- Represented CutisPharma, Inc., a specialty pharmaceutical company that develops and commercializes compounding kits that help patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and recently launched FDA-approved drug Firvanq, in its sale to NovaQuest Capital Management, L.L.C.
- Represented Arsanis, Inc., a clinical-stage biopharmaceutical company developing targeted monoclonal antibodies (mAbs) for pre-emptive and post-infection treatment of serious infectious diseases, in the closing of its $45.5 million Series D financing.
- Succeeded in encouraging CMS to initiate a process to revise its outdated coverage policies for positron electronic tomography (PET) scans.
- Represented multiple Fortune 100 employers to develop a successful strategy for complying with the Summary of Benefits and Coverage (SBC) provisions of Affordable Care Act, and worked with regulators to craft less-bureaucratic policies.
- Crafted legal arguments that persuaded CMS to update its policies regarding coverage and payment for complex molecular diagnostic tests.
- Worked with two long-term care associations and their state Medicaid agencies to develop a workable strategy for providing home and community based services to elderly individuals who wanted to remain in the community.
- Successfully represented an organization before CMS whose state Medicaid agency had mistakenly classified the organizations an institution for mental disease (IMD).
- Successfully persuaded CMS to create a new technology add-on payment for a prescription drug administered in the inpatient setting, the first time in 15 years that CMS had ever adopted such a policy for an orally-administered drug.
- Helped two start-up pharmaceutical companies develop a strategy for coverage of drugs used to treat patients with end-stage renal disease (ESRD) in a way that assured coverage even with the bundled payment system for dialysis services.
- Helped a Medicare Advantage plan assess the HIPAA consequences of a data breach and develop a process for weighing the merits of disclosure.
- Provided crisis counseling for a hospital management service organization whose clients had been accused by CMS of EMTALA violations.
- Helped a Medicare Advantage plan secure designation by a state Medicaid agency and CMS as a dual-eligible special needs plan (Dual SNP).
- Successfully persuaded a state Department of Public Health to ease its overly-restrictive interpretation of a physician gift ban on pharmaceutical and medical device manufacturers.