By Ken Perez, healthcare marketing, strategy and policy consultant
The 340B Drug Pricing Program was created in 1992 to give safety-net providers—those that deliver a significant level of both healthcare and other health-related services to the uninsured, Medicaid, and other vulnerable populations—discounts on outpatient drugs to “stretch scare federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
In brief, the program requires drug makers participating in Medicaid and Medicare Part B to provide discounts on outpatient drugs to 340B providers, which include various types of hospitals and certain federal grantees, such as federally qualified health centers (FQHCs) and comprehensive hemophilia treatment centers. These providers are referred to as covered entities (CEs).
In recent years, there has been much debate regarding the legality of the use of contract pharmacies by 340B CEs. One other, arguably even more fundamental, issue is the definition of a “patient” of a 340B CE who is eligible to receive a 340B drug.
On November 3, the U.S. District Court for the District of South Carolina issued a monumental decision endorsing a broader view of the definition of such a patient. In Genesis Healthcare, Inc. v. Becerra, the South Carolina district court overturned part of the government’s definition of a 340B-eligible patient, ruling in favor of Genesis Healthcare, Inc., a FQHC CE that filed a lawsuit in 2018 challenging a Health Resources and Services Administration (HRSA) audit finding that Genesis violated the 340B statute by using 340B drugs for ineligible patients.
According to the Veterans Health Care Act of 1992, the law which established the 340B Program, CEs are prohibited from transferring or reselling a 340B drug to a “person who is not a patient of the entity.” The definition of a 340B-eligible patient is critical to a CE’s ability to benefit from 340B participation because CEs can generate 340B savings by purchasing outpatient drugs at discounted prices, administering or dispensing them to eligible patients, and receiving payer reimbursement. The scope of the 340B patient definition determines how widely CEs can use 340B drugs and generate 340B savings.
By Ken Perez, marketing and strategy advisor to Vindeca Health and former vice president of healthcare policy and government affairs, Omnicell.
On Jan. 30, the Biden administration notified Congress that it plans to let the public health emergency (PHE) and the national emergency declarations related to the COVID-19 pandemic expire on May 11. The end of these declarations logically follows President Joe Biden’s “Sixty Minutes” interview that aired on Sept. 18, 2022 during which he stated, “The pandemic is over. We still have a problem with COVID. We’re still doing a lot of work on it, but the pandemic is over. If you notice, no one’s wearing masks. Everybody seems to be in pretty good shape.”
Accordingly, on February 9, the Department of Health and Human Services (HHS) cited these developments since the peak of the Omicron surge at the end of January 2022 to justify the end of the two emergency declarations:
Daily COVID-19 reported cases are down 92%
COVID-19 deaths have declined by over 80%; and
New COVID-19 hospitalizations are down nearly 80%
Background
On Jan. 31, 2020, then-HHS Secretary Alex Azar, under section 319 of the Public Health Service Act, declared a public health emergency because of the continued spread of COVID-19. As of that date, there had been an estimated 16 cases of COVID-19 in the U.S., nearly 10,000 people had been diagnosed with the virus globally, and more than 200 had died, all in China. The following day, the World Health Organization (WHO) declared a global health emergency.
By Ken Perez, vice president of healthcare policy and government affairs, Omnicell, Inc.
Although it took eight days for most of the dust to settle after the 2022 midterm elections, it is now clear that the following conclusions can be drawn:
The widely predicted “red wave,” in which Republicans were to take back both the House and the Senate, did not materialize.
The Democrats have at least 50 seats in the Senate, and thus will retain the majority in that chamber, with Vice President Kamala Harris serving as the tiebreaker.
The Republicans have taken back the House, though with a very slim margin.
Divided government
Given the Republican majority in the House, the U.S. will have a divided government for the next two years. A divided government describes a situation in which one party controls the White House (the executive branch), while another party controls one or both chambers of Congress (the legislative branch).
In recent decades, a divided government has become quite common. The U.S. has had a divided government in 20 of the 32 years since 1990.
What’s good and what’s bad about divided government?
Those in favor of divided government contend that it encourages more policing of those in power by the opposition, and it limits spending and the proliferation of undesirable laws. Conversely, critics of divided government argue that it often results in gridlock.
What does the future hold with this latest occurrence of divided government?
In the wake of the 2022 midterm elections, business publisher Kiplinger stated, “After the midterms, expect gridlock to reign on Capitol Hill. A bitterly divided Congress will fight over everything. Plus, a GOP House will be eager to launch investigations.” Investment management company T. Rowe Price predicted, “With Republicans expected to take control of the House of Representatives and Democrats securing control of the Senate in the midterm elections, we anticipate limited legislative achievement in the next Congress.”
While its climate change provisions captured top billing, the IRA is also arguably the most impactful health legislation since the Patient Protection and Affordable Care Act of 2010.
Hospitals and health systems have long advocated for lower prescription drug prices. In March, in a statement to the Senate Finance Committee, the American Hospital Association contended that prescription drug price inflation constituted “an urgent need to lower drug prices in Medicare.” The AHA statement advocated for increased competition and innovation, greater drug pricing transparency, inflation-based rebates for Medicare drugs, and protection of the 340B Drug Pricing Program. However, the hospital association stopped short of advocating for Medicare negotiation of prescription prices.
Details about Medicare negotiation of prescription drug prices
As the centerpiece of the IRA’s various drug pricing reforms, Medicare is allowed to “negotiate” what it will pay for many single-source branded drugs that account for the highest total expenditures for Medicare. In practice, Medicare will be able to dictate those prices. Starting next year, Medicare will negotiate directly with pharmaceutical companies to set the maximum fair price (MFP) for certain prescription drugs, with application of the negotiated prices starting in 2026 for 10 negotiation-eligible drugs from Part D.
By Ken Perez, vice president of healthcare policy and government affairs, Omnicell, Inc.
The 340B Drug Pricing Program was created in 1992 to give safety net providers—those that deliver a significant level of both healthcare and other health-related services to the uninsured, Medicaid, and other vulnerable populations—discounts on outpatient drugs to “stretch scare federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
In brief, the program requires drug makers participating in Medicaid and Medicare Part B to provide discounts on outpatient drugs to 340B providers, which include various types of hospitals and certain federal grantees, such as federally qualified health centers and comprehensive hemophilia treatment centers.
The change to the reimbursement rate and ensuing debate
On Nov. 1, 2017, the Centers for Medicare and Medicaid Services (CMS) issued its final rule for the calendar year (CY) 2018 Outpatient Prospective Payment System (OPPS), the system through which Medicare decides how much money a hospital or community mental health center will get for outpatient care provided to patients with Medicare. That rule included a 28.5% reimbursement rate cut—from average selling price (ASP) plus 6% to ASP minus 22.5% for the 340B Program. The American Hospital Association estimated that the cut aggregated to $1.6 billion annually for 340B hospitals.
On July 31, 2020, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit), by a 2-1 vote, upheld the U.S. Department of Health and Human Services’ (HHS) decision to allow CMS to implement the 28.5% reimbursement rate cut, ruling against the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), America’s Essential Hospitals (AEH), and hospital plaintiffs Northern Light Health in Brewer, Maine, Henry Ford Health System in Detroit, Mich., and AdventHealth Hendersonville in Hendersonville, N.C.
By Ken Perez, vice president of healthcare policy and government affairs, Omnicell, Inc.
Discussions about the cost of healthcare in the United States often take the form of debates, pitting one sector against the other. Classic examples are health insurers (payers) versus hospitals and health systems (providers), and pharmaceutical manufacturers versus providers. Often at stake in these clashes are the relative sizes of the healthcare economic pie received by the different sectors.
Looking at healthcare through a societal lens helps one avoid participating in these debates and instead focus on macro issues. For years, how much the U.S. spends in total on healthcare—across all payers and for all healthcare—has been at the top of the macro issues list.
National health expenditures (NHE) are the universally accepted measure of that. On March 28, the Centers for Medicare and Medicaid Services (CMS) released the 2021-2030 National Health Expenditure report, which was prepared by the CMS Office of the Actuary.
How much did the U.S. in total spend on healthcare last year? In 2021, national health spending totaled $4.3 trillion, equal to 18.8% of the nation’s gross domestic product (GDP) and down from a record 19.7% of GDP in 2020 that reflected the significant spending incurred to respond to COVID-19. Because of the pandemic, NHE grew sharply (9.7%) from 2019 to 2020, and its growth slowed to 4.2% in 2021. Per capita health expenditures were $13,037 in 2021. To put that in perspective, last year, the U.S. spent almost $1,100 per month on healthcare for the average per person.
Comparisons with Other Countries
Since healthcare consumes almost a fifth of the nation’s GDP, one has to ask whether that is good or bad. One basis for answering that question is to compare U.S. healthcare spending with that of similarly advanced industrialized countries. Two measures are commonly used to perform that comparison: 1) healthcare spending as a percentage of GDP; and 2) per capital health expenditures.
By Ken Perez, vice president of healthcare policy and government affairs, Omnicell.
Originally, the Great Resignation was an idea, proposed by Anthony Klotz, a professor at Texas A&M University, that predicted a large number of people would leave their jobs after the COVID-19 pandemic ends and life returns to “normal.”
Despite the continuation of the pandemic, a massive number of Americans did not wait to quit their jobs in 2021. According to the U.S. Bureau of Labor Statistics, in April 2021 a record 3.8 million people resigned, followed by a string of more record resignations in subsequent months: 3.9 million in June, 4.2 million in July, 4.3 million in August, and 4.4 million in September. In total, more than 24 million Americans quit their jobs from April to September 2021. One writer described the United States as “a nation of quitters.” And during this period, the number of job openings was generally more than double the number of resignations. For example, there were 10.4 million openings at the end of September 2021.
Of course, the big question was why did this mass, sustained exodus from the workforce occur? Not surprisingly, the top reason was the cumulative stress and burnout caused by the COVID-19 pandemic. This led workers to seek relief and assert their rights, or at least their desires, for better compensation, more flexibility, less stress, and increased job satisfaction.
Resignations have been the most pronounced in the technology and healthcare industries, where workers experienced extreme increases in demand due to the pandemic, resulting in heavier workloads and burnout. From February 2020 to September 2021, healthcare lost an astounding 524,000 workers. The confluence of increased demand for care—driven by increased case volume as well as higher acuity—and an aging workforce that has not been sufficiently replaced by younger generations led to the record numbers of worker departures.
By Ken Perez, vice president of healthcare policy and government affairs, Omnicell, Inc.
Although they are usually the first person patients see when they walk into a pharmacy, the important roles that pharmacy technicians play are not well understood by the public.
How pharmacy technicians support patient care is becoming more evident as the United States is experiencing a widespread shortage of pharmacy technicians. Last month, I met with a dozen chief pharmacy officers from leading hospitals and health systems from across the nation, and a large majority of them said they were struggling to staff enough pharmacy technicians. Similarly, a nationwide survey conducted in late May by the National Community Pharmacists Association (NCPA) found that nearly 90% of the survey’s 278 respondents said they couldn’t find pharmacy technicians.1
What’s causing the shortage? It’s primarily due to externalities. The pharmacy technician shortage is part of the broader problem affecting entry-level hiring across all industries—for various reasons, many people are reluctant to return to work.
Consequently, many large corporations are offering new workers unprecedentedly high starting hourly wages. Walmart, the nation’s largest private employer, recently raised its hourly pay for more than 565,000 store workers by at least $1, bringing the chain’s U.S. average hourly wage to $16.40.2 Also, Amazon, the nation’s second-largest private employer, also recently increased its average starting wage to more than $18 an hour, and it announced plans to hire 125,000 warehouse and transportation workers.3 In contrast, the U.S. average hourly wage for pharmacy technicians is approximately $15.
