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News Connection

September/October 2022 Industry Updates

September 2022

HHS Announces New Tools to Bolster Oversight on Medicaid, CHIP Managed Care Programs

The US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced new resources and programs to bolster federal and state oversight of Medicaid and CHIP plans, as well as care access for beneficiaries.

The new toolkits and updated tactics were released in a Center for Medicaid and CHIP Services Informational Bulletin (CIB), and HHS shared details in a press release.

“The tools we’re releasing today reflect the latest—and certainly not the last—step CMS is taking to increase transparency and ensure that people served through Medicaid and CHIP managed care programs are receiving high-quality, high-value care,” said CMS Administrator Chiquita Brooks-LaSure.

To improve state reporting and oversight of managed care programs, the resources include updates to a new web-based portal for reporting, additional reporting templates, and a new technical assistance toolkit.

The new templates will allow states to report medical loss ratios and network adequacy to CMS in a standardized format. CMS will also make reports available after an initial review rather than upon request. States will be able to view all reports made through Managed Care Reporting on a new webpage on Medicaid.gov.

The CIB also includes information to aid timely, accurate payment for Indian Health Care providers, as well as recommendations for “implementing statutory and regulatory Medicaid managed care protections for Alaska Natives and American Indians,” the press release said.

Additionally, CMS announced the “Promoting Access in Medicaid and CHIP Managed Care: Managed Long-Term Services and Supports Access Monitoring Toolkit.” According to the press release, the toolkit is intended to improve program monitoring and address concerns over beneficiaries’ access to quality long-term care services.

The CIB expands on information provided in a June 2021 informational bulletin, which included a template for the Annual Managed Care Program Report, resources for states to oversee behavioral health network adequacy, and more.

“We are working hand-in-hand with states and doubling down on our efforts to improve access to health care for the millions of Americans enrolled in these programs,” said HHS Secretary Xavier Becerra. —Maria Asimopoulos

FDA Issues Final Rule Establishing New Category of OTC Hearing Aids

The US Food and Drug Administration (FDA) established a new category of over-the-counter (OTC) hearing aids which will enable consumers to purchase the devices without a prescription. The FDA announced the final rule in a press release.

The FDA anticipates the rule will encourage innovation and market competition in the hearing aid technology space while reducing costs and access barriers for consumers. In addition to not needing a prescription, individuals with mild to moderate hearing impairment will be able to purchase hearing aids without a medical examination or fitting adjustment by an audiologist.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Xavier Becerra, secretary, US Department of Health and Human Services, in the press release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost effective and accessible.”

Under the new rule, certain air-conduction hearing aids for adults with mild to moderate hearing impairment will be eligible for sale over the counter, but prescription devices intended for those younger than 18 years of age or with more severe hearing impairment will not be included.

Per the press release, an estimated 30 million US adults could benefit from using hearing aids.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M Califf, MD. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neighborhood store or online.”  

The final rule was issued on the heels of President Biden’s Executive Order on Promoting Competition in the American Economy, which established a deadline for the FDA to make hearing aids accessible over the counter.

The final rule modifies aspects of the proposed rule, which was announced in October 2021. Among other changes, the FDA lowered the maximum sound output of the hearing aids, revised the insertion depth limit in the ear canal, and required all OTC hearing aids to include user-adjustable volume control. The FDA also issued guidance to clarify the differences between hearing aids and personal sound amplification products.

According to the press release, the FDA anticipates OTC hearing aids could become broadly available to the public as soon as mid-October 2022. —Maria Asimopoulos

Increased Costs, Utilization Associated With Long-Haul COVID-19

An increase in costs and resource utilization was associated with COVID-19 6 months postdiagnosis, suggesting a prolonged burden on the health care system, according to findings in BMC Health Services Research.

“There is extensive evidence that COVID-19 leads to functional decline and that symptoms related to either mild or critical COVID-19 hospitalizations can persist for 60 days or longer,” researchers said, adding that gaining a better understanding of long-term outcomes “is of major public health importance.”

Using claims data from the COVID-19 Research Database, investigators conducted a population-based retrospective cohort study. Patients were included if they had COVID-19 between March 2020 and September 2020 and their last recorded claim was not a hospitalization for severe
symptoms. Researchers observed costs and utilization from January 2019 through March 2021.

There were 250,514 patients included in the final cohort. On average, participants had a mean total of 0.4783 (4.0839) monthly visits prediagnosis, compared to 1.2078 (8.4962) visits postdiagnosis. Average total costs also increased from $128.06 (1182.78) to $351.67 (2473.63) following diagnosis.

“COVID-19 diagnosis [was] associated with .7269 (95% CI, 0.7088 to 0.7449 visits; P < .001) more total health care visits and an additional $223.60 (95% CI, 218.34 to 228.85; P < .001) in monthly costs,” researchers found.

Utilization also increased across the following services:

  • inpatient visits (0.5319 more visits, 95% CI 0.5158 to 0.5480 visits; P < .001);
  • emergency care (0.0626 more visits, 95% CI 0.0600 to 0.0653 visits; P < .001);
  • telemedicine (0.0359 more visits, 95% CI 0.0351 to 0.0367 visits; P < .001);
  • surgery (0.0179 more visits, 95% CI 0.0170 to 0.0190 visits; P < .001); and
  • cardiology services (0.0165 more visits, 95% CI 0.0156 to 0.0174 visits; P < .001).

Outcomes varied depending on age, authors noted. Patients who were 17 years of age or younger experienced minor excess utilization and costs that only persisted for 5 months. Those aged 18-44 years saw modest increases, and excess was most prevalent in those aged 45-64 years and over 65 years. The greatest long-term increases in costs and utilization occurred in patients aged 45-64, but those aged 65 years and older experienced the greatest short-term increases.

“COVID-19 diagnosis is associated with more health care visits and greater costs with the latter diminishing more gradually than the former over time. Taken together, this implies that the rise in utilization and costs following COVID-19 diagnosis is manifesting in the form of increasingly costly medical encounters,” researchers said. —Maria Asimopoulos

Identifying Barriers to Medications for OUD, Improving Care Practices

Researchers collected perspectives from community pharmacists, peer recovery coaches, and prescribers to determine access barriers to current medications for opioid use disorder (OUD) and optimize patient care. Findings were recently published in the Journal of the American Pharmacists Association.

The study included 10 peer recovery coaches, 10 pharmacists, and 6 prescribers who were individually interviewed with a focus on stakeholders’ perspectives on their current role in medications for OUD care practices and areas for improvement.

All groups identified stigma as a major barrier. Other top identified barriers included limited patient engagement at pharmacies and lack of access to patient specific health information in community pharmacy settings.

“Pharmacists also identified additional barriers including Drug Enforcement Administration regulations and difficulties balancing patient care with external factors like insurance and legal policies,” reported researchers.

Participants identified positive prescriber/pharmacist relationships as a facilitator of care.

Community medications for OUD resource information being available at pharmacies, increased collaboration between pharmacists and prescribers, and further education for pharmacists on medications for OUD were all listed as opportunities for improvement.

“Additional pharmacist medications for OUD care education and intentional collaboration between pharmacists, peer recovery coaches, and prescribers would facilitate better care and leverage the accessibility of pharmacists within their communities,” wrote study authors. —Samantha Matthews

Indirect, Direct Cost Burden of Multiple Sclerosis Underestimated in the United States

The burden of multiple sclerosis (MS) in the United States has been underestimated, according to study findings published in Neurology.

“MS is a costly chronic disease, with direct costs of prescription drugs and indirect productivity loss being important cost drivers,” wrote study authors.

Researchers utilized a prevalence-based approach to estimate the total economic burden of MS in the United States in 2019. Direct costs were obtained from claims from Medicare Current Beneficiary, Medicare Standard Analytical File, and Optum de-identified Normative Health Information System. Indirect costs such as home modification, labor market productivity losses, and costs of paid and unpaid caregivers were assessed through a survey of 946 patients with MS.

According to findings, the estimated total economic burden was $85.4 billion with a direct medical cost of $63.3 billion and indirect and nonmedical costs of $22.1 billion. The 3 largest components of direct costs were retail prescription medication (54%); clinic-administered drugs, medication, and administration (12%); and outpatient care (9%).

Disease-modifying therapies at $35,154 per person accounted for the largest portion of the average excess per-person annual medical costs of $65,612. Depending on sex and age, the cost per disease modifying therapy ranged from $57,202 to $92,719.

The largest indirect cost components reported were lost earnings due to premature death, presenteeism, and absenteeism losses. For patients with MS the average nonmedical and indirect costs were $18,542 per year, but if caregivers’ costs were included that number rose to $22,875.

Authors concluded that while MS is already known to be a higher financial burden to patients and the health care system, it is even more expensive than previously understood. —Samantha Matthews

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