Updates from your ACE team
As we continue to head to the close of the year and start to reevaluate our quarterly plan to close the year strong, while also planning a strategic Q1 in 2021; it’s important to review your business model and evaluate it and the services you offer your patients to help pave the way toward your financial independence. We understand the desire to be financially independent and how that can seem like a daunting task – and we’re here to help you through to the finish line.

This newsletter focuses on expansion and how to capitalize on it while better serving your patient base, follows the ongoing challenge between pharmaceutical manufacturers and Health Resources and Services Administration's (HRSA) 2010 guidance that allows covered entities to distribute 340B drugs through contract pharmacies and Congress’ latest ask on how to better improve the 340B Program for the underserved and uninsured and has several news and COVID-19 vaccine updates. This newsletter also shares some of HRSA’s latest grants that you can take advantage of. The grants included in this newsletter all close from December 2020 through February 2021.
Happy Holidays!
We’d like to wish you and your loved ones the happiest of holidays this holiday season. We will be closed Friday, December 25 for the Christmas holiday. We’d like to remind you and your loved ones to continue practicing social distancing and wearing a mask to protect yourself, your family and others as we continue to navigate the pandemic together.

We’d also like the time to thank you for all the services you provide the communities you serve and thank you for allowing us to be a part of it.
Achieving financial independence through RCM
COVID-19 has put a lot of pressure on the health care industry – especially its revenue, regardless of the clinical setting. It’s important for all entities to ensure their medical claims are properly coded, starting from the front desk through the back end to coding and medical billing specialists. Everyone must work together to get the claims paid correctly the first time. An important addition to any billing department are A/R Specialists that review and work through the A/R to ensure all claims are paid and do not hit timely filing. It’s also a great strategy to monitor all the self-pay patients as they may become eligible for Medicaid up to 5 years after their initial visit.

We can help with this! We have a trained team of specialists that understand every aspect of FQHC billing: from the full credentialing cycle, advising your front desk for a smooth transition to the back office to ensure claims are paid, don’t hit timely filing and denials are reduced, A/R is paid off instead of written off, and self-pay patients that become Medicaid beneficiaries have their claims paid through our retro payment Medicaid program.  
Achieving financial independence through the 340B Program
The 340B Program provides several benefits to a covered entity and its patients.

Most Americans have an “I want it now” attitude and desire instant gratification. Additionally, most people will say they will “do it later” and never do it because “later” never comes.

An in-house 340B Pharmacy provides medication to the covered entities’ patients at an affordable rate, preventing a large financial strain on the overall health care system that FQHCs work together to eliminate through their treatment plans. Additionally, covered entities may provide additional services to their patient base from the savings the 340B Program allows. More on expanding to offer your patient base additional services and how it works in the next section.

It’s important to note that humans are creatures of habit and that some patients will not pick up the prescriptions from an in-house 340B Pharmacy and may prefer to go to their conveniently located CVS or Walgreens, for example. While the manufacture vs. HRSA challenge hasn’t been settled yet, covered entities are still able to write contracts with contract pharmacies to provide access to 340B medication for their patients (more on this in the following sections).

Interested in a 340B Pharmacy Program? HRSA is allowing covered entities to apply to be a part of the 340B Program on a weekly basis instead of quarterly because of the pandemic. The list of covered entities with a 340B Program is updated every Friday. Check HRSA’s website to enroll and view new enrollees in the program.

No matter where you are on your 340B Pharmacy journey, we can assist with your 340B Pharmacy needs! From writing contracts with contract pharmacies, implementing and/or managing or overseeing your in-house 340B Pharmacy to ensure continued 340B status through internal and external audits of your program.
Achieving financial independence through expansion
Arthur Ash once said, “start where you are. Use what you have. Do what you can.” Practice expansion can seem like a daunting task, but it doesn’t have to be. Ash’s famous quote is the key to SMART (specific, measurable, achievable, realistic and timely) practice expansion.

We touched on a story last month about practice expansion through a FQHC’s desire to meet its patients where they are through the opioid crisis in PA. The practice expansion model touches on reviewing where your patients are now, where they want to go, and implementing programs that act as the bridge to move them from point A to point B in a reasonable amount of time.

Does your patient base require a 340B Pharmacy, a specialty or additional specialist? What would it look like to write a contract with a local specialty practice, hire a/an additional specialist(s), either full time or on a rotating schedule?
The chess match between pharmaceutical manufacturers and HRSA continues
We’ve been following the ongoing challenge between HRSA and some pharmaceutical manufacturers concerning distribution of 340B drugs through contract pharmacies. Manufacturers are concerned that some of the underserved and uninsured patients, for which the 340B Program was created to benefit, are not receiving the price break they should be. Manufacturers have been challenging contract pharmacy arrangements in their own way because they cannot verify or control duplicate discounts on the 340B medications. The Obama Administration worked with HRSA to allow covered entities to write contracts with as many contract pharmacies as necessary to provide patients with more affordable access to their medication(s). HRSA has not engaged with the manufacturers as they continue to distribute notices and updates to covered entities. HRSA, on November 18, 2020, "advanced a final rule to the White House for approval to create a binding administrative dispute resolution (ADR) process for the 340B Program." The contents of the rule is still unknown.

“In [its updated] notice, Lilly says it will provide 340B pricing on its insulin products, only if the contract pharmacy does not mark up the drug or otherwise charge a dispensing fee. Lilly cites President Trump’s Executive Order for its justification for conditioning its sale based on what the contract pharmacy charges for the drug.” In response to the American Hospital Association’s (AHA)’s letter to several pharmaceutical companies, “Sanofi’s Senior Vice President Adam Gluck said he is ‘surprised and disappointed’ by the group’s ‘unfounded claims and incendiary tone. Sanofi supports the 340B Program’s core objective of increasing access to outpatient drugs among [the] uninsured [and underserved] and is committed to strengthening the Program’s mission, a goal that is only supported and advanced through [Senofi’s] initiative to prevent illegal and/or inappropriate duplicate discounts.’ Sanofi will continue to offer its drugs to all 340B covered entities. ‘At most, if a covered entity refuses to provide the requested data, [Sanofi] will restrict the entity’s use of contract pharmacy arrangements, but these entities will remain eligible to purchase at 340B prices for shipment to their own facilities,’” Gluck said. Lilly has allowed affected covered entities to email it for an application. Lilly has determined for a covered entity that lacks an in-house pharmacy to qualify for its 340B drug pricing, "the entity cannot have any pharmacies registered as ship-to sites in 340B OPAIS, the federal 340B program database."

In response to the various pharmaceutical companies, “Walgreens said ‘to avoid the unexpected adverse financial impact this manufacturer action may have on [a covered entities’] 340B program, effective October 1, Walgreens will be blocking the specific AstraZeneca products that were listed in [its] notice.” Meaning, Walgreens will no longer dispense AstraZeneca products to a covered entities’ patients at the 340B rate. Walgreens will be dispensing the drugs at the retail rate.

“Ryan White Clinics (RWC-340B) is the latest group to join in on the 340B fight. RWC-340B is calling on Congress, the United States Department of Health and Human Services (HHS) and HRSA to stop these actions. [President of RWC-340B Shannon Stephenson joined the conversation] that 'it is particularly concerning that drug manufacturers have taken these actions during the pandemic. Ryan White clinics are [working to treat its patients throughout the pandemic in addition to] continuing to work through the HIV/AIDS epidemic. Without access to 340B drug discounts, RCW-340B’s members would be forced to provide fewer services, serve fewer patients and/or some clinics may be forced to close.’”

The National Association of Community Health Centers (NACHC) has jumped to aid community health centers/covered entities in this drawn out debate. NACHC also "sued HHS [for] its failure to do anything about the manufacturers' actions. NACHC asked the federal district court in Washington DC to declare [that] Azar and HHS violated the 340B statute and the federal Administrative Procedure Act by failing to promulgate 340B administrative dispute resolution (ADR) regulations and implement a 340B ADR process. NACHC also asked the court to require Azar and HHS to publish and implement final 340B ADR regulations no later than 60 days from its order. NACHC [declares] HHS' failure to establish the 340B ADR process deprived health centers [the ability] to protect themselves against the manufacturers' denials of 340B pricing. Ryan White Clinics have also sued Azar and HHS over the manufacturers' denials of 340B pricing and is seeking an order giving Azar and HHS 60 days to promulgate the long-delayed 340B ADR regulations, among other relief.

U.S. congressman Fred Keller from rural central Pennsylvania questioned the head of Novartis’ US operations about the company’s plan to put conditions on 340B discounts on its products during a hearing about its and other companies’ ‘unsustainable drug prices.’”

“Covered entities are saying that Sanofi and other manufacturers using 340B ESP as their agent are not entitled to the claims data [the manufacturers are seeking because it’s] absent demonstration of reasonable cause and outside of the scope of a formal manufacturer-initiated audit authorized by HRSA. [Manufacturers] do not have [the] legal right to request data that could be used to address Medicaid managed care, Medicare Part D and commercial duplicate discounts. The data collection will be burdensome, could invade patients’ privacy - [a] violation of federal law - and requires [covered entities] to accept disagreeable terms of service.”

“HHS’ general counsel told Lilly in a [letter from September 21] that HRSA ‘has significant initial concerns’ about Lilly’s new 340B policy, continues to review the policy, ‘and has yet to make a final determination as to any potential action.’ He said Lilly ‘cannot and should not’ interpret HRSA’s non-response to Lilly’s request for a final answer to its question about whether its 340B price restructuring will subject the company to sanctions ‘as somehow endorsing Lilly’s policy.’”

The latest developments are starting to affect patients – especially the uninsured and underserved. Patient education is especially important. Patient education provides a win-win situation for the patient and covered entity. Patient education can encourage patients to get their prescriptions filled in-house, allowing them to benefit from the discount and boost your capture rate, driving your 340B revenue. We will continue to follow this unfolding issue and keep you updated.

If you don’t have an in-house 340B Pharmacy, the time to have one is now, especially as pharmacies begin to take a stand to protect their bottom line. 
Congress asks 340B Pharmacy stakeholders how to modernize and improve the program

AHA’s response pointed out that the 340B Program is already complex and most rural hospitals do not have an in-house 340B Pharmacy, so they utilize contract pharmacies to serve their patients. AHA’s letter notates that because of the latest hurdle manufactures have thrown at covered entities, underserved and uninsured patients may not receive their medications. AHA’s letter points out the poor timing of the manufacturers challenge due to the pandemic.

PhRMA’s letter notes that the 340B Program has strayed from its original purpose: providing medications to the underserved and uninsured. PhRMA’s letter points out and shares research that while the medication is provided to the covered entity at a discounted rate, the patient doesn’t always receive the discount. Instead, some covered entities have found ways to utilize the program as an additional stream of revenue. The company insists that the program needs to be reformed and offers the following suggestions:
  • “Providing broader program accountability and transparency,
  • Ensuring clarity for all stakeholders on which patients are eligible for the program,
  • Addressing the asymmetry between contract pharmacies’ growth and patient benefit,
  • Establishing more meaningful linkages between care for vulnerable patients and program eligibility standards, and
  • Improving audits and program violation enforcement to prevent diversion and duplicate discount violations.”

Dr. Fein’s letter combines the findings from PhRMA’s letter and dives into his research of and within the pharmaceutical industry, including the 340B Program. Dr. Fein estimates “that the 340 Program has grown to account for more than 8 percent of the total U.S. drug market and as much as 16 percent of manufacturer’s total rebates and discounts for brand-name drugs.”

When the Obama Administration opened the cap that allowed covered entities to partner with as many contract pharmacies as needed to better benefit the underserved and uninsured patient population, there was a growth unlike any other within the market. “This growth means that almost half of the US [pharmaceutical] industry now [profits] from the 340B Program, which was designed as a narrow support to certain hospitals and providers. The 340B Program is now approaching the size of the nation’s Medicaid outpatient drug market, which was projected to be $34.9 billion in 2019.” The contract pharmacies are an issue because even though the entity is purchasing the prescriptions at a discounted rate, there is no regulation of or proof that the patient is receiving the discount. According to the letter, “the Office of Inspector General (OIG) found that in a sample of 15 hospitals, 10 (67 percent) required uninsured patients to pay the full, non-340B price, even though [the] hospitals were purchasing the drugs at the deeply discounted 340B price. The Government Accountability Office (GAO) found that in a sample of 28 hospitals, 16 (57 percent) did not provide discounted drug prices to low-income, uninsured patients who filled prescriptions at the hospital’s 340B contract pharmacy.” Dr. Fein points that these problems are due to contract pharmacy management issues and a lack of formal regulation(s). Part of the problem, as outlined by the OIG, is the loose definition and terms for what qualifies a 340B patient as such.

It will be interesting to see where and how the program is revamped for the coming years. We’ll keep you updated as this issue develops.
From the Hill and other useful info
Trump issues drug pricing that impacts the 340B Program and FQHCs
The 340B Program has a lot of attention on it right now. Our September newsletter discussed President Trump's Executive Orders; one addressed FQHCs to ensure they provide their patients the 340B discount they receive on insulin and injectable epinephrine. This rule hasn't been finalized yet and will be soon.

On November 20, 2020, HHS announced that "Medicare-participating 340B hospital outpatient departments will have to take part in the Trump administration's 'most favored nation' (MFN) payment test for Medicare Part B drugs." Centers for Medicare and Medicaid Services (CMS) acknowledged in its interim final rule that covered entities may not be able to provide additional services to their patients if the payments paid by Medicare is lower than the covered entities' current Medicare payment. The rule takes affect on January 1, 2021. CMS is accepting comments on the rule and all comments are due at 5 p.m. on January 26, 2021.

"The administration also announced an HHS OIG final rule [that prevents] drug manufacturers from offering rebates to pharmacy benefit managers (PBMs) and Medicare Part D plans. The rule gives manufacturers protection under the Anti-Kickback Statue for drug price reductions to patients at [the] point of sale and fixed-fee service arrangements between manufacturers and PBMs." This rule takes affect on January 1, 2021.

We still have to play the waiting game as the final rules have not been released or finalized and may be modified or repealed by the incoming Biden Administration.

Biden chooses Mary Wakefield for his transition team for a HHS role
Following the election, President-elect Biden has been doing what he can, within the allowed guidelines, to start building his team to best serve the American people. He has selected Mary Wakefield "(who ran HRSA during most of the Obama Administration) to serve on his transition team for HHS." It's still unknown if she will be responsible for HRSA and its Office of Pharmacy Affairs (OPA), which is responsible for the 340B Program.

Why is this particularly interesting? Wakefield is responsible for the 340B Program's growth in 2010, which was allowed by allowing covered entities to access an unlimited amount of contract pharmacies to better serve their patients, especially those that are uninsured and underserved. It will be interesting to see how this affects the current 340B Program standoff between covered entities and manufacturers.

COVID-19 vaccine updates
As the holiday season begins, whether we’re ready for them or not, the push for a COVID-19 vaccine remains high. “The Food and Drug Administration (FDA) may have to decide by year’s end whether to allow use of the first vaccines against the virus.” Former FDA scientist Dr. M. Miles Braun warned that “the first vaccine [may not be] the best vaccine. Pfizer Inc. [is working] with Germany’s BioNTech [and] is developing one of the leading [vaccines. Pfizer] told [the] FDA that if its granted emergency use authorization, it ‘would have an ethical obligation’ to alert [those that received the placebo vaccine in the study]. The Infectious Diseases Society of America warns that “clearing a vaccine based on premature or faulty data ‘could cause more harm’ by ‘further eroding public confidence in all vaccines.” Johnson & Johnson also joined the conversation and “cautioned that early FDA clearance of one vaccine could ‘jeopardize integrity’ of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.” As the FDA continues to monitor the COVID-19 vaccine’s progress, it will also be reviewing “electronic health records (EHR) and insurance claims for red flags.”

“An analysis from researchers at Duke University’s Global Health Innovation Center shows [that] rich countries have already [purchased] billions of doses of potential [COVID-19] vaccines [to allow them to vaccinate their entire population. This could] potentially [leave] poor countries without enough supply for years to come. [It’s estimated that this could prevent low-income countries from receiving the vaccine until 2024].

Also, recently in the news, CMS announced “its Medicare reimbursement rate and official coverage strategy for the [COVID-19] vaccine, [once] one has been approved, to ensure all Americans have access to the vaccine – at no cost.” CMS’ press release states, “the Medicare payment rates will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of two or more doses, the initial dose(s) administration payment rate will be $16.94 and $28.39 for the administration of the final dose in the series.”

CMS is also taking steps to ensure – once a treatment plan has been approved – that CMS’ reimbursement rate is increased.

A South African firm, Aspen, and Johnson & Johnson have a deal, if the Johnson & Johnson vaccine is approved in South Africa and internationally. Johnson & Johnson’s vaccine, Ad26.COV3-S, is one of the four vaccines currently being tested in South Africa. Should the vaccine be approved, Johnson & Johnson will be responsible for providing the vaccine in large batches and Aspen would be responsible for packaging the vaccine into vials for distribution.

HRSA released a Health Center Program Look-Alike COVID-19 Survey. The data included in the National Summary Report includes the latest data from October 23, 2020 and can be accessed by clicking HERE.

HRSA has a few funding opportunities. See the list below for those that close December 2020 through February 2021.
  • Rural Health Care Services Outreach Program – 12/1/2020
  • Rural Policy Analysis Program – 12/14/2020
  • Rural Health Clinic Technical Assistance Program – 12/21/2020
  • Thalassemia Program – 12/21/2020
  • Regional Telehealth Resource Center Program – 1/19/2021
  • National Telehealth Resource Center Program – 1/21/2021
  • Maternal Child Health (MCH) Research Network on Promoting Healthy Weight among Children with Autism Spectrum Disorder and other Developmental Disabilities – 2/3/2021


October was Domestic Violence Awareness month. On October 27, 2020, NACHC released the blog, New Learning Collaboratives for Health Centers: Domestic Violence and Human Trafficking. NACHC is certain that every health center in the nation has treated a patient going through domestic violence/abuse. Domestic abuse cases have increased since the pandemic. The stats prior to the pandemic are alarming:

  • “1 in 4 women have reported experiencing intimate partner violence in their lifetime.
  • 1 in 7 men have reported experiencing severe physical violence by an intimate partner in their lifetime.
  • 44 percent of lesbians and 26 percent of gay men have experienced rape, physical violence and/or stalking by an intimate partner in their lifetime.
  • Transgender individuals are 1.7 times more likely to experience domestic violence.”

For many, healthcare staff, especially now, can be a lifeline that starts as a simple conversation that uncovers so much more. Click the link above for new opportunities to learn and strategies to treat domestic violence.