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The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

By Kenneth Yood, Melissa Gertler & Dhara Waghela

September 17, 2020

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 The order repealed and replaced a similar Executive Order, which was previously signed on July 24, 2020 but was held back from release by the Trump administration, and follows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…

Healthcare Law Blog

CMS Finalizes Medicare Advantage Price Transparency Requirements, Despite Industry Criticism

By Kathleen Stratton & Theresa Thompson

September 11, 2020

On September 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) filed the unpublished version of the forthcoming Inpatient Prospective Payment Systems (“IPPS”) Final Rule for 2021. One of the more controversial provisions in the IPPS Final Rule finalizes CMS’ proposal, with modification, to require hospitals to report certain market-based payment rate information on their Medicare cost report for cost reporting periods ending on or after January 1, 2021. Specifically, this includes requiring hospitals…

Healthcare Law Blog

The Scope-of-Practice Debate Takes Center Stage: The 2021 Medicare Inpatient Rehabilitation Facility Prospective Payment System Final Rule”

By Theresa Thompson

August 26, 2020

As noted in our March 31, 2020 blog article, “Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare” and in our May 8, 2020 blog article, “COVID-19: Medical Liability for Expanded Scope of Services,” the COVID-19 pandemic has revealed limitations in the healthcare system that have impeded access to medical care, often for rural, low-income, and minority communities. In order to increase healthcare access, many…

Healthcare Law Blog

President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

By Kenneth Yood, Melissa Gertler & Dhara Waghela

August 18, 2020

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…

Healthcare Law Blog

CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

By Kenneth Yood & Patrick Callaghan

August 18, 2020

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…

Healthcare Law Blog

It’s Official: Telehealth Benefits Have Been Expanded For Medicare Beneficiaries

By Matthew Shatzkes, Erica Kraus & Kimberly Rai

August 10, 2020

On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals living in rural areas and implements the following mechanisms:…

Healthcare Law Blog

CMS Launches New ACO Toolkit Highlighting Effective Strategies For Achieving Provider Engagement

By Stephanie Awanyai

August 10, 2020

In July 2020, the Centers for Medicare & Medicaid Services (“CMS”) released part three of its ongoing Accountable Care Organization (“ACO”) Learning System and Toolkit Series: Provider Engagement Toolkit (the “Toolkit”), focusing on strategies to effectively engage healthcare providers in the ACO and in quality improvement activities. In particular, the Toolkit showcases the various effective strategies Medicare ACOs are currently using to help primary care and specialty providers in the ambulatory setting to improve health…

Healthcare Law Blog

Venture Capital And Private Equity Investors Take Note: Primary Care May Be The Next Behavioral Health

By Aytan Dahukey, Kenneth Yood & Samuel O'Brien

August 5, 2020

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.…

Healthcare Law Blog

Hospitals, Home Health Agencies, and Skilled Nursing Facilities: The Costs of COVID-19 and Federal Relief for Healthcare Providers

By Kenneth Yood & Hector Grajeda

July 30, 2020

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…

Healthcare Law Blog

A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect

By Erica Kraus

July 27, 2020

On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the most negative reaction from the pharmaceutical industry – would create a “most-favored nation” policy to limit the price Medicare Part B pays for certain drugs to the lowest price paid in another Organization for Economic Cooperation and Development country. The White…

Healthcare Law Blog

Shaping the World of Healthcare Law

Blog Authors

The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

CMS Finalizes Medicare Advantage Price Transparency Requirements, Despite Industry Criticism

The Scope-of-Practice Debate Takes Center Stage: The 2021 Medicare Inpatient Rehabilitation Facility Prospective Payment System Final Rule”

President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

It’s Official: Telehealth Benefits Have Been Expanded For Medicare Beneficiaries

CMS Launches New ACO Toolkit Highlighting Effective Strategies For Achieving Provider Engagement

Venture Capital And Private Equity Investors Take Note: Primary Care May Be The Next Behavioral Health

Hospitals, Home Health Agencies, and Skilled Nursing Facilities: The Costs of COVID-19 and Federal Relief for Healthcare Providers

A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect

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