Updates from your ACE team
Happy New Year! We are closed for the holiday and wish you all a wonderful, safe, and socially distanced new year. We will be back in the office tomorrow, January 2, 2021.

We made it to 2021! 2020 was quite a year from pharmaceutical manufacturers challenging Health Resources and Services Administration’s (HRSA) 2010 guidance, HRSA and U.S. Department of Health and Human Services (HHS) waiting to see what other lengths manufacturers would go to challenge the guidance and Congress asking for recommendations on how to update the 340B Program for current patient’s – all during a global pandemic that has put a lot of people in a bind. The same global pandemic allowed telehealth to advance, HRSA to fund free COVID-19 testing and allowed covered entities to apply to enroll in the 340B Program on a weekly basis.

This newsletter follows up on last month’s 340B Program’s latest news and what it means for covered entities today (this issue is still unfolding); various government bodies are standing behind covered entities and are challenging HHS’ Alex Azar’s lack of response to and involvement in the issue, National Association of Community Health Centers’ (NACHC) strategy for community health centers to be able to receive and vaccinate their patients for COVID-19 and the flu, Centers for Medicare and Medicaid (CMS) released its Healthcare Common Procedural Coding System (HCPCS) codes to be reimbursed for Medicaid beneficiaries that receive the U.S Food and Drug Administration (FDA) approved COVID-19 vaccines, and CMS’ final rule and what it means for telehealth and other providers. This newsletter also discusses practice expansion and how implementing programs can save lives through offering services patients need, such as the OB/GYN specialty. 
Saving lives by reducing the pregnancy mortality rate through practice expansion
Women have been giving birth for centuries, but even with the advancements health care has made to date, there is still a high mortality rate – which is higher in rural areas. “Approximately 700 women die every year in the US [because of] pregnancy-related complications. 25,000 women suffer unintended outcomes of labor and delivery that can result in significant short- or long-term consequences to their health. The Centers for Disease Control and Prevention (CDC) estimates that two out of three pregnancy-related deaths are preventable.”

As a result of these stats, HHS released an action plan and has partnered to work to reduce maternal deaths and disparities that put women at risk pre, during and post pregnancy. HHS’ action plan works to:
  • Reduce the maternal mortality rate by 50 percent
  • Reduce low-risk cesarean deliveries by 25 percent
  • Achieve blood pressure control by 80 percent of women with reproductive age with hypertension

Georgia Health Policy Center and the Association of Maternal & Child Health Programs partnered and released an issue brief, Promoting Access to Care for Women of Reproduction Age with Mental Health and Substance Use Disorders in Rural Communities. Mortality rates are higher in rural areas than in urban areas and there are significant barriers between care and the patients that need it in rural areas. While pregnancy can be an exciting time, it’s also hard on the body over time and some expecting mothers suffer from depression. The issue brief mentions depression rates and drug use in women pre- and post-pregnancy. Mental health services aren’t the only services that are harder to access in rural areas; OB/GYN is too. Mental health services are less likely to be reported as extremely accessible. OB/GYN care lacks because of obstetric unit closures and a limited number of OB/GYN providers overall. There are less providers across specialties in rural areas.
340B Pharmacy manufacturer challenge leads to new HRSA guidance
Here we go.

The newsletter last month touched on the absolute chaos pharmaceutical manufacturers have brought to covered entities, which are working tirelessly to treat patients regularly and COVID-19 patients – especially those that are underserved and uninsured during a pandemic. All this chaos, while it may be frustrating for covered entities, has been brought up with good intensions: to ensure those that need the 340B discount receive it when filling their prescriptions at contract pharmacies. The challenge is that manufacturers can’t verify which patients are and are not receiving the 340B discount, so they’d like to have some additional data; covered entities, however do not feel the need to provide additional data because they’ve never had to and it may be burdensome.

Drug manufacturer Novo Nordish is following in the footsteps of the other manufacturers (Eli Lilly and Co., AstraZeneca, Sanofi, Novartis and United Therapeutics). The company announced on December 1, 2020 that beginning today (1/1/2021), “it will no longer facilitate bill-to/ship-to distribution of 340B product to a contract pharmacy of any of the six hospital covered entity types.” Interestingly, “HRSA told 340B Report that [its] aware of Norvo Nordisk’s plan and is in the process of reviewing and determining [its] next steps.” Novo Nordisk is allowing these covered entities (340B hospitals, that do not have an in-house 340B Pharmacy) to designate one contract pharmacy for distribution.

HRSA advanced a final rule to the White House on November 18 for approval. The rule was approved and creates a binding administrative resolution (ADR) process for the 340B Program. The rule was “formally published” and takes effect January 13, 2021. “In finalizing the rule, HRSA disagreed with commenters who said that, before developing the ADR process, HRSA needed to ‘establish foundational guidance on key issues,’ including finalizing HRSA’s 340B omnibus program guidelines withdrawn in 2017. ‘The 340B statute empowers the 340B ADR Pannel with reviewing a claim, as set forth in this final rule, to determine when there have been statutory violations concerning overcharges, diversion, and duplicate discounts.' [HRSA’s] rule:
  • Set a $25,000 de minimis threshold for monetary claims
  • Set standards for the composition and size of dispute resolution panels
  • Declined recommendations to create a permanent board
  • Decided Office of Pharmacy Affairs (OPA) staff would serve on panels as non-voting ex officio members
  • Declined to designate HHS administrative law judges to settle disputes
  • Set standards for screening panelists for conflicts of interest
  • Established procedural rules and deadlines
  • Rejected recommendations that manufacturers be required to first audit covered entities before bringing claims against the entities
  • Held that challenging a manufacturers’ average manufacturer price or best price calculations was beyond the scope of an ADR panel’s jurisdiction.”

It is unknown if the incoming Biden Administration will “suspend [the rule’s] implementation” to review it or leave it as is. The American Hospital Association (AHA) asked the Biden Administration to place a high priority on protecting the 340B Program during its first 100 days in office.

This is still an unfolding issue and we’ll keep you updated as there are updates. 
AHA asks the Biden Administration to prepare to defend the 340B Program in its first 100 days
A bipartisan group of 29 state attorney generals submitted a letter to HHS Secretary Alex Azar urging him ‘to address drug manufacturers’ unlawful refusal to provide critical drug discounts to covered entities, such as community health centers, under the 340B Drug Pricing Program. AHF is grateful to the attorney generals for standing up for the program that taxpayers do not pay for and strengthens the health care safety net.

The AHA asked the Biden Administration to protect the 340B Program in its first 100 days in office. “The AHA sent president-elect Biden a list of priority recommendations to implement with ending the pandemic as number one.

Florida’s state Medicaid director wrote a letter to Eli Lilly and Co asking the manufacturer “to suspend its restrictions on the 340B [drugs] shipped to [contract pharmacies for the patients of the various] covered entities. [There is] some [speculation] that Florida Medicaid might have signaled it may use its Medicaid preferred drug list as leverage over [the drug manufacturers] that [are] denying 340B pricing for contract pharmacy drugs.

The New York Times, one of the country’s most highly regarded news organizations, [ran] an article about ‘top pharmaceutical companies that have stopped giving federally mandated drug discounts to hospitals and clinics that care for the poorest Americans,’ and the bipartisan pressure building on Azar ‘to demand reinstatement of the price breaks or punish the firms.’” According to the Times’ article, “drug companies say that ‘some hospitals and clinics were exploiting [the program] to [pay] their own bottom lines, and that individual patients are not being hurt’ by their 340B pricing denials. Drug makers [are saying that the program] has grown larger than originally intended, costing billions of dollars each year in part because of the decision” and work the Obama Administration and HRSA did together to open the cap on the number of contract pharmacies covered entities can utilize to distribute 340B medications to their patient base, increasing pharmaceutical services to the underserved and uninsured. 

We'll keep you updated as this issue continues to update.
From the Hill and other useful info
A new COVID-19 bill is being discussed. The bill would provide $908 billion to “provide more financial support for health care providers, [adding] $35 billion to the Provider Relief Fund, including $7 billion for rural providers and $1 billion for tribes, tribal organizations, urban Indian health organizations and health services providers to tribes.”

COVID-19 vaccine updates
The CDC has published some guidance for all levels of the government to consider, once a FDA vaccine for COVID-19 is approved. The CDC is concerned that the demand will be higher than the supply once a vaccine is public and suggests providing the vaccine to health care workers and then those living in long-term care facilities as they are the most at-risk groups for COVID-19. 

CMS released Medicare billing codes for [the] new COVID-19 vaccine that was recently approved by the FDA. The Healthcare Common Procedural Coding System (HCPCS) code Q0243 may be used for the injection (2,400 milligrams of Regeneron’s investigational monoclonal antibody therapy cocktail) and M0243 for the intravenous infusion and post-administration monitoring.”

On December 1, 2020 “CMS released the annual Physician Fee Schedule (PFS) final rule, prioritizing CMS’ investment in primary care and chronic disease management by increasing payments to physicians and other practitioners for the additional time they spend with patients, especially those with chronic conditions.” This removes the red tape and “allows non-physician practitioners [to] practice at the top of their license, spend more time with [their] patients [and less time on] paperwork.” This rule aligns with the Trump Administration’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, which includes expanding other alternatives like telehealth. This rule adds over 60 services to the Medicare telehealth list that will be covered” post pandemic.


There have been several conversations around the pandemic, specifically and more recently COVID-19 vaccines and the importance of getting this year’s flu vaccine. NACHC and community health centers have been working throughout the pandemic to ensure that community health centers and their patients have what they need throughout the pandemic.

NACHC acknowledges that there is a lot of planning and patient education to do to ensure that more people receive both COVID-19 vaccines than not.