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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

CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

By Michael Paddock, Kathleen Stratton, Erica Kraus & Theresa Thompson on October 10, 2019

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the…

Healthcare Law Blog

California Expands Medicaid Telehealth Policy

By Matthew Shatzkes & Susan Ingargiola on October 7, 2019

The California Department of Health Care Services (“DHCS”) recently revised its Medi-Cal telehealth policy to allow providers increased flexibility in their use of telehealth as a modality for delivering medically necessary services to their patients. The policy is retroactively effective as of July 1, 2019, and fee-for-service providers must submit claims for services provided via telehealth according to the new policy. Updates to the telehealth policy include the following:…

Healthcare Law Blog

OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

By Matthew Shatzkes & Susan Ingargiola on October 4, 2019

In its recently updated Work Plan, the Office of the Inspector General (“OIG”) at the Department of Health & Human Services (HHS) announced that it will conduct an audit focusing on how selected state Medicaid agencies and Medicaid managed care organizations (“MCOs”) leverage telehealth to provide behavioral healthcare.…

Healthcare Law Blog

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

By Allison Fulton & Sarah Blitz on September 30, 2019

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to…

Healthcare Law Blog

Bipartisan Push To Repeal ACA’s Cadillac Tax

By Matthew Goldman, Jordan Grushkin & Samuel O'Brien on September 25, 2019

One of the most controversial taxes of the Affordable Care Act (ACA) is in danger of repeal. The tax colloquially known as the “Cadillac Tax” was supposed to take effect in 2018, but Congress has delayed it twice. With the tax now slated to take effect in 2022, opponents of the tax have taken the opportunity to attempt to repeal it for good. On July 17, 2019, the House of Representatives overwhelming voted, 419-6, to…

Healthcare Law Blog

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

By Allison Fulton on September 20, 2019

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.…

Healthcare Law Blog

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus Provider-Based Departments Was Improper

By Michael Paddock, Erica Kraus & Theresa Thompson on September 19, 2019

On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for certain outpatient hospital services provided at certain off-campus provider-based departments (“PBDs”).…

Healthcare Law Blog

California Department of Managed Health Care Opposes AB 1249

By Lynsey Mitchel, Matthew Goldman & John Tilton on September 18, 2019

On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the “Department”) released a letter of opposition (the “Letter”) to Assembly Bill 1249 (“AB 1249”). The Letter was addressed to Brian Maienschein of the California State Assembly, who is the lead author of AB 1249.…

Healthcare Law Blog

The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

By Michael Paddock & Erica Kraus on September 11, 2019

In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for the purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of their conclusion, with no other evidence to prove the falsity of…

Healthcare Law Blog

Shaping the World of Healthcare Law

Blog Authors

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

CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

California Expands Medicaid Telehealth Policy

OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Bipartisan Push To Repeal ACA’s Cadillac Tax

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus Provider-Based Departments Was Improper

California Department of Managed Health Care Opposes AB 1249

The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

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