On April 10, 2023, the Centers for Medicare and Medicaid Services (CMS) released their proposed inpatient hospital payment rule for FY 2024. While most hospital payment changes in the rule were minimal (MS-DRGs, wage index, new-technology add-on payments, etc.). CMS is proposing numerous changes to hospital quality programs under Medicare.
Final Rule Prohibits Deceptive Marketing of MA Plans
Medicare Advantage (MA) plans and Medicare prescription drug plans will face tougher requirements on marketing plans, according to a rule finalized by the Centers for Medicare and Medicaid Services (CMS) on Wednesday. The final rule is part of an overarching effort by the administration to crack down on deceptive and misleading marketing of MA plans, which have been growing in popularity. Nearly half of Medicare beneficiaries are enrolled in MA plans, which are operated by private insurers. According to the rule, MA plans can no longer run advertisements that use the Medicare name or mention the federal government deceptively. Ads are also prohibited from running without mentioning a specific plan name. Aside from addressing deceptive marketing, the final rule streamlines prior authorization requirements by requiring prior authorization approval for care to remain valid for as long as “medically necessary” to avoid disruptions in care.
ACA Premiums Up 3.4% Thanks to Inflation, Higher Spending
Affordable Care Act (ACA) premiums rose in 2022-2023 due to inflation and higher health care spending, according to a recent analysis by the Robert Wood Johnson Foundation (RWJF). The higher premiums mark the reversal of a trend towards gradually lower premiums over the past few years. The analysis notes that inflation will continue to put upward pressure on premiums, particularly due to high labor costs. Another reason for higher premiums cited in the report was uncertainty over whether the ACA’s enhanced premium tax credits would be extended. Over 16 million Americans enrolled in marketplace plans in 2023.
NCI Releases National Cancer Action Plan
To help achieve the administration’s goal of “ending cancer as we know it,” the National Cancer Institute (NCI) released its National Cancer Plan on Tuesday. The plan is centered around eight goals: preventing cancer, detecting cancer early, developing effective treatments, eliminating inequities, delivering optimal care, engaging every person, maximizing data utility, and optimizing the workforce. According to NCI, the framework is intended to engage all stakeholders involved in treating cancer, including health care providers and researchers. The Biden administration has notably laid out a goal of reducing the cancer death rate by 50% over the next 25 years.
Gallup: More Americans Concerned about Health Affordability, Drug Use
A growing number of Americans are concerned about drug use and affordable health care, according to a new Gallup survey. While inflation and the economy were the top two key issues the respondents were worried about, health care affordability and drug use saw a respective 5% and 8% increase in concern compared to a 2022 poll. The poll results come amid growing fears over high health care costs and a near-record high in drug overdose deaths. Gallup conducted the survey in March 2023 and polled over 1,000 US adults.
ICYMI: The Library of Congress Reading Room Will Soon Be Open to Visitors
Currently, only individuals with a photo ID library card are allowed to visit the main reading room of the Library of Congress. However, starting next Tuesday, the Library of Congress will kick off a new pilot program that will allow visitors to access the ornate reading room during two hour-long periods on Tuesday through Friday. The main reading room sits below a 160-foot-high dome that’s painted with imagines representing human understanding and intellectual progress. Additionally, the library is changing its rules to allow non-flash photography in the reading room. Visitors are still required to reserve timed passes to access the Library of Congress.
FDA Allows Narcan to Be Sold Over the Counter
On Wednesday, the Food and Drug Administration (FDA) approved Narcan, an opioid overdose-reversal drug, to be sold over the counter without a prescription. The announcement comes as opioid overdose deaths hover near record highs. At a press conference, the Director of the White House Office of National Drug Control Rahul Gupta said businesses, such as restaurants, banks, and schools will be encouraged to purchase the drug. Narcan manufacturer Emergent BioSolutions said the spray will be available for online and over the counter purchase by the summer.
JAMA: Telehealth Linked to Fewer Opioid Overdoses
A study published in the Journal of the American Medical Association (JAMA), found that the utilization of telehealth services for opioid use disorder during the COVID-19 pandemic reduced the odds for a fatal overdose among Medicare beneficiaries. The study determined that beneficiaries who started treatment during the pandemic and received telehealth services had a 33% lower risk of a fatal overdose. The study also found that fatal drug overdoses were 59% less likely among individuals who received medication to treat opioid use disorder and 38% less likely among those treated with buprenorphine in an office-based setting.
FDA Proposes Overhaul of Fast-Track Approval Process for Cancer Drugs
The FDA’s accelerated approval pathway could become more stringent, according to a draft guidance document released Tuesday. The accelerated approval pathway allows the FDA to approve a drug based on surrogate endpoints rather than a direct measure of a clinical benefit, which allows for drugs to receive an earlier approval. The draft guidance aims to strike a balance between speed and quality by requiring oncology drugs to go through randomized controlled trials (RTCs) that compare the effectiveness of an experimental drug against a conventional one. The deadline for stakeholders to comment on the draft guidance is May 26, 2023.
Lawmakers Question Becerra on Coverage Determination for Alzheimer’s Drug
In multiple hearings to review the president’s proposed Fiscal Year (FY) 2024 budget, several Republican lawmakers voiced their criticism of a decision by the Centers for Medicare and Medicaid Services (CMS) to limit coverage of a class of Alzheimer’s drugs only to patients who are participating in relevant clinical trials. These drugs, which utilize amyloid plaque-blocking technology, have been marred with controversy due to their high cost and risk of side effects such as brain swelling and brain bleeding. In response to the criticism, Health and Human Services Secretary Xavier Becerra repeatedly explained that FDA and CMS have different criteria for evaluating experimental drugs as mandated by law.
Most Doctors Say COVID-19 Misinformation a Problem
Seven in 10 doctors say misinformation about COVID-19 has made it harder to treat patients, according to a poll by the de Beaumont Foundation and Morning Consult. A similar number of physicians surveyed said misinformation has negatively impacted patient outcomes. The survey also found that 90% of physicians surveyed agreed on the benefits of COVID-19 vaccines. Most doctors also noted that COVID-19 misinformation has seeped into other areas of health care, with two-thirds saying misinformation is common regarding weight loss, dietary supplements, mental health, and other vaccines.
Former Congressional Aide Launches Union Tracker for Senate Staff
A former member of Minnesota Sen. Tina Smith’s staff launched a Senate Union Tracker earlier this month as a way to track which senators support collective bargaining protections for Senate staff and efforts to unionize among their own staff. Motivated by subpar pay and long hours during his time in the Senate, the former staffer hopes the tracker will help improve working conditions for those still working in the Senate. Since the website launch, over a dozen Democrats have favorably voiced their support for unionization in the tracker.
NIH Rejects March-In Rights Petition for Pricey Prostate Cancer Drug
The National Institutes of Health (NIH) rejected a petition to force drugmakers Pfizer and Astellas to lower the price of their prostate cancer drug Xtandi using its “march-in” authority, according to a letter the agency sent to the petitioners on Tuesday. March-in rights, which have never been used before, allow the federal government to forcibly relicense a patent that resulted from any amount of federal funding if an original patent holder does not make the product available to the public on reasonable terms. According to the letter, NIH declined the petition because Xtandi is already widely available, and the agency also noted that a lengthy administrative process and remaining patent life would render authorization of march-in right an ineffective means of lowering the drug’s cost. The same day, the federal government also announced an interagency effort to review the criteria used for determining march-in rights.
Administration Proposes Major Changes to Organ Transplantation System
On Wednesday, the Health Resources and Services Administration (HRSA) announced a new initiative to break up the private nonprofit overseeing the Organ Procurement and Transplantation Network (OPTN) by seeking more contracts to operate the system. In a statement, HRSA said the move is intended to bring more accountability and transparency to the OPTN. The announcement follows years of bipartisan scrutiny of the United Network for Organ Sharing (UNOS), which holds the sole federal contract to oversee the country’s organ procurement organizations and transplant centers. HRSA also called on Congress to more than double annual program funding to $67 million, remove the appropriations cap on OPTN contracts, and expand the scope of eligible contractors.
Biden Signs Bill to Release DOE’s COVID-19 Origin Report
President Joe Biden signed legislation earlier this week to require the Office of the Director of National Intelligence to declassify information within 90 days on any possible links between a lab in China and the origins of the COVID-19 pandemic. However, US intelligence agencies will still retain the right to redact information to protect sources and methods. The push to enact legislation to release classified information on the origins of the pandemic comes after the Energy Department concluded with “low confidence” that the virus is likely the result of an accidental laboratory leak at the Wuhan Institute of Virology. Of note, the US intelligence community is split about the origin of COVID-19.
FDA Panel Sends Mixed Message About Biogen’s ALS Drug
A Food and Drug Administration (FDA) advisory panel voted against recommending full approval of Biogen’s experimental amyotrophic lateral sclerosis (ALS) drug for a rare and aggressive form of the disease. However, the panel voted unanimously to support “conditional accelerated approval” of the drug since the data suggests the drug could be effective in reducing a protein that is associated with disease severity. Conditional accelerated approval allows for faster approval of drugs for serious conditions that fill an unmet medical need. The agency will make a final decision on the drug by April 25th.
North Carolina Poised to Expand Medicaid
North Carolina Governor Roy Cooper (D) is expected to sign legislation to expand Medicaid coverage for hundreds of thousands of residents into law in the coming days after state lawmakers gave the legislation final approval on Thursday. This makes North Carolina the latest state with a Republican-controlled legislatures that has moved to expand Medicaid after years of opposition. Voters in South Dakota approved expansion in a referendum in November, and advocates in Alabama are urging state lawmakers to take advantage of federal incentives to expand Medicaid. There are 2.9 million traditional Medicaid enrollees in North Carolina, and advocates have estimated that expansion could help 600,000 adults.
ICYMI: Potential Pay Cuts for Congressional Staff Sound Alarms
Historically underpaid staffers in the House of Representatives have been earning more since the passage of the Fiscal Year (FY) 2022 omnibus, which provided the largest increase to the Members Representational Allowance (MRA) since 1996 and set a minimum salary for staffers at $45,000. However, an agreement among House Republican leaders to cut spending to FY 2022 could lead to cuts in the MRA and reverse progress in improving staffers’ pay. Some advocates and staffers say higher pay is essential for reducing turnover on the Hill – especially among senior staff – and ensuring that congressional staff come from more diverse socio-economic backgrounds.
