Proposed Law This provision would assist investigations by improving the quality of documentation required by those who order or request payment for program areas that are at risk of waste, fraud, and abuse. Beginning January 1, 2010, the Secretary would have the authority to disenroll, for no more than one year, a Medicare enrolled physician or supplier that fails to maintain and provide access to written orders or requests for payment for DME, certification for home health services, or referrals for other items and services as specified by the Secretary, to the Secretary. Medicare providers would be required to maintain and provide access to documentation relating to written orders or requests for payment for DME, certifications for home health services, or referrals for items and services as specified by the Secretary, to the Secretary. The provision would also extend the OIG's 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 to verify payment. Sec. 1639. Face-to-face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare Current Law Home health services are covered under Medicare Parts A and B. In order to receive payment from Medicare, physicians are required to certify and re-certify that specified services (i.e. inpatient psychiatric services, post-hospital extended care services, and home health services) meet certain conditions. In the case of home health services, physicians are required to certify that such services were required because the individual was confined to his home and needs skilled nursing care or physical, speech, or occupational therapy; a plan for furnishing services to the individual has been established; and such services were provided under the care of a physician. In the case of DME, the Secretary is authorized to require, for specified covered items, that payment be made for items and services only if a physician has communicated to the supplier a written order for the item. Proposed Law This provision would require that after January 1, 2010, physicians have a face-to-face encounter (including through telehealth and other than with respect to encounters that are incident to services involved) with the individual prior to issuing a certification or re-certification for home health services or durable medical equipment as a condition for payment under Medicare Parts A and B. The provision would also apply to physicians making home health certifications in Medicaid and CHIP. Physicians must document that they had the face-to-face encounter with the individual during the 6-month period preceding the certification, or other reasonable timeframe as determined by the Secretary. This section is meant to be compatible with the National Coverage Provision, PHYS-004, subsection H, which states that in medically underserved areas, physicians may send physician extenders (physician assistants or nurses) to see patients in their homes without personal or direct supervision by the physician, and the physician may then bill that service as a physician service. The Secretary would be authorized to apply the face-to-face encounter requirement to other Medicare items and services based upon a finding that doing so would reduce the risk of waste, fraud, and abuse. Sec. 1640. Extension of testimonial subpoena authority to program exclusion investigations Current Law Section 1128 of the SSA provides that the Secretary (and through delegation, OIG) has the authority to exclude individuals and entities from participation in federal health care programs under a variety of circumstances. Exclusion is mandatory for those convicted of certain criminal offenses, and generally the exclusion cannot be for a period of less than five years. OIG also has permissive authority under numerous circumstances to exclude an individual or entity from a federal health program, including the discretion to determine whether and for how long an exclusion will be imposed. Proposed Law The provision is designed to increase the ability of the Secretary to conduct program investigations, applying the subpoena provisions contained in section 205(d) and (e) of the SSA with respect to the Secretary's program exclusion authority. The Secretary would be able to issue subpoenas and require the attendance and testimony of witnesses and the production of any other evidence that relates to matters under investigation or in question by the Secretary. The Secretary would also have the ability to delegate this authority to the OIG and the Administrator of CMS for the purposes of a program exclusion investigation. Certain requirements regarding the serving of subpoenas and compensation for subpoenaed witnesses may apply. This section would also provide for judicial enforcement of subpoenas, including in cases where a person refuses to obey a properly served subpoena. This provision would apply to investigations beginning on or after January 1, 2010. Sec. 1641. Required repayments of Medicare and Medicaid overpay ments Current Law The Secretary is authorized to enter into contracts with private entities to conduct administrative functions, including audits of Medicare participating providers and suppliers to identify_alleged overpayments. These entities are generally referred to as Medicare program integrity or MIP contractors. Medicare statute specifies that identified overpayments to providers or suppliers that are not paid within 30 days of the date of the overpayment determination will accrue interest on the balance of the overpayment at the rate applicable to late payments established by the Secretary of the Treasury. The Secretary is required to enter into repayment plans with providers for which payment within 30 days would constitute a financial hardship. In the case of a provider or supplier for which an overpayment has been identified seeks a reconsideration (the 2nd level of the Medicare appeals process), the Secretary is prohibited from recouping the overpayment until a decision on the reconsideration has been rendered. Proposed Law This provision would require the repayment of overpayments identified by Medicare and Medicaid participating providers, including private health plans. The term "overpayment" would be defined as any funds that a person receives or retains under Medicare or Medicaid of which they are not entitled. Person would be defined as any "person" including a provider of services, supplier, Medicaid managed care organization, MA organization, or PDP sponsor. Any person who knows of an overpayment would be required to report and return the overpayment, along with notification for the reason for the overpayment, to the Secretary, the state, an intermediary, a carrier, or a contractor. "Knows" under this provision means that a person with respect to information has actual knowledge of the information, acts in deliberate ignorance of the truth or falsity of the information, or acts in reckless disregard of the truth or falsity of the information. An overpayment is defined as funds that a person receives or retains under Medicare, Medicaid, or CHIP to which the person, after applicable reconciliation, is not entitled. The reference to applicable reconciliation in this definition refers to reconciliations procedures already be in place for the relevant programs and payments, and is not intended to create any new required reconciliation procedures or rights to reconciliation or appeal. Overpayments would be required to be reported and returned within 60 days of the date the person knows of the overpayment. Overpayments retained after the 60 days would create an obligation as defined in USC section 3729(b)(3) of title 31. If it is determined that the reason for the overpayment was related to fraud, repayment would not limit the provider or supplier's liability for additional administrative obligations such as interest, fines, specialties, or civil and criminal sanctions. Sec. 1642. Expanded application of hardship waivers for OIG exclusions to beneficiaries of any Federal health care program Current Law Under SSA section 1128, the Secretary (and, through delegation, OIG) has the authority to exclude individuals and entities from participation in federal health care programs. Exclusions from federal health programs are mandatory under certain circumstances, and permissive in others (i.e., OIG has discretion in whether to exclude an entity or individual). For purposes of section 1128, the term "federal health care program" means (1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States government other than the health insurance program under chapter 89 of title 5, United States Code (governing health insurance for federal employees); or (2) any state health care program, as defined by the Social Security Act. Subject to exceptions, in the case of a mandatory exclusion, the minimum period of exclusion cannot be less than five years. How ever, under SSA section 1128(c)(3)(B), upon the request of a federal health care program administrator who determines that the exclusion would impose a hardship on individuals entitled to benefits under Medicare Part A or enrolled under Medicare Part B (or both), the Secretary may waive the exclusion under certain circumstances with respect to that program, in the case of an individual or entity that is the sole community physician or sole source of essential specialized services in a community. Proposed Law This new provision would increase the ability of the Secretary to use discretion to protect beneficiaries in cases where providers are subject to program exclusion. Under SSA section 1128(c)(3)(B), the Secretary would, in accordance with the requirements of the section, be able to waive a mandatory exclusion period where a hardship is imposed on beneficiaries of other federal health care programs, in addition to Medicare Part A and Part B beneficiaries. Sec. 1643. Access to certain information on renal dialysis facilities Current Law None. Proposed Law This provision is designed to allow additional oversight of financial relationships that may exist between medical directors and dialysis organizations, and the extent to which these may affect prescribing decisions. This provision would require End State Renal Disease Facilities to provide the Secretary with access to information relating to any ownership or compensation arrangement between the facility and the medical director of such facility or between the facility and any physician for the purposes of an audit or evaluation. Sec. 1644. Billing Agents, Clearinghouses, or Other Alternate Payees Required to Register Under Medicare Current Law CMS has implemented regulations requiring Medicare providers and suppliers to submit an application to enroll in the Medicare program in order to receive billing privileges. Providers and suppliers must resubmit and recertify the accuracy of their enrollment information every 5 years. The enrollment application requires that providers and suppliers include the names, addresses, and tax ID numbers for billing agencies on their applications. Proposed Law This provision is designed to reduce waste, fraud, and abuse by providing for registration of financial intermediaries that handle payments for Medicare providers. Beginning January 1, 2012, this provision would require billing agencies, clearinghouses, or other payees that submit claims on behalf of a health care provider to register with the Secretary in a form and manner as determined by the Secretary. A similar provision is put in place with respect to the Medicaid program by section 1759 of this Act. Sec. 1645. Conforming civil monetary penalties to False Claims Act amendments Current Law SSA section 1128A(a) authorizes the imposition of civil monetary penalties (CMPs) on any person, including an organization, agency, or other entity, who engages in various types of improper conduct with respect to federal health care programs. Under 1128A(a)(1), CMPs may be imposed on any person who knowingly presents or causes to be presented to certain government officers, employees, agents, or agencies certain false or fraudulent claims for items or services. As defined by section 1128A(i), an item or service includes any particular item, device, medical supply, or service purportedly provided to a patient and listed in an itemized claim for payment. A claim is defined by this section as an application for payments for items and services under a federal health care program. Section 1128A generally provides for monetary penalties of up to $10,000 for each item or service claimed, and $15,000 or $50,000 under other circumstances, as well as additional assessments. Under Section 1128A(a)(4), certain persons excluded from participating in Medicare or a state health care program who retain a direct or indirect ownership or control interest in an entity that is participating in Medicare or a state health care program and know or should know of the action constituting the basis for the exclusion, or who are an officer or managing employee of such an entity, may be subject to civil penalties. SSA section 1128A(c)(1) provides that the Secretary may initiate a proceeding to determine whether to impose a civil monetary penalty, assessment, or exclusion under the section only as authorized by the Attorney General pursuant to procedures agreed upon by them. The Secretary may not initiate an action with respect to any claim, request for payment, or other occurrence described in this section later than six years after the date the claim was presented, the request for payment was made, or the occurrence took place. The federal False Claims Act (FCA), codified at 31 U.S.C. §§ 3729-3733, provides for judicial imposition of CMPs and damages for the knowing submission of false claims to the United States government. The recently enacted Fraud Enforcement and Recovery Act of 2009 (FERA), P.L. 111-21, made several amendments to the False Claims Act that, according to legislative history, were intended to clarify the meaning of several provisions of the FCA in light of judicial interpretations of the statute that were said to run contrary to congressional intent and limit the scope of the law. Among the changes made by FERA, the Act removed a requirement under 30 U.S.C. 3729(a)(1) that provided that in order for liability to attach, a false claim must be presented "to an officer or employee of the United States Government or a member of the Armed Forces of the United States." In addition, FERA expanded the definition of the term "claim" to include to include "any request or demand, whether under a contract or otherwise, for money or property and whether or not the United States has title to the money or property, that . . . is made to a contractor, grantee, or other recipient, if the money or property is to be spent or used on the Government's behalf or to advance a Government program or |