Medicaid program; time limitation on recordkeeping requirements under the drug rebate program. Final rule

This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.     

Medicaid program; time limitation on record keeping requirements under the drug rebate program. Interim final rule with comment period

On August 29, 2003, we published a final rule with comment period in the Federal Register that finalized two specific provisions: it established new 3-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and set a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announced the pressing need for codification of fundamental recordkeeping requirements. On September 26, 2003, we issued a correction notice to change the effective date of the August 29, 2003 rule from October 1, 2003 to January 1, 2004. In this interim final rule with comment period, we are removing the 3-year recordkeeping requirements, replacing them with 10-year recordkeeping requirements on a temporary basis, and soliciting comments on the 10-year requirements. Manufacturers must retain records beyond the 10-year period if the records are the subject of an audit or a government investigation of which the manufacturer is aware. These provisions contain a sunset date with respect to the record retention requirements to ensure that we reexamine whether the retention rule remain necessary and effective. This interim final rule with comment period also responds to public comments on the August 29, 2003 final rule with comment period that pertain to the 3-year recordkeeping requirement at Sec. 447.534(h).     

Medicaid program; Medicaid eligibility quality control (MEQC) program requirements--HCFA. Final rule with comment period

This rule revises the regulations governing the Medicaid eligibility quality control (MEQC) program to include more specific program requirements and to establish new timeframes for completing and reporting MEQC case findings to HCFA. The rule also establishes a performance-based threshold for States to meet before HCFA will consider good faith waiver requests of disallowance of Federal financial participation (FEP) in erroneous Medicaid payments and provides more definitive criteria for evaluating States' good faith efforts to meet the national standard error rate. In addition, the rule makes several technical changes and provides that a State may rebut its projected error rate only when it can present evidence that its projected error rate was based on erroneous data. These revisions will strengthen the basic MEQC program and provide flexibility and incentives to States to produce accurate Medicaid eligibility determinations.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. Because of misunderstanding created by certain portions of that rule, we are publishing this interim final rule to withdraw and cancel it and to set forth a clearer interim final rule on donations and taxes.     

Medicaid program and State Children's Health Insurance Program (SCHIP) payment error rate measurement. Interim final rule with comment period

This interim final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and the State Children's Health Insurance Program (SCHIP), as required under the Improper Payments Information Act (IPIA) of 2002. The IPIA requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and, submit a report on actions the agency is taking to reduce erroneous payments. We published a proposed rule on August 27, 2004 to propose that States measure improper payments in Medicaid and SCHIP and report the State-specific error rates to us for purposes of computing the improper payment estimates for these programs. After extensive analysis of the issues related to having States measure improper payments in Medicaid and SCHIP, including public comments on the provisions in the proposed rule, we are revising our proposed approach. Our new approach incorporates commenters' suggestions to engage a Federal contractor by contracting with that entity to complete the data processing and medical reviews and calculate the State-specific error rates. Based on the States' error rates, the contractor also will calculate the improper payment estimates for these programs which will be reported by the Department of Health and Human Services as required by the IPIA. This interim final rule sets out the types of information that States would need to submit to allow CMS to conduct medical and data processing reviews on claims made in the fee-for-service (FFS) setting. CMS will address estimating improper payments for Medicaid managed care and eligibility and SCHIP FFS, managed care and eligibility at a later time. This rule responds to the public comments on the proposed rule, sets forth the requirements for States to assist us and the contractor to produce State-specific error rates in Medicaid and SCHIP which will be used as the basis for a national error rate, and outlines future plans for measuring eligibility, which may include greater State involvement than the level required for the medical and data processing reviews.     

Medicaid program; allocation of enhanced federal matching funds for increased administrative costs resulting from welfare reform--HCFA. Notice with comment period

This notice with comment period announces the methodology used to determine the allocation, among the States and certain Territories, of a $500 million fund to assist them with the additional expenses attributable to eligibility determinations incurred as a result of the provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, which decouples Medicaid eligibility from receipt of cash assistance for families and children. Also, it announces the actual allocation amount for each State and Territory. The special fund is available for matching a State's or Territory's allowable administrative expenditures incurred only during Federal fiscal years 1997 through 2000, and only during the first 12 calendar quarters in which the State's Temporary Assistance to Needy Families program, which replaced the Aid to Families with Dependent Children program, is in effect after August 21, 1996.     

Medicaid program; state share of financial participation--HCFA. Withdrawal of interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. On October 31, 1991, we published a clarifying interim final rule with comment (56 FR 56132), which withdrew and cancelled the September 12, 1991, interim final rule. After further consideration, the Secretary has also decided to withdraw the October 31, 1991 interim final rule.     

Recordkeeping and reporting under Title VII and the ADA--EEOC. Final rule

This final rule is based on two separate Notices of Proposed Rulemaking (NPRM) published on February 13, 1989 (54 FR 6551), and March 5, 1991 (56 FR 9185). This final rule amends 29 CFR part 1602, EEOC's regulations on Recordkeeping and Reporting under title VII of the Civil Rights Act of 1964 (title VII), to add recordkeeping requirements under the Americans with Disabilities Act of 1990 (ADA). It increases the records retention period required in part 1602 for title VII and the ADA from 6 months to one year. The Commission also is adding a new subpart R to part 1602, 29 CFR 1602.56, that will clarify that the Commission has the authority to investigate persons to determine whether they comply with the reporting or recordkeeping requirements of part 1602. In addition, the Commission is making several minor changes to sections 1602.7 and 1602.10. The Commission also is deleting section 1602.14(b) of its title VII recordkeeping regulations, which provides that the section 1602 recordkeeping requirements do not apply to temporary or seasonal positions. Information regarding such employees now must be reported on Standard Form 100 on September 30 of each year, in the same fashion as information regarding permanent employees is reported. Similarly, the Commission is deleting sections 1627.3(b) and 1627.4(a)(2) of the Age Discrimination in Employment Act recordkeeping regulations, which provide for a 90-day retention period for temporary positions, and is clarifying the mandatory nature of such recordkeeping. The Commission is not issuing a final rule on proposed section 1602.57 at this time.     

Medicaid program; early and periodic screening, diagnosis, and treatment (EPSDT) program--HCFA. Proposed rule

This proposal would modify present regulations to conform to recent legislative changes enacted by section 2181 of Pub. L. 97-35, the Omnibus Budget Reconciliation Act of 1981. That section eliminates the penalty which reduces by one percent Federal funds for a States's Title IV-A program, Aid to Families with Dependent Children (AFDC), for any quarter during which a State fails to: (1) inform all AFDC families of the availability of early and periodic screening, diagnosis, and treatment EPSDT services; (2) provide or arrange for requested screening services; and (3) arrange for corrective treatment of health problems found. In addition, section 2181 mandates that States incorporate these three requirements into their State Medicaid plan with respect to all EPSDT eligibles. Further, this proposed rule would modify current Medicaid EPSDT regulations to reflect Congressional intent that States should continue to develop fully effective EPSDT programs; however, current requirements which entail a large volume of paperwork should be significantly streamlined.     

Medicaid program; required coverage of nurse practitioner services--HCFA. Final rule

This final rule stipulates the requirements for coverage of and payment for pediatric and family nurse practitioner services under the Medicaid program. The coverage of these additional services under the Medicaid program increases the availability and accessibility of medical care for specified Medicaid recipients. This final rule adds to the Medicaid regulations provisions of sections 1902(a)(10)(A) and 1905(a)(21) of the Social Security Act, as amended by section 6405 of the Omnibus Budget Reconciliation Act of 1989.     

Medicaid program; elimination of reimbursement under Medicaid for school administration expenditures and costs related to transportation of school-age children between home and school. Final rule

Under the Medicaid program, Federal payment is available for the costs of administrative activities "as found necessary by the Secretary for the proper and efficient administration of the State plan." This final rule eliminates Federal Medicaid payment for the costs of certain school-based administrative and transportation activities because the Secretary has found that these activities are not necessary for the proper and efficient administration of the Medicaid State plan and are not within the definition of the optional transportation benefit. Based on these determinations, under this final rule, Federal Medicaid payments will no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and for transportation from home to school. In addition, this final rule responds to public comments received on the September 7, 2007 proposed rule.     

Disclosure of children's free and reduced price meals and free milk eligibility information in the child nutrition programs. Final rule

This final rule establishes requirements for the disclosure of children's free and reduced price meals or free milk eligibility information under the Child Nutrition Programs. The Child Nutrition Programs include the National School Lunch Program, School Breakfast Program, Special Milk Program, Summer Food Service Program, and Child and Adult Care Food Program. Within certain limitations, children's free and reduced price meal or free milk eligibility information may be disclosed, without parental/guardian consent, to persons directly connected to certain education programs, health programs, means-tested nutrition programs, the Comptroller General of the United States, and some law enforcement officials. Additionally, officials also may disclose children's free and reduced price meal or free milk eligibility information to persons directly connected with State Medicaid (Medicaid) and the State Children's Health Insurance Program (SCHIP) when parents/guardians do not decline to have their information disclosed. These regulations affect State agencies and local program operators that administer the Child Nutrition Programs and households which apply for and/or are approved for free and reduced price meals or free milk. The final rule reflects the disclosure provisions of the Healthy Meals for Healthy Americans Act of 1994 and comments received on the proposed rule published in anticipation of implementing those provisions. Additionally, this final rule includes the regulatory disclosure provisions implementing the Agricultural Risk Protection Act of 2000 and comments received on the interim rule issued to implement those provisions. This final rule also implements nondiscretionary provisions of the Child Nutrition and WIC Reauthorization Act of 2004, allowing certain third party contractors access to children's eligibility status and will allow school officials to communicate with Medicaid and SCHIP officials to verify that children are eligible for free and reduced price school meals or free milk. The disclosure provisions are intended to reduce paperwork for administrators of certain programs that target low-income households and for low-income households which may benefit from those programs by allowing some sharing of household's free and reduced price meal eligibility information. This rule also includes several technical amendments.     

Records and reports regulations for radiation emitting electronic products--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding the requirements for recordkeeping and reporting of adverse experiences and other information relating to radiation emitting electronic products. This rule reduces recordkeeping and reporting requirements for some products, requires only abbreviated reporting for other products, and clarifies certain requirements. The timing and content of certain reports will be revised to enhance the usefulness of the information. These amendments will improve protection of the public health while reducing regulatory burdens on manufacturers, dealers, and distributors of radiation emitting electronic products.     

Medicaid program; Medicaid managed care--HCFA. Proposed rule

This proposed rule would amend the Medicaid regulations to allow the States greater flexibility by giving them the option to require Medicaid recipients to enroll in managed care entities without obtaining waivers. These revisions, which are authorized by the Balanced Budget Act of 1997, would establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services. They would eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. They would also permit State agencies to amend their State plans to require enrollment in managed care organizations subject to certain conditions, including limits on whose enrollment can be mandated, and a requirement for beneficiary choice. In addition, this rule would extend most of these new requirements to prepaid health plans.     

Medicaid program; limitations on aggregate payments to disproportionate share hospitals: FFY 1995--HCFA. Notice

This notice announces the preliminary Federal fiscal year (FFY) 1995 national target and individual State allotments for Medicaid payment adjustments made to hospitals that serve a disproportionate number of Medicaid recipients and low-income patients with special needs. We are publishing this notice in accordance with the provisions of section 1923(f)(1)(C) of the Social Security Act (the Act) and implementing regulations at 42 CFR 447.297 through 447.299. The preliminary FFY 1995 State DSH allotments published in this notice will be superseded by final FFY 1995 DSH allotments to be published in the Federal Register by April 1, 1995.     

Medicaid program; limitations on aggregate payments to disproportionate share hospitals: federal fiscal year 1995--HCFA. Notice

This notice announces the final Federal fiscal year (FFY) 1995 national target and individual State allotments for Medicaid payment adjustments made to hospitals that serve a disproportionate number of Medicaid recipients and low-income patients with special needs. We are publishing this notice in accordance with the provisions of section 1923(f)(1)(C) of the Social Security Act (the Act) and implementing regulations at 42 CFR 447.297 through 447.299. The final FFY 1995 State disproportionate share hospital (DSH) allotments published in this notice supersede the preliminary FFY 1995 DSH allotments that were published in the Federal Register on January 13, 1995 (60 FR 3250).     

Medicare program; modifications to managed care rules. Final rule

This final rule responds to comments that we received on a proposed rule that was published in the Federal Register on October 25, 2002. It implements certain provisions relating to the Medicare+Choice (M+C) program that were enacted in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection (BIPA) Act of 2000. It also addresses comments on, and makes revisions to, regulations that were discussed in the October 2002 proposed rule that were based on M+C program experience and feedback from M+C organizations.     

Medicaid program; recovery audit contractors. Final rule

This final rule implements section 6411 of the Patient Protection and Affordable Care Act (the Affordable Care Act), and provides guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs) and the payment methodology for State payments to Medicaid RACs. This rule also directs States to assure that adequate appeal processes are in place for providers to dispute adverse determinations made by Medicaid RACs. Lastly, the rule directs States to coordinate with other contractors and entities auditing Medicaid providers and with State and Federal law enforcement agencies.