Kenneth Yood

Firm/Organization: Sheppard, Mullin, Richter & Hampton LLP

Blogs: False Claims Act Defense, FDA Law Update, Finance & Bankruptcy Law Blog, Healthcare Law Blog, Hospice Law Blog

Latest Articles

INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It

By Kenneth Yood, Vinay Bhupathy, Daniel Eliav & John Tilton on October 17, 2019

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial, patient and industry initiatives, access continues to be a challenge due to a variety of competitive practices and lack of capabilities. Consider the following events and whether they signal real progress: In a September 9, 2019 Press Release issued by the United States…

Healthcare Law Blog

Cross-Plan Offsetting in the Balance: UnitedHealth Group, Inc. Petitions the Supreme Court to Allow Cross-Plan Offsetting; Response to be Filed on or before July 31, 2019

By Kenneth Yood & Daniel Eliav on July 8, 2019

In its decision, the Court concluded that UnitedHealth Group, Inc. (“United”) was not authorized to engage in “cross-plan offsetting.” What is cross-plan offsetting? It is a “self-help” practice that third party administrators (“TPAs”) of employer-funded health plans (“ERISA Plans”) engage in by offsetting alleged overpayments made to an out-of-network provider under one TPA-administered ERISA Plan by withholding payments to the same provider under a different TPA-administered ERISA Plan. Cross-plan offsetting is not an issue for…

Healthcare Law Blog

CMS Proposes Changes to Medicare Wage Index that Would Increase Reimbursement Rates to Rural Hospitals at the Expense of Urban Hospitals

By Kenneth Yood & Eva Schifini* on June 26, 2019

On May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a comprehensive proposed rule (“Proposed Rule”) to revise the Medicare payment structure for inpatient prospective payment systems (“IPPS”) hospitals. According to the preamble of the Proposed Rule, the purpose of the Proposed Rule is to bump up Medicare’s reimbursements to rural hospitals, some of which receive the lowest rates in the country. Unfortunately for urban hospitals, any proposed changes in…

Healthcare Law Blog

Recent Activity in Medicare Audit Programs: CMS Announces Increase in Audit Contractor Oversight

By Kenneth Yood & Melissa Gertler on May 29, 2019

The Centers for Medicare and Medicaid Services (“CMS”) healthcare audit programs – including the Unified Program Integrity Contractors (“UPICs”) audit program, the Recovery Audit Contractor (“RAC”) program, the Comprehensive Error Rate Testing (“CERT”) program, etc. – have been the subject of regular complaints and calls-for-action by the Medicare/Medicaid provider community for many years.…

Healthcare Law Blog

Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the 340B Program

By Kenneth Yood & Melissa Gertler on April 24, 2019

If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services (“HRSA”) finally updated the Office of Pharmacy Affairs 340B Information System website (the “340B Website”) to allow 340B Drug Pricing Program (the “340B Program”) providers – including 340B Program-eligible hospitals and other eligible healthcare providers– to use the 340B…

FDA Law Update

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton & Kenneth Yood on April 22, 2019

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity…

Healthcare Law Blog

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton & Kenneth Yood on April 22, 2019

Healthcare Law Blog

Cybersecurity, Inside Jobs, Outside Jobs, and HIPAA

By Kenneth Yood, Vinay Bhupathy & Daniel Eliav on March 14, 2019

According to a February 12, 2019 Press Release from Protenus, a developer of analytics for patient privacy monitoring and compliance, 15,085,302 patient records were breached in 2018 – a startling number made even more startling by the fact that the number of breached patient records in 2018 is three times greater than the number of records breached in 2017. As evidenced by the Protenus data and information reported by the U.S. Department of Health and…

Healthcare Law Blog

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

By Kenneth Yood & Melissa Gertler on February 11, 2019

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating to price reductions or other remuneration offered by a pharmaceutical manufacturer to a Medicare Part D plan sponsor (“Plan Sponsor”),…

Healthcare Law Blog

California AG Aims to Block County’s Purchase of Two San Jose-Area Hospitals

By Taylor Ashton & Kenneth Yood on January 18, 2019

On January 9, 2019, California Attorney General Xavier Becerra filed a motion with the U.S. Bankruptcy Court for the Central District of California – Los Angeles Division (the “Court”), requesting that the court stay its December 27th Sale Order, which approved Santa Clara County’s $235 million bid to purchase two hospitals from Verity Health System of California (“Verity”).[1] The Sale Order authorized Santa Clara County’s (the “County”) acquisition of O’Connor Hospital in San Jose…

Kenneth Yood

INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It

Cross-Plan Offsetting in the Balance: UnitedHealth Group, Inc. Petitions the Supreme Court to Allow Cross-Plan Offsetting; Response to be Filed on or before July 31, 2019

CMS Proposes Changes to Medicare Wage Index that Would Increase Reimbursement Rates to Rural Hospitals at the Expense of Urban Hospitals

Recent Activity in Medicare Audit Programs: CMS Announces Increase in Audit Contractor Oversight

Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the 340B Program

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

Cybersecurity, Inside Jobs, Outside Jobs, and HIPAA

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

California AG Aims to Block County’s Purchase of Two San Jose-Area Hospitals

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