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This Week (October 3-7)

With passage of the CR, the House and Senate are now expected to be in recess until after the midterm elections. This Week in Health Policy will return when Congress reconvenes.

Last Week (September 26-30)

Health Care Highlights

Congress passes government funding package with FDA User Fees. On Friday (Sept. 30), the House voted 230-201 to advance a stopgap funding bill to the President's desk to avert a shutdown that would start at midnight. The continuing resolution (CR), which was passed by a 72-25 margin by the Senate on Thursday (Sept. 29), extends federal funding at current levels through Dec. 16 and reauthorizes FDA user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices for five years. The deal, which was announced Monday (Sept. 26), does not contain any of the policy riders that previously passed out of the House, but does reauthorize several programs set to expire at the end of the fiscal year, including those for orphan drug grants and the Medicare-Dependent and Low-Volume Hospital programs, through Dec. 16. Advocates are expected to push to get the policy riders included in an omnibus spending bill, which Congress must pass by Dec. 16. The stopgap funding bill also provides $12 billion to help Ukraine defend itself against Russia, and billions more for domestic disaster relief. Notably, the bill does not contain the White House's $22.4 billion request for COVID-19 funding. The House is expected to take up the package before government funding for the current fiscal year expires on Oct. 1. A section-by-section summary can be found here.

House passes health care bills. The House this week advanced several pieces of health care legislation:

• The House voted 414-7 to pass the "Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act" (S. 958), allowing Health Resources & Services Administration (HRSA)-funded health centers to use New Access Point grants to set up a mobile unit regardless of whether the health center also establishes a permanent health care delivery site. The bill now heads to the President for his signature.
• The House voted 296-127 to pass the "Improving Trauma Systems and Emergency Care Act" (H.R. 8163) which would authorize $24 million annually from fiscal 2023 through 2027 for trauma care-related programs. The bill now heads to the President for his signature.
• The House voted 220-205 to pass the "Mental Health Matters Act" (H.R. 7780) which aims to increases the number of school-based mental health services providers through establishing requirements for higher education institutions concerning students with disabilities and prohibiting arbitration and discretionary clauses in employer-sponsored benefit plans. The bill heads to the Senate amid stiff Republican opposition.

White House hosts conference on hunger, nutrition, and health. On Wednesday (September 28), the White House convened the first White House Conference on Hunger, Nutrition, and Health since 1969, convening elected officials, advocates and activists, and leaders of business, faith, and philanthropy from across America to meet a bold conference goal: ending hunger in America and increasing healthy eating and physical activity by 2030. In opening the conference, U.S. Secretary of Agriculture Tom Vilsack provided an overview of the Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health — a five pillar strategy that was released in advance of the conference.

• For additional details on White House's Conference on Hunger, Nutrition, and Health, see WCEY Alert: White House Holds Conference on Hunger, Nutrition, and Health, Releases National Strategy and Announces Other Agency Actions

The administration also announced other actions and commitments in coordination with the conference, including:

• A fact sheet detailing more than $8 billion in new stakeholder commitments as part of the Conference's call to action, including public-private partnerships geared toward improving health through nutrition;
• A U.S. Food and Drug Administration (FDA) proposal to update criteria for when foods can be labeled with the nutrient content claim "healthy" on their packaging; and
• The Centers for Medicare and Medicaid Services (CMS) approval of Medicaid 1115 Waivers in Massachusetts and Oregon, which among other things will provide new authority to address unmet health-related social needs by testing coverage for evidenced-based nutritional assistance and medically tailored meals, as well as continuous eligibility for children under six years old.

Judge rules HHS must adjust 340B payments now. On Wednesday (Sept. 28), a federal judge ruled that HHS cannot wait until 2023 to reverse cuts to outpatient reimbursement rates made through the 340B Drug Pricing Program and must immediately begin reimbursing 340B entities the full amount. The ruling comes after the Supreme Court ruled earlier this year that the agency's reimbursement rate cut was unlawful. CMS in the 2023 Outpatient Prospective Payment System proposed rule acknowledged the ruling and said it "fully anticipates" returning the hospital pay rate for 340B drugs to 106% of the average drug sales price, which must be done in a budget neutral manner and will therefore resulting in cuts to other outpatient services under the payment system.

CMS unveils 2023 Medicare premiums. On Tuesday (Sept. 27), CMS announced that the standard monthly premium for Medicare's Part B plan, which offers coverage for outpatient care, will fall 3%, or $5.20, in 2023, while the annual deductible will fall $7 — from $233 in 2022 to $226 in 2023. The decline is partially due to a $21.60 increase in 2022 linked to the approval of the Alzheimer's drug Aduhelm, although CMS subsequently drastically reduced the coverage of the drug in a National Coverage Determination. In addition, CMS announced Medicare Part A deductible will increase $44 to $1,600 in 2023. The announcement comes ahead of the beginning of Medicare open enrollment, which runs from Oct. 15 through Dec. 7. On Thursday (Sept. 29), CMS announced the average Medicare Advantage (MA) premium will be $18 a month for 2023, down about 8% from 2022. CMS projected 31.8 million people will sign up for an MA plan for 2023 during the upcoming open enrollment period.

FDA medical device criteria. On Wednesday (Sept. 28), FDA released final guidance outlining four criteria it will use to determine whether clinical decision support software will be subject to the agency's regulatory oversight. The guidance states the agency will focus its oversight efforts on "software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended," such as software that uses patient data to detect and alert providers to a potential stroke or sepsis case.

Medical groups seek information blocking extension, APM incentive extension . On Monday (Sept. 26), the American Hospital Association, the American Medical Association and eight other medical trade groups sent a letter to Health and Human Services Secretary Xavier Becerra and National Coordinator for Health IT Micky Tripathi asking for HHS to delay an Oct. 6 compliance deadline to meet new federal information blocking standards until 2023. Tripathi cast doubt on a delay, however, saying "we don't believe patients or providers can afford to wait any longer." On Wednesday, over 800 provider groups sent a letter to Congressional leadership asking for the extension of incentive payments intended to encourage participation in risk-bearing alternative payment models (APMs).

Reports, Studies, and Journals

CMS: Program Enrollment Information. The latest federal enrollment figures show as of June 2022, 64,682,105 people are enrolled in Medicare, including 29,751,672 who are enrolled in a Medicare Advantage or other health plan. In addition, the report found 89,444,160 people are enrolled in Medicaid and CHIP.

Government Accountability Office: Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks. The report concluded that CMS currently lacks the ability to comprehensively measure the quality of telehealth visits that occurred during the pandemic and patients are not fully informed of the risks posed by storing their personal data on phones or tablets during telehealth calls. In addition, the report concluded that audio-only telehealth visits should be reimbursed at a lower rate than other forms of telehealth, such as video.

JAMA: Comparison of Quality Performance Measures for Patients Receiving In-Person vs Telemedicine Primary Care in a Large Integrated Health System. In study, telemedicine exposure for primacy care patients (as opposed to those with office-only care) was associated with significantly better performance or no difference in 13 of 16 comparisons, mostly in testing-based and counseling-based quality measures. Patients with office-only visits had modestly better performance in 3 of 5 medication-based quality measures.

Congressional Budget Office: Policy Approaches to Reduce What Commercial Insurers Pay for Hospitals' and Physicians' Services. CBO identified policy approaches that federal lawmakers could adopt to reduce the prices that commercial insurers pay for hospitals' and physicians' services, thereby lowering health insurance premiums and the cost of federal subsidies.

The Commonwealth Fund: State of U.S. Health Insurance in 2022: Biennial Survey. The report, which is based on responses from 6,000 people between March and July 2022, found 23% of working-age adults were underinsured in 2022. The report found those with individual market or marketplace plans were more likely to be underinsured (44%) than those with employer-sponsored plans (29%).

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