FDA Examines Cancer Drug Effectiveness; HHS Promotes Care Access, Marketplace Enrollment

April 28, 2021 - The FDA remains busy as Johnson & Johnson vaccine review ends and cancer drug approval discussions commence. Meanwhile, HHS allocates funding to medically underserved health centers to improve infrastructure and promotes Special Enrollment Period to Black Americans through trusted partnerships.

Several telehealth-related bills have also recently been introduced to Congress promote the expansion of covered services from home health to diabetes prevention, continuing to raise the question of the pandemic’s lasting effects on healthcare.

CDC Lifts Outdoor Mask Recommendation for Fully Vaccinated Individuals

The CDC recently released recommendations that fully vaccinated individuals do not need to wear a mask outdoors, provided they are not in a large crowd. Masking recommendations remain in place for individuals who are partially vaccinated or not vaccinated at all. READ MORE

CMS Proposed Rule Funds Rural Residency Programs

On April 27, CMS proposed a new rule to bolster rural physician workforces. Under the proposed rule, 1,000 new medical residency positions would be made available in the next five years to address physician shortages in rural and underserved communities. The rule aims to support training and retaining high-quality physicians to address rural health disparities. Another feature of the proposed rule would increase fee-for-service payment rates for acute care inpatient hospitals and long-term care hospitals by $2.5 billion in fiscal year 2022. READ MORE

FDA Committee Kicks off 3-Day Meeting on Cancer Drug Approvals

On April 27, the FDA Oncologic Drugs Advisory Committee began a three-day meeting to discuss several previously approved cancer therapeutics. The committee plans to determine if these drugs, including Tecentriq, Keytruda, and Opdivo, will stay on the market or if additional, post-market studies are needed. Drug manufacturers and cancer experts will partake in the conversation to discuss the drugs’ effectiveness.  READ MORE

American Rescue Plan Funds Support HRSA-Health Centers

As a part of the American Rescue Plan, HHS announced $1 billion in funding for Health Resources and Services Administration (HRSA) funded health centers. The funding can be used for constructing new facilities, renovating or expanding existing facilities, and purchasing new equipment, as well as financial recovery from the COVID-19 pandemic. Aligning with HHS efforts to ensure equitable care delivery, the funding aims to expand access to primary care and preventive services to medically underserved communities. Over 1,400 HRSA-funded health centers are eligible for funding and applications are due by June 24. READ MORE

HHS Partners to Boost Marketplace Enrollment for Black Americans

HHS is combining efforts with several partners in an effort to boost Marketplace enrollment among Black Americans. Currently, Black Americans represent 13 percent of the US population but 16 percent of the uninsured. Meanwhile, 66 percent of these individuals are predicted to be eligible for zero-dollar premium plans, according to a press release from HHS. Some of the 23 identified partner organizations include the NAACP, National Action Network, and the National Urban League. This announcement comes about a week after HHS granted $80 million in funding for navigators to assist with outreach and education during the Marketplace Special Enrollment Period through August 15. READ MORE

Re-introduced Telehealth Bills Aim to Expand Access

Two new telehealth-focused bills were re-introduced to Congress that aim to improve access to care. The first is the Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-Based Strategies (PREVENT DIABETES) Act. Currently, CMS does not reimburse for telehealth-based care as a part of the Medicare Diabetes Prevention Program. As an evidence-based program, the office says research has yet to support the effectiveness of virtual care in diabetes prevention efforts. Many disagree, so the proposed bill would allow for Medicare coverage of connected health services through the Medicare Diabetes Prevention Program. READ MORE

The second piece of legislation would expand Medicare coverage for home health services throughout the remainder of the COVID-19 public health emergency. Under the proposed bill, CMS would have the authority to issue waivers for home healthcare services, including video and audio telehealth services, delivered during the pandemic. The change would improve access to care and reduce potential COVID-19 exposure to patients. READ MORE

Johnson & Johnson’s Vaccine Pause Lifted

On April 23, the FDA and CDC lifted the pause on the Johnson & Johnson COVID-19 vaccine. The decision comes after vaccine safety concerns paused the distribution of the vaccine a few weeks ago. After review by the FDA and CDC, the agencies reaffirm confidence in the vaccine’s safety and effectiveness toward preventing COVID-19. READ MORE