National, Federal and State Policy Updates: October 2022
Federal Policy Updates
Congress Passes Continuing Resolution with FDA Reauthorization
- On September 30, Congress passed a continuing resolution to fund the government through December 16, when a full funding bill for fiscal year 2023 must be reached. The bill included important legislation for FDA user fee reauthorization for prescription drugs, biosimilars, and medical devices for the next 5 years and certain provisions for laboratory accreditation, and extensions of various FDA programs, e.g., orphan drug grants. The bill did not include any FDA “riders” or add-ons such as support for public health and monkeypox related issues, accelerated approval reform, clinical trial diversity requirements, and regulation of diagnostic testing that has previously been debated by the House.
House Passes MA Prior Authorization Bill
- On September 14, the House passed the Improving Seniors Timely Access to Care Act of 2021, which would establish prior authorization (PA) requirements in Medicare Advantage plans including transparency measures and real-time decisions. The bill would direct the HHS Secretary to identify which items and services would be subject to PA requirements, collect data from plans on PA requests (e.g., the number of requests and appeals), and establish enrollee protection standards. The bill also aims to reduce turnaround times for PA to no longer than 7 days, which have become more common and time consuming for clinicians with MA patients in recent years due to non-standard processes between plans.
White House Release Biomanufacturing EO
- On September 12, the Biden Administration released a new executive order (EO) aimed at increasing biotechnology manufacturing in the US to increase supply chain resilience, a long-standing priority of domestic manufacturing. Examples included diagnostics, therapeutics, vaccines, genetic engineering, and based agriculture. Broad benefits listed in the EO included enhanced biosecurity, ethical implementation of biological data, and equitable use of science breakthroughs. Objectives for policy were investment in research and development, advancing data sharing, improving production capacity, promoting standards and metrics for system development, and evaluating risk management of biosafety.
Research Finds Few Differences Between D-SNP and MA-PD Plans for Dual Eligibles
- On September 12, a study published in Health Affairs investigated the differences in patient satisfaction between dual-eligible special needs plans (D-SNPs) versus other Medicare prescription drug coverage. They found that dual-eligible patients in D-SNPs had greater access to care, use of preventive services, and satisfaction overall than traditional fee-for-service Medicare but minimal differences with other Medicare Advantage Part D plans (MA-PDs), especially for dual eligibles of color identifying as Black or Hispanic, suggesting areas for improvement in D-SNP care.
State Policy Updates
NY Submits $13.5M Medicaid Waiver Proposal
- On September 2, NY submitted a Medicaid 1115 waiver that would aim to improve health disparities, behavioral healthcare treatment, and care coordination through value-based care delivery and payment by focusing on whole-person care and health-related social needs. Strategies include an integrated social care system, transitional housing, addressing workforce shortages, and state-wide digital health and telehealth infrastructure. The demonstration would last for 5 years and fund services for populations with outcomes exacerbated by the pandemic such as older adults, those with disabilities, those involved in the criminal justice system, and those experiencing homelessness. NY’s Medicaid program covers approximately 7.56 million people and increased substantially during the course of the pandemic.
Blue Cross’ Value-Based Blue Premier Program Boasts of Healthcare Savings
- On September 14, Blue Cross NC announced it had achieved $130 million in savings during 2021 and $500 million dollars over 3 years through its Blue Premier program. The initiative rewards health systems for quality of care and prevention, reducing hospitalizations, and improving outcomes and also has an Advanced Kidney Care component. The program served 1.4 million members in 2021 and compared to 2020 saw: a 5% reduction in unplanned hospital readmissions, a 12% increase in patients more actively managing their blood pressure, and 24,000 additional colorectal cancer screenings. The program’s shared-risk agreements allowed providers to earn nearly $321 million in bonus payments for 2021 while reducing overall expenditures. Blue Premier has agreements in place with 12 major hospitals, and roughly 800 independent primary care practices, accounting for about 70% of Blue Cross NC’s medical costs.
House Committee Asks HHS to Investigate HCA Healthcare Facilities
- On September 13, the House Ways and Means Committee sent a letter to the HHS Secretary to look into reports of HCA Healthcare’s facilities engaging in unnecessary inpatient admissions from emergency departments, chronic understaffing, and corporate policies. The letter outlined allegations that leadership set admissions targets and threatens retaliation against staff that do not meet those targets. HCA’s joint venture with EmCare, a subsidiary of the private equity firm Envision Healthcare, previously entered a federal settlement in 2017 over similar allegations for contracted physician services with another hospital chain. Other understaffing issues have been documented in HCA hospitals, leaving to preventable patient deaths, breakdown of infection controls, and one hospital threatened with losing its ability to participate in the Medicare program.
Amazon Announces Health Equity Startup Program Finalists
- On August 31, Amazon Web Services (AWS) announced 10 participants in its 2022 Health Accelerator program focused on health equity through improvements in data, medical transport, housing connections, and social determinants of health. Examples of finalists’ business models include technology supporting clinical decision-making, data-science platforms using machine learning, AI-based solutions for maternal healthcare risks, engagement between sponsors and community-based organizations, and other areas in health equity. The program provides startups with 4 weeks of technical and business mentorship, up to $25,000 in web services, and opportunities to work with AWS healthcare customers and stakeholder partners.