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Find our analysis on legislation, regulations, MedPAC meetings, and more. 

What Happened, What You Missed: June 19-23, 2023

AMA Downplays Importance of BMI

Physicians should deemphasize the use of body mass index (BMI) when assessing a patient’s health and obesity, according to a new policy statement from the American Medical Association (AMA). The policy was born from an AMA report that found BMI to be a flawed way to measure body fat in multiple groups because it does not account for differences across “racial/ethnic groups, sexes, genders, and age-span.” BMI was initially determined by a Belgian mathematician in the 19th century who only analyzed White non-Hispanic individuals. While the AMA acknowledges that BMI is strongly tied to the amount of fat mass in the general population, the measure becomes less relevant when applied to individuals.

USPSTF Recommends Anxiety Screening for All Adults

Most adults should be screened for anxiety and depression even in the absence of symptoms, according to two final recommendations from the US Preventatives Services Task Force (USPSTF). In one recommendation statement, USPSTF said that all adults should be screened for major depressive disorder, including those who are pregnant, postpartum, and age 65 and older. In another recommendation statement, USPSTF said adults under age 65 should be screened for anxiety. However, USPSTF declined to recommend screening adults 65 and older for anxiety due to insufficient evidence. The new recommendations come amid a rise in adults reporting symptoms consistent with anxiety and depression since the start of the COVID-19 pandemic.

Mandy Cohen Tapped to Lead CDC

President Joe Biden announced his intent to appoint Mandy Cohen, MD, MPH as director of the Centers for Disease Control and Prevention (CDC). Cohen will begin as soon as outgoing CDC Director Rochelle Walensky, MD officially steps down on June 30, since the position won’t require Senate confirmation until January 2025. Currently CEO of Aledade Health Care Solutions, Cohen previously served as Secretary of Health in North Carolina and deputy director of the Center for Medicare and Medicaid Innovation. Biden’s announcement has drawn praise from health care stakeholders across the nation.

CDC Recommends RSV Vaccines for Older Adults

A CDC advisory panel voted 9-5 to recommend two respiratory syncytial virus (RSV) vaccines for adults ages 65 and older, from drug manufacturers Pfizer and GSK. Thirteen committee members, with a single abstention, also voted to recommend the vaccines for adults ages 60 to 64 based on individual risk factors and in consultation with a physician. While RSV is generally mild for most healthy adults, up to 10,000 people ages 65 and older die from RSV each year. CDC Director Rochelle Walensky is expected to endorse the vaccines soon, which is the last hurdle the vaccines must clear become they can become available to the public. Drug manufacturers and pharmacies have pledged to make the vaccines available to older adults by late fall, just in time for the winter respiratory virus season.

ICYMI: Smithsonian Folklife Festival Returns

Visitors to the nation’s capital will have another fun outdoor entertainment option when the Smithsonian Folklife Festival returns next weekend. The festival, which runs from June 29 to July 9, features participants and events from all 50 states and over 100 countries. Key programs this year include events honoring living religions in the US, the programming on culture of the Ozarks, and activities celebrating the music and food of Ukraine. Volunteers are encouraged to sign up and participate.

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What Happened, What You Missed: May 8-12, 2023

New Guidelines Call for Women to Get Mammograms at Age 40

Women should start getting mammograms to screen for breast cancer at the age of 40, according to new draft recommendations from the US Preventative Services Task Force (USPSTF). While current guidelines recommend mammograms starting at age 50, a growing number of women at risk for breast cancer have started screening in their 40s. The USPSTF issued the draft recommendations based on new evidence that shows a growing number of women in their 40s are getting breast cancer. The draft recommendations also call for biennial screenings instead of annual screening, which runs counter to leading medical organizations like the American College of Radiology and the American Cancer Society. According to the USPSTF, starting mammograms earlier will allow doctors to detect breast cancer sooner and save more lives. Breast cancer is currently the most common cancer among women, and it is the second-leading cause of cancer-related death in women.

Senate Panel Advances Bipartisan PBM Bill

The Senate Health, Education, Labor, and Pensions (HELP) Committee passed by a 18-3 vote legislation to reform pharmacy benefit manager (PBM) practices. The legislation was among a group of bipartisan bills and amendments approved by the committee that are aimed at addressing high drug costs. The bill’s most notable component would ban PBMs from using spread pricing, which is the practice of charging health plans for prescription drugs more than what they pay the pharmacy and pocketing the difference. Other measures approved by the committee would direct the Department of Labor to conduct a study into the fiduciary duties of PBMs and require PBMs to pass on all rebates they get from drug manufacturers to health plans.

mRNA Vaccine for Pancreatic Cancer Shows Promise

A group of pancreatic cancer survivors who were found to have an immune response from an experimental mRNA vaccine showed no signs of relapse, according to a study published in Nature. Conducted by researchers at Memorial Sloan Kettering Cancer Center in New York City, the study involved 16 patients who had their tumors surgically removed. All 8 patients whose immune systems responded to the vaccine made T-cells against their tumors that have persisted for at least 2 years. Researchers believe the spleen could be key to understanding who could benefit from the vaccine, as 5 of the 8 patients who didn’t generate an immune response had their spleens removed. Scientists have been working to develop cancer vaccines for decades, and only in recent years have mRNA vaccines shown promise in treating the disease. In April, early-stage clinical trial results for a personalized vaccine using mRNA technology was found to be effective in preventing melanoma from reoccurring.

FDA Updates Blood Donation Policy for Gay, Bisexual Men

Gay and bisexual men in monogamous relationships are now allowed to donate blood at any time, according to an updated blood donation policy from the Food and Drug Administration (FDA). The update is part of an effort to ease blood shortages by loosening restrictions on who can donate. Previously, men who have sex with men were only permitted to donate blood after three months from their last sexual encounter with other men. The new policy nixes time-based restrictions in favor of individual risk-based questions that will be the same for every donor, regardless of sexual orientation, sex, or gender. The FDA originally proposed the new policy in January 2023.

End of COVID-19 PHE Means End to Emergency Rules, Waivers

With the end of COVID-19 public health emergency (PHE) yesterday, numerous rules and waivers that have been in place for over more than years are now out of the picture. The Centers for Disease Control and Prevention (CDC) will no longer be able to access some surveillance data based on new case numbers; instead, the CDC will use hospital admissions to determine the level of community risk. Additionally, Medicare and private insurers will no longer be required to fully cover 8 rapid antigen tests per month, although the administration is urging insurers to continue covering the test. Furthermore, certified registered nurse anesthetists will once again require physician supervision, and patients will again have to spend 3 consecutive days in a hospital before being eligible to move to a skilled nursing facility.

ICYMI: Jazz in the Garden Returns Next Week

Jazz in the Garden, a popular free summer concert series held in the National Gallery of Art’s outdoor Sculpture Garden, will return on May 19 and run through August 4. To cope with high demand, the National Gallery is instituting for the first time a free lottery system that will open the Monday before a concert and close Friday at noon. However, admission will remain free. This year’s concerts will feature jazz, zydeco, Latin fusion, bluegrass, and other musical performances.

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What Happened, What You Missed: February 20-24, 2023

Multiple Problems Plague Primary Care in America

Primary care across the nation is in a dire state, according to a new report from the Milbank Memorial Fund and the Physicians Foundation.  Among the most concerning findings is an increase in the percentage of adults who don’t have a usual source of care, and the fact that too few primary care physicians are being trained in community settings.  According to the report, a major contributing factor to these problems is inadequate investment in primary care.  For example, average spending on primary care for all insurance types declined from 6.2% in 2013 to 4.6% in 2020, which is far below average spending in other wealthy nations.

FDA Begins Review of Babies’ RSV Vaccine

The Food and Drug Administration (FDA) granted priority review for a vaccine to protect infants up to six months of age from respiratory syncytial virus (RSV), according to an announcement from Pfizer.  The priority review status means the agency will try to review the application within six months instead of the standard 10.  There are currently no RSV vaccines available for infants, and the FDA offers priority review for drugs that promise “significant improvements” over existing drugs.  If deemed effective, the Pfizer’s RSV vaccine could be available for infants ahead of a likely RSV season next winter.

FDA Issues First Fines to E-Cigarette Manufacturers

The FDA fined four electronic cigarette manufacturers over their alleged sales of unauthorized products on Wednesday, marking the first time the agency has issued civil money penalty complaints against tobacco product manufacturers for allowing products to go to market without federal approval.  According to a press release, the FDA has sent more than 550 warning letters since the start of 2021 to companies that manufacture, sell, or distribute new tobacco products without being allowed. Most of the companies that received warning letter have taken their products off the market and are now complying with FDA regulations.

Poll: High Costs Is America’s Number 1 Public Health Worry

Reducing high drug and health costs was the top public health priority for 50% of Americans, according to a new poll from Axios-Ipsos.  In comparison, 14% said reducing gun deaths and another 14% listed research into cures and treatment for major diseases as a top priority for government intervention.  When asked to name the number one threat to public health, over a quarter of respondents said opioids and fentanyl, 21% cited obesity, 17% listed gun violence, and 12% said cancer.  Additionally, a large majority of respondents said the country is not prepared to handle another pandemic.  The poll was conducted in February and included over 1,200 adults.

ICYMI: Cicilline to Resign from Congress in June

Rep. David Cicilline (D-RI) announced earlier this week that he will officially leave Congress on June 1, 2023.  A member of the Foreign Affairs and Judiciary committee, the 61-year-old Cicilline has been elected to seven terms in Congress.  Prior to entering Congress, he served in the Rhode Island state legislative and as mayor of Providence.  Cicilline is leaving to Congress to lead the Rhode Island Foundation, which supports community programs in the Ocean State through grants and investments.  His retirement will trigger a special election in the heavily Democratic 1st Congressional District.

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What Happened, What You Missed: November 14-18

CDC: Drug Overdose Deaths May Have Peaked

Drug overdose deaths in the US have declined for the past three consecutive months, according to new data from the Centers for Disease Control and Prevention (CDC).  The CDC found that there were about 107,600 overdose deaths for the 12-month period between July 2021 and June 2022, which is 40 fewer overdose deaths than in calendar year 2021.  Public health officials in several states attribute the decline to social media and health education campaigns on the dangers of drug use, greater access to substance abuse treatment, and expanded distribution of opioid overdose-reducing treatment naloxone.  While trends indicating a peak in overdose deaths is hopeful, some public health experts are skeptical due to the fact that previous periods of decline have not lasted long.

Cassidy Poised to Become Top Republican on HELP Committee

Sen. Rand Paul (R-KY) announced Thursday that he plans to serve as the top Republican on the Senate Homeland Security and Government Affairs (HSGA) Committee in the next Congress, thereby allowing Sen. Bill Cassidy (R-LA) to become the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee.  Paul likely chose to become ranking member of the HSGA Committee because he would have subpoena power – something he would lack had he chosen to become the top GOP member on the HELP Committee.  Since Paul’s announcement, Cassidy has publicly expressed his desire to serve as the ranking member of the HELP Committee, where he will be the Republican counterpart to expected incoming Chairman Bernie Sanders (I-VT).  Health care stakeholders have already voiced a preference for Cassidy to become the ranking member due to his history of deal-making and bipartisanship.

Pediatric Organizations Press for New PHE

The Children’s Hospital Association (CHA) and the American Academy of Pediatrics (AAP) said in a letter to the Department of Health and Human Services (HHS) on Monday that due to alarming spike in hospitalizations from respiratory syncytial virus (RSV) and influenza the administration should declare a new public health emergency (PHE). With pediatric hospitals facing a dwindling number of available beds, the CHA and AAP say a PHE would help address capacity issues by allowing the waiver of certain Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) requirements to enable providers to share resources. The pediatric organizations also asked the federal government to encourage state Medicaid agencies to support telehealth and out-of-state care flexibilities to help manage hospital capacity.

Moderna: Bivalent Booster Less Effective against New Subvariants

Moderna announced on Monday that its new bivalent COVID-19 booster yields higher levels of antibody protection against the Omicron BA.4 and BA.5 subvariants compared to the booster shot using the company’s original formula.   According to a press release, Moderna’s bivalent shot triggered antibody responses against BA.4/BA.5 that were average 15.1-fold higher compared with the company’s first vaccine.  Moderna also said that while its bivalent booster also generated an immune response to the growing Omicron BQ.1.1 subvariant, the booster was not as effective as it was against BA.5.  While BA.5 is currently the dominant COVID-19 strain the US accounting for nearly 30% of new cases, BQ.1 and BQ.1.1 make up for about 44% of new infections.

FDA: Some E-Cigarettes Resemble Toys, Target Children

The Food and Drug Administration (FDA) issued warning letters to five electronic-cigarette manufacturers for packaging their products to resemble toys, which appeals to children.  According to the letters, some of the e-cigarettes were designed to look like glow sticks, video game consoles, and walkie-talkies, or food products like popsicles.  Additionally, some of the companies’ e-cigarette products features the likenesses of characters from “The Simpsons,” “Family Guy,” and “Rick and Morty.”  The FDA noted that failure to correct the violations can result in additional injunctions, seizure of products, or civil money penalties.

ICYMI: Naomi Biden to Wed at White House on Saturday

On Saturday, Naomi Biden, the granddaughter of President Joe Biden, and her fiancé Peter Neal will marry on the South Lawn, marking the 19th wedding to take place at the White House.  Naomi Biden, 28, and Neal, 25, are both attorneys who met through mutual friends about four years ago in New York City, and the pair currently resides in Washington, DC.  This Saturday’s nuptials will mark the first wedding with a president’s granddaughter as the bride.  The most recent weddings to take place at the White House are Richard Nixon’s daughter, Tricia, in 1971, and Lyndon B. Johnson’s daughter, Lynda, in 1967.

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What Happened, What You Missed: November 7-11

Voters Approve Medicaid Expansion, Medical Debt Reform, Flavored Tobacco Ban

Voters in Tuesday’s midterm elections weighed in on several key health care questions in handful of states.  In South Dakota, 56% of voters approved expanding Medicaid, which will allow 42,000 state residents to become eligible for Medicaid coverage.  The vote makes South Dakota the seventh Republican-controlled state to expand Medicaid.  In Arizona, voters passed a proposition to reduce medical debt by dropping interest from 10% to 3%.  The proposition will also increase the value of the debtor’s home protection from and decrease the portion of weekly disposable income subject to debt collection.  In California, voters approved a ban on most flavored tobacco products and rejected a measure that would have required a doctor, nurse practitioner or physicians’ assistant to be present during treatment at outpatient dialysis facilities.

SFC Offers New Policy Recommendations on Mental Health

The Senate Finance Committee put forth several legislative proposals to address mental health in a discussion draft released on Thursday morning.  The discussion draft includes proposals to create a bundled payment in Medicare for crisis stabilization, create a standardized payment in Medicare for mobile crisis response team services, and increase payment rates to help providers integrate behavioral health and primary care.  While there is interest among members of both parties to advance mental health reform, next steps on the discussion draft are unclear as control of the next Congress has yet to be determined.

Stakeholders Call for Additional PHE Extension

The current public health emergency (PHE) related to COVID-19 is set to expire on January 11, 2023, and with the new year fast approaching, stakeholders are already calling on the administration to extend the PHE at least one more time.  This week, Families USA said an extension is necessarily to give states more time to prepare for one-year Medicaid redetermination process that will begin as soon as the PHE ends.  Families USA said the extra preparations are needed to ensure states can connect the millions of beneficiaries who are expected to lose coverage with other sources of coverage.  Earlier this month, the American Health Care Association (AHCA) similarly called for another PHE extension to help prepare for coverage disruptions.  With COVID-19 case numbers projected to rise during the winter, many expect the administration will indeed extend the PHE at least one more time next year.

Study: Antivirals Could Reduce Risk of Long COVID

Antivirals like Paxlovid could lessen a person’s chances of getting long COVID, according to a new study from the Department of Veterans Affairs.  The study found that patients who took Paxlovid were 26% less likely to develop one of more symptoms of long COVID such as heart issues, fatigue, and trouble breathing within one to three months from infection.  Researchers conducted the study analyzing electronic health records (EHRs) from more than 56,000 patients in the VA health system who tested positive for COVID-19 between March and June 2022 and compared health outcomes with 9,000 patients that had taken Paxlovid with 47,000 who did not.   Currently, Paxlovid is only authorized for use in patients who have risk factors for complications with COVID-19, like being older or having underlying health conditions.

ICYMI: Debate Continues on Reopening of the Capitol

Senior House Republicans are pledging to fully reopen US Capitol Complex to visitors once they regain a majority in the House of Representatives, as current trends indicate.  All visitors to the House and Senate office buildings are currently required to have a staff escort, and while virtual meetings are likely to persist to some extent, many advocacy professionals agree that in-person meetings are the most effective way to get a message across.  However, in the wake of the attack on husband of Speaker Nancy Pelosi (D-CA), many Democratic lawmakers remain concerned about security, and questions remain on how the US Capitol Police will handle a fully-reopen Capitol amid ongoing staffing issues.

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