Secretary determines appropriate. Authorizes payment adjustments for providers and suppliers with the same tax identification number for past-due obligations. Authorizes a temporary moratorium on enrollment of new providers and suppliers if determined necessary to prevent or combat fraud, waste or abuse (no requirement for Secretary to determine that beneficiary access will not be adversely affected, but states are not required to comply with any temporary moratorium if it would adversely impact Medicaid/CHIP beneficiary access to medical assistance).

Effective 3/23/2011, requires providers or suppliers enrolling or re-enrolling under Medicare, Medicaid, or CHIP to disclose any current or previous affiliation with a provider or supplier that has uncollected debt or with a person or entity that has been suspended or excluded under the program, subject to payment suspension, or has had its billing privileges revoked. Permits Secretary to deny enrollment if a previous

affiliation poses an undue risk of fraud, waste or abuse.

For periods beginning after 1/1/2011, requires the Secretary to withhold Medicare

payments for 90 days in the case of claims submitted by new durable medical equipment suppliers if the Secretary determines there is a significant risk of fraudulent activity. Requires providers and suppliers “within a particular industry sector or category” to establish a compliance program to reduce waste, fraud and abuse. The Secretary must specify the core elements of such compliance program. The Secretary must develop an implementation timeline.

Requires states to comply with processes for screening providers and suppliers and other oversight established for Medicare elsewhere in the Act. Requirements include providing for an enhanced period of oversight for new providers and suppliers,

disclosure requirements, temporary moratoria on enrolling new providers, except if the state determines it would adversely impact beneficiary access to services, compliance programs, reporting of adverse provider actions, or use of national provider identification.

Sec. 6402. Enhanced Medicare and Medicaid program integrity provisions (as modified by sec. 1303 of HCERA).

Requires CMS to complete development of a comprehensive Integrated Data Repository (expands program data sources and data sharing/matching across Federal programs, for the purpose of identifying potential fraud, waste and abuse under Medicare and Medicaid). Authorizes the OIG and the Attorney General to access Medicare, Medicaid and CHIP claims and payment data for purposes of conducting law enforcement and oversight activities.

Requires prompt reporting and repayment of identified Medicare and Medicaid

overpayments. The deadline for repayment is the later of (1) the date which is 60 days after the date on which the overpayment was identified or (2) the date any corresponding cost report is due, if applicable.

Mandates unspecified (“appropriate”) administrative penalties for knowing participation by a beneficiary in a health care fraud scheme.

Mandates the promulgation of a regulation that requires, not later than 1/1/2011, all providers and suppliers under Medicare and Medicaid to include their national provider identifier on all applications to enroll in such programs and on all claims submitted for payment under such programs.

Mandates withholding of Federal Medicaid matching payments for states that fail to report enrollee encounter data in the Medicaid Statistical Information System.

Clarifies that Medicare Part D plans may waive the beneficiary copayment for the first generic prescription filled to encourage use of lower-cost generic drugs without violating Federal fraud and abuse provisions. Effective on date specified by the Secretary but in no case earlier than 1/1/2011.

Imposes penalties for false statements on provider or supplier enrollment applications, including managed care organizations and PDP sponsors. Imposes financial penalties on excluded individuals who nevertheless order an item or service covered by a Federal health care program.

Creates the following new exceptions to prohibited offers or transfers of remuneration to beneficiaries (likely to influence their choice of provider or supplier of health care

services): (1) any remuneration which promotes access and poses a low risk of harm; (2) the offer or transfer of items or services for free or less than fair market value if they consist of coupons, rebates, or other rewards from a retailer, are available to the general public regardless of health insurance status, and not tied to the provision of other items or services reimbursed under Medicare or a state health care program; (3) the offer or transfer of items or services for free or less than fair market value if not offered as part of

any advertisement or solicitation, not tied to the provision of other services reimbursed under Medicare or a state health care program, are reasonably connected to the medical care of the individual, and provided after determining in good faith that the individual is in financial need; and (4) effective on a date specified by the Secretary (but not earlier than 1/1/2011) the waiver by a PDP or MA-PDP plan of the first fill of a generic drug.

Authorizes program exclusions and financial penalties for any entity making false statements or misrepresenting material facts, including Medicare Part C and D plans, Medicaid managed care organizations, and entities that apply to participate as providers of services or suppliers in such managed care organizations and plans. Applies

authority to subpoena witnesses to program exclusion investigations.

Revises the intent requirement under the anti-kickback statute to specify that a person need not have actual knowledge of the law or specific intent to violate the law.

Authorizes the Secretary to require durable medical equipment suppliers and home health agencies to obtain a surety bond in an amount in excess of $50,000 that is “commensurate with the volume of the billing” of the supplier or agency. Authorizes the Secretary to require other providers and suppliers to obtain a surety bond if the

Secretary determines this is appropriate based on the level of risk involved with respect to these providers and suppliers.

Permits the Secretary to suspend payments under Medicare pending investigation of credible allegations of fraud, and to deny Medicaid payments to states failing to suspend Medicaid payments to such individuals.

Increases Health Care Fraud and Abuse Control (HCFAC) funding by $10 million each year for 10 years, and appropriates an additional $250 million for FYs 2011-2016 for HCFAC. Permanently indexes amounts appropriated from the HCFAC Fund to HHS, OIG, the FBI, and the Medicare Integrity Program. For fiscal years after FY 2010, indexes Medicaid Integrity Program funding by CPI-U.

Requires Medicare and Medicaid Integrity Program contractors to submit performance statistics and requires the Secretary to conduct periodic evaluations of these contractors. Permits waivers of program exclusions that the Secretary determines would impose undue hardship on beneficiaries of any Federal health care program (not just Medicare beneficiaries), such as exclusions involving a sole community physician or a sole source of essential specialized services in a community.

Sec. 6403. Elimination of duplication between the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank.

Sunsets the Healthcare Integrity and Protection Data Bank (HIPDB) and transitions to having the National Practitioner Data Bank (NPDB) serve as the central repository for information about adverse actions taken against health care providers. Beefs up state reporting requirements.

Sec. 6404. Maximum period for submission of Medicare claims reduced to not more than 12 months.

Effective for services furnished on or after 1/1/2010, reduces the time allowed for submitting Medicare Part A and Part B claims from 36 months to 12 months (claims for services provided before 1/1/2010 must be submitted by 12/31/2010).

Sec. 6405. Physicians who order items or services required to be Medicare enrolled physicians or eligible professionals (as modified by Sec. 10604).

Effective 7/1/2010, only a Medicare-enrolled physician can order Medicare-covered home health services, and only a Medicare-enrolled physician or health professional can order Medicare-covered durable medical equipment. The Secretary may expand this requirement to other categories of items or services, including Part D drugs.

Sec. 6406. Requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse.

Effective 1/1/2010, authorizes the Secretary to disenroll from Medicare (for up to 1 year for each act) providers, physicians and suppliers who fail to maintain and, upon request, provide access to, documentation relating to written orders for DME and home health and for referrals for other items and services ordered by such provider, physician or supplier under Medicare, as specified by the Secretary.

Sec. 6407. Face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare (as modified by sec. 10605).

Effective 1/1/2010, requires physicians certifying or re-certifying the need for Medicare home health services or ordering DME to have a face-to-face encounter with the patient (including through telehealth) during the preceding 6 months or other reasonable

timeframe determined by the Secretary. In the case of home health services, the face- to-face encounter may also be conducted by a nurse practitioner, a clinical nurse specialist, a physician assistant, or a certified nurse-midwife. In the case of DME, the face-to-face encounter may also be conducted by a nurse practitioner, a clinical nurse specialist, or a physician assistant. The preceding requirements also apply to Medicaid. The Secretary may expand the policy to other items and services but such expansion would only apply to Medicare.

Sec. 6408. Enhanced penalties.

Makes conforming changes to civil monetary penalty provisions in light of other changes being made in the bill. Effective 1/1/2010, imposes financial penalties for submission of false claims data under a Federal health care program.

Effective 1/1/2010, imposes financial penalties for failure to grant timely access to OIG auditors and investigators. Amends current law to ensure timely inspections relating to contracts with Medicare Advantage Organizations.

Effective 1/1/2010, imposes enhanced penalties for Medicare Advantage and Part D marketing violations, including enrolling or transferring individuals without their prior consent.

Effective 1/1/2010, broadens existing penalties relating to investigation obstruction to apply to audit obstruction.

Sec. 6409. Medicare self-referral disclosure protocol.

Not later than 9/23/2010, mandates the establishment of a protocol to enable health care providers and suppliers to disclose actual or potential violations of the physician self- referral prohibitions. The Secretary may reduce amounts owed for self-disclosing entities. Not later than 9/23/2011, the Secretary must submit a report to Congress on the implementation of this provision.

Sec. 6410. Adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies competitive acquisition program.

Expands the number of metropolitan areas to be included in Round II of DME competitive bidding from 70 to 91 (by including the next 21 largest metropolitan statistical areas by total population), and requires the Secretary to extend the competitive bidding program or apply competitive bid rates to all remaining areas by 2016.

Sec. 6411. Expansion of the Recovery Audit Contractor (RAC) program.

Extends the Recovery Audit Contractor (RAC) program to Medicare Parts C and D and Medicaid. RACs must ensure that each Medicare Advantage organization and Part D plan has an anti-fraud plan.

Subtitle F—Additional Medicaid Program Integrity Provisions

Sec. 6501. Termination of provider participation under Medicaid if terminated under Medicare or other State plan.

Requires states to terminate participation under Medicaid of any provider terminated under another state Medicaid plan or Medicare. Certain existing exceptions to apply. Generally effective 1/1/2011 (see sec. 6508).

Sec. 6502. Medicaid exclusion from participation relating to certain ownership, control, and management affiliations.

States must exclude from Medicaid for a period any entity or individual that owns, controls, or manages an entity that has unpaid overpayments determined to be delinquent; whose participation in Medicaid is suspended, excluded or terminated; or who is affiliated with an individual or entity that has been suspended, excluded or terminated. Generally effective 1/1/2011 (see sec. 6508).

Sec. 6503. Billing agents, clearinghouses, or other alternate payees required to register under Medicaid.

Requires that any agent, clearinghouse or other alternate payee that submits claims on behalf of a health care provider to register with the state and the Secretary in the form and manner specified by the Secretary. Generally effective 1/1/2011 (see sec. 6508).

Sec. 6504. Requirement to report expanded set of data elements under MMIS to