A biweekly publication from the Healthcare Group at Feeley & Driscoll, P.C.
Please visit us at our 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. OIG’s Semiannual Report to Congress for April-September of FY 2006 and an Accompanying Press Release
2. Review of Royalty Payments for Intramural Inventions Received by the National Institutes of Health in Fiscal Year 2004 (A-03-04-03000)
3. Review of Corrective Actions Concerning the Human Subject Research Program (A-06-06-00042)
4. Review of Medicaid Outpatient Drug Expenditures in Nebraska for the Period October 1, 1997, Through September 30, 2004 (A-07-05-04056)
5. Review of Comprehensive Outpatient Rehabilitation Facility Therapy Services Provided by Absolute Therapy, Inc. (A-04-04-02010)
1. OIG’s Semiannual Report to Congress for April-September of FY 2006 and an Accompanying Press Release
OIG Reports More Than $38 Billion in Savings and Recoveries for FY 2006
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) Semiannual Report to Congress reported significant audit, evaluation, and investigation accomplishments for the second half of fiscal year (FY) 2006 (April 1, 2006 - October 30, 2006). The report announced that OIG had achieved a record $38.2 billion in savings and expected recoveries for FY 2006.
Specifically, OIG's $38.2 billion in savings and expected recoveries encompasses $35.8 billion in implemented recommendations and other actions to put funds to better use, $789.4 million in audit receivables, and $1.6 billion in investigative receivables.
"These savings and recoveries reflect our commitment to protect the financial integrity of the Department's programs and ensure their efficient and effective operation," said Inspector General Daniel R. Levinson. "We will continue to employ all of our audit, evaluation, investigation, and legal tools and collaborate with OIG's government partners to accomplish this mission."
To access the full publication, click here: http://tinyurl.com/ymhujv
To access the press release, click here: http://tinyurl.com/ygzw5g
2. Review of Royalty Payments for Intramural Inventions Received by the National Institutes of Health in Fiscal Year 2004 (A-03-04-03000)
Under its technology transfer program, the Office of Technology Transfer (OTT), within NIH's Office of Intramural Research, enters into license agreements to move new technologies developed in its laboratories to the private sector for further development and commercialization. NIH retains title to these licensed technologies and receives royalty payments from the licensees. OIG’s objective was to determine whether OTT monitored the fiscal year (FY) 2004 royalty payments that it received for intramural inventions and ensured timely collection of the payments.
For FY 2004, OTT did not adequately monitor the royalty payments that it received or ensure the timely collection of payments. Contrary to the requirements of the "United States Public Health Service Technology Transfer Manual" (the Manual), OTT did not review all licensee sales and earned royalty reports or require licensees that met the $2 million sales threshold to obtain compliance audits of earned royalties. OTT also did not take all steps required by the Manual to collect delinquent royalty payments, nor did it seek to impose interest and penalty charges or terminate license agreements.
OIG recommended that NIH (1) finalize Chapter 310 of the Manual and implement a process to ensure that OTT performs and documents reviews of all sales and earned royalty reports; (2) develop and follow a revised policy regarding audits of earned royalties; and (3) enforce the requirement to send late notices, terminate delinquent license agreements when appropriate, and forward delinquent licensees to the NIH Debt Collection Office to be considered for interest and penalty charges. In its comments on the draft report, NIH concurred with the first and third recommendations but disagreed with the second recommendation, saying that OTT had an effective system for identifying unpaid royalties and that OTT planned to revise its compliance audit policy. Accordingly, OIG modified their second recommendation.
To access the full article, click here: http://oig.hhs.gov/oas/reports/region3/30403000.pdf
3. Review of Corrective Actions Concerning the Human Subject Research Program (A-06-06-00042)
At the request of the Commissioner of Food and Drugs, OIG assessed the implementation of corrective actions designed to address problems identified in a clinical study and to prevent future problems in FDA's human subject research program. Their objective was to determine the status, as of October 2005, of the six corrective actions specified in the Commissioner's letter of March 21, 2003. The corrective actions direct FDA's centers and the Office of Science to (1) initiate an inventory and audit of clinical studies, (2) examine research monitoring programs and develop quality assurance programs, (3) establish a policy of accountability to the Commissioner, (4) have the Chief Counsel's Office help ensure appropriate "regulatory schemes," (5) provide additional funding for oversight, and (6) initiate a mandatory education and certification program.
FDA undertook several efforts to improve its human subject research program. Some efforts were still underway at the time of this review. Specifically, for each action: (1) The centers conducted inventories and submitted to the Office of Science 71 human subject studies that had not been submitted to the IRB for approval or recorded in the IRB database. The Office of Science then added the 71 studies to the database. From March 2003 to October 2005, FDA audited only 3 of the 297 studies listed in the February 11, 2004, database. (2) Of the four centers that OIG visited, none had an operational research monitoring program. (3) FDA did not have a written policy setting forth the center Directors' accountability to the Commissioner for noncompliance with clinical research requirements. The Directors of three of the four centers OIG visited said that they were accountable to the Commissioner. (4) The IRB representative from the Office of the Chief Counsel informed OIG that she helped ensure that clinical research reviewed by the IRB complied with applicable regulations. (5) The FDA Deputy Commissioner for Operations stated that FDA had not provided any additional funds to the Office of Science to strengthen its oversight function and that the Office of Science had not requested additional funds related to this corrective action. (6) In 2002, FDA began requiring its researchers to complete a course on human subject research issues and to pass an examination to receive a certificate of completion.
OIG recommended that FDA increase its efforts to accomplish the Commissioner's corrective actions. FDA agreed with their recommendation.
To access the full article, click here: http://oig.hhs.gov/oas/reports/region6/60600042.pdf
4. Review of Medicaid Outpatient Drug Expenditures in Nebraska for the Period October 1, 1997, Through September 30, 2004 (A-07-05-04056)
OIG’s objective was to determine whether the Nebraska Department of Health and Human Services, Finance and Support's (the State agency) claims for reimbursement of Medicaid outpatient drug expenditures complied with Federal requirements. OIG found that not all of the State agency's claims for reimbursement of Medicaid outpatient drug expenditures complied with Federal requirements. Specifically, for Federal fiscal years (FYs) 1998 through 2004, the State agency claimed duplicate expenditures for some outpatient drugs and for FYs 2003 and 2004, the State agency claimed unallowable expenditures ($266,752 Federal share) for drugs that were terminated, less than effective, or inadequately supported. The State agency also claimed expenditures ($608,624 Federal share) for drug products that were not listed on the quarterly drug tapes.
OIG recommended that the State agency: (1) refund $562,101 to the Federal Government for duplicate reported expenditures and drug expenditures that were not eligible for Medicaid coverage; (2) work with CMS to resolve $608,624 in payments for drugs that were not listed on the quarterly drug tapes and that may not have been eligible for Medicaid coverage; and (3) strengthen internal controls to ensure that claimed Medicaid drug expenditures comply with Federal requirements. The State agency concurred with OIG’s recommendations and provided comments on their characterization of two findings. (November 16, 2006)
To access the full article, click here: http://oig.hhs.gov/oas/reports/region7/70504056.pdf
5. Review of Comprehensive Outpatient Rehabilitation Facility Therapy Services Provided by Absolute Therapy, Inc. (A-04-04-02010)
The objective of OIG’s review was to determine whether payments to Absolute Therapy, Inc. (Absolute) for physical therapy, speech-language pathology, and occupational therapy services were provided in accordance with Medicare reimbursement requirements. Absolute received $5,928 in unallowable payments associated with 20 sampled claims, which contained 246 services that did not meet Medicare reimbursement requirements because: services were rendered under unapproved or incomplete plans of care; documentation did not indicate that the plan of care was reviewed at least every 60 days; and documentation did not meet Medicare standards to support that services were actually provided.
OIG recommended that Absolute: (1) refund to the Medicare program the $414,712 in payments for services Absolute billed in 2002 that did not meet Medicare reimbursement requirements; (2) follow its policies and procedures for ensuring plans of care contain all required elements, for documenting that plans of care were reviewed at least every 60 days, and for documenting that services were actually provided; and (3) identify and submit adjusted claims for services provided subsequent to OIG’s audit period that did not meet Medicare reimbursement requirements. In written comments to OIG’s draft report, Absolute officials generally disagreed with their findings and recommendations. In view of issues Absolute raised in its written comments, OIG requested the program safeguard contractor (PSC) review 27 claims and OIG adjusted their findings and recommendations based on the results of the PSC’s reevaluation.
To access the full article, click here: http://oig.hhs.gov/oas/reports/region4/40402010.pdf
Send Page To a Friend
For the List of Excluded Individuals/Entities (LEIE), follow this link:
http://oig.hhs.gov/fraud/exclusions/listofexcluded.html
For the index of recent OIG Advisory Opinions, follow this link: http://oig.hhs.gov/fraud/advisoryopinions/opinions.html
To see "Frequently Asked Questions" (FAQs) on the OIG Advisory Opinion process, go here: http://oig.hhs.gov/fraud/advisoryopinions/aofaq.htm
For more information regarding the OIG's Exclusion Program, please follow this link: http://oig.hhs.gov/fraud/exclusions.html
If you have any questions or would like to discuss any of these issues with one of Feeley & Driscoll’s healthcare specialists, please contact us at (617) 742-7788 or via e-mail at info@fdcpa.com. |
