Healthcare Policy News

Pfizer’s COVID-19 Vaccine Granted Full FDA Approval As CMS Ups Its Reimbursement

As Pfizer-BioNTech’s COVID-19 vaccine receives full FDA approval, CMS announced it will increase Medicare reimbursement for vaccines administered in home settings.

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By Emily Sokol, MPH

- COVID-19 remains in the spotlight of this week’s policy recap as Pfizer-BioNTech’s COVID-19 vaccine is granted full FDA approval. And CMS boosts reimbursement rates for COVID-19 vaccines administered at home. Meanwhile, telehealth enters the abortion debate and vaccine status is not covered by the HIPAA Privacy Rule.

CMS Request MA Plans Relax Prior Authorizations

Amid the surge of COVID-19 cases sparked by the Delta variant, CMS asked Medicare Advantage plans to relax or waive prior authorizations. The goal of the request is to alleviate undue administrative burden, particularly on acute-care hospitals moving patients to skilled nursing, long-term care, inpatient rehabilitation, or home healthcare. READ MORE

House Resolution Would Increase Telehealth Access for Abortion Services

A recently introduced House resolution would open access to telehealth services for a common medical abortion drug, mifepristone. Under current guidelines from the FDA, the drug falls under the Risk Evaluations and Mitigation Strategies protocol that requires the drug be administered in a healthcare setting under the direct supervision of a certified care provider. The resolution would allow the consultation and administration to take place via telehealth, but opponents say medical abortions are too dangerous for virtual practice. READ MORE

Vaccine Status Not Covered Under HIPAA Privacy Rule

Asking an individual’s vaccination status is not a HIPAA violation, despite rising misconceptions. A blog post from Harvard Health Publishing broke down the HIPAA privacy rule and highlighted exactly what was covered under the law:

  • Information an individual’s healthcare provider puts in a patient’s medical record
  • Conversations with a provider about patient care or treatment with another provider
  • Information about a patient in a health insurer’s system
  • Billing information

The scope of HIPAA does not expand far beyond healthcare providers, meaning employers, store owners, and most law enforcement officers, for example, can ask about a patient’s vaccination status. READ MORE

Pfizer-BioNTech COVID-19 Vaccine Has Full FDA Approval

On Monday, the FDA announced the full approval of Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 and older. Previously administered under an emergency use authorization in December 2020, the vaccine is the first COVID-19 vaccine to have full FDA approval and will be marketed under the name Comirnaty. READ MORE

CMS Ups Reimbursement for COVID-19 Vaccination

Medicare announced it will pay an additional $35 per dose for COVID-19 vaccines administered in a patient’s home. The new reimbursement rate includes a maximum of five vaccine administration services per home or communal living space as a part of agency’s latest effort to increase vaccination rates. READ MORE

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