On Sept.19, House Speaker Nancy Pelosi introduced her much-anticipated government price negotiation plan that would empower the U.S. Department of Health and Human Services (HHS) to negotiate drug prices that would apply to all payers. A summary of the revised bill includes one major change from a draft plan (leaked on Sept. 9): the final version instructs HHS to negotiate prices on drugs without generic or biosimilar competition. Price negotiation would apply to drugs with no competition that are among the top 250 most costly drugs to Medicare and the U.S. health system. Under Pelosi's plan, the negotiated prices would be available to all payers, including commercial payers, and HHS would be required to negotiate a minimum of 25 drugs per year. (The earlier draft plan included price negotiation on drugs with less than two competing two competing generics or biosimilars.)
Pelosi's plan also proposes a $2,000 out-of-pocket cap on prescription drugs for Medicare beneficiaries and disabled individuals.
The House Energy & Commerce Committee's Health Subcommittee is scheduled to hold a hearing on drug pricing legislation next week on Wednesday, Sept 25.
Both FDA and the U.S. Centers for Disease Control (CDC) are working to investigate incidents of severe respiratory illness associated with use of vaping products.
While federal and state health officials work to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA has some information that consumers can use to help protect themselves.
Access the FDA information.
The Centers for Medicare & Medicaid Services (CMS) Aug. 30 announced efforts underway to support Florida in response to Hurricane Dorian. Health and Human Services Secretary Alex Azar declared a public health emergency in the state. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Dorian. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.
Below are key administrative actions CMS will be taking in response to the public health emergency declared in Florida:
Waivers and Flexibilities for Hospitals and other Healthcare Facilities: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will also issue a number of blanket waivers, listed on the website below, and the CMS Regional Office will grant other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. More information is available here.
Special Enrollment Opportunities for Hurricane Victims: CMS will make available special enrollment periods for certain Medicare beneficiaries and individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. More information available here and here.
Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. Access more information and the toolkit.
Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease (ESRD) Network of Florida, ESRD NW7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD NW hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The ESRD NW7 toll-free hotline is 800-826-3773 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website.
Medical equipment and supplies replacements: CMS will be temporarily suspending certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in Florida, but will continue to investigate allegations of immediate threat to patient health and safety.
Ensuring Access to Care in Medicare Advantage and Part D: During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.