Reimbursement
Parrish Law Offices is among the top law firms in the United States in obtaining and protecting reimbursement revenues for health care providers, including hospitals and health systems; physicians and physician groups; and manufacturers, suppliers, and laboratories. We have expertise working with device, diagnostic, and therapeutic products and services.
We address a comprehensive range of reimbursement matters involving both public (Medicare, Medicaid, Tricare) and private payers.
These matters include:
- Individual claims appeals, before the Office of Medicare Hearings and Appeals (“OMHA”). We are one of the top filers of appeals before OMHA and have participated in more than 1,000 cases. Through these appeals, we have succeeded in (1) recovering reimbursement on previously-denied claims, and (2) establishing favorable claims treatment going forward, thus ending the need for further appeals.
- Broad challenges to payer coverage policies, for entire states and geographic regions. We are one of the top filers of challenges to Local Coverage Decisions (“LCDs”). Through both formal and informal resolutions to our challenges, we have succeeded in reversing unfavorable coverage policies and in achieving favorable coverage policies for both products and services.
- Audits, both pre- and post-payment, by public and private payers. We have secured tens of millions of dollars for our clients from payers trying to withhold, or to recover, these revenues. We have experience handling Recovery Audit Contractor (“RAC”) audits; Zone Program Integrity Contractor (“ZPIC”) audits; Comprehensive Error Rate Testing (“CERT”) audits; Benefit Integrity audits; and private payer audits.
- Design of reimbursement strategies for launching products and services. We have particular expertise in working with providers regarding new medical technologies just entering the marketplace. We help to develop coding, coverage, and payment strategies to minimize the need to undertake claims appeals and coverage challenges, and/or to help providers plan for and overcome the obstacles that often confront the introduction of medical innovations.
Intellectual Property
Parrish Law Offices provides a range of intellectual property services with a particular emphasis on intellectual property litigation. Based on the technical backgrounds of its practitioners who are members of the patent bar, Parrish Law Offices has had experience in a broad range of technologies including wireless, cloud computing, cell phone, medical devices, assays and mechanical devices.
Our services include:
- Patent litigation. We have experience in the major patent litigation venues before well-known judges (e.g., Stark, Andrews, Robinson, Alsup, Illston and Tigar0. WE haves extensive discover experience including Patent Local Rules practice, depositions (domestic and foreign), eDiscovery and written discovery. We have experience in IPR practice including the interplay between IPR and pending litigation.
- Copyright and trademark matters. We have conducted searches and prepared and filed copyright and trademark applications for multiple classes of services and products. We also have experience with claims of infringement, unfair competition, fair use, and additional matters.
- Licensing agreements. We have handled numerous aspects of licensing agreements involving individuals and for-profit and not-for-profit entities. We have negotiated such agreements between companies and their founders and other employees; corporate partnerships and other business development transactions; and acquisitions, spin-outs, and additional transactions.
- College and university-developed technology transfers. We have worked with dozens of situations involving the development of technology with colleges and universities and the out-licensing of that technology. We are familiar with transfer policies and procedures of various institutions across the country and we have negotiated and drafted agreements providing for a range of technology development and compensation mechanisms.
- IT agreements: We have negotiated master license, service, maintenance, pilot and development agreements for various IT companies.
- Consulting agreements: We have negotiated consulting agreements for IT professionals and physicians developing new technology.
Research Integrity
Parrish Law Offices is among the top law firms in the United States in handling research integrity and misconduct matters. Debra Parrish began handling cases involving research misconduct in 1989, worked with the Department of Health and Human Services’ Office of Research Integrity, and has handled numerous cases since returning to private practice.
We have counseled regional, national and multi-national companies and educational and research institutions, as well as individual scientists and journal editors and publishers. The firm has been involved in more than 100 cases of research misconduct, including numerous high profile cases. We have written a number of peer-reviewed published articles on the issue of research misconduct and frequently are asked to make presentations on the issue.
We have worked on matters under the jurisdiction of the (1) HHS’ Office of Research Integrity; (2) National Science Foundation; (3) Food and Drug Administration; (4) HHS’ Office for Human Research Protections; and (5) Office of Laboratory Animal Welfare. Based on our extensive experience and on our library, which includes the majority of institutional reports making findings of research misconduct since 1989, we are able to quickly assess and provide practical guidance on how to manage the process, including third party reporting issues, the financial impact, and correction of the literature.
These matters include:
- Agency inquiry, investigation, and review of allegations of misconduct. We have advised numerous institutions throughout multiple agencies’ examination of both substantive allegations of misconduct and institutional compliance with requirements for a thorough, unbiased, expert response to allegations of misconduct.
- Institutional implementation of policies and procedures for responding to allegations of research misconduct. We have worked with multiple institutions regarding review and revision of their policies and procedures.
- Federal civil litigation. We have defended, in multiple federal court jurisdictions, a range of institutions and journals in actions involving allegations of research misconduct and purported mis-handling of responses.
- Federal criminal investigations. We also have handled multiple criminal investigations stemming from allegations of research misconduct.
- Journal publications. We have advised a range of journal editors regarding manuscripts and publications alleged to reflect research misconduct.
- Research integrity training. We have provided research integrity workshops to institutions as part of legal, administration, and/or future professor training programs.
- Expert testimony. We have provided expert opinions and testimony regarding whether an activity constitutes research misconduct.
Regulatory Compliance
Parrish Law Offices works closely with hospitals and health systems; physician practice groups and individual physicians; companies; and academic medical centers on various regulatory, contracting and billing issues.
We have counseled clients on:
- Stark, Anti-Kickback, and False Claims issues. We have worked with both entities and individuals on civil and criminal matters relating to marketing and sales practices; ongoing operations; and partnerships, joint ventures, and additional financial transactions. We have provided prospective analysis and planning; responsive representation before agencies; and representation before federal courts, including in qui tam actions.
- OIG investigations. As part of our efforts to address Stark, Anti-Kickback, and False Claims issues, we have worked with clients both to appropriately avoid and to respond to OIG investigations. We have a depth of familiarity with OIG advisory opinions, enforcement actions, and court cases and have worked with clients to address all parts of the OIG’s processes.
- CLIA compliance. We have worked with numerous laboratories regarding legal requirements for clinical testing. Our experience encompasses assisting clients with certification processes; counseling them on a range of operational matters; and working with them both to prepare and to respond to inspections.
- HIPAA issues. We have handled numerous issues regarding the protection of information, the use of EHR and conduct of electronic transactions, and HIPAA’s fraud and abuse provisions. We have worked both with providers and with researchers.
- Sponsored research agreements. In connection with our research integrity and misconduct practice, we have experience with a significant number of sponsored research agreements. We have advised clients on virtually every aspect of these agreements, including drafting, negotiation, compliance review, and representation before multiple agencies.
- FDA audits and agreements. We have expertise regarding the FDA’s good laboratory, good clinical, and good manufacturing practices, and we have counseled clients on research and production processes; relevant financial interests and agreements; and inspections.
- Time and effort reporting. We have conducted and reviewed internal audits and self-reporting.
- Human subject regulation compliance. We have particular expertise working with clients to help to ensure the safety and welfare of human research subjects, including creation and operation of IRBs, institution of and adherence to informed consent requirements, and appropriate conduct of testing.
