*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options. Continue Reading Adapting To FDA’s Proposal For Diagnosis Support Software

On May 1, 2019, the Department of Justice (“DOJ”) filed an initial brief (the “Brief”) with the U.S. Court of Appeals for the Fifth Circuit (the “Fifth Circuit”) on behalf of the United States, in favor of upholding the lower court’s decision that found the entire Patient Protection and Affordable Care Act (the “ACA”) unconstitutional.

As we discussed previously in our December 2018 blog post, a federal district court judge in Texas struck down the entire ACA by ruling that the “individual mandate,” which was reduced to $0 as part of the 2017 Tax Cuts and Jobs Act, no longer raises revenue and thus is no longer a constitutional exercise of Congress’s taxing power. The judge went on to determine that the unconstitutional individual mandate was inseverable from the rest of the ACA and therefore, the entire ACA was unconstitutional. The decision was then appealed to the Fifth Circuit. Continue Reading Update to Texas v. United States: DOJ Files a Brief in Support of Eliminating the ACA

In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described in the Proclamation, the goal of Awareness Week is to “raise awareness about the prescription opioid and heroin epidemic and to consider concrete follow up activities.” Continue Reading Congress Passes “SUPPORT for Patients and Communities Act” — A Rare Example of Bi-Partisanship

The Texas Medical Association (TMA) and Blue Cross Blue Shield of Texas are launching a new services company, TMA PracticeEdge, to facilitate bringing the benefits of value-based reimbursements to the state’s independent physicians.

Independent practitioners face challenges to participating in (and benefitting from) alternatives to fee-for-service payment, such as having the funds necessary to invest upfront in resources for improved care management. TMA PracticeEdge aims to help providers address the barriers. The company, for example, will offer consultations on basic practice management and administrative simplification, assistance with the implementation of health information technology infrastructure, and experience with risk-based contracts. Additional services will be available for practices interested in creating care teams or developing an Accountable Care Organization.

Continue Reading New Venture Seeks to Support Independent Physicians in Texas

Approximately one-third of Medicaid spending, $136 billion, is on long-term services and supports (LTSS).  While the majority of Medicaid LTSS takes place in institutional settings, such as nursing facilities and mental health facilities, there is an ongoing emphasis on the role of non-institutional facilities. A growing number of states, from 8 in 2004 to 16 in 2012 and an expected 26 through 2014, are adopting a managed care approach to expanding home-and community-based services. This transition is commonly referred to as a “rebalancing” of LTSS systems.

Continue Reading New Approaches – and Increasing Oversight – for Medicaid Managed Long Term Services and Support

On October 4, 2021, California Governor Gavin Newsom signed California bill SB-664 “Hospice licensure: moratorium on new licenses” (the “Bill”) into law.  The Bill, which passed the California Assembly on September 8, 2021 and the California Senate on September 9, 2021, imposes a moratorium on the California Department of Public Health (the “Department”) issuing new hospice licenses on or after January 1, 2022.  Under the California Hospice Licensure Act of 1990, a person, political subdivision of the state, or other governmental agency must obtain a license from the Department to provide hospice services to an individual who is experiencing the last phase of life due to a terminal disease.  The moratorium will end either three hundred and sixty five (365) days from the date the California State Auditor publishes a report on hospice licensure or when the provisions of the Bill are repealed on January 1, 2027, whichever is sooner.  The Department may grant an exception to the moratorium upon making a written finding that an applicant for a new license, or with a license application pending on January 1, 2022, has shown a ‘demonstrable need’ for hospice services in the area.  However, the Bill does not affect the Department’s ability to renew existing licenses.

Continue Reading New California Law Imposes Moratorium on New Hospice Licenses

As the world continues to shift and adapt to the ongoing COVID-19 pandemic, the digital health sector has experienced tremendous growth and the momentum has only accelerated in 2021.

Continue Reading Trends in Digital Health Funding and Transactions: A Tremendous Year So Far

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower Drug Costs Now Act, proposes to grant the U.S. Department of Health and Human Services (“HHS”) the authority to negotiate directly with pharmaceutical companies in order to lower drug prices in Medicare Part B and Medicare Part D (the “Proposal”).  The Proposal would require that 125 brand-name drugs that cost Medicare the most to be subject to negotiation by Medicare, with a cap on the price for each drug set at 120% of the average price paid in six other countries.  The Proposal is part of a $3.5 trillion budget proposal that, as of this writing, faces an uncertain future in Congress.  While not a novel idea, the Proposal is controversial and faces strong opposition from pharmaceutical companies in particular.

Continue Reading Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act (“FCA”) by knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Sutter Health’s contracted Medicare Advantage (“MA”) Plans.[1]  The Sutter Health settlement is the largest FCA settlement ever paid by a health care provider for alleged MA fraud.

Continue Reading Sutter Health Settles Medicare Fraud Case For $90 Million: The Largest Settlement For Medicare Advantage Fraud

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other changes, the Final Rule repeals the price transparency requirement for hospitals, discussed in our September 2, 2020 blog post, obligating hospitals to report certain contract terms with Medicare Advantage (“MA”) plans for cost reporting periods ending on or after January 1, 2021.

Continue Reading CMS Backs Off Price Transparency for Providers and Plans