A biweekly publication from the Healthcare Group at Feeley & Driscoll, P.C.
Please visit us at OIG’s website: www.fdcpa.com/healthcare.htm.
This OIG Update is also accessible from the F&D website, by visiting www.fdcpa.com/oig.updates.htm.
In This Issue:
1. Review of Social Security Act Section 1915(c) Waiver Payments for Home and Community-Based Services at Trinity Services, Inc., July 1, 2004, through June 30, 2005 (A-05-07-00056)
2. Tennessee Home and Community-Based Mental Retardation Services for July 1, 2002, Through June 30, 2003 (A-04-03-03026)
3. The Food and Drug Administration’s Oversight of Clinical Trials (OEI-01-06-00160)
4. Improper Payments for Medicaid Pediatric Dental Services (OEI-04-04-00210)
5. 1-800-MEDICARE: Caller Satisfaction and Experiences (OEI-07-06-00530)
1. Review of Social Security Act Section 1915(c) Waiver Payments for Home and Community-Based Services at Trinity Services, Inc., July 1, 2004, through June 30, 2005 (A-05-07-00056)
The OIG’s objective was to determine whether the Illinois Department of Healthcare and Family Services’ (the State agency) claim for Medicaid reimbursement for home and community-based services (HCBS) provided by Trinity Services, Inc. (Trinity) during State fiscal year (SFY) 2005 complied with Federal and State requirements. Of the 3,877 HCBS reviewed, 78 were unallowable because Trinity did not provide the services or did not meet documentation requirements.
The OIG recommended that the State agency refund to the Federal Government the $50,670 paid to Trinity for unallowable HCBS claimed in SFY 2005 and require Trinity to implement internal controls to ensure it documents and claims reimbursement only for HCBS actually provided. The State agency did not address the OIG’s first recommendation but stated it would use the OIG’s findings to reiterate required policies and improve its administration of the HCBS program.
To view the full report, click here: http://www.oig.hhs.gov/oas/reports/region5/50700056.pdf
2. Tennessee Home and Community-Based Mental Retardation Services for July 1, 2002, Through June 30, 2003 (A-04-03-03026)
The OIG’s objectives were to determine whether the State Medicaid agency claimed Federal reimbursement for home and community-based services (HCBS) that were adequately supported in the providers’ records and provided in accordance with the beneficiaries’ approved plans of care. Based on the OIG’s sample results, the OIG estimates that during State fiscal year 2003, the State Medicaid agency claimed approximately $11 million ($7 million Federal share) for HCBS that were not supported by provider records. The Federal reimbursement for these unallowable claims occurred because the State Medicaid agency did not ensure that HCBS costs were allowable.
The OIG recommended that the State Medicaid agency (1) refund to the Centers for Medicare & Medicaid Services the $7 million estimated excess Federal reimbursement for State fiscal year 2003; (2) direct the Division of Mental Retardation Services to establish controls and procedures to account for changes in the actual level of services provided, ensure that claims are adequately supported, and ensure that HCBS are rendered in accordance with the beneficiary’s plan of care; and (3) review its claims filed after the OIG’s audit period and refund any overpayments identified. The State Medicaid agency did not specifically address the OIG’s first recommendation. With respect to the second and third recommendations, the State Medicaid agency acknowledged that additional oversight and controls were needed and said that it had increased its monitoring efforts.
To view the full report, click here: http://www.oig.hhs.gov/oas/reports/region4/40303026.pdf
3. The Food and Drug Administration’s Oversight of Clinical Trials (OEI-01-06-00160)
The Federal Food, Drug, and Cosmetic Act generally requires all new drugs and medical devices to undergo clinical trials on human subjects to demonstrate the safety and efficacy of these products prior to approval for sale in the United States. The sponsors, clinical investigators, and institutional review boards (IRBs) that conduct and oversee these trials must comply with FDA regulations designed to protect the human subjects participating in them. Three FDA centers monitor and approve medical investigational products for human use: the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. FDA’s Bioresearch Monitoring (BiMo) Program is a cross-center program that conducts inspections to verify clinical trial data and confirm that human subjects are adequately protected. FDA’s Office of Regulatory Affairs conducts onsite BiMo inspections of sponsors, clinical investigators, and IRBs as assigned by the centers. OIG received a congressional request to evaluate FDA’s oversight of clinical trials after a series of news articles highlighted vulnerabilities.
The OIG identified data limitations and other factors that affect FDA’s ability to effectively manage the BiMo program. For example, FDA is unable to identify all clinical trials and IRBs, and it lacks a single database for tracking its own inspections. Furthermore, the three FDA centers and the Office of Regulatory Affairs inconsistently classify some inspections. In addition, FDA’s guidance and regulations do not reflect current clinical trials practices. Finally, the OIG estimates that FDA inspected about 1 percent of clinical trials for the fiscal year 2000–2005 period. FDA should take the following steps to improve its information systems and processes: (1) develop a clinical trial database that includes all clinical trials, (2) create an IRB registry, (3) create a cross-center database that allows complete tracking of BiMo inspections, (4) establish a mechanism to provide feedback to BiMo investigators on their inspection reports and findings, and (5) seek legal authority to provide oversight that reflects current clinical trial practices. FDA concurred with four of these five recommendations. FDA did not address the OIG’s recommendation to establish a mechanism to provide feedback to BiMo investigators on their inspection reports and findings.
To view the full report, click here: http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf
4. Improper Payments for Medicaid Pediatric Dental Services (OEI-04-04-00210)
Under the Early and Periodic, Screening, Diagnostic, and Treatment (EPSDT) program, children and youth enrolled in Medicaid receive routine and preventive health care services, including dental services. Federal regulations require State Medicaid programs to ensure claims for the EPSDT services are accurate, supported by documentation, and provided as medically necessary. The Medicaid policies established in each of the five States the OIG reviewed (Idaho, Indiana, Massachusetts, North Carolina, and Texas) also include these requirements. The OIG used a medical record review contractor to examine the appropriateness of payments for a stratified random sample of Medicaid pediatric dental services provided in the five States during calendar year 2003. The OIG determined if the services met requirements for proper documentation, billing, and medical necessity.
The OIG found that 31 percent of Medicaid pediatric dental services provided during 2003 in the five States did not meet Federal and State requirements for the EPSDT services. These services resulted in improper payments of approximately $155 million, of which the Federal share was approximately $96 million. Documentation errors accounted for $138 million (89 percent) of the total improper payments the OIG identified. These errors prevented medical record reviewers from determining if the services were medically necessary and billed appropriately. Documentation errors consistently accounted for the largest amount of improper payments in all five States.
To address these findings, the OIG recommend CMS increase efforts to ensure States enforce existing policies relating to the proper documentation of pediatric dental services. CMS should also provide assistance to States to promote provider awareness and ensure compliance with documentation requirements. CMS stated that it does not disagree with the OIG’s recommendations and that the OIG’s recommendations dovetail into the Medicaid Integrity Group's charge to provide effective support and assistance to States.
To view the full report, click here: http://www.oig.hhs.gov/oei/reports/oei-04-04-00210.pdf
5. 1-800-MEDICARE: Caller Satisfaction and Experiences (OEI-07-06-00530)
CMS uses various outreach efforts to educate and assist Medicare’s 42 million beneficiaries with decisions that affect their health care. The most commonly used communication channel is the telephone customer service system, which callers access by calling 1-800-MEDICARE. This report assesses callers’ satisfaction and experiences with Medicare telephone customer service and makes comparisons with 2004 baseline data. OIG found that 71 percent of callers who completed their calls were satisfied overall with the customer service they received, a decrease of 13 percentage points compared to the 2004 baseline data. More callers in 2007 than in 2004 reported hanging up before receiving an answer to their question and had concerns about wait times. Similar to the 2004 baseline data, 44 percent of callers in the 2007 evaluation had difficulty accessing information.
OIG recommends that CMS (1) reassess the level of resources directed toward improving the question‑answering capabilities of the Interactive Voice Response system; (2) ensure that callers receive all needed information; and (3) continue to seek ways to reduce caller wait times. In its comments to the draft report, CMS did not indicate whether it concurred with the OIG’s recommendations. However, CMS described several actions that it has taken or planned that relate to the OIG’s findings and recommendations.
CMS stated that it will further determine how best to simplify choices and menu options within the Interactive Voice Response system, conduct a study to help determine why callers are not receiving the information they need, and implement technological solutions to provide beneficiaries with options for obtaining answers to their questions without having to wait to talk to a customer service representative. CMS provided information on efforts underway or planned for the future aimed at improving call-center operations. The OIG asks that, in its final management decision, CMS more clearly indicate whether it concurs with the OIG’s recommendations and what steps, if any, it will take to implement them.
To view the full report, click here: http://www.oig.hhs.gov/oei/reports/oei-07-06-00530.pdf
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