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Ken is a partner in the Corporate Practice Group in the firm's Los Angeles office and a member of the Healthcare Team.

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by applicable manufacturers and group purchasing organizations about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.
Continue Reading On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data Collection And Reporting Requirements

On November 10, 2020, the U.S. Supreme Court heard oral arguments for California v. Texas, a case that will potentially decide the fate of the Patient Protection and Affordable Care Act (“ACA”).
Continue Reading Texas v. California: SCOTUS Hears Oral Arguments About the Constitutionality of the ACA

As highlighted in a May 2020 Milbank Memorial Fund white paper titled, “How Payment Reform Could Enable Primary Care to Respond to COVID-19,” the COVID-19 public health emergency has driven transformation in the provision of primary care services across the country.  Whether it’s the use of telehealth technology to facilitate “virtual visits” or the development of new treatment protocols to identify and treat patients who need behavioral health support to manage the emotional challenges endemic to the public health emergency, changes in primary care delivery have drawn increased attention to the need for concomitant changes in the way primary care is financed.
Continue Reading Primary Care First: CMS’s New Value-Based Approach to Primary Care

G force is used to describe the acceleration of an object relative to gravity. The Wright brothers understood that the lift of the airplane had to be greater than the force of gravity.  In much the same way, the pull of gravity that healthcare providers are facing today is COVID-19.
Continue Reading And We Have Lift-Off: Improvements in Healthcare Revenue Cycle Management to Address COVID-19 Challenges

On September 19, 2020, the Health Resources and Services Administration (“HRSA”) of the Department of Health and Human Services (“HHS”) issued guidance (“September Guidance”) regarding the post-payment reporting requirements applicable to providers who received more than $10,000 in relief fund payments from the Provider Relief Fund (“PRF”) – a fund created by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (the “CARES Act”) and the Paycheck Protection Program and Health Care Enhancement Act (the “PPP Act”) to provide financial relief to hospitals, physicians, and other health care providers.  In addition to the reporting requirements, the September Guidance includes information regarding the PRF audit procedures applicable to PRF recipients.
Continue Reading Department of Health and Human Services Releases New Provider Relief Fund FAQs: Reporting, Single Audits and What You Can Do Now

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the “Order”).  The order repealed and replaced a similar Executive Order, which was previously signed on July 24, 2020 but was held back from release by the Trump administration, and follows the signing of the Buy American Executive Order mandating the purchase of U.S.-manufactured drugs that we analyzed here.
Continue Reading The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of Defense, and Department of Veteran’s Affairs must be US-manufactured (the “Buy American Order” or the “Order”). The list of “essential medicines, medical countermeasures and critical input” that fall under this Order will be determined by the Food and Drug Administration (“FDA”). The Order also calls on the FDA to conduct a greater amount of unannounced inspections of overseas drug plants to ensure that production of drugs is compliant with safety standards and to encourage more advanced drug manufacturing techniques.
Continue Reading President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” (the “Proposed Rule”).  The Proposed Rule is designed to implement statutory amendments to the Medicaid Drug Rebate Program (“MDRP”) statute, and add new regulatory provisions to encourage value-based purchasing (“VBP”) arrangements between drug manufacturers and state Medicaid programs and Medicaid-contracting payors.
Continue Reading CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

According to a Centers for Medicare and Medicaid Services (“CMS”) study reported in Health Affairs on March 24, 2020, national health care spending reached $3.81 trillion in 2019 and is projected to increase to $4.01 trillion by the end of 2020.  CMS also projects that by 2028, health care spending will reach $6.19 trillion, and will account for 19.7% of GDP, up from 17.7% in 2018.
Continue Reading Venture Capital And Private Equity Investors Take Note: Primary Care May Be The Next Behavioral Health

In a July 21, 2020 American Hospital Association (AHA) Press Release, the AHA announced the results of a new analysis prepared by Kaufman, Hall & Associates, LLC that, “highlights the dire impact of the COVID-19 crisis on the financial health of hospitals and health systems.”  According to the Press Release, the analysis shows that, without further government support, margins could sink to -7% in the second half of 2020, with half of all hospitals operating in the red.  In this same Press Release, the AHA referenced its own studies that estimate a minimum of $323.1 billion in COVID-19 – related financial losses for hospitals and health systems in 2020.
Continue Reading Hospitals, Home Health Agencies, and Skilled Nursing Facilities: The Costs of COVID-19 and Federal Relief for Healthcare Providers