HealthCare Roundtable e-News – May 12, 2021

U.S. Senate Finance Committee Remains Split as Cornyn Continues Brooks-LaSure Hold Over Texas 1115 Waiver

President Biden continues to face a split Senate Finance Committee over whether to confirm the his nominee to lead the Centers for Medicare & Medicaid Services. Senate Republicans have generally opposed Biden’s pick for CMS administrator, with party members saying their dissent wasn’t due to the nominee’s qualifications but the administration’s nixing a Trump-era waiver approval.

Last month, Sen. John Cornyn (R-TX) asked the committee to postpone its hearing to confirm Chiquita Brooks-LaSure as CMS administrator after Cornyn raised questions regarding Brooks-LaSure’s stance on CMS’ recent decision to revoke the 10-year extension of a Texas 1115 Medicaid waiver granted in the final days of the Trump administration. Cornyn has not since lifted his hold on a floor vote, creating pressure for the Biden administration to restore the Trump-era’s 10-year extension of the state’s 1115 Medicaid waiver.

Texas Republican lawmakers recently penned a letter to HHS Secretary Xavier Becerra asking him to reconsider rescinding the waiver extension and to work with Texas going forward, citing the “unprecedented action by CMS jeopardizes billions of dollars in funding for Texas’ Medicaid program…additionally, this action deters future State innovation in the Medicaid program and will negatively impact the level of trust between States and the agency.” (InsideHealthPolicy)

Brooks-LaSure, a former healthcare policy official and Obama-alum, faced Senate lawmakers in confirmation hearings for the first time last month for the nomination as CMS administrator, alongside Andrea Palm, who was being considered to serve as Department of Health and Human Services (HHS) deputy secretary. Brooks-LaSure was questioned about several policy areas that she will oversee if she is confirmed.

Final Rule Enabling Breakthrough Device Coverage Pathway Under Review at White House OMB

The Biden administration is in the process of reviewing a final rule to establish instant Medicare coverage of FDA breakthrough devices, according to White House officials. The final rule would create a pathway allowing coverage of breakthrough devices for four years after the FDA authorizes the technology. After that point, coverage would depend on additional data collected by the manufacturer.

Several groups, including the Advanced Medical Technology Association and the Medical Device Manufacturers Association, have advocated for the rule and offered that the administration should not be concerned about operational challenges or the number of devices that could be eligible under the rule, several issues that had come up during the comment period. Critics of the rule, including all stakeholders, have shared concerns over the rule’s reasonable and necessary definition, but medical device groups and other health industry professionals have said CMS should not let that portion hold up the entire rule. (InsideHealthPolicy)

The rule is being reviewed by the White House Office of Management and Budget after a previous version of the rule was proposed by the Trump administration to set up a new coverage pathway called Medicare Coverage of Innovative Technology. The rule was set to go into effect on March 15th of this year; however, the Biden administration delayed the rule until May 15 in order to conduct an additional 30-day comment period. (InsideHealthPolicy)

Pfizer, BioNTech Seek Full FDA Approval of COVID-19 Vaccine; Agency Approves Emergency Vaccine Use for Teens Ages 12-15

Last Friday, COVID-19 vaccine manufacturers Pfizer and BioNTech initiated their application to the FDA for full approval of its vaccine for people ages 16 and older. The vaccine is currently being administered in the US for Americans ages 16 and older on an emergency use basis, but the companies are the first in the US to be assessed and apply for full approval from the FDA.

The two companies submitted clinical data last month that included an analysis of their vaccine trials. According to the report, two doses of the vaccine have proven to be effective up to six months after users receive their second dose. Moderna, the manufacturer of the second mRNA two-dose vaccine available in the US, also recently announced its plans to seek full approval of its COVID-19 vaccine later this month.

Albert Bourla, chairman and chief executive officer of Pfizer, stated that he is “proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government. We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

The FDA recently approved the Pfizer-BioNTech COVID vaccine on an emergency use basis to protect children ages 12 to 15, making it possible for many middle school students to receive the vaccine ahead of the 2021-2022 academic year. Public health experts say that the FDA clearing use of the shot in teens will also accelerate the nation’s efforts to drive down infections.

HHS to Enforce Prohibitions on Sex Discrimination in Line with Supreme Court Decision

HHS announced this week that it would be enforcing the Affordable Care Act’s protections against discriminatory actions toward transgender or LGBTQ individuals. The announcement comes after the Supreme Court ruled against a Trump-era rule in the case, Bostock vs. Clayton County, which had originally rolled back those protections.

According to the Court, the Civil Rights Act’s prohibition on discrimination ‘on the basis of sex’ includes sexual orientation and gender identity. As of this week, the OCR will interpret the ACA’s section 1557 in line with that decision, according to HHS Secretary Xavier Becerra.

“Fear of discrimination can lead individuals to forgo care, which can have serious negative health consequences. It is the position of the Department of Health and Human Services that everyone—including LGBTQ people—should be able to access health care, free from discrimination or interference, period,” said Becerra. (InsideHealthPolicy)

The decision was praised by American Medical Association President Susan Bailey, who says the Biden administration made the right decision by terminating the Trump-era rule. However, many supporters also agree that more can be done and will continue to fight to ensure other pieces of the Trump administration rule, which also eliminated some language requirements and narrowed the scope of the Obama-era regulation, are also reversed. (InsideHealthPolicy)