CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020

CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020

April 30, 2020

On April 24, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized and published a survey intended to capture the actual amounts paid by 340B covered entities (excluding critical access hospitals) for 340B drugs. CMS then intends to use the data collected from the survey to adjust the Medicare Part B reimbursement rate for 340B drugs purchased by certain covered entities. This survey is an offshoot of the ongoing litigation surrounding the Medicare Part…

HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

March 23, 2020

As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. At the highest level, HRSA OPA acknowledges that “this public health emergency may warrant additional flexibilities, especially to affected 340B covered entities.”…

GAO Report Suggests Increased Oversight of 340B Program

February 3, 2020

On January 10, 2020, the Government Accountability Office (GAO) released a report which “found weaknesses in the Health Resources and Services Administration’s (HRSA) oversight [of the 340B Program] that may result in some hospitals receiving discounts for which they are not eligible.” The GAO report primarily focused on the extent to which HRSA is monitoring and reviewing nongovernmental hospitals’ contracts with state or local governments. These contracts, required by statute as a condition of participation in the 340B…

Franchising in Cambodia

By Robert A. Smith, Jay Cohen & Mealtey Oeurn

October 7, 2019

Introduction Cambodia has a rapidly growing economy with a sustained impressive growth rate of 7.7% between 1995 and 2018 (World Bank, Cambodia Overview). During that time, Cambodia has transitioned from being classified by the World Bank as a low-income country to a lower middle-income country. In addition, a sizable middle class had developed, particularly in Phnom Penh. Along with economic growth, an expanding middle class, and a welcoming investment framework, Cambodia has witnessed the entrance…

New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing

September 18, 2019

While much attention has been paid to the ongoing litigation related to the ongoing 340B Medicare Part B payment reduction litigation (which is now pending before the US Court of Appeals for the DC Circuit), new legislation at the state level may also have a significant impact on covered entity reimbursement for 340B drugs.…

Franchising in Germany

By Robert A. Smith & Tom Billing

September 4, 2019

The Federal Republic of Germany has the strongest economy in Europe and is one of the leading economies in the world. With a population of 81 million, it also is the most populous country in Europe. Germany is a mature and successful franchise market with more than 950 franchised systems operating in the country. It has been ranked 24th out of 185 countries in the World Bank Group’s Ease of Doing Business Rankings.…

Interesting 340B Takeaways from 2020 OPPS Proposed Rule

August 6, 2019

The Centers for Medicare & Medicaid Services (CMS) “respectfully disagreed” with a recent federal district court’s “understanding of the scope of CMS’ adjustment authority” in making cuts to Medicare Part B reimbursement for drugs purchased through the 340B program, saying it plans to continue its 28.5 percent reduction in reimbursement while it pursues an appeal in federal court.…

Franchising in Laos

By Robert A. Smith & Dino Santaniello

July 25, 2019

Introduction Hidden between some of the most prominent powerhouses in Asia—China, Thailand, and Vietnam—Laos has often been overlooked by foreign investors seeking to capitalize on investment opportunities in the region. However, thanks to an increased commitment from the government to ease restrictions on foreign direct investment (FDI) and efforts to create a more well-rounded economy that is less dependent on natural resources, Laos has witnessed a surge of new franchise operations over the past few…

340B Litigation Updates and Other Program Developments

July 9, 2019

340B Medicare Part B Adjustment Litigation Update In the latest development of the ongoing 340B Medicare Part B payment reduction controversy, US District Judge Rudolph Contreras again concluded that the Department of Health and Human Services (HHS) exceeded its statutory authority in implementing a reduced Medicare reimbursement rate for 340B Program drugs for 2019. In issuing the opinion, the court relied upon the same analysis it employed to declare the same 2018 reimbursement reductions unlawful.…