Alissa represents health systems, hospitals, pharmacies, long-term care providers, home health agencies and medical practices, as well as nonprofit and municipal organizations. Alissa’s transactional practice includes contracts, leases, mergers, acquisitions and joint ventures. Alissa’s regulatory practice includes the interpretation and application of state and federal fraud and abuse laws, Medicare and Medicaid rules, tax-exemption laws, HIPAA and privacy laws, EMTALA laws, licensing matters, employment laws, governmental audits and open records and open meetings matters. She also assists with corporate and health system governance issues, including the revision and negotiation of medical staff bylaws.
The Centers for Medicare & Medicaid Services (CMS) is “actively working” on updates to regulations under the federal physician self-referral law (or “Stark Law”), according to CMS Administrator Seema Verma during a March 4, 2019 speech. Verma stated that the updated regulations will be issued later this year, and “will represent the most significant changes...
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements. On August 27, 2018, the OIG published a Request for Information (RFI) seeking input...
On May 11, 2018, President Trump gave his long-awaited speech on his administration’s plan to lower prescription drug prices. In addition, the administration published its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket costs. The blueprint can be found here. The blueprint focuses on four areas for reform including strategies to: (1) improve competition; (2)...
Last week, with bipartisan support, both the Iowa House and Senate passed, unanimously, HF 2377 (“An Act Relating to the Regulation of Certain Substances, Including the Regulation of the Practice of Pharmacy, Providing Penalties, and Including Effective Date Provisions”). The bill is expected to be signed into law by the Governor in the coming days....
All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...
When the U.S. Department of Health and Human Services (“HHS”) announced a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (“OCR”), it framed a problem and a solution. The press release stated that “fundamental and unalienable rights of conscience and religious freedom” are not being fully enforced on...
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a question being answered in the negative by courts across the country, who have concluded that the government (or a...
Perhaps lost amid the healthcare news coverage of competing proposals regarding “Medicare for All” and the repeal of Obamacare, the Centers for Medicare & Medicaid Services (“CMS”) last month announced the expansion of its Targeted Probe and Educate (“TPE”) claims review program to the entire country by the end of the year. CMS’s announcement can...
On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes discounts on certain prescriptions and clinical services offered by the retail chains’ pharmacies and in-store clinics. Presently, the pharmacy chain’s...
Alissa SmithAlissa represents health systems, hospitals, pharmacies, long-term care providers, home he...
Hannah McCallumHannah brings specialized knowledge and real-life experience to help her clients make infor...
Andrew BrantinghamAndrew's experience spans a wide range of industries, and has particular depth in...
Rebecca BrommelBecki assists clients in the areas of litigation and administrative law wit...
Katie CownieKatie has worked on business and corporate issues for more than 20 years. Many of...
Lillie CoxLillie assists a wide array of healthcare industry clients with corporate transact...
Ross C. D'EmanueleRoss works in the health care provider, payor, and drug and medical device segment...
Nathan EbnetNate represents clients in all stages of complex civil disputes, from pre-...
Elise FesterElise counsels a wide variety of clients in the Health Care industry on regulatory...
Adam FreedAdam provides strategic advice to health care providers through all stage...
Randall HansonRandall is an associate in Dorsey’s health transactions and regulations practice group.
Alan IversonAlan is a litigator in Dorsey’s trial group with a focus on clients in...
Michael JenkinsMike serves clients in highly regulated industries, including health care and gam...
Jamie McCartyJamie counsels clients in the healthcare industry in connection with complex busi...
Neal N. PetersonNeal regularly advises clients regarding compliance with laws specific to the he...
Mara SandersMara regularly advises clients on matters of state and federal regulatory complia...
Vanessa J. SzalapskiVanessa's practice focuses on litigation in the healthcare industry, including gen...
Claire H. ToppClaire works in three diverse sectors – health care, tax exempt organizations,...