Insights & Analysis
There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.
Treatment Disruption due to COVID-19 Poses Challenges to Practices in OCM
Oncology practices with a substantial proportion of Oncology Care Model (OCM) episodes in areas with high numbers of COVID-19 cases—such as Connecticut, Louisiana, Massachusetts, New Jersey, New York, and Pennsylvania—may face new challenges in containing total expenditure below target amounts.
FDA Guidance on Digital Devices for Mental Health During COVID-19
To protect the public’s health during the COVID-19 pandemic, the Food & Drug Administration (FDA) released guidance expanding the availability of digital health therapeutic devices and applications for psychiatric disorders by clarifying which regulatory requirements it does not plan on enforcing as well as which products do not necessitate FDA oversight. This guidance intends to limit extraneous contact between patients (users) and providers by providing regulatory flexibility for low risk products. The policies will last until the national public health emergency ends.
Patients Using DMARDs for Autoimmune Diseases May Encounter Access Challenges
As COVID-19 deaths increase, the FDA is evaluating and considering approval of treatments more quickly, but the rush to find treatment options is creating new access considerations for patients and providers.
Considerations for the Role of Pharmacies and the Retail Pharmacy Business Model in Response to COVID-19
As COVID-19 continues to stress the US healthcare system, pharmacists and retail pharmacies may help respond to the pandemic.
Provider Impact of COVID-19 Telehealth Policies by Specialty
Approximately ⅓ of physician services payments are eligible for telehealth reimbursement under Medicare (fee-for-service) FFS through existing Center for Medicare and Medicaid Services (CMS) guidance as of January 2020, in addition to temporary coding guidance specific to COVID-19 effective as of March 1, 2020. Avalere’s analysis highlights the immediate potential for specific physician specialties to utilize telehealth based on temporary flexibilities regarding which procedures are eligible for telehealth reimbursement.
How Nonprofit Hospitals Can Use Community Benefit Dollars to Address SDOH
As of 2018, almost 70% of hospitals in the United States are not-for-profit entities according to the American Hospital Association (AHA).
COVID-19 Complicates Access to Provider-Administered Autoimmune Treatments
The large-scale disruptions resulting from COVID-19 are significantly reshaping how patients receive care. In particular, patients taking infused and injectable drugs administered by a healthcare professional at a physician office, infusion center, or hospital outpatient department now face greater challenges receiving their medications.
Amid COVID-19 Pandemic, Influenza Disease Burden Remains Significant
Although influenza disease burden is high, vaccine uptake remains low.
Medicare Part D Plans Continue to Require Cost Sharing for Vaccines
An Avalere analysis finds that Medicare Part D plans allow $0 cost-sharing for select vaccines just 4% of the time, likely affecting immunization uptake.
COVID-19 Considerations for Medicare Advantage Plans
The COVID-19 pandemic will have ongoing, market-wide implications as Medicare Advantage (MA) plans contend both with responding to the virus and the disruption to their normal activities.
Home Testing Can Keep People Safe and Get Them Back to Work—Here’s How
On April 7, Gillian Woollett authored a Health Affairs blog piece with Ge Bai from the Johns Hopkins Carey Business School and Bruce Pyenson from Milliman about the role that testing plays in recovering from the COVID-19 pandemic.
What COVID-19 May Mean for Future FDA Regulatory Oversight
The FDA has adjusted its priorities in response to the COVID-19 pandemic and the agency is expediting decisions on testing, therapies, and vaccines on a daily basis.
Medicare Spending on Treatments for Ophthalmic Conditions
Avalere analysis finds that new users account for a large share of Medicare spending on opthalmic medications.
COVID-19: Future Considerations for Biopharma
As the COVID-19 pandemic unfolds, stakeholders across the healthcare system are facing new realities that will affect the environment in which drugs are commercialized and accessed.
State Legislature Suspensions due to COVID-19 Leave Policy Agendas Unfinished
In response to the novel coronavirus (COVID-19) pandemic, a majority of state legislatures have either suspended their ongoing legislative sessions or adjourned sine die, which marks the definitive end of a state’s session, earlier than originally scheduled.
What the COVID-19 Pandemic Will Mean for Drug Development
In response to the COVID-19 pandemic, FDA has announced actions that may have much broader implications for drug development, lifecycle management, and oversight.
Where We Stand on COVID-19 Treatments
Globally, the need to flatten the epidemic curve of COVID-19 cases has become the top public health priority to save lives and minimize the burden on the health care system. In the absence of treatments and prophylactics for the novel coronavirus, social distancing and quarantine strategies continue to be implemented in the US.
New Federal Rule Could Affect Infusion Site of Care Amid COVID-19 Pandemic
The Centers for Medicare & Medicaid Services (CMS) issued a new Interim Final Rule (IFR) that is intended to allow additional beneficiaries, especially those who are at high-risk, to receive home infusions amid COVID-19 transmission concerns. Specifically, the CMS clarified the definition of “homebound” under the Medicare Home Health Benefit and temporarily suspended enforcement of the National and Local Coverage Determinations (NCD and LCD) related to home infusion services. Uncertainties remain as to how these new flexibilities will be utilized, as well as how these flexibilities could impact treatment outcomes.
Select Part D Plans Have Higher PMPM Spending for LIS in Most Protected Classes
As plans continue to assess the proposed changes to their liability in the Medicare Part D benefit, understanding variations in spending by enrollee can help elucidate how policy changes might affect their spending. This Avalere analysis examines a subset of MA-PD and PDP plans with at least 75% of their enrollment comprising those with LIS. This analysis aims to quantify spending on drugs within the 6 protected classes for low-income subsidy (LIS) and non-LIS beneficiaries in this subset of PDP and MA-PD plans.
Ensuring COVID-19 Vaccine Affordability
On March 30, Avalere policy experts published a piece in the Health Affairs blog about the existing programs in place to ensure patient access to affordable COVID-19 vaccines.

