This Week in Congress

U.S. Senate

Congress is in Recess: The Senate returns on September 6 and the House on September 13.

Inflation Reduction Act:  After more than a year of debate and negotiations over the overall cost of the legislation, taxes, tax credits and regulations, President Biden signed the Inflation Reduction Act into law. The new law includes a $369 billion investment in climate and energy programs, $64 billion to extend a policy under the Affordable Care Act to reduce health insurance costs, and a 15 percent corporate minimum tax aimed at companies that earn more than $1 billion a year.

A summary can be found here.

Other Legislation and Happenings Around the Nation

CDC Reorganization:  The CDC is undergoing an overhaul following criticism of how it handled the coronavirus pandemic and, more recently, the growing monkeypox outbreak. Federal regulators conducted reviews of the agency and determined that the “traditional scientific and communication processes were not adequate to effectively respond to a crisis the size and scope of the COVID-19 pandemic.” CDC Director Walensky stated that the CDC had failed to respond quickly enough to the pandemic and needed to be overhauled and that CDC’s future depended on whether it could absorb the lessons of the last few years, during which much of the public lost trust in the agency’s ability to handle the pandemic.  Dr. Walensky has “appointed Mary Wakefield, a former deputy health secretary in the Obama administration, to lead the effort, which she cautioned “will take time and engagement at all levels of the organization.” The changes include:

• An equity office will be established to improve the agency’s diversity across the organization, from hiring to policy.
• The CDC website will be revamped and streamlined to simplify its public health guidance.
• The agency will give staff incentives to gear their data and research toward public health policy action instead of scientific publications. In addition, measures to speed up the publication of data and research findings are being considered.
• Additional staff will be trained to quickly respond to public health emergencies. Emergency staffing will be set up to ensure there are no personnel gaps during a crisis.

Monkeypox

Statistics: For the second consecutive week, monkeypox cases increased by about 20 percent, with most case increases seen in Europe and North America, according to the WHO. More than 35,000 cases of monkeypox have now been reported from 92 countries and territories, with 12 deaths. “Almost all cases continue to be reported among men who have sex with men. In the US, the CDC reported 799 more cases, raising the nation’s total to13,500. New York has the most cases with 2,620, followed by California with 1,945. In Texas, Harris County has reported a pediatric monkeypox case, the nation’s eighth pediatric case. Officials said the child does not attend daycare or school and has no immediate family members infected.

Vaccines

Expedited Doses: On August 18, the White House and health-industry officials announced a deal to expedite millions of doses of monkeypox vaccines by moving some manufacturing to the US. Under the arrangement, Denmark-based Bavarian Nordic will work with Michigan-based Grand River Aseptic Manufacturing to package 2.5 million doses of vaccine that the US had ordered in July. Bavarian Nordic produces Jynneos, the only vaccine against monkeypox approved by the FDA, while Grand Rapids Antiseptic specializes in helping package pharmaceutical products. “The partnership will significantly increase the capacity to fill and finish government-owned doses for the first time in the U.S., and allow us to deliver our current and future supply more quickly to locations nationwide,” White House monkeypox coordinator Bob Fenton said.  Officials said that work was already underway to transfer technology from Bavarian Nordic to Grand River Aseptic Manufacturing and that manufacturing of the additional doses could begin later this year. Administration officials also approached vaccine manufacturers such as Pfizer or Merck to partner with Bavarian Nordic, but those discussions are still underway.

August Vaccine Release:  The Administration also announced that another tranche of the Jynneos monkeypox vaccine will be available on August 22, making 1.8 million doses of the vaccine available for jurisdictions to order.

Pilot Program:  This week the Biden Administration also announced the launch of a pilot program to provide monkeypox vaccines, testing, and educational information to LGBTQ people at community events, like Pride, taking place across the country over the next several months. About 50,000 doses of Jynneos monkeypox vaccine from the Strategic National Stockpile will be available for jurisdictions to provide to community members. White House Monkeypox Response Coordinator Robert Fenton said. Jurisdictions requesting the vaccine doses for community events will be required to submit plans explaining how they will educate the population on monkeypox prevention and treatment strategies, and their ability to reach community members who are most affected — that is, men who have sex with men. CDC is providing a toolkit for jurisdictions planning LGBTQ community events.

Medicare, Medicaid will Cover Monkeypox Testing: Medicare will cover medically necessary monkeypox tests under Part B – which means beneficiaries will generally not be responsible for any cost-sharing – while Medicaid will cover medically necessary monkeypox testing with nominal cost-sharing for adults if states so choose. “Medicaid-eligible adults are covered for medically necessary testing, including monkeypox testing, through Medicaid’s mandatory laboratory benefit. States can impose nominal cost sharing, including copayments, coinsurance, deductibles, and other similar charges, for such testing, and the amounts that can be charged vary with income.” The agency said that if a school is an approved Medicaid provider in its state, the school can seek reimbursement for monkeypox testing. However, CMS says it does not provide testing guidelines for Medicaid and the Children’s Health Insurance Program, and points back to the CDC’s testing guidelines. For Medicaid, monkeypox testing is covered for both adults and children.

Monkeypox as an STI:  The AIDS Healthcare Foundation (AHF) is calling for monkeypox to be treated and formally classified as a sexually transmitted infection (STI). AHF believes classifying the virus as an STI more accurately reflects the transmission of the new clade or strain of the virus, which is primarily affecting gay men and men who have sex with men and is urging that our collective public health response immediately adopt an approach that considers monkeypox as an STI. The article can be found here.

Breakthrough Cases:  As demand for monkeypox vaccines increases, the WHO has begun to receive preliminary reports on the efficacy of the shots, which suggests there are breakthrough cases occurring. “We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it, and that we don’t have firm efficacy data or effectiveness data in this context,” officials said.  The article can be found here.

340(b):  Last week, the Department of Health and Human Services asked the D.C. district court to let it proceed with its rulemaking to undo the 340B drug pay cuts overturned by the Supreme Court, indicating the agency has multiple options to handle the situation, including potentially paying 340B hospitals prospectively to make up for the cuts and putting out a survey on 340B hospital drug acquisition costs to determine whether repaying the hospitals is even necessary. The agency has already published a notice of proposed rulemaking that seeks public comments on the best way to craft any proposed, potential remedies affecting calendar years 2018-2022. Hospitals earlier this month asked the court to compel CMS to pay for 340B hospitals’ drugs at the same rate they pay other hospitals for the rest of the year and to order the agency to quickly pay 340B hospitals back for the pay cuts between 2018 and 2022 — plus interest — without recouping funds from other hospitals. The HHS responded to the hospitals’ request that the court immediately stops the 2022 cuts, saying the court needs to let the already-in-process regulatory work proceed, though it asked for more time to respond to some of the hospitals’ other arguments.

COVID-19

Dr. Ashish Jha, the COVID coordinator said the newly updated shots, which target the BA.4 and BA.5 omicron subvariants as well as the original virus, will be available in a few weeks.  He further stated that the shots will be available and every American over the age of 12.

Abortion

North Carolina:  Abortions in North Carolina are no longer legal after 20 weeks of pregnancy, a federal judge ruled this week. The Judge reinstated an unenforced 20-week abortion ban, with exceptions for urgent medical emergencies, after he said the June U.S. Supreme Court decision overturning Roe v. Wade erased the legal foundation for his 2019 ruling that placed an injunction on the 1973 state law.

South Carolina:  This week, the South Carolina Supreme Court temporarily blocked the state’s near-total abortion ban, which barred patients from terminating a pregnancy at around six weeks, after a fetal heartbeat can be detected. The ban took effect shortly after the U.S. Supreme Court ruling on Roe v. Wade.

Idaho:  A legal battle over abortion rights is pitting, one of the most Republican states in the nation, against the U.S. government. Twenty states, Washington, D.C., the American College of Emergency Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and others are among those who have filed “friend of the court” briefs, siding with the federal government’s claims that Idaho’s near-total abortion ban violates federal health care law.

Florida:  An appellate court has upheld a lower court ruling that a parentless 16-year-old girl in the Florida Panhandle was not “sufficiently mature” to end her pregnancy while seeking a waiver from a state law that requires minors to get parental consent for an abortion. The teen in court papers had told the lower court that she wasn’t ready to have a baby, didn’t have a job and the father was unable to assist her. She was pursuing a GED and living with a relative. The teen also told the lower court that her appointed guardian was “fine” with her decision to have an abortion.