[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)] [Rules and Regulations] [Pages 292-355] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-34220] [[Page 291]] _______________________________________________________________________ Part II Department of Health and Human Services _______________________________________________________________________ Health Care Financing Administration _______________________________________________________________________ 42 CFR Parts 413, 440, 441, and 489 Medicare and Medicaid Programs, Surety Bond and Capitalization Reqirements for Home Health Agencies; Final Rule Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Rules and Regulations [[Page 292]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration 42 CFR Parts 413, 440, 441, and 489 [HCFA-1152-FC] RIN 0938-AI31 Medicare and Medicaid Programs; Surety Bond and Capitalization Requirements for Home Health Agencies AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Final rule with comment period. ----------------------------------------------------------------------- SUMMARY: The Balanced Budget Act of 1997 (BBA '97) requires each home health agency (HHA) to secure a surety bond in order to participate in the Medicare and Medicaid programs. This requirement applies to all participating Medicare and Medicaid HHAs, regardless of the date their participation began. This final rule with comment period requires that each HHA participating in Medicare must obtain from an acceptable authorized Surety a surety bond that is the greater of $50,000 or 15 percent of the annual amount paid to the HHA by the Medicare program, as reflected in the HHA's most recently accepted cost report. The BBA '97 also requires that provider agreements be amended to incorporate the surety bond requirement; this rule deems such agreements to be amended accordingly. The BBA '97 prohibits payment to a State for home health services under Medicaid unless the HHA has furnished the State with a surety bond that meets Medicare requirements. This final rule with comment period requires that, in order to participate in Medicaid, each HHA must obtain from an acceptable authorized Surety, a surety bond that is the greater of $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services for which Federal Financial Participation (FFP) is available. In addition to the surety bond requirement, an HHA entering the Medicare or Medicaid program on or after January 1, 1998 must demonstrate that it actually has available sufficient capital to start and operate the HHA for the first 3 months. Undercapitalized providers represent a threat to the quality of patient care. DATES: Effective Date: January 1, 1998. Comment Period: Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on March 6, 1998. ADDRESSES: Mail written comments (one original and three copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA-1152-FC, P.O. Box 26688, Baltimore, MD 21207-0488. If you prefer, you may deliver your written comments (one original and three copies) to one of the following addresses: Room 309-G, Hubert H. Humphrey Building, 00 Independence Avenue, SW, Washington, DC 20201, or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. In commenting, please refer to file code HCFA-1152-FC. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 309-G of the Department's offices at 200 Independence Avenue, SW, Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: (202) 690-7890). FOR FURTHER INFORMATION CONTACT: Ralph Goldberg (410) 786-4870 (Medicare Surety Bond Provision); John Eppinger (410) 786-4518 (Medicare Capitalization Provision); Mary Linda Morgan (410) 786-2011 (Medicaid Provisions). SUPPLEMENTARY INFORMATION: On September 15, 1997, the Department of Health and Human Services (HHS) issued a press release announcing that HHS was halting Medicare certification of new home health agencies (HHAs) and, during the interim, would be developing new regulations to fight home health fraud and abuse. In this final rule with comment period we implement the statutory requirement in the Balanced Budget Act of 1997 (BBA '97), (Public Law 105-33), enacted August 5, 1997, that requires an HHA to post a surety bond as a condition of its approval as a Medicare provider or Medicaid provider of home health services. Also, on the basis of authority found in sections 1861(o)(8), 1866(b)(2), and 1891(b), of the Social Security Act (the Act), we institute a requirement that a new HHA, under the terms of its provider agreement, must have enough funds on hand to operate for the first 3 months. The purpose of both requirements is to establish the financial stability of home health providers. The discussion below deals with both provisions. I. Background: Surety Bonds Home health agencies (HHAs) that meet certain requirements are approved to be paid for medical and other services furnished to Medicare and Medicaid beneficiaries. Section 1861(o) of the Social Security Act (Act) defines the term ``home health agency'' under the Medicare program and thereby establishes certain conditions and requirements that an HHA must meet in order to participate in Medicare. As a Medicare participating provider of services, HHAs also must comply with applicable requirements for provider agreements and supplier approval located in our regulations at 42 CFR part 489. Sections 1902(a)(10)(D) and 1905(a)(7) of the Act provide for the coverage of home health services as medical assistance under an approved State Medicaid plan. Implementing regulations for these statutory provisions are located at 42 CFR 440.70 and 441.15. Section 440.70(d) specifies that a home health agency under Medicaid is an agency that meets the requirements for participating in Medicare. Section 441.15 specifies State plan requirements for home health services. Section 4312(b)(1) of BBA '97 amended section 1861(o) of the Act to require each HHA, on a continuing basis, to furnish us with a surety bond in a form we have specified and in an amount that is not less than $50,000. The BBA '97 provides for a waiver of this requirement, which we discuss below. This provision is to be implemented effective for services furnished to Medicare beneficiaries on or after January 1, 1998. However, our regulations do not currently contain such a requirement. This change affects our regulations at 42 CFR part 489. Section 4312(b)(2) of BBA '97 amended the definition of ``reasonable cost'' in section 1861(v)(1)(H) of the Act to provide that the cost of a surety bond is not included as an allowable Medicare cost. This change affects our regulations at 42 CFR part 413, subpart F, which concern specific categories of Medicare costs. Section 4724(b) of BBA '97 also amended section 1903(i) of the Act by adding a new paragraph (18) to prohibit Federal financial participation (FFP) in payments under Medicaid for home health services unless the HHA provides the State Medicaid agency, on a continuing basis, a surety bond in a form that we have specified for Medicare participation and in an amount that is not less than $50,000 or some other comparable surety bond under State law. This change affects our regulation at 42 CFR Part 441. [[Page 293]] II. Surety Bond Requirements for HHAs Under Medicare A. Scope of Requirement In general, every HHA that participates or that seeks to participate in the Medicare program must obtain a surety bond. The surety bond must name the HHA as Principal, HCFA as Obligee, and the surety company as Surety. The statute permits us to waive the requirement of a surety bond in the case of an agency or organization that provides a comparable surety bond under State law. We are not, as a general matter, implementing the full scope of this waiver authority at this time, because we are still considering what standards and criteria would be appropriate to implement such a waiver. If a State has a comparable bond requirement, we can waive the Medicare bond requirement with respect to those HHAs that furnish us with a bond in compliance with that State's law. At the moment, we are only aware that Florida has a bond requirement which is for $50,000, whereas our requirement begins at $50,000 and is higher under certain circumstances. We believe that this is consistent with the intent of the Congress that established $50,000 as the minimum amount of the bond. Although we have been apprised that other States are considering legislation, we are not aware that any of this legislation has been enacted into law. As a result, we are seeking public comment on what States currently require in order for HHAs to be in compliance with State law. We are also seeking public comment with respect to comparable experiences in the private sector on the establishment of surety bond requirements for HHAs. In addition, we are seeking public comment on the impact of our not choosing to waive the Medicaid bond required in the case of an agency or organization that provides a comparable surety bond under State law. We are, however, waiving the requirement for an HHA operated by a Federal, State, local, or tribal government agency if, during the preceding 5 years, the HHA has not incurred long-term unpaid debts owed to us based on unrecovered Medicare overpayments or on unpaid civil money penalties or assessments, and none of its claims have had to be referred by us to the Department of Justice or the General Accounting Office because of nonpayment. A government-operated HHA that does not qualify for waiver must submit a surety bond. We are waiving the surety bond requirement for government-operated HHAs only to the extent such HHAs have a good history of paying their Medicare debts. Our anecdotal experience suggests that such HHAs timely pay their Medicare debts. The basis for this waiver is principally that because government-operated HHAs are a component of government, and because a government has the power to tax, it is unlikely such HHAs will be unable to pay their Medicare debts. Thus, government-operated HHAs, by their public nature, furnish a comparable or greater guarantee of payment as would be afforded us by a surety bond issued by a private surety company. Nevertheless, government-operated HHAs with a poor history of paying their Medicare debts, if there are any such HHAs, are subject to the surety bond requirement. We solicit comments on appropriate criteria we may use for waiving other HHAs from the requirement to purchase a surety bond. B. Relationship to Provider Agreements Section 4312(f)(2) of BBA '97 specifies that the surety bond requirement must be incorporated into existing Medicare provider agreements by January 1, 1998. Inasmuch as this mandate would require the modification of over 10,000 HHA provider agreements by the January 1, 1998 deadline, we are implementing these modifications by this rule. Therefore, this rule deems such agreements to be modified so as to incorporate the surety bond requirement effective January 1, 1998. We will verify that each HHA has obtained a bond in the correct amount and that the bond otherwise conforms to the specifications we establish. If an HHA fails to timely file a surety bond that meets the requirements of our rules, we may terminate a participating HHA's existing provider agreement or refuse to enter into a provider agreement with an HHA that seeks to participate in Medicare. The surety bond requirement will be incorporated into participating HHAs' existing provider agreements and all new HHA provider agreements effective January 1, 1998. C. What Constitutes a Surety Bond The ``surety bond'' in this final rule with comment period is an instrument obtained by an HHA from a surety company in which the surety company, acting as Surety, guarantees that it will be responsible for unrecovered debts owed to us by an HHA. We are requiring that the bond be obtained from a company that has been issued a Certificate of Authority by the U. S. Department of Treasury (which has issued generally applicable regulations governing the surety bond industry with respect to Federal agencies, thereby creating a well-regulated market). Such companies are listed in the Department of Treasury's Circular Number 570 ``Companies Holding Certificates of Authority as Acceptable Sureties on Federal Bonds and as Acceptable Reinsuring Companies.'' We limit the purchase of a bond from a company listed on the Department of Treasury's list of approved companies that have been issued a ``Certificate of Authority'' to ensure that a Surety we rely on meets certain minimum standards. Also, the company must not have been determined by us to be an unauthorized surety for the Medicare program. We will determine a surety company to be unauthorized if:The surety company fails to furnish us, upon request, timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a surety bond. The surety company fails to pay us timely after we have presented to the surety a proper claim for payment and sufficient evidence to establish the surety company's liability on the bond. The surety company, by other similar action, furnishes us with good cause to determine that the company is not acceptable as a surety for the Medicare program. A determination that a surety company is not an authorized source for surety bond for Medicare will be effective immediately upon publishing a notice of the determination in the Federal Register and remains in effect until we publish a notice of reinstatement in the Federal Register. However, any such determination does not affect any surety bond issued by the surety company to an HHA before the effective date of the determination. If a Surety is determined to be an unauthorized surety company, we will also determine whether and how such a determination will affect HHAs that have obtained a current bond from the now unauthorized company. We may require that HHAs obtain replacement bonds. A determination by us that a surety company is an unauthorized surety company for the purposes of this rule is not a debarment, suspension, or exclusion for the purposes of Executive Order 12549. D. Surety Company Obligations The surety company must guarantee to pay us, up to the face amount of the bond, the full amount of any unpaid Medicare overpayment, plus accrued interest, based on payments we made to the HHA during the term of the bond. Also, the surety company must guarantee to pay us, up to the face amount of the bond, the full amount of [[Page 294]] any unpaid civil money penalty or assessment we have imposed on the HHA during the term of the bond based on an authority under Title XI, Title XVIII, or Title XXI of the Act, plus any accrued interest. When the term of the surety bond expires, the Surety remains liable for any claims that are not timely paid that have been or will be identified based on Medicare payments made during the term of the bond and for civil money penalties or assessments that were determined during the term of the bond and are not timely paid. We will demand payment from a Surety when the Surety becomes liable under a bond even if we have available to us alternative legal means to pursue collection of the monies due us. Additional requirements for obtaining a surety bond are addressed in order to specify the conditions under which the surety company becomes liable to us. E. HHA Surety Bond Purchase Requirements Except for an HHA operated by a Federal, State, local, or tribal government agency determined by us to meet the waiver criteria for this requirement, every other participating HHA must submit to us by February 27, 1998 a surety bond that is effective beginning January 1, 1998 through the end of the HHA's current fiscal year. Thereafter, a participating HHA must submit to us, on an annual basis, a new surety bond to be effective for the HHA's fiscal year. The HHA must submit the bond to us not later than 30 days before the start of the fiscal year. (For an HHA whose fiscal year begins February 1, 1998 or March 1, 1998 the submission of the second bond would not be due until March 31, 1998.) We require each HHA to obtain a new surety bond each year in lieu of a multiple-year bond or continuous bond. We believe neither a multi-year bond nor a continuous bond gives the Medicare Trust Funds the level of protection of a one-year bond. In addition, a one-year bond makes it easier to administratively tie a particular bond with a particular year's Medicare payments. Also, if the Surety's liability is renewed each year up to the limit of the surety bond, any penalties and assessments have a greater opportunity of being repaid by the HHA. If a one-year bond is required, it is easier to link the Surety's liability with a particular term of the bond and the fiscal year. An HHA that seeks to participate in Medicare for the first time must submit a surety bond to us with its enrollment application (form HCFA-855, OMB approval number 0938-0685) but no later than the completion date of its certification survey. An HHA that seeks to become a participating HHA through the purchase or other transfer of the ownership interest of a participating HHA must also ensure that the surety bond is effective from the date of the purchase or transfer of the ownership interest. For an HHA that undergoes a change of ownership, the 15 percent is computed on the basis of Medicare payments made by us to the HHA for the most recently accepted cost report. F. Amount of Surety Bond We are establishing a flat rate to determine the amount of the bond that will be used in combination with a $50,000 minimum bond. The flat rate is related to the volume of business a HHA does with Medicare. The bond amount is the maximum amount for which a surety company would be liable to HCFA. The flat rate is generally 15 percent of the annual amount paid to the HHA by the Medicare program as reflected in the HHA's most recently accepted cost report. However, if an HHA's payments have increased or decreased by 25 percent for the first 6 months of the HHA's current fiscal year, we will determine the amount of the bond required for the next fiscal year based on such payments and notify the HHA of the required bond amount based on the annualized amount of such payments. In either case, the amount of the surety bond and the premium paid by the HHA for the surety bond are directly tied to the amount of Medicare payments received by the HHA. We believe a bond amount tied to 15 percent of an HHA's Medicare payments is needed to ensure that we will recover on most uncollectible overpayments. In 1993, Medicare overpayments were 4 percent of total Medicare payments made to all HHAs. In 1996, Medicare overpayments had grown to 7 percent of total Medicare payments made to all HHAs. Thus, the industry-wide ratio of overpayments to payments has risen dramatically (nearly doubling). Also, although the industry percentage was only 7 percent in 1996, the overpayments of a particular HHA, as a percentage of that HHA's Medicare payments could greatly exceed the percentage of overpayments of all HHAs. We also believe that generally the 15 percent is a reasonable percentage on which to base the amount of the bond, since it would not be too high as to be a barrier for small companies, yet high enough to provide the Trust Funds with a reasonable ability to recover debts owed to the program. In determining this percentage amount, we consulted with an insurance industry trade group. For HHAs currently participating in Medicare, the amount of the initial surety bond (i.e., the bond effective from January 1, 1998) is to be based on the HHA's most recently accepted cost report. For an HHA that seeks to participate in the Medicare program on or after January 1, 1998 and purchases the assets or ownership interest of a participating (or formerly participating) HHA, the amount of the initial surety bond will be based on the total amount of Medicare payments to the participating (or formerly participating) HHA in the most recently accepted cost report. For an HHA that seeks to participate in the Medicare program on or after January 1, 1998 and has not purchased the assets or ownership interest of a participating (or formerly participating) HHA, the amount of the initial surety bond will be $50,000. The amount of each subsequent surety bond will be based on the annual total amount of Medicare payments made to the HHA in the most recently accepted cost report. If an HHA's overpayment for the most recently accepted cost report exceeds 15 percent of annual payments, Medicare may require the HHA to secure a bond up to or equal to the amount of the overpayment, provided the amount of the bond is not less than $50,000. G. Cost of Surety Bonds We have been advised by surety industry sources that well-operated and sufficiently capitalized companies can expect to incur costs, on average, of approximately $10 per thousand dollars of the face amount of the bond. Thus, on average, a $50,000 bond will cost an HHA approximately $500. As noted earlier, under section 4312(b)(2) of BBASec. '97 the cost of surety bonds is not to be reimbursed by Medicare. The costs associated with obtaining surety bonds is further discussed in the regulatory impact analysis section of this preamble. III. Surety Bond Requirements Under Medicaid Section 4724(b) of BBA '97 amended section 1903(i) of the Act to prohibit Federal Financial Participation (FFP) to a State for home health services under Medicaid unless the home health agency furnishing the services provides the State with a surety bond that meets the requirement established by section 1861(o)(7) of the Act. This provision is effective for services furnished on or after January 1, 1998. This change affects our regulations at 42 CFR part 441. [[Page 295]] In general, every HHA that participates or that seeks to participate in the Medicaid program must obtain a surety bond. The statute requires that the Medicaid surety bond must be in the form specified by the Secretary for surety bonds under the Medicare program. Therefore, in general, the requirements for surety bonds for HHAs in the Medicare program, discussed in section II of this preamble, also apply to HHAs participating in the Medicaid program. However, certain differences between the Medicare and Medicaid programs require that the surety bond requirement be tailored to fit the Medicaid program. Medicare reimbursement for services furnished by participating HHAs is provided through fiscal intermediaries based on claims submitted directly to HCFA. Payment for home health services under Medicaid is made to the HHA by the State Medicaid agency. The State Medicaid agency submits a quarterly expenditure report to HCFA in order to claim Federal matching funds, usually at the 50 percent rate, for home health services provided under Medicaid by participating HHAs. In general, we are adopting for the Medicaid program the surety bond requirements set forth in the Medicare program, as provided for under the BBA '97. Appropriate changes are made to establish that the HHA participating in the Medicaid program must submit the surety bond to the State Medicaid agency, rather than HCFA, and that the State Medicaid agency must take the applicable actions with regard to compliance with the statutory and regulatory requirements in order to receive FFP for home health services. For these reasons, we are allowing the State Medicaid agency to specify any other requirements for the HHA that it deems necessary to ensure that it receives a surety bond from an authorized surety company. Surety bonds must be submitted to the Medicaid agency by February 27, 1998, and carry an effective date of January 1, 1998. The term of the bond must be 1 year and the amount of the bond must be $50,000 or 15 percent of the amount paid to the HHA by the State Medicaid program for the most recent annual period for which data are available, whichever is greater. As in Medicare, the Medicaid agency may require a bond greater than 15 percent of annual payments if the HHA's overpayments exceed that percentage of payments. The Medicaid agency, rather than HCFA, is the obligee for surety bonds required under the Medicaid program. We are specifying that each State will make the determination that a surety company has met a condition to cause it to be unauthorized for Medicaid purposes in its State. Since each State will be making this determination, we are allowing the State to establish its own requirements for notifying the HHAs and the public that a surety company is not authorized for Medicaid purposes in the State. Each State is provided the flexibility to set the annual period for which bonds in their State will apply. The surety bond under Medicaid is for unpaid overpayments only, not for civil money penalties or assessments, as is the case under Medicare. Civil money penalties against HHAs are not authorized under the Medicaid statute and neither HCFA nor the States can impose assessments to HHAs similar to those assessments imposed by HCFA under Medicare. IV. Capitalization Requirements for HHAs A. Background One potential difficulty with many small businesses is that they are often undercapitalized. That is, they do not have adequate capital, or up-front funds, with which to operate the business pending development of an adequate and reliable stream of revenue. Even under ideal conditions, a business must incur costs before any revenues are realized. Costs of planning and organizing the business are incurred before any services can be rendered or goods can be sold. Afterwards, once the business has begun to operate, there is a period of time when services are rendered or goods are sold before any revenues from these activities actually will begin to flow into the business. Until that happens, the business must have other funds available to operate in order to pay employee salaries, to pay rent, to pay costs of heat, light and power, and so forth. Under less than ideal conditions, the need for adequate up-front operating funds is even more critical. For example, the demand for the services or goods may not be as great as anticipated; a temporary (or longer) downturn in the market may depress sales; the normal turn- around in billing and receiving payment may be longer than anticipated; or particular customers may lag in paying for goods and services. New HHAs generally are small businesses and have the same need for adequate capitalization as have other small businesses which are just starting. As with other small businesses, a lack of funds in reserve to operate the business until a stream of revenues can be established can seriously threaten the viability of the business. In addition, for new HHAs, which are in business to render patient care services, any condition threatening the viability of the new business can adversely affect the quality of care to their patients and, in turn, the health and safety of those patients. That is, if lack of funds forces an HHA to close its business, to reduce staff, or to skimp on patient care services because it lacks sufficient capital to pay for the services, the overall well-being of the HHA's patients could be compromised. In fact, there could be the risk of serious ill effects as a result of patients not receiving adequate services. The level of services provided to an HHA's patients is of serious concern to us for the following reason. The process by which an HHA participates in the Medicare program is one that involves a survey by HHS or an accrediting organization. This survey is essentially a snapshot of the agency's activities. For a new agency that is undercapitalized, it may be unable to sustain the level of services it is able to provide at the time of the survey over the period of time necessary for it to begin receiving a steady stream of revenue from Medicare. The period in question could last as long as two or even three months. Since a survey has already been conducted, the new HHA's services are not routinely inspected during this period and so there is increased danger that lack of operating funds could result in inadequate care that is not discovered. B. Effects of Threatened Financial Viability To assure quality of care to patients who receive care from a new HHA, we are establishing initial capitalization requirements for new HHAs in order to increase the likelihood of their viability and to minimize situations that could adversely affect the health and safety of their patients. These requirements will be effective January 1, 1998. We believe that these requirements are urgently needed, particularly in light of the findings of the Office of Inspector General (OIG) regarding undercapitalized or bankrupt HHAs and the adverse impact such HHAs have on the Medicare program and public monies. In its July 1997 report, ``Home Health: Problem Providers and Their Impact on Medicare'' (OEI-09-96-00110), the OIG stated, in part: If it were not for Medicare accounts receivable, problem agencies would have almost nothing to report as assets. Agencies tend to lease their office space, equipment, and vehicles. They are not required by Medicare to own anything, and they are almost always undercapitalized. On average, [[Page 296]] cash on hand and fixed assets amount to only one-fourth of total assets for HHAs, while Medicare accounts receivable frequently equal 100 percent of total assets. These agencies are almost totally dependent on Medicare to pay their salaries and other operating expenses. For a home health agency, there are virtually no startup or capitalization requirements. In many instances, the problem agencies lease everything without collateral. They * * * do not even have enough cash on hand to meet their first payroll. We agree that it is unacceptable that an HHA can enter the Medicare program in many cases with little or no reserves with which to operate pending receipt of reimbursement from Medicare (and other payers). To do business in this manner sets a new HHA up for potential problems from the beginning and exposes Medicare to unnecessary risk. Accordingly, we believe it is imperative that Medicare set capitalization requirements for new HHAs promptly. Section 1891(b) of the Act states that it is ``the duty and responsibility of the Secretary to assure that the conditions of participation and requirements specified in or pursuant to section 1861(o) and subsection (a) of this section and the enforcement of such conditions and requirements are adequate to protect the health and safety of individuals under the care of a home health agency and to promote the effective and efficient use of public moneys.'' Section 1861(o)(8) itself authorizes the Secretary to establish ``such additional requirements * * * as the Secretary finds necessary for the effective and efficient operation of the program.'' Section 1866(b)(2) provides that the Secretary may refuse to enter into an agreement under section 1866 after determining ``that the provider fails to comply substantially with the provisions of the agreement'' or ``with the provisions of [Title 18] and regulations thereunder'' or ``that the provider fails substantially to meet the applicable provisions of section 1861.'' It is on the basis of these authorities that we are, by regulation, establishing this new requirement that an HHA must have a certain minimum amount of capital necessary to assure the financial success of the business and, thus, to minimize the possibility of quality problems or financial loss to the Medicare program as a result of shortfalls in business revenue. C. Capitalization Requirements For an HHA that seeks to participate in the Medicare or Medicaid program beginning on or after January 1, 1998, we will determine whether the HHA has sufficient capitalization, that is, the initial reserve operating funds that the HHA will need to operate for the first three months as a participating Medicare or Medicaid provider. Capitalization is required for all HHAs that are seeking, for the first time, to participate in Medicare, including new HHAs as a result of a change of ownership if the change of ownership results in a new provider number being issued. These capitalization requirements apply to Medicaid HHAs as well as Medicare HHAs. As provided in 42 CFR 440.70(d), a home health agency for the Medicaid program means a public or private agency or organization, or part of an agency or organization, that meets requirements for participating in Medicare. Most HHAs participate in both the Medicare and Medicaid programs. However, even those HHAs that participate solely in Medicaid but not in Medicare must meet the Medicare requirements. Therefore, the following discussion, which is directed to Medicare HHAs, must be read to apply also to HHAs that seek participation in both programs or only in the Medicaid program. However, in the case of Medicaid-only HHAs, the Medicaid State agency is responsible for determining whether the capitalization requirements set forth in 42 CFR 489.28 are met in the same manner that Medicare intermediaries make the determination for HHAs requesting to enter the Medicare program only or both the Medicare and Medicaid programs. As discussed further below, through our Medicare intermediaries we will determine the amount of capital that each new HHA is required to have before becoming certified in the Medicare program. This amount is to enable the HHA to operate for three months after becoming certified to participate as a Medicare provider of services. That is, as of the date that the HHA becomes certified in the Medicare program, which sometimes could be retroactive back to the date the HHA met all condition level requirements, it must have available the amount of capital determined by us as sufficient under criteria established by this rule. After the date of certification, it is expected that the HHA will expend some, or in some cases all, of the funds in providing care to its patients, including Medicare beneficiaries, pending developing a stream of patient care revenue from Medicare and other payers. There may be several ways to structure a capitalization requirement for new HHAs, but we believe the method discussed below is reasonable and likely to meet the objectives of enhancing the financial viability of the Medicare program. We will determine the sufficiency of the capitalization of an HHA that seeks to participate in the program based on the first-year experience of other HHAs, i.e., on cost data from submitted cost reports for the first full year of operation from at least three other comparable HHAs. Although a number of factors could be relevant in determining an adequate capitalization amount, we believe the following core-approach serves to tailor the capitalization needed by an HHA which is seeking to participate in the Medicare program. First, the intermediary determines an average cost per visit based on first-year cost report data from the as-filed cost reports for at least three HHAs that it serves that are comparable to the HHA that is seeking to enter the Medicare program, considering such factors as geographic location and urban/rural status, number of visits, provider- based vs. free-standing, and proprietary vs. non-proprietary status. The average cost per visit is determined by dividing the sum of the total reported costs of care for all patients of the HHAs by the sum of their total visits. Then, the intermediary multiplies the average cost per visit by the projected number of visits for all patients (Medicare, Medicaid, and all other patients) for the first three months of operation of the HHA that is seeking to enter the program. By developing an average cost per visit using first year cost data from at least three comparable HHAs in the same area, then applying this cost per visit to the new HHA's own projected visits, the initial reserve operating funds so determined should closely approximate the needs of the new HHA. Finally, if the number of annual visits projected by the HHA seeking to enter the program is less than 90 percent of the average number of annual visits reported by the HHAs from which the average cost per visit was developed (that is, total reported visits divided by the total number of HHAs used), the intermediary will substitute for the HHA's projected visits 90 percent of one calendar quarter of the average reported visits (that is, the average number of visits for three months) for the new HHAs already in the program. This step serves to set a reserve amount for the new HHA in line with the experience of comparable HHAs in the same area and prevents the new HHA from being undercapitalized, and putting the HHA and the Medicare program at risk. The intermediary also will submit the average cost per visit that it has developed to the HCFA regional office that is involved in certifying the HHA. [[Page 297]] We will collect this information and analyze it to determine the feasibility of establishing average per visit costs regionally or centrally or developing some other measure of initial capitalization. Following publication of these new regulations, we will develop program instructions that will describe this process more fully. The process we have laid out here will work acceptably, we believe, because regional home health intermediaries (RHHIs) serving HHAs are limited in number and have both the expertise and recent cost reporting files to estimate the capital requirements laid out in this rule. We recognize, however, that the process relies to some extent on the recent cost reports available to the RHHIs and that it could be improved if the capitalization amounts required could be derived from a larger data base and could be computed to a greater degree by provider type. We have recently begun to receive HHA cost reports in an automated system; however, the available reports are limited and additional information from survey and certification files and HHA claims data would be necessary to help develop the data we need. We have begun to look at these data to determine if it is feasible to compute capitalization amounts from them. If so, we will use this data in further developing in the future, the capitalization requirements established in this final rule. The HHA must provide us sufficient evidence to prove that the initial reserve operating funds are available to it and that at least 50 percent of the amount comprises the HHA's own, non-borrowed funds which are not in any way encumbered. If an owner uses his/her own funds in the business, whether loaned or contributed to the business, the funds are considered the owner's investment in the business and, therefore, those funds are part of the HHA's own funds. (However, if the owner lends funds to the business, any interest the HHA pays the owner would not be allowable as interest under the Medicare program (42 CFR 413.153(c)(1)). If an organization plans to do business with the Medicare program as a new HHA, we believe it is reasonable that it would have 50 percent of the capitalization requirement as non-borrowed funds. Fifty percent of the requirement in non-borrowed funds demonstrates that the organization is earnest in its attempt to become a financially sound provider of home health services under the Medicare program. And from Medicare's perspective, 50 percent of the capitalization minimizes Medicare's risk that the HHA will become financially insolvent in the beginning stages of starting its business. At least one State, (the State of New York), which imposes operating capital requirements as part of its certificate-of-need process for HHAs, requires the applying HHA to document that it has contributed at least 50 percent of its own (non-borrowed) funds in meeting the capital requirement. To support that the HHA has met the requirement, it must provide the intermediary with a copy of the statement(s) of the HHA's savings, checking, or other account(s) which contain(s) the funds, accompanied by an attestation from an officer of the bank or other financial institution that the funds are in the account(s) and are immediately available. Although Medicare generally expects the funds available to be cash funds, in some cases an HHA may have all or part of the initial reserve operating funds in cash equivalents. For the purposes of this section, cash equivalents are short-term, highly liquid investments that are readily convertible to known amounts of cash and that present insignificant risk of changes in value. If a cash equivalent is not readily convertible to a known amount of cash as needed during the initial three month period for which the initial reserve operating funds are required, the cash equivalent does not qualify in meeting the initial reserve operating funds requirement. Examples of items commonly considered to be cash equivalents are Treasury bills, commercial paper, and money market funds. As with funds in a checking, savings, or other account, the HHA also must be able to document the availability of any cash equivalents. Depending on the elapsed time between the time the HHA originally establishes that it has the funds available and the time needed for us to determine that the HHA has met all other requirements necessary for certification, we later may require the HHA to furnish us with another attestation from the financial institution that the funds remain available upon the HHA's certification into the Medicare program or, if applicable, documentation from the HHA that any cash equivalents remain available. Also, the officer at the HHA who will be certifying to the accuracy of the information on the HHA's cost report must certify as to the portion of the required initial reserve operating funds that constitutes non-borrowed funds, an amount which must be at least 50 percent of the total required funds. The remainder of the initial reserve operating funds may be secured through borrowing or line of credit from an unrelated lender. An unrelated lender is defined in the regulations providing for the reimbursement of allowable interest expense under the Medicare program. In determining whether interest is proper under the Medicare program, 42 CFR 413.153(b)(3) provides that ``interest be--(ii) Paid to a lender not related through control or ownership, or personal relationship to the borrowing organization.'' Funds borrowed from a person or entity contrary to the provisions in Sec. 413.153(b)(3)(ii) do not qualify as funds to meet the initial reserve operating funds requirement. If borrowed funds are not in the same account(s) as the provider's own funds, the HHA also must provide proof that the borrowed funds are available for use in operating the HHA, by providing to the intermediary a copy of the statement(s) of the HHA's savings, checking, or other account(s) containing the borrowed funds, accompanied by an attestation from an officer of the bank or other financial institution that the funds are in the account(s) and are immediately available. As with the provider's own funds, we later may require the HHA to furnish another attestation by the financial institution that the funds remain available upon the HHA's certification into the Medicare program. If the HHA chooses to establish the availability of a portion of the initial reserve operating funds with a line of credit, it must provide the intermediary with a letter of credit from the lender. As with funds in a bank or other financial institution, as discussed above, we later may require the HHA to furnish us with an attestation from the lender that the HHA, upon its certification into the Medicare program, continues to be approved to borrow the amount specified in the letter of credit. We will not enter into a provider agreement with an HHA until we are satisfied, through the intermediary, that the capitalization requirement has been met, that is, that the HHA has the initial reserve operating funds available as discussed above. V. Provisions of the Final Rule With Comment Period A. Surety Bond Requirements Under Medicare We are adding a new Subpart F to 42 CFR part 489, consisting of Secs. 489.60 through 489.73, to establish the surety bond requirements that pertain to HHAs under Medicare. In Sec. 489.60 (``Definitions'') we specify the meaning of the terms ``assessment'', ``assets'', ``civil money penalty'', ``participating home health agency'', [[Page 298]] ``surety bond'', ``unpaid civil money penalty or assessment'', and ``unpaid claim'' to clarify the meaning of these terms in the context of the surety bond requirements. We define the terms as follows: Assessment means a sum certain that HCFA may assess against an HHA in lieu of damages under Titles XI, XVIII, or XXI of the Social Security Act or under regulations in this chapter. Assets includes but is not limited to any listing that identifies Medicare beneficiaries to whom home health services were furnished by a participating or formerly participating HHA. Civil money penalty means a sum certain that HCFA has the authority to impose on an HHA as a penalty under Titles XI, XVIII, or XXI of the Social Security Act or under regulations in this chapter. Participating home health agency means a ``home health agency'' (HHA), as that term is defined by section 1861(o) of the Social Security Act, that also meets the definition of a ``provider'' as set forth at Sec. 400.202 of this chapter. Surety bond means one or more bonds issued by one or more surety companies under 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225, provided the bond otherwise meets the requirements of this section. Unpaid civil money penalty or assessment means a civil money penalty or assessment imposed by HCFA on an HHA under Titles XI, XVIII, or XXI of the Social Security Act, plus accrued interest, that, 90 days after the HHA has exhausted all administrative appeals, remains unpaid (because the civil money penalty or assessment has not been paid to, or offset or compromised by, HCFA) and is not the subject of a written arrangement, acceptable to HCFA, for payment by the HHA. In the event a written arrangement for payment, acceptable to HCFA, is made, an unpaid civil money penalty or assessment also means such civil money penalty or assessment, plus accrued interest, that remains due 60 days after the HHA's default on such arrangement. Unpaid claim means a Medicare overpayment for which the HHA is responsible, plus accrued interest, that, 90 days after the date of the agency's notice to the HHA of the overpayment, remains due (because the overpayment has not been paid to, or recouped or compromised by, HCFA) and is not the subject of a written arrangement, acceptable to HCFA, for payment by the HHA. In the event a written arrangement for payment, acceptable to HCFA, is made, an unpaid claim also means a Medicare overpayment for which the HHA is responsible, plus accrued interest, that remains due 60 days after the HHA's default on such arrangement. In Sec. 489.61 (``Basic requirement for surety bonds'') we stipulate that, in general, each Medicare participating HHA or HHA that seeks to become a Medicare participating HHA must obtain and furnish us with a copy of a surety bond. The BBA '97 requires that HHAs must obtain a surety bond effective January 1, 1998. In addition, we believe that requiring a HHA to purchase a surety bond will help ensure that we are able to recover overpayments we cannot collect using other methods. In Sec. 489.62 (``Requirement waived for Government-operated HHAs'') we stipulate that, under certain conditions, government- operated HHAs are deemed to have furnished a comparable surety bond under State law. When the necessary conditions are met, we waive the bond requirement. We believe that government-operated HHAs tend not to use fraudulent or abusive Medicare billing practices and when overpaid almost invariably honor their debts. Our anecdotal experience suggests that such HHAs timely pay their Medicare debts. More importantly, given the taxing authority of the government of which the HHA is a part, such government will generally be able to raise funds to meet its just debts. As such, we believe such taxing power affords us a comparable if not greater level of protection as would a surety bond issued by a private surety company and that any Medicare debt a government-operated HHA might inadvertently incur would be easily collectible. Therefore, we believe that government-operated HHAs represent a minimum risk to Medicare. Consequently, we have waived the surety bond requirement for government-operated HHAs to the extent such HHAs have a good history of paying their Medicare debts. Government-operated HHAs with a poor history of paying their Medicare debts, if there are any such HHAs, will not meet the standard necessary for waiver of the surety bond requirement. In Sec. 489.63 (``Parties to the bond'') we specify the format of the names of the three entities on the bond. This provides guidance to the HHA as to how to name the three parties to the bond. By specifically naming the parties to the bond in this manner, clarity is provided as to the rights and obligations of each party of this three- party instrument. In Sec. 489.64 (``Authorized Surety and exclusion of surety companies'') we stipulate that the surety bond must be obtained from an Authorized Surety and define what conditions must be met for a surety company to be considered an Authorized Surety under this section. We believe that allowing HHAs to obtain bonds only from surety companies that have been issued a Certificate of Authority by the U.S. Department of the Treasury helps ensure that the HHA is obtaining a bond from a company that meets certain minimum standards. To ensure that the HHA has properly fulfilled the surety bond requirement as specified in this rule, we will ask the Surety to furnish timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a bond the HHA has furnished to us. If the Surety fails to comply with our request for such information, we will determine the Surety to be unauthorized as a source of bonds for Medicare purposes, since without such confirmation from the Surety we can not determine if the HHA has properly complied with the surety bond requirements. Similarly, if we demand payment according to the terms of the bond, and the Surety fails without justification to pay us, we may determine that such surety company cannot be relied upon to fulfill its commitments and may then determine the surety company to be unauthorized for future use by any HHA. If a Surety is determined to be an unauthorized surety company, we also determine whether and how such a determination will affect HHAs that have obtained a current bond from the now unauthorized company. We may require that HHAs obtain replacement bonds. A determination by us that a surety company is an unauthorized surety company for the purposes of this rule is not a debarment, suspension, or exclusion for the purposes of Executive Order 12549. Section 489.65 (``Amount of the bond'') covers the methods of how to calculate the surety bond amount for participating HHAs and HHAs that seek to participate in Medicare. We believe that 15 percent of the annual Medicare payments received by the HHA during its fiscal year is generally a reasonable percentage on which to base the amount of the bond, subject to the statutory minimum of $50,000. By using 15 percent of the amount of annual Medicare payments, the amount of the surety bond and the premium for the surety bond are directly tied to the amount of Medicare payments received by the HHA. As stated earlier, in 1993 overpayments were 4 percent of total Medicare payments made to all HHAs. In 1996, overpayments were 7 percent of total Medicare payments made to all [[Page 299]] HHAs. Of course, the percentage of overpayments to total payments for a particular HHA could be significantly higher. However, we believe that the 15 percent standard is a generally reasonable level and will usually ensure that we recover most uncollectible overpayments. Also, we believe that the 15 percent is a reasonable percentage on which to base the amount of the bond, since it would not be too high as to be a barrier for small companies, yet high enough to provide the Trust Funds with a reasonable ability to recover debts owed to the program. In determining this percentage amount, we consulted with an insurance industry trade group. However, we recognize that the 15 percent standard may be insufficient for HHAs that incur large overpayments. Therefore, instead of applying the 15 percent standard to such HHAs, we may require a bond greater than 15 percent of annual payments if the HHA's overpayments exceed that percentage of payments. Section 489.66 (``Additional requirements of the surety bond'') specifies the bases under which the Surety becomes liable to pay HCFA under the bond, and the conditions under which the Surety's guarantee to HCFA under the bond is not extinguished. Although a surety bond requirement has been implemented in other Federal government agencies, it is new to us as an element of program administration. Therefore, we believe that in order to provide maximum protection to Medicare, it is our obligation to provide specific guidance to the HHAs as to the terms that must be included in the bond. In Sec. 489.67 (``Submission date and term of the bond'') we specify when HHAs must submit their initial and subsequent surety bonds. We believe neither a multi-year bond nor a continuous bond gives Medicare the level of protection of a one-year bond. The Medicare payments received by HHAs change yearly, usually increasing. Thus, a one-year bond makes it easier to administratively tie the required bond amount with a particular year's Medicare payments, helping to eliminate confusion for the HHA, the Surety, and us if we demand payment from the Surety. We chose for an initial term of the bond a period from January 1, 1998 to the close of each HHA's current fiscal year. (``Current'' means as of January 1, 1998, and not as the date of the publication of the rule.) In Sec. 489.68 (``Effect of failure to obtain, maintain, and timely file a surety bond'') we state that failure to obtain a surety bond in accordance with this rule is a sufficient basis for us to terminate an HHA's provider agreement or for us to refuse to enter into such an agreement. Such a policy is an administratively efficient means of enforcing the surety bond requirement while affording participating HHAs and HHAs that wish to participate in Medicare appropriate rights of due process as specified in 42 CFR part 498. In Sec. 489.69 (``Evidence of compliance'') we specify that we may, at any time and in a manner we choose, require an HHA to demonstrate that the HHA is in compliance with the surety bond requirements. We also provide that the failure of the HHA to demonstrate such compliance is sufficient reason to terminate the HHA's provider agreement or refuse to enter into such an agreement. We believe that in order to ensure that an HHA not only obtains a surety bond but also that it does not terminate the bond during the bond's one-year term, it is necessary that we have the ability to make sure the bond is still in effect. In addition, conditions may arise, such as the Surety terminating its business operations, where the bond may become unenforceable. Therefore, in order to safeguard our ability to recover on unpaid debts from HHAs, a method is needed to ascertain the continuing validity of the financial security represented by the bond we have been furnished. Also, if the Surety's liability is renewed each year up to the limit of the surety bond, any penalties and assessments have a greater opportunity of being repaid by the HHA. If a one-year bond is required, it is easier to link the Surety's liability with a particular term of the bond and the fiscal year. In Sec. 489.70 (``Effect of payment by the Surety'') the payment by the Surety to HCFA on the bond constitutes collection of the unpaid claim or unpaid civil money penalty or assessment owed by the HHA and is a sufficient basis for termination of the HHA's provider agreement. We believe that having to resort to the Surety for payment of a Medicare debt owed by the HHA, and having the Surety acknowledge our demand for payment as valid, is a sufficient basis to conclude that the HHA is not complying with the provisions of Title XVIII and our implementing regulations. In Sec. 489.71 (``Surety's standing to appeal Medicare determinations'') we specify that a Surety has the same appeal rights of the HHA, provided the Surety has paid us under the surety bond, the HHA has assigned its right of appeal to the Surety, and the Surety satisfies all jurisdictional and procedural requirements that applied to the HHA. By extending appeal rights to the Surety in this manner, we are further protecting it from improper financial loss in those cases where the HHA did not exercise the HHA's appeal rights and our demand for and receipt of payment under the bond was erroneously determined. In Sec. 489.72 (``Effect of review reversing HCFA's determination'') we specify that if a Surety has paid HCFA on the basis of a Medicare debt incurred by an HHA and the HHA (or the Surety) successfully appeals HCFA's determination that was the basis of the debt (and the Surety's payment), then HCFA will refund to the Surety the amount that the Surety paid to HCFA to the extent such amount relates to the successful appeal, provided all review, including judicial review, has been completed on the matter. We believe this provision protects the Surety from undue financial loss due to error on our part. In Sec. 489.73 (``Incorporation into existing provider agreements'') we specify that the requirements of Subpart F of Part 489 are deemed incorporated into existing HHA provider agreements effective January 1, 1998. Due to the BBA '97, we must incorporate the HHA surety bond requirement into all HHA provider agreements by January 1, 1998. Given that the BBA '97 was enacted in August 1997, we find that the only practicable means to accomplish this task in timely fashion is by our regulatory authority. In new Sec. 413.92 we specify that the costs incurred by a HHA to obtain a surety bond are not included as allowable Medicare costs. This provision implements section 4312(b)(2) of the BBA '97 which amended section 1861(v)(1)(H) of the Act to exclude the cost of these surety bonds as a reimbursable cost under Medicare. B. Surety Bonds Requirements Under Medicaid We have established a new Sec. 441.16 (the previous Sec. 441.16 is redesignated as Sec. 441.17) to specify the prohibition on FFP in expenditures for home health services unless the HHA meets the surety bond requirements. In this section, we also include the surety bond requirements specific to Medicaid. As discussed earlier, generally, we are adopting the surety bond requirements under Medicare for the requirements under Medicaid. However, there are program differences that require changes to the Medicare program requirements and are reflected in the discussion below of the changes to the Medicaid regulations. [[Page 300]] In Sec. 441.16(a) we define the terms ``assets'', ``participating home health agency'', ``surety bond'', and ``uncollected overpayment'' as these terms apply to Medicaid. Section 441.16(b) contains the prohibition on FFP provision. Section 441.16(c) includes the basic requirement for the HHA to obtain a surety bond and furnish a copy of the bond to the Medicaid agency. Section 441.16(d) allows government-operated HHAs, under certain conditions, to be exempt from the surety bond requirements under Medicaid as we have allowed them under Medicare except that we have not included provisions for unpaid civil money penalties or assessments and having claims referred to the Department of Justice or the General Accounting Office (which are not applicable under Medicaid). In Sec. 441.16(e), we define the parties to the bond. Under paragraph (f)(1) of Sec. 441.16, we stipulate that an HHA may obtain a surety bond only from an authorized surety. We have expanded the Medicare provision on the definition of an authorized surety for Medicaid purposes to allow the Medicaid agency to include any other conditions that the Medicaid agency considers necessary for the proper and efficient administration of the program. We also have included the Medicare criteria for determining an unauthorized surety under paragraph (f)(2). Under paragraph (f)(3) of Sec. 441.16, we have allowed the Medicaid agency to specify the manner by which public notification of a determination of an unauthorized Surety is given and the effective date of the determination instead of the determination being published in the Federal Register. In Sec. 441.16(g), we stipulate that the amount of the bond must be $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the State Medicaid agency for home health services furnished for which FFP is available, whichever is greater. The computation of the 15 percent for participating HHAs is to be done by the State Medicaid agency on the basis of Medicaid payments made to the HHA for the most recent annual period for which information is available as specified by the State Medicaid agency. Likewise, the computation of 15 percent for an HHA that seeks to become a participating HHA by obtaining assets or ownership interest is computed using the most recent annual period as specified by the State Medicaid agency. The 15 percent computation does not apply to an HHA that seeks to become a participating HHA without obtaining assets or ownership interest. However, we recognize that the 15 percent standard may be insufficient for HHAs that incur large overpayments. Therefore, instead of applying the 15 percent standard to these HHAs, we are providing that the State Medicaid agency may require a bond greater than 15 percent of annual payments if the HHA's overpayments exceed that percentage of payments. In paragraph (h) of Sec. 441.16 we include the same Medicare provisions on the surety's liability for full and timely payment of the HHA's unpaid overpayments, up to the stated amount of the bond, plus accrued interest, as applicable, for which the HHA is responsible. However, we do not include provisions relating to unpaid civil money penalties or assessments, which are not imposed by us or the States with respect to Medicaid. This section also includes the conditions under which the Surety's liability is not extinguished. In paragraph (h)(1) we have specified the submission dates and terms of the bond. For all participating HHAs, we have made the initial term of the bond to be effective from January 1, 1998 through a date specified by the State Medicaid agency. For subsequent terms, we have provided that the State may specify the date by which a bond must be submitted, and that the term will be effective for an annual period as specified by the Medicaid agency. We require that an HHA that seeks to become a participating HHA must submit a surety bond before a provider agreement under Sec. 431.107 of the Medicaid regulations can be entered into. An HHA that experiences a change of ownership (as ``change of ownership'' is defined by the State Medicaid agency) must submit a surety bond effective the date of the change of ownership for a term through a date specified by the State Medicaid agency. We also require that a government-operated HHA that does not qualify for waiver submit a surety bond. In addition, we require that an HHA that obtains a replacement surety bond from a different surety to cover the remaining term of a previously obtained bond must submit the new surety bond to the State Medicaid agency within 60 days (or such earlier date as the State Medicaid agency may specify) of obtaining it from the new Surety for an annual term specified by the State Medicaid agency. Section 441.16(j) specifies the effect of an HHA's failure to obtain, maintain, and timely file a surety bond. Section 441.16(k) specifies that the State Medicaid agency may require an HHA to furnish further evidence of compliance with the surety bond requirement and also specifies actions the Medicaid agency may take if the HHA fails to furnish it with such evidence of compliance. Section 441.16(l) allows the Medicaid agency to establish procedures for granting or denying appeal rights to sureties since the Medicare appeal procedures would not be applicable for State agencies. C. Capitalization We are adding new Sec. 489.28 to establish an initial reserve operating fund requirement for HHAs that are seeking, for the first time, to participate in the Medicare program on or after January 1, 1998. Under this requirement, HCFA, through its intermediaries, will determine the amount of reserve funds that each new HHA is required to have before becoming certified in the Medicare program. We are also revising the Medicaid regulations at Sec. 440.70(d), which already apply the Medicare HHA requirements for participation to Medicaid, to reference the Medicare capitalization requirement in Sec. 489.28. This initial reserve operating fund requirement is to ensure that the HHA will be able to operate for three months after becoming certified to participate as a Medicare provider of services. The required amount is based on the average cost per visit of comparable new HHAs, using data from submitted cost reports from those HHAs for the first full year of operation. The HHA must provide proof that it has the funds to meet the requirement, with no more than 50 percent of the funds being borrowed funds, and that the funds are immediately available. The purpose of this requirement is to establish the financial stability of HHAs newly entering the Medicare program and thus to assure quality of care to the HHA's patients, including Medicare beneficiaries. The requirement is being established in order to increase the likelihood of the viability of an HHA entering the program and to minimize situations that could adversely affect the health and safety of its patients. Lack of adequate initial reserve operating funds, that is, undercapitalization, sets up a new HHA for potential problems from the beginning, exposes Medicare to unnecessary risk, and can adversely affect the quality of care to the HHA's patients. We are establishing the requirement now because we believe it is urgently needed, particularly in light of the findings of the Office of Inspector General that problem HHAs entering the Medicare program are almost always undercapitalized--often with not even [[Page 301]] enough cash on hand to meet the first payroll. VI. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, agencies are required to provide a 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: Whether the information collection is necessary and useful to carry out the proper functions of the agency; The accuracy of the agency's estimate of the information collection burden; The quality, utility, and clarity of the information to be collected; and Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are, however, requesting an emergency review of this final rule with comment period. In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we are submitting to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed before the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320, to ensure compliance with section 4312(b) and 4724(b) of BBA '97 which requires Medicare and Medicaid participating HHAs to secure a surety bond, as of January 1, 1998, in order to continue participation in the Medicare and Medicaid programs. We cannot reasonably comply with normal clearance procedures because public harm is likely to result if the agency cannot enforce the capitalization requirement to prevent undercapitalized HHAs from entering the Medicare program or cannot enforce the surety bond requirements of the BBA '97 in order to protect the Federal government (especially the Medicare Trust Funds) from losses due to uncollectible debts incurred by HHAs. HCFA is requesting OMB review and approval of this collection within 3 working days from the date of publication of this regulation, with a 180-day approval period. Written comments and recommendations will be accepted from the public if received by the individuals designated below within 2 working days from the date of publication of this regulation. During this 180-day period, we will publish a separate Federal Register notice announcing the initiation of an extensive 60-day agency review and public comment period on these requirements. We will submit the requirements for OMB review and an extension of this emergency approval. We are soliciting public comment on each of these issues for the provisions summarized below that contain information collection requirements: Section 441.16 Home health agency requirements for surety bonds. Section 441.16(h)(3)(i) requires that a Surety must furnish the Medicaid agency with notice of any action by the HHA or the Surety to terminate or limit the scope or term of the bond and that such notice must be furnished not later than 10 days after the date of notice of such action by the HHA, or not later than 60 days before the effective date of the action by the Surety. The burden associated with this requirement is the time required for a Surety to provide a State Medicaid agency with a notice no later than 10 days after any action by the HHA or the Surety to terminate or limit the scope or term of the bond. HCFA met with surety bond industry representatives to discuss the time and effort associated with furnishing a notice to terminate or limit the scope or term of a bond. It is estimated that less than 1 percent (80 entities) of all 8,062 participating HHAs will terminate or limit the scope or term of a bond. It is also estimated that it will take a surety company 5 minutes to generate and furnish a notice of such action (80 entities * 5 minutes = 400 minutes or 7 hours). Section 441.16(i) requires each participating HHA that is not exempted by paragraph (d) of this section to submit to the Medicaid agency an initial surety bond by February 27, 1998, effective for the term January 1, 1998, through a date specified by the State Medicaid agency and for subsequent terms annually thereafter by a date as the Medicaid agency may specify, effective for an annual period specified by the Medicaid agency. The burden associated with this requirement is the time required for each participating HHA to furnish the Medicaid agency a copy of a surety bond with original signatures on an annual basis. It is estimated that it will take 8,062 providers 5 minutes for an annual burden of 40,310 minutes = 672 hours. Section 441.16(i)(2)(i) requires that HHAs seeking to become a Medicaid participating HHA must submit a surety bond before a provider agreement described under Sec. 431.107 of this subchapter can be entered into. The burden associated with this requirement is the time required for each HHA seeking Medicaid participation to furnish the State agency with a copy of a surety bond with original signatures. It is estimated that it will take 900 new providers 5 minutes for an annual burden of 4,500 minutes that is 75 hours. Section 441.16(i)(3) requires an HHA that undergoes a change of ownership to furnish the State agency with a copy of a surety bond with original signatures effective from the date of the change of ownership. The burden associated with this requirement is the time required for each participating HHA that undergoes a change in ownership to furnish the Medicaid agency a copy of a surety bond with original signatures. It is estimated that it will take 287 providers 5 minutes for an annual burden of 1,435 minutes, that is 24 hours. Section 441.16(i)(4) requires that a government-operated HHA, that as of January 1, 1998 meets the criteria for waiver of the requirements of this section but thereafter is determined by the Medicaid agency to not meet such criteria, must submit a surety bond within 60 days after it receives notice from the Medicaid agency that it no longer meets the criteria for waiver. The burden associated with this requirement is the time required for each government-operated HHA that no longer meets the criteria for waiver to furnish the State agency a copy of a surety bond with original signatures. It is estimated that on an annual basis less then 10 entities will be required to comply with this information collection. Section 441.16(i)(5) requires that an HHA that obtains a replacement surety bond from a different Surety to cover the remaining term of a previously obtained bond must submit the new surety bond to the Medicaid agency within 60 days (or such earlier date as the Medicaid agency may specify) of obtaining it from the new Surety for a term specified by the Medicaid agency. The burden associated with this requirement is the time required for each HHA that obtains a replacement surety bond to furnish the State agency with a copy of a surety bond with original signatures. It is estimated that it will take 80 providers 5 minutes for an annual burden of 400 minutes, that is, 7 hours. Section 489.28 Required proof of availability of initial reserve operating funds. In summary, the information [[Page 302]] collection requirements for capitalization referenced in Sec. 489.28 requires that an HHA seeking to participate in the Medicare and/or Medicaid program on or after January 1, 1998, must demonstrate that it has sufficient capital, that is, ``initial reserve operating funds,'' to operate for the initial three months of its participation in the program. In particular, the HHA must provide HCFA or the State Medicaid agency a copy of the statement(s) of the HHAs savings, checking, or other account(s) which contain the funds, (e.g. cash, cash equivalents, borrowed funds or line of credit) accompanied by an attestation from an officer of the bank or other financial institution that the funds are in the account(s) and are immediately available. We estimate that the annual number of HHAs submitting this information to be 900, based on the average number of new HHAs entering the Medicare and/or Medicaid program from 1994 through 1996. An HHA, whether it requests participation in both Medicare and Medicaid, or in one program only, will have to submit this information only once. We estimate this activity to take approximately 900 entities 30 minutes for an annual burden of 450 hours. Section 489.66 Additional requirements of the surety bond. Section 489.66 (c)(1) provides that the Surety's liability on the bond is not extinguished unless, in the event the HHA or the Surety takes any action to terminate or limit the scope or term of the bond, the Surety furnishes us with notice of such action not later than 10 days after receiving notice of such action by the HHA, or not later than 60 days before the effective date of such action by the Surety. The burden associated with this requirement is the time required for a Surety to provide Medicare with a notice no later than 10 days after any action by the HHA or the Surety to terminate or limit the scope or term of the bond. It is estimated that less than 1 percent (80 entities) of all 8,062 participating HHAs will terminate or limit the scope or term of a bond. It is also estimated that it will take a surety company 5 minutes to generate and furnish a notice of such action (80 entities at 5 minutes = 400 minutes or 7 hours). Section 489.67 Submission date and term of the bond. Section 489.67(a) requires each participating HHA that does not meet the criteria for waiver under Sec. 489.62 must submit to HCFA, in such a form as HCFA may specify, a surety bond by February 27, 1998, effective for the term beginning January 1, 1998, through the end of the HHA's fiscal year and for subsequent terms not later than 30 days before the HHA's fiscal year, effective for a term concurrent with the HHA's fiscal year. The burden associated with this requirement is the time required for each Medicare participating HHA to furnish HCFA a copy of a surety bond with original signatures on an annual basis. It is estimated that it will take 8,062 providers 5 minutes for an annual burden of 40,310 minutes = 672 hours. Section 489.67(b)(1) requires that an HHA seeking to become a participating HHA must submit a surety bond with its enrollment application (Form HCFA-855, OMB number 0938-0685). The burden associated with this requirement is the time required for each HHA seeking Medicare participation to furnish us a copy of a surety bond with original signatures. It is estimated that it will take 900 new providers 5 minutes for an annual burden of 4,500 minutes that is 75 hours. Section 489.67(c) requires an HHA that undergoes a change of ownership to furnish HCFA a copy of a surety bond with original signatures effective from the date of the change of ownership. The burden associated with this requirement is the time required for each participating HHA that experiences a change of ownership to furnish HCFA a copy of a surety bond with original signatures. It is estimated that it will take 287 providers 5 minutes for an annual burden of 1,435 minutes, that is, 24 hours. Section 489.67(d) requires that a government-operated HHA, that as of January 1, 1998 meets the criteria for waiver under Sec. 489.62 but thereafter is determined by HCFA to not meet such criteria, must submit a surety bond within 60 days after it receives notice from HCFA that it no longer meets the criteria for waiver. The burden associated with this requirement is the time required for each government-operated HHA that no longer meets the criteria for waiver to furnish HCFA a copy of a surety bond with original signatures. It is estimated that on an annual basis less then 10 entities will be required to comply with this information collection. Section 489.67(e) requires that an HHA that obtains a replacement surety bond from a different Surety to cover the remaining term of a previously obtained bond must submit the new surety bond to HCFA within 30 days of obtaining it from the new Surety. The burden associated with this requirement is the time required for each HHA that obtains a replacement surety bond to furnish HCFA a copy of a surety bond with original signatures. It is estimated that it will take 80 providers 5 minutes for an annual burden of 400 minutes, that is, 7 hours. As a note, the provider/supplier enrollment forms HCFA-855, HCFA- 855C, HCFA-855R, and related instructions, which are currently approved under OMB Approval No. 0938-0685, are in the process of being revised to incorporate the relevant HHA surety bond requirements reflected in this regulation. In particular, an emergency clearance of these information collection requirements was also requested by HCFA. A notice was published in the Federal Register on December 18, 1997, requesting that OMB approve the revised collection by December 31, 1997. In that notice the public was given from the date of the notice's publication, until December 29, 1997 to comment on the proposed collection. It should be noted that these emergency clearances sought by HCFA would have a maximum approval period of 6 months from the date of OMB approval. Also, the addendum to this regulation displays the revised HCFA-855, HCFA-855R, HCFA-855C, and related instructions that will implement the surety bond requirements, which were submitted to OMB for emergency approval. We continue to solicit comment on these forms and instructions. The table below indicates the annual number of responses for each regulation section in this proposed rule containing information collection requirements, the average burden per response in minutes or hours, and the total annual burden hours. Estimated Annual Burden ------------------------------------------------------------------------ Average burden per Annual CFR section Responses response burden (minutes) hours ------------------------------------------------------------------------ 441.16(h)(3)(i).................. 80 5 7 [[Page 303]] 441.16(i)........................ 8,062 5 672 441.16(i)(2)(i).................. 900 30 75 441.16(i)(3)..................... 287 5 24 441.16(i)(5)..................... 80 5 7 489.28........................... 900 5 450 489.66(c)(1)..................... 80 5 7 489.67(a)........................ 8,062 5 672 489.67(b)(1)..................... 900 5 75 489.67(c)........................ 287 5 24 489.67(e)........................ 80 5 7 ------------ Total........................ ........... ........... 2,020 ------------------------------------------------------------------------ We have submitted a copy of this final rule with comment to OMB for its review of the information collection requirement. These requirements are not effective until they have been approved by OMB. A notice will be published in the Federal Register when approval is obtained. If you comment on any of these information collection and record keeping requirements, please mail copies directly to the following: Health Care Financing Administration, Office of Information Services, Information Technology Investment Management Group, Division of HCFA Enterprise Standards, Room C2-26-17, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: John Burke HCFA-1152-FC Fax number: (410) 786-1415 and, Office of Information and Regulatory Affairs, Office of Management and Budget Room 10235, New Executive Office Building Washington, D.C. 20503, Attn.: Allison Herron Eydt, HCFA Desk Officer Fax numbers: (202) 395-6974 or (202) 395-5167. VII. Impact Analyses A. Regulatory Impact Analyses We have examined the impacts of this final rule with comment period under Executive Order (E. O.) 12866, the Unfunded Mandate Reform Act of 1995, and the Regulatory Flexibility Act. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits. In addition, a Regulatory Impact Analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more annually). The Unfunded Mandate Reform Act of 1995 requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits before proposing any rule that may result in an annual expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million. The rule has no consequential effect on State, local, or tribal governments. The impact on the private sector is well below the $100 million threshold. Consistent with the Regulatory Flexibility Act, we prepare a Regulatory Flexibility Analysis (RFA) unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The RFA is to include a justification of why action is being taken, the kinds and number of small entities which the proposed rule will affect, and an explanation of any considered meaningful options that achieve the objectives and would lessen any significant adverse economic impact on the small entities. For purposes of the RFA, HHAs with annual revenues of $5 million or less and non-profit organizations are considered to be small entities. Because of the scope of this rule, all HHAs will be affected, but we do not expect that effect to be significant. Nonetheless, we have prepared the following analysis, which in conjunction with other material provided in this preamble, constitutes an analysis under the Regulatory Flexibility Act. The following regulatory impact analysis is divided into three parts to discuss separately the Medicare surety bond requirement, the Medicaid surety bond requirement, and the capitalization requirement. 1. Medicare Surety Bond Regulatory Impact Analysis Section 4312(b) of BBASec. '97 contains a requirement that HHAs obtain a surety bond in an amount not less than $50,000. In addition to using the statutory minimum amount of the bond as a floor, we link the required amount of the surety bond to the amount of Medicare payments we make to the HHA each year by establishing that the bond amount equal 15 percent of such payments. However, if that amount is not sufficient, we may link the required amount of the bond to Medicare overpayments. We believe that tying the amount of the bond to the amount of annual payments or, when necessary, the amount of Medicare overpayments will better protect the Trust Funds from losses due to uncollectible debts incurred by HHAs. Although we generally require a bond in an amount that equals 15 percent of annual Medicare payments, we recognize the 15 percent standard may be insufficient for HHAs that incur very large overpayments. Therefore, instead of applying the 15 percent standard to such HHAs, we may require a bond greater than 15 percent of annual payments if the HHA's overpayments exceed that percentage of payments. We believe one effect of our rule will be to encourage inefficient or poorly managed HHAs to reform their billing practices. Also, to the extent some HHAs are intent on providing excessive or inappropriate services or defrauding the Medicare program, this rule may discourage such HHAs from continuing to participate in the Medicare program. We expect to have a ``significant impact'' on an unknown number of such entities, effectively preventing some of them from repeating their past aberrant billing activities. The majority of HHAs will not be significantly affected by this rule. In addition, we believe this rule [[Page 304]] reinforces the behavior of HHAs that are not currently billing inappropriately, by encouraging them to continue billing only for appropriate Medicare services. We expect reduction in unrecovered program overpayments as a result of this rule either by having debts guaranteed by a surety company, or by high risk businesses being unable to obtain surety bonds and, thus, being unable to comply with their provider agreements. Because of the large influx of HHAs (nearly 450 additional HHAs come into the Medicare program each year) and because HHAs will be able to furnish services to additional beneficiaries, we do not expect an adverse effect on Medicare beneficiaries. However, we do not know precisely how many HHAs will not enter the Medicare program because of these requirements. As a result, we are soliciting comments on these foregoing assertions and assumptions. a. Rationale and purposes. We believe an HHA is an essential link in the chain of health care providers needed by Medicare beneficiaries to achieve optimum health. However, some HHAs consistently bill Medicare inappropriately and incur significant Medicare overpayments. Some of these overpayments, amounting to hundreds of millions of dollars, are never recovered. This rule will provide better protection of Medicare funds by establishing a mechanism, the surety bond, to replenish the Medicare Trust Funds from the losses incurred by unpaid debts. In addition, an HHA's failure to comply with the surety bond requirement will provide a basis for us to refuse to enter into or to terminate a Medicare provider agreement. We believe that such HHAs as are unable or unwilling to obtain a surety bond are the most likely HHAs to be unable or unwilling to repay their Medicare debts. We expect this rule to deter HHAs from abusive billing practices and from defrauding the Medicare program and, to the extent certain HHAs are not deterred, the surety bond required by this rule furnishes us with greater assurance that we may recover on Medicare debts. Fraudulent practices include billing the Medicare program for services that were not furnished, not furnishing services as billed, or not furnishing services in accordance with Medicare policies. Table 1 illustrates the total claims paid to HHAs from 1993 through 1996 and associated overpayment information for those years. This table illustrates that uncollected overpayments have been rising significantly both in absolute dollar amounts and as a percentage of the original amount of overpayment. Table 1.--Overpayments ---------------------------------------------------------------------------------------------------------------- Overpayment Annual HHA claims Original amount percentage Current Percent of Year paid to date of overpayments of claims uncollected overpayments paid overpayments uncollected ---------------------------------------------------------------------------------------------------------------- 1993........................ $9,710,473,021 $360,987,031 4 $17,976,042 5 1994........................ 12,683,597,818 567,570,313 4 25,827,042 5 1995........................ 15,430,623,631 794,637,131 5 98,646,416 12 1996........................ 14,357,504,894 1,061,157,961 7 153,628,056 14 ---------------------------------------------------------------------------------------------------------------- b. Costs. According to a home health industry source, Medicare accounts for approximately 49 percent of the average HHA's revenue. (The approximate percentage amounts for other revenue sources are: private insurance--4 percent, Medicaid--24 percent, and consumer's out- of-pocket--22 percent.) Table 2 shows the number of participating HHAs by Medicare reimbursement ranges and demonstrates that approximately 94 percent of all HHAs were paid $5 million or less by Medicare in 1996. Because Medicare accounts for approximately only 49 percent of the average HHA's total revenue, we estimate that approximately 84 percent of these HHAs would qualify as small entities under the Regulatory Flexibility Act. We estimate that these HHAs would have a total annual bond cost of approximately $9.5 million and an average annual cost per HHA of approximately $1200. Table 2.--Total Number of HHAs Arranged by Medicare Payment [Dates of Service--January to December 1996] ------------------------------------------------------------------------ Number of Dollars reimbursed HHAs ------------------------------------------------------------------------ >50,000...................................................... 744 50,001-100,000............................................... 452 100,001-200,000.............................................. 735 200,001-334,000.............................................. 767 334,001-1,000,000............................................ 2854 1,000,001-2,499,000.......................................... 2406 2,500,000-5,000,000.......................................... 939 5,000,001-10,000,000......................................... 415 10,000,001-20,000,000........................................ 103 20,000,001-30,000,000........................................ 20 30,000,001-40,000,000........................................ 6 40,000,001-50,000,000........................................ 2 50,000,001-150,000,000....................................... 0 >150,000,001................................................. 1 ---------- Totals................................................. 9444 ------------------------------------------------------------------------ There were approximately 2800 non-profit HHAs during the time period specified in Table 2. We estimate that all but 150 of them were reimbursed less than $5 million and are already part of the cost estimate developed for small businesses. By including these 150 in the small business category there would not be any significant change to the cost estimates already developed. This rule will require an HHA to have a surety bond in an amount that is the greater of $50,000 or 15 percent of Medicare payments made to the HHA in the most recent fiscal year for which a cost report is accepted, or if payments in the first six months of the current fiscal year differ from such an amount by more than 25 percent, then the amount of the bond is 15 percent of such payments projected on an annualized basis. However, if an HHA's overpayment in the most recently accepted annual cost report exceeds 15 percent, Medicare may require the HHA to secure a bond up to or equal to the amount of the overpayment, provided the amount of the bond is not less than $50,000. We believe that any additional cost attributable to the percentage of the Medicare reimbursement calculation does not represent a significant economic impact on most HHAs that will be required to purchase a surety bond in an amount greater than $50,000. Moreover, those HHAs that will incur a substantial cost for obtaining a surety bond are those few HHAs that generate Medicare billings in the tens of millions of dollars or more. In order to have some [[Page 305]] reasonable assurance of being able to recover a significant portion of otherwise unrecoverable Medicare debts, we believe that using a percentage of total annual Medicare payments to determine surety bond amounts above $50,000 is both reasonable and necessary. Thus, we have chosen alternatives that we believe are cost effective and will ensure that HHAs have bonds in appropriate amounts. Moreover, we believe that for most HHAs the cost of obtaining a surety bond will be outweighed by the benefits gained by participating in the Medicare program. Thus, the surety bond requirement should not result in substantial changes in the number of well-managed and appropriately-billing HHAs. Nonetheless, we are soliciting comments on surety bond amounts that would strengthen protection to the Medicare program and be cost effective. We believe that 15 percent is a reasonable percentage on which to base the amount of the bond since it would not be too high as to be a barrier to entry for small entities, yet high enough to provide the Medicare Trust Fund with some recourse for compensation for debts owed to the program. We are interested in comments about the reasonableness of the 15 percent amount. However, if an HHA's overpayments in the most recently accepted annual cost report exceeds 15 percent of payments, Medicare may require the HHA to secure a bond up to or equal to the amount of the overpayment, provided the amount of the bond is not less than $50,000. We solicit comments on this approach. A surety company charges its underwriting fee based on the amount of the bond. We have been advised by the Surety Association of America that for this type of surety bond the surety industry usually has an underwriting charge that ranges between $2 to $30 per thousand dollars of the face amount of the bond. However, we have also been advised by the Surety Association of America that, for such a bond as is required by this rule, the average cost is likely to be approximately $10 per thousand. Based on this average cost, Table 3 indicates the average cost of a surety bond in relation to the HHA's annual Medicare revenue. Table 3 also indicates that the total costs of bonds would be approximately $22.5 million if all Medicare participating HHAs in 1996, including government-operated HHAs, purchased surety bonds. However, as stated earlier, the requirement is waived for an HHA operated by a Federal, State, local, or tribal government agency if, during the preceding 5 years, the HHA has not had any unrecovered Medicare overpayments or unpaid civil money penalties or assessments, and has not had any HCFA claims referred to the Department of Justice or the General Accounting Office because of nonpayment. Therefore the total cost of the surety bond requirement based on the number of HHAs in calendar year 1996 is approximately $18.4 million as illustrated in Table 4. Table 3.--Cost of Surety Bond -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Average Dollars reimbursed Number Reimbursement by reimbursement Average amount cost of Total cost of of HHAs range per HHA of bond bond bonds -------------------------------------------------------------------------------------------------------------------------------------------------------- <50,000..................................................... 744 14,801,083 19,894 50,000 \1\ 500 372,000 50,001-100,001.............................................. 452 33,825,800 74,836 50,000 \1\ 500 226,000 100,001-200,000............................................. 735 107,909,794 146,816 50,000 \1\ 500 367,500 200,001-334,000............................................. 767 202,035,624 263,410 50,000 \1\ 500 383,500 334,001-1,000,000........................................... 2854 1,827,498,253 640,329 96,049 960 2,741,247 1,000,001-2,499,000......................................... 2406 3,810,798,797 1,583,873 237,581 2,376 5,716,198 2,500,000-5,000,000......................................... 939 3,256,036,561 3,467,558 520,134 5,201 4,884,055 5,000,001-10,000,000........................................ 415 2,827,979,666 6,814,409 1,022,161 10,222 4,241,969 10,000,001-20,000,000....................................... 103 1,356,573,414 13,170,616 1,975,592 19,756 2,034,860 20,000,001-30,000,000....................................... 20 462,520,233 23,126,012 3,468,902 34,689 693,780 30,000,001-40,000,000....................................... 6 207,852,076 34,642,013 5,196,302 51,963 311,778 40,000,001-50,000,000....................................... 2 95,830,624 95,830,624 14,374,594 143,746 287,492 50,000,001-150,000,000...................................... 0 0 0 0 0 0 >150,000,001................................................ 1 153,842,969 153,842,969 23,076,445 230,764 230,764 ------------------------------------------------------------------------------------------- Totals................................................ 9444 14,357,504,894 1,520,278 228,042 2,280 22,491,145 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ These costs represent the cost of the minimum bond required by BBA '97, section 4312(b). Table 4 illustrates that there are approximately 1382 government- operated HHAs. If a government-operated HHA does not qualify for a waiver, it must obtain a surety bond and submit it to us. It is estimated government-operated HHAs would account for approximately $4 million of the Medicare surety bond program cost. If government- operated HHAs are waived then their surety bond costs are removed. The net cost to the industry is then approximately $18.4 million as illustrated in Table 4. We request comment on the accuracy of these estimates. Table 4.--Surety Bond Cost by Waiving Requirement for Government-Operated HHAs -------------------------------------------------------------------------------------------------------------------------------------------------------- Number Number Total of of HHAs reimbursement of Average Average amount Average Total cost of Total number of HHAs Govt. subject HHAs subject to reimbursement of bond cost of bonds HHAs to bond bond per HHA bond -------------------------------------------------------------------------------------------------------------------------------------------------------- 9444...................................................... 1382 8062 $12,256,481,236 $1,520,278 $228,042 $2,280 $18,384,722 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 306]] We realize that surety bonds represent a new cost of approximately $18.4 million to HHAs that furnish services to Medicare beneficiaries. In addition, we note that the use of a percentage of the Medicare reimbursement method adds approximately $13.7 million more to the cost of bonds as compared to the cost that would be incurred by HHAs if they were subject only to the $50,000 minimum amount required under the law. However, we believe that the benefits to the Medicare program and Medicare beneficiaries outweigh these additional costs. Our fiscal intermediaries report that, currently, uncollected overpayments total over $150 million (based on 1996 data per Table 1). These funds are at risk of not being recovered because the HHAs responsible for these uncollected overpayments may be unwilling to repay these debts or may go (or may have already gone) out of business. We believe that if each HHA obtains a surety bond in an amount proportional to the amount of Medicare payments it receives, the Medicare program will increase its recoveries of uncollected overpayments, thereby reducing losses to the Trust Funds. We project that there will not be any savings to the Trust Funds in fiscal year 1998 or 1999 because of the lengthy process of determining overpayments. In fiscal years 2000, 2001, and 2002, we estimate direct savings of $10 million, $20 million, and $20 million, respectively. Uncollected overpayments represented about .185 percent of total HHA payments in fiscal year 1993. We consider .185 percent the most reliable estimate because of the time lag discussed in collecting overpayments. We are estimating that the savings for each year is only half of this percentage because we do not know whether or not 15 percent of an agency's payments would cover all of their uncollectable overpayments. In addition, we believe that the sentinel effect of the surety bond, although indeterminable with any specificity, is likely to result in much higher savings to the Medicare Trust Funds beginning in fiscal year 1998. c. Discussion of alternatives. We believe it was the Congress' intent to strengthen HHA standards to protect beneficiaries and the Medicare program from fraudulent and abusive billing practices, and to protect the Trust Funds from growing losses due to unrecoverable Medicare debts incurred by HHAs. Therefore, we did not choose the alternative of requiring, across-the-board, a surety bond in the minimum statutory amount of $50,000. Instead of relying on this amount for all HHAs, we have tied the bond amount to a percentage of each HHA's annual Medicare payments. We realize this policy choice increases the cost of obtaining a bond for all HHAs that receive more than $334,000 in Medicare payments annually. However, this policy choice also increases the protection the surety bond requirement gives to the Medicare Trust Funds. We solicit comments on this approach. Although we are authorized to waive the surety bond requirement if an HHA provides a comparable surety bond under State law, with the exception of government-operated HHAs, we have not implemented that waiver authority in this rule. The limited amount of time available to us between the enactment of BBA '97 and the effective date of the surety bond requirement did not permit us sufficient time to effectively analyze the potential specifications of a general waiver provision. However, we are mindful that some States may already have, or may be considering implementing, surety bond requirements that could affect HHAs. Moreover, section 4724 of BBA '97 establishes a Medicaid surety bond requirement that the States will be implementing. We do not want to add unnecessary costs to HHAs that may be required to obtain multiple surety bonds. However, our principal concern is to safeguard the Medicare Trust Funds from the losses resulting from dramatically increasing unrecovered Medicare debts for which a growing number of HHAs are responsible. We solicit comments on useful standards and criteria for implementing a waiver of our surety bond requirements that would, nonetheless, maintain the same or a greater level of protection of the Medicare Trust Funds achieved by this rule. Because of the short duration between when BBA '97 became law and the effective date of its surety bond provision, we had little time available to develop a surety bond rule. As such, we did not attempt to also develop and secure approval for a surety bond form to accompany this rule. Instead, as described previously, we have specified certain minimum requirements of an acceptable surety bond. However, our present intention is to develop such a form and to seek approval from the Office of Management and Budget for its use. The development of such a form may eliminate the need to state in regulation some of the various requirements of a surety bond for Medicare purposes and would furnish to HHAs, the surety industry, and our own fiscal intermediaries an unambiguous standard with respect to the required format of a Medicare surety bond. We solicit comments on the advisability of mandating the use of a HCFA-designed surety bond form. In addition, we solicit recommendations regarding the format and other features of a HCFA- designed surety bond form. We have established that the Surety would be liable for unpaid civil money penalties, assessments imposed by us and for Medicare overpayments. We also considered including within the scope of the Surety's potential liability a guarantee of payment for unpaid civil money penalties and assessments that were imposed by the Office of the Inspector General. However, because of the short time period between when the BBA '97 was enacted and the effective date of the Surety bond provision, we were unable to fully consider this option. In addition, because of our unfamiliarity with surety bonds as a component of program administration, we believed that we did not fully understand how best to implement this option. We solicit comments on the advisability of including within the scope of the Surety's potential liability unpaid Office of Inspector General-imposed civil money penalties and assessments. 2. Medicaid Surety Bond Regulatory Impact Analysis Section 4724(b) of the BBA '97 contains a requirement that HHAs obtain a surety bond in a minimum amount of $50,000. In addition to using the statutory minimum amount of the bond as a floor, we link the required amount of the surety bond to the amount of estimated Medicaid payments made to the HHA each year. We follow the same rationale used for tying the amount of the bond to Medicaid payments as Medicare uses for tying the amount of the bond to Medicare payments. Likewise, we believe that the effect of our rule will mirror the justification used for imposition of the bond requirement on participating Medicare HHAs. This rule requires an HHA participating in Medicaid to have a surety bond in an amount that is the greater of $50,000 or 15 percent of annual Medicaid payments made to the HHA. However, we recognize the 15 percent standard may be insufficient for HHAs that incur large overpayments. Therefore, instead of applying the 15 percent standard to such HHAs, we may require a bond in a greater amount if the HHA's overpayments exceed that percentage of payments. In examining the impact that this final rule with comment period will have on Medicaid participating HHAs, we followed the same rationale and methodology that [[Page 307]] was used for the determination of the impact of the surety bond requirement on Medicare participating HHAs. Likewise, we expect this rule to encourage some inefficient HHAs to reform their billing practices and to deter other HHAs from abusive billing practices and from defrauding the Medicaid program. Our analysis is based on the information that there are virtually the same number of HHAs participating in Medicaid as there are in Medicare and that in 1995 total Medicaid payments for home health services amounted to approximately $1.9 billion. We have estimated the average amount of Medicaid payment per HHA and on this amount have based the total cost of surety bonds for Medicaid participating HHAs. After excluding costs associated with government-operated HHAs that meet our waiver requirements, we estimate the total cost of surety bonds for Medicaid-participating HHAs to be approximately $4.8 million. Unlike the Medicare program, the Medicaid program savings are indeterminable because there is no data comparable to the overpayment data used to produce the Medicare estimates. However, combined with the sentinel effect, we believe the Medicaid savings will equal or exceed the modest cost estimated for the bonds. Using the latest data available, the following tables show the total number of HHAs arranged by Medicaid payment, the total cost of surety bonds if all HHAs in the Medicaid program obtain a surety bond, and the cost of surety bonds if only non-government-operated HHAs in the Medicaid program had obtained a surety bond. Table 1.--Total Number of HHAs Arranged by Medicaid Payment ------------------------------------------------------------------------ Number of Dollars paid HHAs ------------------------------------------------------------------------ <50,000.................................................... 2964 50,001-100,000............................................. 1750 100,001-150,000............................................ 1244 150,001-200,000............................................ 834 200,001-334,000............................................ 1217 334,001-1,000,000.......................................... 1190 1,000,001-2,500,000........................................ 214 2,500,001-5,000,000........................................ 27 5,000,001-10,000,000....................................... 3 10,000,001-20,000,000...................................... 1 ------------ Totals................................................. 9444 ------------------------------------------------------------------------ Table 2.--Cost of Surety Bond -------------------------------------------------------------------------------------------------------------------------------------------------------- Number Reimbursement by Average Average Total cost of Dollars reimbursed of HHAs range reimbursement Average bond cost bonds -------------------------------------------------------------------------------------------------------------------------------------------------------- >50,000..................................................... 2964 $58,990,371 $19,902 $50,000 $500 $1,482,000 50,001-100,000.............................................. 1750 129,314,787 73,894 50,000 500 875,000 100,001-150,000............................................. 1244 152,441,149 122,541 50,000 500 622,000 150,001-200,000............................................. 834 144,767,688 173,582 50,000 500 417,000 200,001-334,000............................................. 1217 310,906,680 255,470 50,000 500 608,500 334,001-1,000,000........................................... 1190 647,061,386 543,749 81,562 816 970,592 1,000,001-2,500,000......................................... 214 298,295,160 1,393,903 209,085 2,091 447,443 2,500,001-5,000,000......................................... 27 87,119,660 3,226,654 483,998 4,840 130,679 5,000,001-10,000,000........................................ 3 17,578,870 5,859,623 878,944 8,789 26,368 10,000,001-20,000,000....................................... 1 20,000,000 20,000,000 3,000,000 30,000 30,000 ------------------------------------------------------------------------------------------- Totals.................................................. 9444 1,866,475,751 197,636 59,400 594 5,609,582 -------------------------------------------------------------------------------------------------------------------------------------------------------- Table 3.--Effect on Total Cost of Bonds by Waiving Requirement for Government-Operated HHAs -------------------------------------------------------------------------------------------------------------------------------------------------------- Number HHAs HHAs subject to Average Average Total number of HHAs of Govt subject bond reimbursement Average amount cost of Total cost of HHAs to bond reimbursement per HHA of bond bond bonds -------------------------------------------------------------------------------------------------------------------------------------------------------- 9444...................................................... 1382 8062 $1,593,341,432 $197,636 $59,400 $594 $4,788,697 -------------------------------------------------------------------------------------------------------------------------------------------------------- In our discussion of the Medicare surety bond requirement, we identified and invited comments on several alternative courses of action. These alternatives also apply to Medicaid, and we solicit comments on their application in that context. 3. Capitalization Regulatory Impact Analysis The effect of the capitalization requirement in this rule will be to prevent HHAs that are undercapitalized from participating in the Medicare program. Also, as provided in 42 CFR 440.70(d), a home health agency for the Medicaid program means a public or private agency or organization, or part of an agency or organization, that meets requirements for participation in Medicare. Most HHAs participate in both the Medicare and Medicaid programs. However, even those HHAs that participate in Medicaid but not Medicare must meet the Medicare requirements. Therefore, the following discussion, which is directed to Medicare HHAs, must be read to apply to HHAs that seek participation in both programs or only in the Medicaid program. We do not know if the capitalization requirement will have a significant economic impact on a substantial number of small entities. However, we believe that it will not adversely affect an HHA that is properly capitalized, that is, has sufficient operating funds to see it through the early months of operation until it develops a stream of revenue from Medicare, Medicaid, and other payers. An organization that is earnest in its attempt to be a financially sound provider of home health services under the Medicare program will already be properly capitalized without the need for Medicare to require such capitalization. Furthermore, the capitalization requirement is structured to minimize significant economic impact on new HHAs. Amounts that will be required for capitalization will be derived from actual experiences of new HHAs under Medicare, so we are confident that HHAs coming into the program should be incurring the same level of expenditures independently of our requirement. Therefore, the regulation simply captures as an entry requirement the amount of capital that [[Page 308]] actual HHAs need to operate. Accordingly, its impact on an HHA that plans to succeed with due regard for appropriate quality of patient care and without resorting to fraudulent or abusive billing practices is negligible because the HHA would need to raise this much capital despite Medicare's requirement. To the extent that any of the funds are not needed in operating the business during the first three months, the funds simply remain with the HHA. Furthermore, any possible impact that this requirement may have on HHAs entering the Medicare program is more than offset by savings to the Trust Funds in situations in which HHAs go out of business due to undercapitalization, leaving the program unable to recover overpayments. Second, the requirement should not disproportionally affect small HHAs because the amount of capitalization is based on the new HHA's projected number of visits. Therefore, in determining the capitalization for three months, HCFA will expect that an HHA that projects 25,000 visits in the first year will need only one quarter of the capitalization of an HHA projecting 100,000 visits. Of course, if HCFA determines that a new HHA has under-projected its visits, HCFA will base the capitalization on the number of visits of other new HHAs in the program that are of comparable size to the HHA seeking to enter the program. Finally, it is important to be clear that the need for this requirement is not solely related to financial concerns. Paramount to Medicare's concerns is the need for an HHA to provide quality care to its patients, including its Medicare patients. A lack of funds in reserve to operate the business until a stream of revenues can be established can seriously threaten the viability of the business. For a new HHA, any condition threatening the viability of the new business can adversely affect the quality of care to its patients and, in turn, the health and safety of those patients. That is, if lack of funds forces an HHA to close its business, to reduce staff, or to skimp on patient care services because it lacks sufficient capital to pay for the services, the overall well-being of the HHA's patients could be compromised. In fact, there could be the risk of serious ill effects as a result of patients not receiving adequate services. This capitalization requirement serves to greatly minimize that possibility. If a new HHA for some reason cannot raise the capital necessary to meet Medicare's requirement and, therefore, is not permitted to enter the Medicare program, that clearly has an economic impact on the HHA. However, we believe that such an economic impact is necessary. If the HHA cannot raise the capital, the HHA is not beginning its business on a sound financial footing. In such a case, we find the likelihood of the HHA's being forced to reduce its patient care due to reduced patient care staff or even to go out of business too great for the Medicare program, and a risk that Medicare does not want to take. Quality care is too important to risk on an HHA that may perform poorly or go out of business due to undercapitalization. We believe that many HHAs have recently entered the Medicare program undercapitalized and that, absent this rule, more would do so. As discussed above, this requirement will prevent that situation. We believe that there is no reasonable alternative to this requirement. If an HHA is to provide quality care, it must be properly capitalized to do so. B. Rural Hospital Impact Statement Section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Such an analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds. We are not preparing a rural impact statement since we have determined, and certify, that this rule would not have a significant impact on the operations of a substantial number of small rural hospitals. In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget. VIII. Waiver of Proposed Rulemaking A. Surety Bond Rules We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite prior public comment on proposed rules. The notice of proposed rulemaking can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and it incorporates a statement of the finding and its reasons in the rule issued. We find good cause to waive the notice-and-comment procedure with respect to this rule because it is impracticable to employ such a procedure in this instance with respect to both the Medicare and Medicaid regulations, because it is unnecessary with respect to the Medicare regulations, and because the delay in promulgating both the Medicare and the Medicaid regulations would be contrary to the public interest. Issuing a proposed rule with a comment period before issuing a final rule would be impracticable because the Congress has established a statutory deadline of January 1, 1998 for the implementation of the surety bond requirement (BBA '97, sections 4312(f)(2) and 4724(b)(2)). We cannot publish a proposed rule, followed by a final rule, and meet this statutory deadline. The urgency of the Congress to have us implement this requirement was underscored by its further mandate that HHA Medicare participation agreements must be amended by January 1, 1998. Further, because Federal Financial Participation (FFP) will not be available to States after January 1, 1998 for Medicaid home health services unless the surety bond requirement is met by Medicaid HHAs, and because it is necessary to tailor the requirement to the Medicaid program to address the differences between Medicare and Medicaid, it is necessary to issue a Medicaid rule by the statutory deadline. However, it would be impracticable to employ notice-and-comment procedures and accomplish these results. The only practical means of amending the Medicare participation agreements by the statutory deadline is by issuing this rule now as a final rule with comment period and deeming such agreements to be amended as of January 1, 1998 to incorporate the surety bond requirement. Similarly, the only practical means of tailoring the surety bond requirement to the Medicaid program so as to make FFP available for home health services by January 1, 1998 is by issuing this rule now as a final rule with comment period. Therefore, notice-and-comment procedures are impracticable for this rule with respect to both the Medicare and Medicaid surety bond regulations. Issuing a proposed rule prior to issuing a final rule is also unnecessary with respect to the Medicare surety bond regulation because the Congress has provided that a Medicare rule need not be issued as a proposed rule before issuing a final rule if, as here, a statute establishes a specific deadline for the implementation of a provision and the deadline is less than 150 days after the enactment of the statute in which the deadline is contained (42 U.S.C. 1395hh(b)(2)(B), section 1871(b)(2)(B) of the Social Security Act). BBA '97 was enacted on August 5, 1997, less than 150 days from the statute's effective date for the surety bond requirement of [[Page 309]] January 1, 1998. Therefore, notice-and-comment procedures are not necessary for the Medicare rule. Issuing a notice of proposed rule before issuing a final rule would also be contrary to the public interest with respect to both the Medicare and Medicaid surety bond regulations because it would prevent us from complying with the statutory deadline imposed by the Congress, would delay significantly the implementation of an effective gatekeeping device to deter undercapitalized and unscrupulous home health operators from participating in the Medicare or Medicaid program, would delay significantly the implementation of fiscal guarantees on potentially hundreds of millions of dollars of Medicare and Medicaid overpayments, and would delay significantly the issuance of essential guidance to the home health industry, the surety industry, and the State Medicaid agencies. Conversely, if notice-and-comment procedures were employed in issuing this final rule with comment, the delay would leave the Medicare Trust Funds and other Federal Government funds vulnerable to a variety of fraudulent and abusive activities at a time when certain unscrupulous operators appear to have targeted the home health industry as a means to improperly obtain Medicare and Medicaid payment. (See, e.g., Department of Health and Human Services, Office of Inspector General report--Home Health: Problem Providers and Their Impact on Medicare, OEI-09-96-00110.) Therefore, for the foregoing reasons we find that, with respect to both the Medicare and Medicaid surety bond regulations, employing notice-and-comment procedures would be contrary to the public interest. For these reasons, we find good cause to waive publishing a proposed rule and to issue this final rule with comment period. We invite written comments on this final rule and will consider comments we receive by the date and time specified in the Dates section of this preamble. Although we cannot respond to comments individually, if we change this rule as a result of our consideration of timely comments, we will respond to such comments in the preamble of the amended rule. B. Capitalization We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite prior public comment on proposed rules. The notice of proposed rulemaking can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and it incorporates a statement of the finding and its reasons in the rule issued. We find good cause to waive the notice-and-comment procedure with respect to the capitalization requirements of this rule because the delay in promulgating this rule would be contrary to the public interest. Issuing a notice of proposed rulemaking before issuing a final rule would be contrary to the public interest because to do so would permit HHAs that are undercapitalized, and therefore not adequately financially prepared to do business, to continue to enter into the Medicare and Medicaid programs. Preventing the participation in Medicare and Medicaid of undercapitalized HHAs will have an immediate positive effect in ensuring that a lack of capital will not affect care and will have an immediate sentinel effect on preventing further losses to the Medicare Trust Funds and other Federal funds due to the undercapitalization. The immediacy of this problem and the urgent need to correct it has been well documented. In its July 1997 report, ``Home Health: Problem Providers and Their Impact on Medicare'' (OEI-09-96-00110), the OIG found that entrepreneurs are able to open and operate HHAs without fixed assets or startup costs, relying almost exclusively on Medicare for income and assets. It stated, in part: If it were not for Medicare accounts receivable, problem agencies would have almost nothing to report as assets. Agencies tend to lease their office space, equipment, and vehicles. They are not required by Medicare to own anything, and they are almost always undercapitalized. On average, cash on hand and fixed assets amount to only one-fourth of total assets for HHAs, while Medicare accounts receivable frequently equal 100 percent of total assets. These agencies are almost totally dependent on Medicare to pay their salaries and other operating expenses. For a home health agency, there are virtually no startup or capitalization requirements. In many instances, the problem agencies lease everything without collateral. They * * * do not even have enough cash on hand to meet their first payroll. It is unacceptable that an HHA currently can enter the Medicare or Medicaid program with little or no reserves with which to operate. An HHA inadequately prepared to do business runs the risk of having to reduce staff or of going out of business pending receipt of a regular and continuous stream of patient care revenues. With this comes the risk of the HHA's providing inadequate care to its patients due to lack of staff or being forced to stop rendering patient care altogether. Equally importantly, a cash poor HHA limping along to provide patient care or an HHA that has gone out of business exposes Medicare and Medicaid to the risk of being unable to recover payments to the HHA which are later determined to be overpayments, resulting in a drain on the Medicare Trust Funds and other Federal funds. Publishing this final rule with comment period requiring adequate capitalization for new HHAs prevents HHAs which are not financially prepared to do business from entering the Medicare or Medicaid program, thereby greatly reducing the attendant risk of inadequate care to patients and misuse of the Medicare Trust Funds and other Federal Government funds. Employing notice of proposed rulemaking procedures, on the other hand, would continue to permit financially ill-prepared HHAs to enter these programs. Permitting a situation to continue that can result in inadequate health care to an HHA's patients, thus potentially threatening the health and safety of those patients, as well as a situation that can result in the improper disbursement of monies from the Medicare Trust Funds and other Federal funds, is contrary to the public interest. Moreover, although there is currently a moratorium in effect on the entry of new HHAs into the Medicare program, a prolonged moratorium could, itself, eventually create a threat of reduced access to home health services in some markets. Therefore, ending the moratorium timely is also in the public interest. However, ending the moratorium before the capitalization requirement is established would be counterproductive. Therefore, the capitalization requirement should be implemented without significant delay, an objective not achievable if notice and comment procedures are employed. Therefore, HCFA believes that it would be contrary to the public interest to employ notice and comment procedures to implement the capitalization requirement. For these reasons, we find good cause to waive notice and comment procedures and to issue this final rule with comment period. We invite written comments on this final rule and will consider comments we receive by the date and time specified in the DATES section of this preamble. IX. Waiver of 30-Day Interim Period Before Rule Is Effective We ordinarily make the effective date of a final rule at least 30 days after the publication of the rule in the Federal Register. However, the 30-day interim [[Page 310]] period can be waived if an agency finds good cause for making the effective date of the rule earlier than 30 days after the publication of the rule and the agency publishes a brief statement with the rule of its findings and the reasons therefore. We find good cause to make both the surety bond and the capitalization provisions of this rule effective January 1, 1998. For the reasons discussed above in VIII of this preamble ``Waiver of Proposed Rulemaking,'' i.e., because we find that making the rule effective after January 1, 1998 would be impracticable, unnecessary, and contrary to the public interest, we find good cause to waive the 30-day interim period for this rule. Therefore, we have made the effective date of this rule January 1, 1998. Although we have waived the 30-day interim period, we invite written comments on this final rule with comment period. We will consider comments we receive by the date and time specified in the DATES section of this preamble. X. Response to Comments Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments received by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we will respond to the comments in the preamble to that document. List of Subjects 42 CFR Part 413 Health facilities, Kidney diseases, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 440 Grant programs-health, Medicaid 42 CFR Part 441 Family planning, Grant programs-health, Infants and children, Medicaid, Penalties, Reporting and recordkeeping requirements. 42 CFR Part 489 Health facilities, Medicare, Reporting and recordkeeping requirements. 42 CFR Chapter IV is amended as set forth below: PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES A. Part 413 is amended as follows: 1. The authority citation for part 413 is revised to read as follows: Authority: Secs. 1102, 1861(v), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395x(v), and 1395hh). 2. Section 413.92 is added to read as follows: Sec. 413.92 Costs of surety bonds. Costs incurred by a provider to obtain a surety bond required by part 489, subpart F of this chapter are not included as allowable costs. PART 440--SERVICES: GENERAL PROVISIONS B. Part 440 is amended as follows: 1. The authority citation for part 440 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. In Sec. 440.70, paragraph (d) is revised as follows: Sec. 440.70 Home health services. * * * * * (d) ``Home health agency'' means a public or private agency or organization, or part of an agency or organization, that meets requirements for participation in Medicare, including the capitalization requirements under Sec. 489.28 of this chapter. * * * * * PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES C. Part 441 is amended as follows: 1. The authority citation for part 441 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. Section 441.10 is amended by redesignating paragraphs (h) through (k) as paragraphs (i) through (l), respectively and adding a new paragraph (h) to read as follows: Sec. 441.10 Basis. * * * * * (h) Section 1903(i)(18) for the requirement that each home health agency provide the Medicaid agency with a surety bond (Sec. 441.16). 3. In Sec. 441.15 a new paragraph (d) is added to read as follows: Sec. 441.15 Home health services * * * * * (d) The agency providing home health services meets the capitalization requirements included in Sec. 489.28 of this chapter. Sec. 441.16 [Redesignated as Sec. 441.17] 4. Section 441.16 is redesignated as Sec. 441.17. 5. A new Sec. 441.16 is added to read as follows: Sec. 441.16 Home health agency requirements for surety bonds; Prohibition on FFP. (a) Definitions. As used in this section, unless the context indicates otherwise-- Assets includes but is not limited to any listing that identifies Medicaid recipients to whom home health services were furnished by a participating or formerly participating HHA. Participating home health agency means a ``home health agency'' (HHA) as that term is defined at Sec. 440.70(d) of this subchapter. Surety bond means one or more bonds issued by one or more surety companies under 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225, provided the bond otherwise meets the requirements of this section. Uncollected overpayment means an ``overpayment,'' as that term is defined under Sec. 433.304 of this subchapter, plus accrued interest, for which the HHA is responsible, that has not been recouped by the Medicaid agency within a time period determined by the Medicaid agency. (b) Prohibition. FFP is not available in expenditures for home health services under Sec. 440.70 of this subchapter unless the home health agency furnishing these services meets the surety bond requirements of paragraphs (c) through (l) of this section. (c) Basic requirement. Except as provided in paragraph (d) of this section, each HHA that is a Medicaid participating HHA or that seeks to become a Medicaid participating HHA must-- (1) Obtain a surety bond that meets the requirements of this section and instructions issued by the Medicaid agency; and (2) Furnish a copy of the surety bond to the Medicaid agency. (d) Requirement waived for Government-operated HHAs. An HHA operated by a Federal, State, local, or tribal government agency is deemed to have provided the Medicaid agency with a comparable surety bond under State law, and is therefore exempt from [[Page 311]] the requirements of this section if, during the preceding 5 years, the HHA has not had any uncollected overpayments. (e) Parties to the bond. The surety bond must name the HHA as Principal, the Medicaid agency as Obligee, and the surety company (and its heirs, executors, administrators, successors and assignees, jointly and severally) as Surety. (f) Authorized Surety and exclusion of surety companies. An HHA may obtain a surety bond required under this section only from an authorized Surety. (1) An authorized Surety is a surety company that-- (i) Has been issued a Certificate of Authority by the U.S. Department of the Treasury in accordance with 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225 as an acceptable surety on Federal bonds and the Certificate has neither expired nor been revoked; (ii) Has not been determined by the Medicaid agency to be an unauthorized Surety for the purpose of an HHA obtaining a surety bond under this section; and (iii) Meets other conditions, as specified by the Medicaid agency. (2) The Medicaid agency may determine that a surety company is an unauthorized Surety under this section-- (i) If, upon request by the Medicaid agency, the surety company fails to furnish timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a surety bond that an HHA presents to the Medicaid agency that shows the surety company as Surety on the bond; (ii) If, upon presentation by the Medicaid agency to the surety company of a request for payment on a surety bond and of sufficient evidence to establish the surety company's liability on the bond, the surety company fails to timely pay the Medicaid agency in full the amount requested up to the face amount of the bond; or (iii) For other good cause. (3) The Medicaid agency must specify the manner by which public notification of a determination under paragraph (f)(2) of this section is given and the effective date of the determination. (4) A determination by the Medicaid agency that a surety company is an unauthorized Surety under paragraph (f)(2) of this section-- (i) Has effect only within the State; and (ii) Is not a debarment, suspension, or exclusion for the purposes of Executive Order No. 12549 (3 CFR 1986 Comp., p. 189). (g) Amount of the bond. (1) Basic rule. The amount of the surety bond must be $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services furnished under this subchapter for which FFP is available, whichever is greater. (2) Computation of the 15 percent: Participating HHA. The 15 percent is computed by the Medicaid agency on the basis of Medicaid payments made to the HHA for the most recent annual period for which information is available as specified by the Medicaid agency. (3) Computation of 15 percent: An HHA that seeks to become a participating HHA by obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA by purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent is computed on the basis of Medicaid payments made by the Medicaid agency to the participating or formerly participating HHA for the most recent annual period as specified by the Medicaid agency. (4) Computation of 15 percent: Change of ownership. For an HHA that undergoes a change of ownership (as ``change of ownership'' is defined by the State Medicaid agency) the 15 percent is computed on the basis of Medicaid payments made by the Medicaid agency to the HHA for the most recent annual period as specified by the Medicaid agency. (5) An HHA that seeks to become a participating HHA without obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA without purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent computation does not apply. (6) Exception to the basic rule. If an HHA's overpayment in the most recent annual period exceeds 15 percent, the State Medicaid agency may require the HHA to secure a bond in an amount up to or equal to the amount of the overpayment, provided the amount of the bond is not less than $50,000. (h) Additional requirements of the surety bond. The surety bond that an HHA obtains under this section must meet the following additional requirements: (1) The bond must guarantee that, upon written demand by the Medicaid agency to the Surety for payment under the bond and the Medicaid agency furnishing to the Surety sufficient evidence to establish the Surety's liability under the bond, the Surety will timely pay the Medicaid agency the amount so demanded, up to the stated amount of the bond. (2) The bond must provide that the Surety's liability for uncollected overpayments is based on overpayments that arise from Medicaid payments that are made by the Medicaid agency to the HHA during the term of the bond, regardless of when the overpayments are determined by the Medicaid agency or when the overpayments become uncollected overpayments. (3) The bond must provide that the Surety's liability to the Medicaid agency is not extinguished by any of the following: (i) Any action by the HHA or the Surety to terminate or limit the scope or term of the bond unless the Surety furnishes the Medicaid agency with notice of such action not later than 10 days after the date of notice of such action by the HHA to the Surety, or not later than 60 days before the effective date of the action by the Surety. (ii) The Surety's failure to continue to meet the requirements of paragraph (f)(1) of this section or the Medicaid agency's determination that the surety company is an unauthorized surety under paragraph (f)(2) of this section. (iii) Termination of the HHA's provider agreement described under Sec. 431.107 of this subchapter. (iv) Any action by the Medicaid agency to suspend, offset, or otherwise recover payments to the HHA. (v) Any action by the HHA to-- (A) Cease operation; (B) Sell or transfer any assets or ownership interest; (C) File for bankruptcy; or (D) Fail to pay the Surety. (vi) Any fraud, misrepresentation, or negligence by the HHA in obtaining the surety bond or by the Surety (or by the Surety's agent, if any) in issuing the surety bond, except that any fraud, misrepresentation, or negligence by the HHA in identifying to the Surety (or to the Surety's agent) the amount of Medicaid payments upon which the amount of the surety bond is determined shall not cause the Surety's liability to the Medicaid agency to exceed the amount of the bond. (vii) The HHA's failure to exercise available appeal rights under Medicaid or to assign such rights to the Surety (provided the Medicaid agency permits such rights to be assigned). (4) The bond must provide that actions under the bond may be brought by the Medicaid agency or by an agent that the Medicaid agency designates. (i) Submission date and term of the bond. (1) Each participating HHA that is not exempted by paragraph (d) of this [[Page 312]] section must submit to the Medicaid agency a surety bond as follows: (i) Initial term. By February 27, 1998, effective for the term January 1, 1998, through a date specified by the State Medicaid agency. (ii) Subsequent terms: By a date as the Medicaid agency may specify, effective for an annual period specified by the Medicaid agency. (2) HHA that seeks to become a participating HHA. (i) An HHA that seeks to become a participating HHA must submit a surety bond before a provider agreement described under Sec. 431.107 of this subchapter can be entered into. (ii) An HHA that seeks to become a participating HHA through the purchase or transfer of assets or ownership interest of a participating or formerly participating HHA must also ensure that the surety bond is effective from the date of such purchase or transfer. (3) Change of ownership. An HHA that undergoes a change of ownership (as ``change of ownership'' is defined by the State Medicaid agency) must submit the surety bond to the State Medicaid agency by such time and for such term as is specified in the instructions of the State Medicaid agency. (4) Government-operated HHA that loses its waiver. A government- operated HHA that, as of January 1, 1998, meets the criteria for waiver of the requirements of this section but thereafter is determined by the Medicaid agency to not meet such criteria, must submit a surety bond to the Medicaid agency within 60 days after it receives notice from the Medicaid agency that it does not meet the criteria for waiver. (5) Change of Surety. An HHA that obtains a replacement surety bond from a different Surety to cover the remaining term of a previously obtained bond must submit the new surety bond to the Medicaid agency within 60 days (or such earlier date as the Medicaid agency may specify) of obtaining the bond from the new Surety for a term specified by the Medicaid agency. (j) Effect of failure to obtain, maintain, and timely file a surety bond. (1) The Medicaid agency must terminate the HHA's provider agreement if the HHA fails to obtain, file timely, and maintain a surety bond in accordance with this section and the Medicaid agency's instructions. (2) The Medicaid agency must refuse to enter into a provider agreement with an HHA if an HHA seeking to become a participating HHA fails to obtain and file timely a surety bond in accordance with this section and instructions issued by the State Medicaid agency. (k) Evidence of compliance. (1) The Medicaid agency may at any time require an HHA to make a specific showing of being in compliance with the requirements of this section and may require the HHA to submit such additional evidence as the Medicaid agency considers sufficient to demonstrate the HHA's compliance. (2) The Medicaid agency may terminate the HHA's provider agreement or refuse to enter into a provider agreement if an HHA fails to timely furnish sufficient evidence at the Medicaid agency's request to demonstrate compliance with the requirements of this section. (l) Surety's standing to appeal Medicaid determinations. The Medicaid agency may establish procedures for granting or denying appeal rights to sureties. PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL D. Part 489 is amended as follows: 1. The authority citation for part 489 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 2. Section 489.1 is amended by adding a new paragraph (e) to read as follows: Sec. 489.1 Statutory basis. * * * * * (e) Section 1861(o)(7) of the Act requires each HHA to provide HCFA with a surety bond. 3. In Sec. 489.10, new paragraphs (e) and (f) are added to read as follows: Sec. 489.10 Basic requirements. * * * * * (e) In order for a home health agency to be accepted, it must also meet the surety bond requirements specified in subpart F of this part. (f) In order for a home health agency to be accepted as a new provider, it must also meet the capitalization requirements specified in subpart B of this part. 4. A new Sec. 489.28 is added to read as follows: Sec. 489.28 Special capitalization requirements for HHAs (a) Basic rule. An HHA entering the Medicare program on or after January 1, 1998, including a new HHA as a result of a change of ownership, if the change of ownership results in a new provider number being issued, must have available sufficient funds, which we term ``initial reserve operating funds,'' to operate the HHA for the three month period after its Medicare provider agreement becomes effective, exclusive of actual or projected accounts receivable from Medicare or other health care insurers. (b) Standard. Initial reserve operating funds are sufficient to meet the requirement of this section if the total amount of such funds is equal to or greater than the product of the actual average cost per visit of three or more similarly situated HHAs in their first year of operation (selected by HCFA for comparative purposes) multiplied by the number of visits projected by the HHA for its first three months of operation--or 22.5 percent (one fourth of 90 percent) of the average number of visits reported by the comparison HHAs--whichever is greater. (c) Method. HCFA, through the intermediary, will determine the amount of the initial reserve operating funds using reported cost and visit data from submitted cost reports for the first full year of operation from at least three HHAs that the intermediary serves that are comparable to the HHA that is seeking to enter the Medicare program, considering such factors as geographic location and urban/ rural status, number of visits, provider-based versus free-standing, and proprietary versus non-proprietary status. The determination of the adequacy of the required initial reserve operating funds is based on the average cost per visit of the comparable HHAs, by dividing the sum of total reported costs of the HHAs in their first year of operation by the sum of the HHAs' total reported visits. The resulting average cost per visit is then multiplied by the projected visits for the first three months of operation of the HHA seeking to enter the program, but not less than 90 percent of average visits for a three month period for the HHAs used in determining the average cost per visit. (d) Required proof of availability of initial reserve operating funds. The HHA must provide HCFA with adequate proof of the availability of initial reserve operating funds. Such proof, at a minimum, will include a copy of the statement(s) of the HHA's savings, checking, or other account(s) that contains the funds, accompanied by an attestation from an officer of the bank or other financial institution that the funds are in the account(s) and that the funds are immediately available to the HHA. In some cases, an HHA may have all or part of the initial reserve operating funds in cash equivalents. For the purpose of this section, cash equivalents are short-term, highly liquid investments that are readily convertible to known amounts of cash and that [[Page 313]] present insignificant risk of changes in value. A cash equivalent that is not readily convertible to a known amount of cash as needed during the initial three month period for which the initial reserve operating funds are required does not qualify in meeting the initial reserve operating funds requirement. Examples of cash equivalents for the purpose of this section are Treasury bills, commercial paper, and money market funds. As with funds in a checking, savings, or other account, the HHA also must be able to document the availability of any cash equivalents. HCFA later may require the HHA to furnish another attestation from the financial institution that the funds remain available, or, if applicable, documentation from the HHA that any cash equivalents remain available, until a date when the HHA will have been surveyed by the State agency or by an approved accrediting organization. The officer of the HHA who will be certifying the accuracy of the information on the HHA's cost report must certify what portion of the required initial reserve operating funds is non-borrowed funds, including funds invested in the business by the owner. That amount must be at least 50 percent of the required initial reserve operating funds. The remainder of the reserve operating funds may be secured through borrowing or line of credit from an unrelated lender. (e) Borrowed funds. If borrowed funds are not in the same account(s) as the HHA's own non-borrowed funds, the HHA also must provide proof that the borrowed funds are available for use in operating the HHA, by providing, at a minimum, a copy of the statement(s) of the HHA's savings, checking, or other account(s) containing the borrowed funds, accompanied by an attestation from an officer of the bank or other financial institution that the funds are in the account(s) and are immediately available to the HHA. As with the HHA's own (that is, non-borrowed) funds, HCFA later may require the HHA to establish the current availability of such borrowed funds, including furnishing an attestation from a financial institution or other source, as may be appropriate, and to establish that such funds will remain available until a date when the HHA will have been surveyed by the State agency or by an approved accrediting organization. (f) Line of credit. If the HHA chooses to support the availability of a portion of the initial reserve operating funds with a line of credit, it must provide HCFA with a letter of credit from the lender. HCFA later may require the HHA to furnish an attestation from the lender that the HHA, upon its certification into the Medicare program, continues to be approved to borrow the amount specified in the letter of credit. (g) Provider agreement. HCFA does not enter into a provider agreement with an HHA unless the HHA meets the initial reserve operating funds requirement of this section. 5. A new subpart F is added to read as follows: Subpart F--Surety Bond Requirements for HHAs Sec. 489.60 Definitions. 489.61 Basic requirement for surety bonds. 489.62 Requirement waived for Government-operated HHAs. 489.63 Parties to the bond. 489.64 Authorized Surety and exclusion of surety companies. 489.65 Amount of the bond. 489.66 Additional requirements of the surety bond. 489.67 Submission date and term of the bond. 489.68 Effect of failure to obtain, maintain, and timely file a surety bond. 489.69 Evidence of compliance. 489.70 Effect of payment by the Surety. 489.71 Surety's standing to appeal Medicare determinations. 489.72 Effect of review reversing HCFA's determination. 489.73 Incorporation into existing provider agreements. Subpart F--Surety Bond Requirements for HHAs Sec. 489.60 Definitions. As used in this subpart unless the context indicates otherwise-- Assessment means a sum certain that HCFA may assess against an HHA in lieu of damages under Titles XI, XVIII, or XXI of the Social Security Act or under regulations in this chapter. Assets includes but is not limited to any listing that identifies Medicare beneficiaries to whom home health services were furnished by a participating or formerly participating HHA. Civil money penalty means a sum certain that HCFA has the authority to impose on an HHA as a penalty under Titles XI, XVIII, or XXI of the Social Security Act or under regulations in this chapter. Participating home health agency means a ``home health agency'' (HHA), as that term is defined by section 1861(o) of the Social Security Act, that also meets the definition of a ``provider'' set forth at Sec. 400.202 of this chapter. Surety bond means one or more bonds issued by one or more surety companies under 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225, provided the bond otherwise meets the requirements of this section. Unpaid civil money penalty or assessment means a civil money penalty or assessment imposed by HCFA on an HHA under Titles XI, XVIII, or XXI of the Social Security Act, plus accrued interest, that, 90 days after the HHA has exhausted all administrative appeals, remains unpaid (because the civil money penalty or assessment has not been paid to, or offset or compromised by, HCFA) and is not the subject of a written arrangement, acceptable to HCFA, for payment by the HHA. In the event a written arrangement for payment, acceptable to HCFA, is made, an unpaid civil money penalty or assessment also means such civil money penalty or assessment, plus accrued interest, that remains due 60 days after the HHA's default on such arrangement. Unpaid claim means a Medicare overpayment for which the HHA is responsible, plus accrued interest, that, 90 days after the date of the agency's notice to the HHA of the overpayment, remains due (because the overpayment has not been paid to, or recouped or compromised by, HCFA) and is not the subject of a written arrangement, acceptable to HCFA, for payment by the HHA. In the event a written arrangement for payment, acceptable to HCFA, is made, an unpaid claim also means a Medicare overpayment for which the HHA is responsible, plus accrued interest, that remains due 60 days after the HHA's default on such arrangement. Sec. 489.61 Basic requirement for surety bonds. Except as provided in Sec. 489.62, each HHA that is a Medicare participating HHA, or that seeks to become a Medicare participating HHA, must obtain a surety bond (and furnish to HCFA a copy of such surety bond) that meets the requirements of this subpart F and HCFA's instructions. Sec. 489.62 Requirement waived for Government-operated HHAs. An HHA operated by a Federal, State, local, or tribal government agency is deemed to have provided HCFA with a comparable surety bond under State law, and HCFA therefore waives the requirements of this section with respect to such an HHA if, during the preceding 5 years the HHA has-- (a) Not had any unpaid claims or unpaid civil money penalties or assessments; and (b) Not had any of its claims referred by HCFA to the Department of Justice or the General Accounting Office in [[Page 314]] accordance with part 401 of this chapter. Sec. 489.63 Parties to the bond. The surety bond must name the HHA as Principal, HCFA as Obligee, and the surety company (and its heirs, executors, administrators, successors and assignees, jointly and severally) as Surety. Sec. 489.64 Authorized Surety and exclusion of surety companies. (a) An HHA may obtain a surety bond required under Sec. 489.61 only from an authorized Surety. (b) An authorized Surety is a surety company that-- (1) Has been issued a Certificate of Authority by the U.S. Department of the Treasury in accordance with 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225 as an acceptable surety on Federal bonds and the Certificate has neither expired nor been revoked; and (2) Has not been determined by HCFA to be an unauthorized Surety for the purpose of an HHA obtaining a surety bond under this section. (c) HCFA determines that a surety company is an unauthorized Surety under this section-- (1) If, upon request by HCFA, the surety company fails to furnish timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a surety bond an HHA presents to HCFA that shows the surety company as Surety on the bond; (2) If, upon presentation by HCFA to the surety company of a request for payment on a surety bond and of sufficient evidence to establish the surety company's liability on the bond, the surety company fails to timely pay HCFA in full the amount requested, up to the face amount of the bond; or (3) For other good cause. (d) Any determination HCFA makes under paragraph (c) of this section is effective immediately when notice of the determination is published in the Federal Register and remains in effect until a notice of reinstatement is published in the Federal Register. (e) Any determination HCFA makes under paragraph (c) of this section does not affect the Surety's liability under any surety bond issued by a surety company to an HHA before notice of such determination is published in accordance with paragraph (d) of this section. (f) A determination by HCFA that a surety company is an unauthorized Surety under this section is not a debarment, suspension, or exclusion for the purposes of Executive Order No. 12549 (3 CFR, 1986 comp., p. 189). Sec. 489.65 Amount of the bond. (a) Basic rule. The amount of the surety bond must be $50,000 or 15 percent of the Medicare payments made by HCFA to the HHA in the HHA's most recent fiscal year for which a cost report has been accepted by HCFA, whichever is greater. (b) Computation of the 15 percent: Participating HHA. The 15 percent is computed as follows: (1) For the initial bond--on the basis of Medicare payments made by HCFA to the HHA in the HHA's most recent fiscal year as shown in the HHA's most recent cost report that has been accepted by HCFA. If the initial bond will cover less than a full fiscal year, the computation of the 15 percent will be based on the number of months of the fiscal year that the bond will cover. (2) For subsequent bonds--on the basis of Medicare payments made by HCFA in the most recent fiscal year for which a cost report has been accepted. However, if payments in the first six months of the current fiscal year differ from such an amount by more than 25 percent, then the amount of the bond is 15 percent of such payments projected on an annualized basis. (c) Computation of 15 percent: An HHA that seeks to become a participating HHA by obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA by purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent is computed on the basis of Medicare payments made by HCFA to the participating or formerly participating HHA in the most recent fiscal year that a cost report has been accepted. (d) Change of ownership. For an HHA that undergoes a change of ownership the 15 percent is computed on the basis of Medicare payments made by HCFA to the HHA for the most recently accepted cost report. (e) An HHA that seeks to become a participating HHA without obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA without purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent computation does not apply. (f) Exception to the basic rule. If an HHA's overpayment in the most recently accepted cost report exceeds 15 percent of annual payments, HCFA may require the HHA to secure a bond in an amount up to or equal to the amount of overpayment, provided the amount of the bond is not less than $50,000. Sec. 489.66 Additional requirements of the surety bond. The surety bond that an HHA obtains under this subpart must meet the following additional requirements: (a) The bond must guarantee that within 30 days of receiving written notice from HCFA of an unpaid claim or unpaid civil money penalty or assessment, which notice contains sufficient evidence to establish the Surety's liability under the bond, the Surety will pay HCFA, up to the stated amount of the bond-- (1) The full amount of any unpaid claim, plus accrued interest, for which the HHA is responsible; and (2) The full amount of any unpaid civil money penalty or assessment imposed by HCFA on the HHA, plus accrued interest. (b) The bond must provide that the Surety's liability for unpaid claims and unpaid civil money penalties and assessments is based on-- (1) Medicare overpayments that arise from Medicare payments that are made by HCFA to the HHA during the term of the bond, regardless of when the overpayments are determined by HCFA or when the overpayments become unpaid claims; and (2) Civil money penalties and assessments that HCFA imposes on the HHA during the term of the bond regardless of when it is determined that the civil money penalties or assessments are unpaid. (c) The bond must provide that the Surety's liability to HCFA under the bond is not extinguished by any action of the HHA, the Surety, or HCFA, including but not necessarily limited to any of the following actions: (1) Any action by the HHA or the Surety to terminate or limit the scope or term of the bond unless the Surety furnishes HCFA with notice of such action not later than 10 days after receiving notice of such action by the HHA, or not later than 60 days before the effective date of such action by the Surety. (2) The Surety's failure to continue to meet the requirements of Sec. 489.64(a) or HCFA's determination that the surety company is an unauthorized Surety under Sec. 489.64(b). (3) Termination of the HHA's provider agreement. (4) Any action by HCFA to suspend, offset, or otherwise recover payments to the HHA. (5) Any action by the HHA to-- (i) Cease operation; (ii) Sell or transfer any asset or ownership interest; (iii) File for bankruptcy; or (iv) Fail to pay the Surety. [[Page 315]] (6) Any fraud, misrepresentation, or negligence by the HHA in obtaining the surety bond or by the Surety (or by the Surety's agent, if any) in issuing the surety bond, except that any fraud, misrepresentation, or negligence by the HHA in identifying to the Surety (or to the Surety's agent) the amount of Medicare payments upon which the amount of the surety bond is determined will not cause the Surety's liability to HCFA to exceed the amount of the bond. (7) The HHA's failure to exercise available appeal rights under Medicare or to assign such rights to the Surety. (d) The bond must provide that actions under the bond may be brought by HCFA or by HCFA's fiscal intermediaries. Sec. 489.67 Submission date and term of the bond. (a) Each participating HHA that does not meet the criteria for waiver under Sec. 489.62 must submit to HCFA, in such a form as HCFA may specify, a surety bond as follows: (1) Initial term: By February 27, 1998, effective for the term beginning January 1, 1998 through the end of the HHA's fiscal year. (2) Subsequent terms: Not later than 30 days before the HHA's fiscal year, effective for a term concurrent with the HHA's fiscal year. (b) HHA that seeks to become a participating HHA. (1) An HHA that seeks to become a participating HHA must submit a surety bond with its enrollment application (Form HCFA-855, OMB number 0938-0685). The term of the initial surety bond must be effective from the effective date of provider agreement as specified in Sec. 489.13 of this part. However, if the effective date of the provider agreement is less than 30 days before the end of the HHA's current fiscal year, the HHA may obtain a bond effective through the end of the next fiscal year, provided the amount of the bond is the greater of $75,000 or 20 percent of the amount determined from the computation specified in Sec. 489.65(c) as applicable. (2) An HHA that seeks to become a participating HHA through the purchase or transfer of assets or ownership interest of a participating or formerly participating HHA must also ensure that the surety bond is effective from the date of such purchase or transfer. (c) Change of ownership. An HHA that undergoes a change of ownership must submit the surety bond to HCFA not later than the effective date of the change of ownership and the bond must be effective from the effective date of the change of ownership through the remainder of the HHA's fiscal year. (d) Government-operated HHA that loses its waiver. A government- operated HHA that, as of January 1, 1998, meets the criteria for waiver under Sec. 489.62 but thereafter is determined by HCFA to not meet such criteria, must submit a surety bond to HCFA within 60 days after it receives notice from HCFA that it no longer meets the criteria for waiver. (e) Change of Surety. An HHA that obtains a replacement surety bond from a different Surety to cover the remaining term of a previously obtained bond must submit the new surety bond to HCFA within 30 days of obtaining the bond from the new Surety. Sec. 489.68 Effect of failure to obtain, maintain, and timely file a surety bond. (a) The failure of a participating HHA to obtain, file timely, and maintain a surety bond in accordance with this subpart F and HCFA's instructions is sufficient under Sec. 489.53(a)(1) for HCFA to terminate the HHA's provider agreement. (b) The failure of an HHA seeking to become a participating HHA to obtain and file timely a surety bond in accordance with this Subpart F and HCFA's instructions is sufficient under Sec. 489.12(a)(3) for HCFA to refuse to enter into a provider agreement with the HHA. Sec. 489.69 Evidence of compliance. (a) HCFA may at any time require an HHA to make a specific showing of being in compliance with the requirements of this Subpart F and may require the HHA to submit such additional evidence as HCFA considers sufficient to demonstrate the HHA's compliance. (b) If requested by HCFA to do so, the failure of an HHA to timely furnish sufficient evidence to HCFA to demonstrate compliance with the requirements of this Subpart F is sufficient for HCFA to terminate the HHA's provider agreement under Sec. 489.53(a)(1) or to refuse to enter into a provider agreement with the HHA under Sec. 489.12(a)(3), as applicable. Sec. 489.70 Effect of payment by the Surety. A Surety's payment to HCFA under a bond for an unpaid claim or an unpaid civil money penalty or assessment, constitutes-- (a) Collection of the unpaid claim or unpaid civil money penalty or assessment (to the extent the Surety's payment on the bond covers such unpaid claim, civil money penalty, or assessment); and (b) A basis for termination of the HHA's provider agreement under Sec. 489.53(a)(1). Sec. 489.71 Surety's standing to appeal Medicare determinations. (a) A Surety shall have standing to appeal any matter that the HHA could appeal provided that: (1) The Surety has made payment of all amounts owed to HCFA by the HHA, up to the amount of the bond. (2) The HHA has assigned its right of appeal to the Surety. (3) The Surety satisfies all jurisdictional and procedural requirements that would otherwise have applied to the HHA. (b) Any assignment of appeal rights by the HHA to the Surety must be in writing and must include the right to appeal all issues contested with respect to the specified cost reporting period. Sec. 489.72 Effect of review reversing determination. In the event a Surety has paid HCFA on the basis of liability incurred under a bond obtained by an HHA under this subpart F, and to the extent the HHA that obtained such bond (or the Surety under Sec. 489.71) is subsequently successful in appealing the determination that was the basis of the unpaid claim or unpaid civil money penalty or assessment that caused the Surety to pay HCFA under the bond, HCFA will refund to the Surety the amount the Surety paid to HCFA to the extent such amount relates to the matter that was successfully appealed by the HHA (or by the Surety), provided all review, including judicial review, has been completed on such matter. Any additional amounts owing as a result of the appeal will be paid to the HHA. Sec. 489.73 Incorporation into existing provider agreements. The requirements of this subpart F are deemed to be incorporated into existing HHA provider agreements effective January 1, 1998. (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare--Hospital Insurance Program, and Program No. 93.778, Medical Assistance Program) Dated: December 1, 1997. Nancy-Ann Min DeParle, Administrator, Health Care Financing Administration. Dated: December 24, 1997. Donna E. Shalala, Secretary. Note: The attached addendum will not appear in the Code of Federal Regulations. 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