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

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 disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance. Continue Reading

Overview of Proposed Rule from the Centers for Medicare & Medicaid Services Regarding Interoperability and Patient Access to Data

On March 4, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a wide-ranging proposed rule (“Proposed Rule”)[1] with the intent to “move the health care ecosystem in the direction of interoperability” in alignment with the objectives set out in the 21st Century Cures Act (“Cures Act”)[2] and Executive Order 13813.[3] According to CMS, this Proposed Rule is a key step in putting patients at the center of their health care and ensuring that they have access to their health information – attempting to solve the problem of accessing complete health information from different providers and payors. CMS believes patients should have the “ability to move from health plan to health plan, provider to provider, and have both their clinical and administrative information travel with them throughout their journey.”[4] A twin goal is that health IT should not “detract from the clinician-patient relationship… or from the quality of work life for physicians, nurses, and other health care professionals.”[5] Continue Reading

Notes from the 2019 Health Evolution Summit: Promoting Quality Healthcare and a Quality Healthcare Experience

Laguna Niguel, California. Another wild year in healthcare is upon us and another insightful and inspiring week of discussions at the 2019 Health Evolution Summit (HES) has just wrapped up in California. HES, which many refer to as “Baby JP Morgan” (a reference to the annual JP Morgan Healthcare Conference in San Francisco, California), brings together some of the most influential minds and leaders in healthcare in an intimate setting offering the opportunity to participate in frank and detailed discussions regarding the healthcare industry, what we’re doing right, what we can do better, and what we envision for the future. Healthcare thought-leaders focused on disruptive technologies and Artificial Intelligence (“AI”), managed care, legislation and policy and virtually all other aspects of the healthcare system all participated in lively discussions throughout the week and we were privileged to join the fun.

Health, Not Healthcare. There was a true focus on consumerism, patient experience, and the delivery of “health, not healthcare” at the conference with an interesting dichotomy among companies focused on engagement of the portion of the population that does not take an active role in managing their own health (i.e., healthy people) and companies focused on those suffering from chronic conditions that require more hands-on involvement to manage a completely different set of challenges. Continue Reading

CMS Expands Telehealth Benefits under Medicare Advantage

On Friday, April 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced that it had finalized policies allowing Medicare Advantage plans (“MA Plans”) to include additional telehealth benefits in their basic benefit packages starting in 2020.  The final rule implementing the changes (the “Final Rule”) will be published in the Federal Register on April 16, 2019. An advance copy of the Final Rule is available here. Continue Reading

Update to Texas v. United States

In our December blog post, we discussed Texas v. United States, No. 19-10011 (5th Cir.), a Texas federal district court decision which struck down the entirety of the Affordable Care Act (“ACA”). The case is being appealed to the United States Court of Appeals for the Fifth Circuit, although a hearing date has not been scheduled. Last week, however, the United States Department of Justice stated in a court filing that the Department’s formal position is that the district court’s judgment should be affirmed in full. If the judgment is upheld as urged by the Department of Justice, the entire ACA would fall. Although the United States Supreme Court is likely to have the final word, and the outcome of this litigation will be far from assured until that time, the effect of the Department’s filing will likely be to make healthcare a top issue as we approach the 2020 election. Healthcare was a focus of Democratic messaging in the 2018 midterm elections, when Democrats regained control of the House of Representatives. If nothing else, this development, and the pending litigation, will be worth following politically as well as legally over the coming months.

Healthcare Executives and Physician Leaders Discuss Latest Trends and Challenges in Delivering High-Quality Patient Care at AMGA’s 2019 Annual Conference

Healthcare in the United States is at a crossroads, with technology, new market “disrupters,” and seemingly intractable problems converging. At least that was the central theme we observed at the annual meeting of the American Medical Group Association held from March 27-30, 2019. Over 2,000 medical group executives and physician-leaders descended on National Harbor, Maryland to attend the conference and hear presentations on a wide range of topics.  Continue Reading

New Regulation Clarifies DMHC’s Position Regarding Knox-Keene Licensing

After a protracted comment period, the California Department of Managed Health Care (the “Department”) formally adopted its much anticipated “global risk” regulation (the “Regulation”), which will go into effect on July 1, 2019. As more specifically set forth in Section 1300.49 of the California Code of Regulations (“CCR”) and as described below, the Department has formalized its long-standing policy that any person that assumes “global risk” must obtain a license to operate a health care service plan and has added a process whereby such a person can seek an exemption from such licensure. As a result of new definitions for the terms “global risk” and “prepaid or periodic charge,” the Regulation marks a significant expansion of the Department’s oversight activity, and is likely to have a substantial impact on a variety of entities and arrangements in the State. Continue Reading

Balanced Billing in California: Update Regarding 2016’s A.B. 72 and an Overview of Newly Introduced Bill A.B. 1611

Balanced billing or “surprise billing” has been getting increased attention at both the federal and state level. Balance bills arise when a payor covers out-of-network care, but the provider bills the patient for amounts beyond what the payor covers and beyond cost-sharing amounts. California has been tackling this issue for over a decade. This article provides an update regarding two pieces of California legislation – A.B. 72, effective in 2017 and A.B. 1611, newly proposed – which concern balance billing. Continue Reading

Cybersecurity, Inside Jobs, Outside Jobs, and HIPAA

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 Human Services (“DHHS”), Office of Civil Rights (“OCR”), a growing number of these breaches relate to third-party hacking, ransomware, and related malware incidents (collectively, “Hacking/IT Incidents”). As such, the OCR data shines a bright light on the obvious difficulties that healthcare entities (“Covered Entities”) covered by the security and confidentiality requirements applicable to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act of 1996 and 45 CFR Parts 160 and 164, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) (collectively referred to hereinafter as “HIPAA”).

The following examines representative HIPAA settlements and rulings from 2018, and considers the 2018 breach statistics and the growing security risk associated with Hacking/IT Incidents. Continue Reading

For Tax-Exempt Employers: 403(b) Retirement Plan Compliance Opportunity

Tax-exempt employers have a special opportunity to fix compliance concerns with their 403(b) retirement plans. They have through March 31, 2020 – the “Remedial Amendment Period” (RAP) – to retroactively self-correct compliance issues with their 403(b) plan documents, without going through the IRS’ more costly and time-consuming process that would normally be required. An overview of this opportunity is below. Continue Reading

LexBlog

By scrolling this page, clicking a link or continuing to browse our website, you consent to our use of cookies as described in our Cookie and Advertising Policy. If you do not wish to accept cookies from our website, or would like to stop cookies being stored on your device in the future, you can find out more and adjust your preferences here.

Agree