This week’s dose
The Senate Finance Committee explored the extension of several public health emergency flexibilities, including telehealth and home hospital. The Health Resources and Services Administration (HRSA) threatened enforcement actions against drug manufacturers who denied the 340B price.
The Senate Finance Committee discussed flexibilities beyond the pandemic
The Finance Committee explored the possible extension of COVID-19 public health emergency-related exemptions and flexibilities (PHE). During the hearing, witnesses and senators acknowledged the critical role that telehealth has played during PHE in advancing health equity, but agreed on which policies to become permanent were difficult. to use. Some senators called for an additional study on the impact of telehealth on quality, utilization, and health care spending before making telehealth flexibilities permanent. In addition, many senators specifically supported home hospital waivers, which have been used during the pandemic to expand the health care system by allowing acute care services that are normally provided in a hospital center to be delivered. at the patient’s home. However, many existing flexibilities linked to the PHE will expire without congressional action, and the legislative path from here remains murky.
The Senate Judiciary Committee examined the impacts of hospital consolidation
Witness testimony focused largely on negative aspects of hospital consolidation, suggesting that it leads to higher health care prices, lower wages for health care workers, and fewer options for patients. The witness also attributed hospital consolidation to government policies that encourage providers to consolidate, such as health care abuse laws, Medicare payment rules, licenses, certificate of necessity laws, and potentially paperwork. growing private capital ownership. Despite these concerns, members and witnesses also discussed how integrated health systems were able to leverage their scale to respond effectively to the pandemic. President Klobuchar (D-MN) indicated that the Department of Justice and the Federal Trade Commission should consider reviewing guidelines regarding antitrust enforcement practices.
House passed the Orphan Drug Exclusivity Act
The bill, sponsored by Rep. Madeleine Dean (D-PA), aims to close a long-standing gap for orphan drugs, a designation given by the U.S. Food and Drug Administration to drugs developed to treat rare diseases. or for which the manufacturer does so. Do not expect to recover development costs. This designation comes with seven years of market exclusivity for the drug, but examination of drug prices has led lawmakers to examine how manufacturers use the designation. Representative Dean’s bill would require manufacturers to prove that they will not recover costs in the first 12 years that the drug is marketed before granting the exclusivity. The bill passed House 402-23. It is unclear whether he will be picked up in the Senate.
HRSA issued letters to six major drug manufacturers with 340B bonds
In notices issued Monday to manufacturers, HRSA warned that these drug manufacturers had to sell drugs at the maximum price of 340B to hire pharmacies and that sales could not be conditioned on the collection of additional data. In what could be a significant step forward in protections for entities covered by 340B, the agency warned that non-compliance could lead to the imposition of civil monetary sanctions. On Thursday, a manufacturer responded by filing an emergency motion to suspend any enforcement action that HRSA could take for noncompliance.
HHS announced funding to lessen the mental health crisis and substance abuse.
The Substance Abuse and Mental Health Services Administration will distribute $ 3 billion guaranteed by the U.S. Rescue Plan Act through two grant programs for mental health and substance abuse treatments. In the early days of the pandemic, experts were concerned that epidemics of mental health and opioid abuse would intensify over long periods of social isolation and financial instability, which would exacerbate the suicides of suicide and substance abuse in public health. The infusion of resources into community behavioral health research and programming joins the creation of a behavioral health coordinating board to “facilitate collaborative, innovative, transparent, equitable, and action-oriented approaches. to address [Department of Health and Human Services] behavioral health agenda. ”Funds will be distributed to states and will generally be administered by state departments of public health and / or social services.
States and courts
Lawsuit filed in Texas to reinstate Medicaid 1115 waiver revoked by Biden administration
In April, the Biden administration revoked a ten-year extension to Texas ’Medicaid demonstration program that would have continued to help offset care without funding and provide services to the uninsured low-income population of Texas. The Texas Attorney General has seen this as an attempt by the Biden Administration to force negotiations with Texas to expand Medicaid. CMS, which has jurisdiction over the waiver approval, said Texas should not have been exempt from public notice and comment before the Trump Administration granted it. Now, Texas is suing the agency, alleging that CMS violated administrative procedures and exceeded its authority, posing a significant threat of disruption to the care of safety nets in the state. Simultaneously, Texas resubmits the same waiver, this time allowing the previously abandoned public comment period.
In the Senate, the appropriations committee examined the president’s budget for disease control and prevention centers; the National Security Committee held the second part of a series on the U.S. medical supply chain; and the health and retirement subcommittee examined the health workforce issues.
The House Oversight Committee held a hearing on the price of drugs on the same day it released a report on price increases for two widely used organic products.
In a proclamation issued last Friday, President Biden reversed a policy that allowed the government to deny entry to immigrants who cannot obtain health insurance coverage within 30 days of arriving in the United States, as well. as a rule that allowed immigrants who had used government-funded programs such as Medicaid to be denied the green card.
New CMS data show that the pandemic has resulted in millions of missed visits by beneficiaries of the Child Health Insurance and Medicaid Program, which have raised concerns about the long-term impacts of health, especially for health. mental.
Four Democratic lawmakers called for the suspension of global and professional direct hiring models.
A bipartisan group of lawmakers called on Secretary Becerra to extend the next-generation model of responsible care organization for a year, emphasizing its value for care coordination and cost savings for Medicare.
Next week’s diagnosis
The House Appropriations Committee examines budget requests from the Centers for Disease Control and Prevention, Health Defense and Preparedness, and the National Institutes of Health. House Energy and Commerce will hold a hearing on vaccine confidence. The Senate Credit Committee will also review the NIH budget.