Holley Lutz concentrates her practice in the areas of Medicare and Medicaid coverage and reimbursement counseling, administrative litigation and clinical research compliance. She represents academic medical centers, community hospitals, large physician groups, hospices and research institutions, as well as a broad array of other health care organizations. In the Medicare and Medicaid arena, Holley:
- Counsels health care organizations with respect to Medicare coverage and reimbursement issues, including those relating to graduate medical education, disproportionate share payment adjustments, and Medicaid financing arrangements including provider-tax and supplemental payment models.
- Represents health care organizations in administrative litigation including PRRB and ALJ appeals.
- Interacts extensively with CMS, obtaining regulatory interpretations and policy clarifications on a wide range of coverage and reimbursement issues.
- Advises clients on formation and operational structure issues, including those relating to compliance with provider-based regulations, provider enrollment, and successor liability in the merger and acquisition context.
- With respect to EMTALA, Holley reviews and revises provider policies and procedures, furnishes in-service training, defends providers against CMS allegations of non-compliance, and negotiates settlement agreements with HHS OIG.
In the clinical research arena, Holley:
- Drafts and revises human subject protection programs, including policies and procedures relating to IRBs generally, IRB member and principal investigator conflicts of interest, and the informed consent process.
- Counsels providers on the application of the Medicare National Coverage Decision relating to services furnished in the context of clinical trials.
- Assists providers in connection with regulatory audits undertaken by ORI, FDA and OHRP, and defends providers against allegations of non-compliance.
- Drafts and negotiates clinical trial agreements with sponsors, CROs and SMOs.
- Assists providers in developing infrastructure to enhance federal research grant compliance.