Welcome back to another month of Zipnosis Regulatory Roundup! There’s been considerable movement in the regulatory landscape in the last month, especially in the federal space. Let’s dive in to see what’s been happening!
On September 3rd, The Biden-Harris administration announced a $65 billion plan to complete a comprehensive review of the United States’ national bio-preparedness policies. This project will review the Administration’s strategy on biodefense and pandemic preparedness to ensure protection against biological threats. This includes the risk of pandemic disease, laboratory accidents, and deliberate use of bioweapons.
The goals of the project include:
- Transforming our Medical Defenses, including dramatically improving vaccines, therapeutics, and diagnostics.
- Ensuring Situational Awareness about infectious disease threats for both early warning and real-time monitoring.
- Strengthening Public Health Systems to respond to emergencies, with a focus on protecting the most vulnerable communities.
- Building Core Capabilities, including personal protective equipment, stockpiles, supply chains, biosafety and biosecurity, and regulatory improvement.
- Managing the Mission, with the seriousness of purpose, commitment, and accountability of the Apollo Program.
American Rescue Plan
The Biden-Harris Administration has allocated an additional $452 million in funding to 13 states to increase the affordability of health coverage costs. In addition to lower premiums, this waiver may help states increase issuer participation and the number of qualified health plans available.
The states receiving the funding: Alaska, Colorado, Delaware, Maine, Maryland, Minnesota, Montana, New Hampshire, North Dakota, Oregon, Pennsylvania, Rhode Island, and Wisconsin.
TRICARE – House Bill 4350
This bill allows fiscal appropriations for 2022. Included in this bill are provisions to modify TRICARE coverage of telehealth services during a covered health emergency. Meaning the removal of things like cost-sharing, including copays and deductibles. It would allow audio-only communications and reimburse out-of-state providers, regardless if they are licensed in the state where the patient is located. This bill would allow the Secretary to extend these provisions beyond the covered health emergency when deemed appropriate.
Senate Bill 457 – Protection of Patient Choice in Telehealth Provider Act
Provides that consideration for internet-based advertising, appointment booking, or any service that provides information to prospective patients of licensees does not constitute a referral of a patient if the service provider doesn’t endorse a specific licensee to a prospective patient.
Includes requirements that protect a patient’s choice in receiving in-person care or telehealth services. Third-party telehealth corporations that do not maintain a physical location should coordinate with a patient’s usual source of care and contribute to the patient record in order to be part of a comprehensive, integrated health care system.
This bill is currently awaiting executive signature.
Senate Bill 365
This bill will require Medi-Cal to reimburse for asynchronous e-consults between the referring provider and the consulting provider. Currently, only the consulting provider can bill for the interaction. This bill will require both providers to be reimbursed for their time. The bill is awaiting the governor’s signature.
Regulation 5617 2021
The Department of Public Health/Professional Licensure Division has adopted and filed rulemaking that outlines the standards of practice related to telepsychology. The rules in the new chapter align with the Board of Medicine’s rules and will ensure that psychologists use uniform standards while providing remote care. Additionally, the chapter includes terminology definitions, requirements for patient record keeping, psychological testing, participation in judicial proceedings, and rules for reporting to the Board.
HJR 1 a
The 2021 House Joint Resolution enacted on September 9, 2021, extends the emergency executive actions and the public emergency. The extension includes the Department of Insurance (DOI) Order, dated March 18, 2020, related to telehealth remote communications and the prior relationship requirement. This order expires on January 15, 2022, unless another extension is executed.
Thanks for checking in for this month’s updates. I hope you learned something. Check back next month for more!
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