Update to Texas v. United States

By Matthew Goldman and Jordan Grushkin on April 4, 2019 Posted in Affordable Care Act (ACA), Healthcare Reform

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

By Jeralin Cardoso and John Golembesky on April 2, 2019 Posted in Healthcare Industry News, Healthcare Information Technology, Healthcare Reform

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

By Eric Klein, Lynsey Mitchel, Matthew Goldman and John Tilton on March 27, 2019 Posted in State Healthcare Legislation

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

By Lynsey Mitchel on March 21, 2019 Posted in State Healthcare Legislation

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

By Kenneth Yood, Vinay Bhupathy and Daniel Eliav on March 14, 2019 Posted in 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

By Tamar Rosenberg and Martin Smith on March 11, 2019 Posted in Labor and Employment

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

OIG Advisory Opinion No. 19-03: The OIG Puts the Healthcare Benefits of Free In-Home Care and the Risks of Patient Steering in the Balance

By Erica Kraus, Michael Paddock and Theresa Thompson on March 8, 2019 Posted in Healthcare Law, Office of the Inspector General ("OIG")

OIG Advisory Opinion No. 19-03

On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge support to patients. The OIG determined that it would not impose sanctions under either the Civil Monetary Penalties law (“CMPL”) or the federal health care program Anti-Kickback Statute (“AKS”), offering some comfort to providers who seek to implement – or who have already implemented – similar programs. However, the OIG’s assertion that the proposed program would not fall within the “promotes access to care” exception to the CMPL indicates a potentially worrisome and narrow interpretation of a facially broad statutory exception. Continue Reading

HIMSS19 Brings Together Thought Leaders on IOT and Telehealth

By Vinay Bhupathy on February 19, 2019 Posted in Healthcare Information Technology

In our February 13, 2019 blog post, “HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology,” we reported on the buzz that emerged from the first two days of the Healthcare Information and Management Systems Society’s (HIMSS) annual global conference that commenced on February 11, 2019. Now that the conference has concluded, it is time to discuss the key takeaways and lessons learned from the conference’s last few days regarding the application of the Internet of Things (IOT) to healthcare. Continue Reading

HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology

By John Booher, Michael Orlando, James Gatto and Abby Meyer on February 13, 2019 Posted in Blockchain, Health Information Technology

Healthcare Information and Management Systems Society (HIMSS) kicked-off its annual global conference this week in Orlando, Florida, addressing leading topics in healthcare information technology. Over 45,000 healthcare and information technology professionals and 1,300+ vendors are expected to attend the week long event. Continue Reading

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

By Kenneth Yood and Melissa Gertler on February 11, 2019 Posted in Healthcare Law, Prescription Drug Issues

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”), a Medicaid managed care organization (“MCO”), and/or a pharmacy benefit manager (“PBM”) under contract with such a sponsor or organization; and (ii) add two new safe harbors: a “Discounts Offered at the Point-of-Sale” safe harbor (“Point of Sale Safe Harbor”) and a PBM Fee Arrangement Safe Harbor (“PBM Safe Harbor”). Continue Reading

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