On July 13, 2023, the Centers for Medicare and Medicaid Services (CMS) released the Physician Fee Schedule and Medicare Shared Savings Program Proposed Rule for Calendar Year (CY) 2024. In its annual payment rule, CMS tackles payment updates, split billing, supervision rules, and changes to the Medicare Shared Savings Program, among other key policies.
On June 7, 2023, the House Ways and Means Committee marked up a series of bills pertaining to healthcare and social security. The bills focused on telehealth, payment for chronic disease, and reduction of paperwork for health care workers. Additional bills on electronic notification of plan benefits for insurance plans and changes to custom group health plans were also adopted.
FDA Fully Approves New Alzheimer’s Drug Leqembi
The Food and Drug Administration (FDA) granted full approval to Leqembi, setting up the stage for the Alzheimer’s treatment drug to become the first to receive broad coverage under Medicare. The announcement comes after months of lobbying by Alzheimer’s disease patients and advocates to make the drug more widely available through full approval. Developed by Eisai and Biogen, the drug slows the progression of Alzheimer’s disease by targeting amyloid plaques in the brain. However, Leqembi has faced controversy for its high $26,500 price tag that could lead to higher Medicare premiums, as well as reports of side effects like brain bleeding and swelling. CMS will require any physician who prescribes Leqembi to submit a patient’s medical information to a registry that will be used to evaluate the drug’s benefits or harms.
CMS Updates Guidance on Drug Price Negotiations
The Center for Medicare and Medicaid Services (CMS) recently issued revised guidance for the Medicare Drug Price Negotiation Program, likely in response to several lawsuits challenging the program. A component of the Inflation Reduction Act, the drug price negotiations are set to take course through next year. Since the IRA became law, the US Chamber of Commerce, Bristol Myers Squibb, Merck, and PhRMA have filed lawsuits against CMS that allege the program violates the First, Fifth and Eighth amendments of the Constitution. The new guidance offers relief for drug manufacturers who choose not to participate in the negotiation program by setting up a program for drugmakers to leave Medicare and avoid excise taxes.
Home Health Providers Sue CMS over Payment Cuts
The National Association for Home Care & Hospice (NAHC) filed a lawsuit against CMS that challenges a 3.925% payment cut for calendar year2023 that applies to home health providers. The lawsuit comes just days after CMS proposed a 2.2% cut in its calendar year 2024 Home Health Prospective Payment System proposed rule. The lawsuit alleges CMS put forth an invalid methodology to determine whether payment model changes are budget neutral. According NAHC, lower payments are forcing home care providers to close their doors, resulting in fewer patients receiving care. To address payment cuts, Sens. Debbie Stabenow (D-MI) and Susan Collins (R-ME) recently introduced legislation to take away some of CMS’s rate-setting authority.
JAMA: Maternal Mortality Rates Double
Maternal mortality rates have more than doubled between 1999 and 2019, according to a new study published by the Journal of the American Medical Association (JAMA). While the study found an increase in pregnancy-related deaths across all racial and ethnic groups, Black and Native American women were observed to have the highest death rates. Additionally, states in the South, the Midwest and the Great Plains saw the highest increases. Common causes of maternal death include mental health conditions, hemorrhages, hypertension, and blood clots. According to the study’s authors, increasing access to health care could prevent many pregnancy-related deaths.
ICYMI: It’s Summer Movie Season on the National Mall
“Summer Movies on the Lawn” officially returns next week with the screening of “Willy Wonka and the Chocolate Factory” (1971) on July 13. Started in 2017 by the Library of Congress, the summer movie series on the National Mall provides an opportunity for visitors to watch the National Film Registry in a scenic setting. The 2023 series will conclude on August 10 with the screening of “Jaws” (1975).
Eli Lilly’s New Obesity Drug Shows Promise
A new obesity drug from Eli Lilly helped patients lose 24% of their weight, according to phase 2 clinical trial results posted this week. Known as retatrutide, the drug is a weekly injection that imitates certain digestive hormones that help patients feel “full” and thus decreases their appetite. The clinical trial included 338 adults who were obese or overweight and had either received retatrutide injection or a placebo treatment. (https://avaana.com.au) The results suggest retatrutide could be more effective than Mounjaro (tirzepatide), another Lilly drug that led to 21% weight loss in trials. The company is currently requiring patients participate in a phase 3 clinical trial.
CDC: Overdose Deaths from Xylazine-Laced Fentanyl on the Rise
Overdose deaths from fentanyl combined with xylazine increased by 276% between January 2019 and June 2022, according to data from the Centers for Disease Control and Prevention (CDC). However, CDC noted that the timing and scale of increase in detection of xylazine overdoses might be due to both increased frequency of testing and increased presence in the drug supply. Known as “tranq,” xylazine is an easily obtainable veterinary drug that used as a sedative and pain reliever. In recent years, drug dealers have been cutting fentanyl with xyzaline to extend a user’s high. In April 2023, the White House Office of National Drug Control Policy designated fentanyl combined with xylazine as an emerging threat.
CMS Proposes Pay Increase for Dialysis Providers
Dialysis providers could get a 1.6% payment bump from Medicare next year, according to a proposed rule for the end-stage renal disease (ESRD) Prospective Payment System (PPS). The rule contains a number of proposals related to ESRD payment policies, including a request for information (RFI) on the potential creation of a new payment adjustment that would increase payment to geographically isolated ESRD facilities. The rule also proposes a requirement on reporting of “time on machine” data, which is the the amount of time that a beneficiary spends receiving an in-center dialysis treatment. Stakeholders have until August 25, 2023 to comment on the proposed rule.
KFF: 1.5M Have Lost Medicaid Coverage since April
1.5 million people have lost Medicaid coverage in 25 states and the District of Columbia since the disenrollment process began in April, according to data from the Kaiser Family Foundation (KFF). Many states have yet to begin the disenrollment process in earnest, and KFF projects that up to 17 million people could lose their coverage. Additionally, 73% of disenrollments are due to technical reasons, such as a state Medicaid office being unable to contact an enrollee or a failure to verify income. The federal government’s options for addressing the coverage losses are limited, given that states are largely responsible for administering the program. However, the Department of Health and Human Services (HHS) did provide new flexibilities for states earlier this month intended to address disenrollment, such as allowing managed care firms to complete Medicaid renewal forms for an enrollee.
ICYMI: First-Ever Thai Festival Comes to National Mall
For the first time ever, the Thai Embassy is hosting a festival on the National Mall to celebrate 190 years of diplomatic relations between Thailand and the US. Visitors can sample various food vendors and enjoy cultural activities including Muay Thai demonstrations, Thai massages, and dance lessons. The festival is scheduled for Sunday, July 2.
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.
