COVID-19 Upates (10-22-21)
PHE Extended
On October 18, 2021, the U.S. Department of Health and Human Services announced that the Public Health Emergency (PHE) has been extended for 90 days from October 18, 2021 until January 16, 2022. The CMS 1135 waiver flexibilities will remain in effect as long as a COVID-19 public health emergency is in effect.
Additionally, as a provision of Section 3706 of the CARES Act, hospice physicians and nurse practitioners may continue to conduct recertification face-to-face encounters through telehealth “during the COVID-19 emergency period.”
President Biden Announces COVID-19 Vaccination Plan for Kids Ages 5-11
On October 26th, the FDA’s independent advisory committee will meet to discuss recommendation of the Pfizer COVID-19 vaccinations for children 5-11 years old. The CDC’s independent advisory committee will convene afterwards, on November 2-3.
In anticipation of eventual approval resulting from the recommendations from these meetings, the Biden Administration announced a plan last Wednesday to ensure that the vaccine would be quickly distributed and available to families across the country. Download the Fact Sheet from the White House website.
FDA Advisers Support Johnson & Johnson Vaccine Booster
As reported by Roll Call, “Advisers to the Food and Drug Administration voted, 19-0, to authorize a Johnson & Johnson COVID-19 booster shot at least two months after the first dose, providing some reassurance to the 14 million Americans who received its vaccine and face a higher risk of mild cases than other vaccinated people. FDA and Centers for Disease Control and Prevention officials said at the meeting that real-world evidence suggests the single dose shot is less effective than the Pfizer-BioNTech and Moderna vaccines, including against hospitalization. Johnson & Johnson argued two doses of its vaccine would ramp up efficacy to 94 percent, comparable to those other authorized vaccines.”
As reported by Axios, “The Food and Drug Administration and Centers for Disease Control and Prevention will likely allow recipients of the Johnson & Johnson COVID-19 to mix and match vaccine boosters depending on their individual health. Fauci acknowledged that data suggests that boosting the J&J vaccine with one of the mRNA vaccines produces more antibodies than a second shot of the J&J vaccine.”
Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say |
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HCPF Update on ARPA Funds Spending Plan & Temporary Rate Increases
HCPF led a webinar on Thursday regarding their ARPA HCBS spending plan. Information included details on both of the wage pass-through proposals: 2.11% for agencies (retroactive to April 2021) and the wage pass-through to support a $15/hr minimum wage for caregivers.
See the attached notes from HHAC's Advocacy Team and the attached Operational Memo from HCPF regarding rate increases. |
[Updated] Landmark Choose Home Bill Introduced in the House
Home Health Care News | By Robert Holly
The Choose Home Care Act of 2021 was introduced in the U.S. House of Representatives early Friday morning.
The legislation was previously introduced in the Senate at the end of July.
If enacted, the landmark Choose Home legislation would create an add-on payment to the traditional Medicare Home Health Benefit, allowing providers to mix in telehealth, transportation, personal care and other services. The goal of the concept is to give nursing home-eligible Medicare beneficiaries more options as to how and where they recover following a trip to the hospital.
The House version of Choose Home was sponsored by U.S. Reps. Henry Cuellar (D-Texas) and James Comer (R-Ky.).
Since being introduced in the Senate, Choose Home has received “an outpouring of support from America’s home health community as well as consumer and patient advocates,” National Association for Home Care & Hospice (NAHC) President William A. Dombi said in a statement released shortly after the bill’s introduction.
“[We believe that] demonstrates how important it is to increase access to safe, cost-effective care at home for Medicare beneficiaries after hospitalization,” Dombi continued. “We commend Reps. Cuellar and Comer for their leadership on issues impacting the delivery of home care and are excited to see this bill introduced in the U.S. House.”
So far, the House version of Choose Home is also co-sponsored by Reps. Sanford Bishop, Jr. (D-Ga.), Brendan Boyle (D-Pa.), Buddy Carter (R-Ga.), Dwight Evans (D-Pa.) and Vicente Gonzalez (D-Texas). Lawmakers Brian Higgins (D-N.Y.), Clay Higgins (R-La.), Eleanor Holmes Norton (D-D.C.), Mike Johnson (R-La.), Tom O’Halleran (D-Ariz.), Tom Suozzi (D-N.Y.) and Paul Tonko (D-N.Y.) also have backed the legislation.
U.S. Sens. Debbie Stabenow (D-Mich.) and Todd Young (R-Ind.) are the lead sponsors of the Senate version, which also has drawn plenty of co-sponsors and bipartisan support.
In addition to NAHC, Choose Home is supported by AARP, LeadingAge, Allies for Independence, the National Council on Aging, Moving Health Home, the Council of State Home Care & Hospice Associations and the Forum of State Associations.
The Partnership for Quality Home Healthcare (PQHH) is likewise a major advocate for Choose Home.
“We applaud Reps. Cuellar and Comer, and all the original co-sponsors, for recognizing the value of home health and the importance of advancing legislation to increase seniors’ care options after hospitalization,” PQHH Executive Director Joanne Cunningham said in a statement. “With their support, we are hopeful we will see the Choose Home Care Act enacted this year in order to help us better protect our nation’s vulnerable aging and sick populations while also modernizing the Medicare Home Health Benefit.”
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FDA Advisory Panel Unanimously Endorses Moderna’s Covid Vaccine Booster for Some Groups
By Matthew Herper and Helen Branswell Oct. 14, 2021
For an archived version of live coverage of the hearing of the FDA’s advisory panel, click here.
AFood and Drug Administration advisory panel voted unanimously Thursday in favor of authorizing booster shots of the Moderna Covid-19 vaccine to people 65 and older, those 18 to 64 with risk factors for severe Covid-19, and those whose jobs put them at high risk for serious complications of Covid-19, such as health care workers.
After hours of deliberation, the Vaccines and Related Biological Products Advisory Committee voted 19-to-0 that the Moderna booster should be authorized for these groups at least six months after receiving their second dose. The panel also discussed at what point boosters should be recommended to all adults over 18, saying that at this point it is far too soon to consider the matter.
The Moderna booster consists of a 50-microgram dose, half the normal dose of the shot.
The groups recommended for the Moderna booster are the same ones authorized for the booster made by Pfizer and BioNTech.
The FDA is not bound by the votes of its advisory committees, which it convenes to ask for guidance, but it generally follows their advice. The booster shot would be granted an emergency use authorization, used to speed the approval of products during public health emergencies, not a traditional approval.
Many panelists said they thought there were holes in Moderna’s data regarding the background of patients studied, but that they were not big enough to justify recommending boosters for groups different than for the Pfizer-BioNTech vaccine. Stanley Perlman, a microbiologist at the University of Iowa, said that although he had concerns, he thought not granting a similar approval would leave people in the U.S. “completely confused.”
Members of the committee were far less willing to consider opening up availability for both the Pfizer and Moderna vaccines to all people over the age of 18.
“I’m uncomfortable with how we’ve sort of tripped down the line for the thought of universal booster dosing, which I just think is wrong,” said Paul Offit, a pediatrician and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Michael Kurilla of the National Institutes of Health worried about the durability of the two vaccines and about how often boosters will be needed, how much space there should be between vaccine doses, and what dose of vaccine to use.
“[It’s] going to be very critical to understand whether or not a six-month boost actually does change the trajectory of the antibody response and provide some better durability,” Kurilla warned.
This summer, the Biden administration said it intended to make booster shots broadly available as early as September. But many scientists have pushed back, saying that there is not enough evidence that the efficacy of the vaccines against severe Covid, hospitalizations, and death is waning.
On Friday, the FDA advisory committee will meet to discuss data regarding giving a booster shot to all people who have received the Johnson & Johnson Covid vaccine, as well as a study that suggests it might be possible, or even advantageous, to mix and match boosters of different vaccines. |
Biden-Harris Administration Greenlights Coverage of LGBTQ+ Care as an Essential Health Benefit in Colorado
New health plan benchmarks expand access to care for transgender patients
For the first time, the Centers for Medicare & Medicaid Services (CMS) approved a request to provide gender-affirming care in the individual and small group health insurance markets as part of Colorado's Essential Health Benefit (EHB) benchmark. Today's landmark step is aligned with the Biden-Harris Administration's efforts to address health care disparities by removing longstanding barriers and expanding access to care for transgender persons.
Colorado's new EHB-benchmark plan will enhance access to coverage for gender-affirming care that meets individual needs and discourages the use of a "one-size-fits-all" framework for transgender persons seeking medical care. Changes to the EHB-benchmark plan will allow access to a wider range of services for transgender individuals in addition to benefits already covered. Such treatments will include eye and lid modifications, face tightening, facial bone remodeling for facial feminization, breast/chest construction and reductions, and laser hair removal. The state is also adding EHBs in the benchmark plan to include mental wellness exams and expanded coverage for 14 prescription drug classes. These changes will take effect beginning on January 1, 2023.
"Health care should be in reach for everyone; by guaranteeing transgender individuals can access recommended care, we're one step closer to making this a reality," said HHS Secretary Xavier Becerra. "I am proud to stand with Colorado to remove barriers that have historically made it difficult for transgender people to access health coverage and medical care."
"Health care should be accessible, affordable and delivered equitably to all, regardless of your sexual orientation. To truly break down barriers to care, we must expand access to the full scope of health care, including gender-affirming surgery and other treatments, for people who rely on coverage through Medicare, Medicaid & CHIP and the Marketplaces," said CMS Administrator Chiquita Brooks-LaSure. "Colorado's expansion of their essential health benefits to include gender-affirming surgery and other treatments is a model for other states to follow and we invite other states to follow suit."
Gender-affirming care is considered a standard level of care by the American Medical Association, the American Academy of Family Physicians, and the American Psychiatric Association. Transgender patients often face discriminatory hurdles in accessing medically necessary health care services that affirm gender identity.
The Affordable Care Act (ACA) requires non-grandfathered health plans in the individual and small group markets to provide coverage in 10 categories of EHBs, including preventive and wellness services, chronic disease management, maternity and newborn care, hospitalization, prescription drugs, mental health and substance use disorder services, behavioral health treatment, and lab services. CMS regulations allow states the flexibility to develop state-specific "benchmark" plans that detail the specific services covered among these broad categories based on a typical employer plan offered in the state.
CMS recognizes that expanded, gender-affirming coverage vastly improves health care outcomes for the LGBTQ+ community, reduces high rates of depression, anxiety, and suicide attempts as well as decreases substance use, improves HIV medication adherence, and reduces rates of harmful self-prescribed hormone use. |
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