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Spring 2023 - Safety

Potential Disruptors: 2023 and Beyond

Financial challenges remain a consistent and growing concern for the healthcare industry, so taking actionable steps to produce tangible results can assist the industry in righting itself after uncertain times of financial instability.

Financial challenges remain a consistent and growing concern for the healthcare industry, so taking actionable steps to produce tangible results can assist the industry in righting itself after uncertain times of financial instability.

Health-Related COVID-19 Federal Emergency Declarations Ending

The Centers for Medicare and Medicaid Services (CMS) has released updated fact sheets for Medicare and Medicaid providers on the status of COVID-19 blanket waivers and flexibilities, some of which will end and some of which will continue after the COVID-19 public health emergency. Although ending the emergency is helping public health officials to focus their resources on the people who remain most vulnerable, it also limits access to tests, vaccines and treatments, especially for uninsured Americans, some of whom are no longer eligible for Medicaid.

The following changes are scheduled for emergency declarations implemented in the early days of COVID-19:

  1. Public health emergency initially declared by the Department of Health and Human Services (HHS) in late January 2020 and renewed several times: Expires May 11, 2023
  2. National emergency declaration issued March 2020: Expires May 11, 2023
  3. A separate emergency use authorization, a mechanism to facilitate availability and use of medical countermeasures determined to be safe and effective but have not yet been formally approved, issued pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act: Conclusion to be determined
  4. A declaration under the Public Readiness and Emergency Preparedness Act, providing liability immunity for activities related to COVID-19 medical countermeasures: Expires Oct. 1, 2024, in most cases (with some exceptions)

Healthcare providers are encouraged to review the implications of these changes at

Preapproval Information Exchange (PIE) Act of 2022

The PIE Act of 2022 (H.R. 7008) was passed to improve patient access to emerging therapies by improving the communication exchange between manufacturers and payers ahead of U.S. Food and Drug Administration (FDA) approval. It creates a statutory safe harbor for the proactive dissemination of certain clinical and economic information to health payers regarding new therapies or new indications of existing therapies not yet approved by FDA. It was believed that by having information ahead of FDA approval, payers would be able to better anticipate new indications and, in turn, increase the speed of coverage decisions, granting access to patients in need. Professional organizations such as the Academy of Managed Care Pharmacy have long supported initiatives to improve preapproval communication, saying: “The need for proactive PIE communication is especially important as the healthcare system continues to evolve from a fee-for-service payment system to a value-based system rewarding quality, improved patient outcomes and cost efficiency.”

Although FDA had provided some PIE guidance as early as 2018, it was unclear whether manufacturers could proactively share information with payers or whether payers needed to request the data, creating legal grey areas and uncertainty for both entities. Now that the PIE Act has passed, health payers ahead of FDA approval can incorporate new therapies into their formularies for the plan year in which approval is anticipated.

FDA Proposes Revising the National Drug Code (NDC) Format

Drug codes are the link between correctly and completely telling a patient’s story and payers understanding which products are being billed for. A revision to the NDC is intended to minimize the potential impact of running out of the current 10-digit NDC combinations as new products come to market. The proposal adopts a single, uniform 12-digit format for FDA-assigned NDCs with three distinct and consistent segments and one uniform format. The revision also includes a change to the drug product barcode label requirements.

Although these changes are not imminent, incorporating them into all parts of dispensing software and bar code scanning on administration involves careful planning long in advance, so now is a good time to purge charge description masters and pharmacy drug masters of duplications and discontinued products.

340B Considerations

Previous cuts to Medicare Part B reimbursement are due for remediation. How this will be carried out is under intense discussion that has many implications. Since the process is deigned to be budget-neutral, repayment may have negative implications on other areas of reimbursement over a yet undefined period of time. If repayment is required, facilities need to be able to resubmit claims. This entails being able to identify traditional Medicare 340 B-eligible patients who received status indicator K drugs in an outpatient setting during the defined period. And, facilities must determine whether they can do this for every patient or if they need to establish a cutoff value.

Other items under considerations are 340B administrative dispute panels and the Protect 340B Act of 2021 with antidiscrimination provisions and a clearinghouse to prevent duplicate discounts.

Pharmacy Benefit Managers (PBMs): Old and New

The rising list prices of drugs are being linked to rising rebates from PBMs. It’s estimated that three major PBMs — Express Scripts, CVS Caremark and OptumRx — control nearly 80 percent of U.S. prescription benefit transactions. PBMs profit from rebates and discounts, failing to pass on an estimated $120 billion back to consumers.

New market entrants (EmsanaRx, a not-for-profit venture owned by the Purchaser Business Group on Health; CostPlus PBM, a startup funded by venture capitalist and Dallas Mavericks owner Mark Cuban; Prescryptive Health, a blockchain-powered prescription data platform; and CapitalRx) are likely to disrupt this pattern, as are the new regulations governing PBMs that have been enacted in several states.

Equitable Community Access to Pharmacist Services (ECAPS) Act

The ECAPS Act enables Medicare patients to receive timely and consistent treatment from pharmacists for pandemic-related health services and allows pharmacists to respond to ongoing and future public health threats. It adds pharmacists as eligible providers for Medicare Part B beneficiaries of pharmaceutical services related to the COVID-19 pandemic and specific infectious diseases such as testing (for COVID-19, flu, respiratory syncytial virus and strep throat), treatment (for COVID-19, flu and strep throat) and vaccinations (for COVID-19 and flu). It also prepares for future emergencies by establishing Medicare coverage and payment for pharmacy- and pharmacist-provided services when there is a public health need such as during a public health emergency or similar event. And, it authorizes the HHS secretary to identify services as needed, including to close gaps in health equity. While this act is limited to states’ scope of practice or physicians’ services (or more broadly if provided under a Public Readiness and Emergency Preparedness Act declaration), it enables pharmacists to provide services to Medicare beneficiaries to address COVID-19 and other pressing health needs in all areas of the country.

2024 Medicare Advantage (MA) and Medicare Part D CMS Advance Notice

If the 2024 Advance Notice for the MA and Part D prescription drug programs passes, payment policies will be updated to strengthen beneficiary protections and incorporate provisions from the Inflation Reduction Act of 2022. Additionally, it will eliminate cost-sharing for Part D prescription drugs in the catastrophic phase and expand eligibility for full cost-sharing and premium subsidies under the low-income subsidy program. The goal is to continue efforts by CMS to provide more equitable, high-quality and person-centered care that is affordable and sustainable, including maintaining strong value and choice for people with Medicare. It also proposes updates to MA payment growth rates and to the MA and Part D payment methodologies. This includes technical updates to the MA risk adjustment model to keep the model up to date and improve payment accuracy such as by fully transitioning to the International Classification of Diseases (ICD)-10 system, which has been in use since 2015. The payment policies for 2024 were scheduled to be finalized and published no later than April 3, 2023.


  1. Cubanski, J, Kates, J, Tolbert, J, et al. What Happens When COVID-19 Emergency Declarations End? Implications for Coverage, Costs, and Access. Kaiser Family Foundation, Jan. 31, 2023. Accessed at
  2. Centers for Medicare and Medicaid Services. Announcements and Documents: 2024 Advance Notice. Accessed at
  3. Centers for Medicare and Medicaid Services. 2024 Medicare Advantage and Part D Advance Notice Fact Sheet. Accessed at
  4. A Celerian Group Company. MLN Connects Newsletter: Prescription Drug Inflation Rebate Program Guidance — Feb. 9, 2023. Accessed at
  5. Centers for Medicare and Medicaid Services. COVID-19 Public Health Emergency (PHE) New Overview Fact Sheet. Accessed at
Bonnie Kirschenbaum, MS, FASHP, FCSHP
Bonnie Kirschenbaum, MS, FASHP, FCSHP, is a freelance healthcare consultant with senior management experience in both the pharmaceutical industry and the pharmacy section of large corporate healthcare organizations and teaching hospitals. She has an interest in reimbursement issues and in using technology to solve them. Kirschenbaum is a recognized industry leader in forging effective alliances among hospitals, physicians, pharmaceutical companies and distributors and has written and spoken extensively in these areas.