HealthCare Roundtable e-News – June 10, 2020

FDA Considers Extending Some COVID-19 Policies Post Pandemic

The FDA is currently exploring policies that had been adopted throughout the COVID-19 crisis that may be more useful on a permanent basis in the post-COVID-19 era, announced Chief Stephen Hahn last week. The policies being considered include remote clinical trial visits and telemedicine, as well as streamlining lab test approvals.

“I think the entire FDA team has now seen firsthand that we need to take a critical look at some of our processes and policies. I’ve instructed my staff to identify the lessons learned from this pandemic and what adjustments may be needed not just to manage this or future emergencies but how to permanently make FDA more efficient in carrying out our regulatory responsibilities,” Hahn told stakeholders last week. (InsideHealthPolicy)

One of the more significant steps the agency is taking is working with the National Institutes of Health and the Centers for Disease Control and Prevention to help implement master protocols that can be used for multiple clinical trials and allow for more than one promising COVID-19 drug to be studied at the same time.

Hahn confirmed that the intention will not be to replace randomized controlled clinical trials; however, the FDA’s pandemic response efforts have shown some policies and processes can be made more efficient, and not just in the context of emergencies. The agency chief also emphasized the importance of considering real-world evidence going forward, noting that the pandemic has enabled researchers to better understand diseases, immunity, and the medical product supply chain. (InsideHealthPolicy)

In Letter to CMS, Insurance Commissioners Request Guidance On Risk Corridor Payments, COVID-19 Testing

In a letter to CMS last month, the National Association of Insurance Commissioners (NAIC) requested more guidance on potential risk corridor payments for COVID-19 testing as the regulators prepare to review filings for 2021 rates. Among the concerns that require more clarity includes which COVID-19 tests should be covered and how they should be financed.

In their letter, the insurance commissioners state they are looking for more guidance on the risk corridors program, after several recent Supreme Court cases have added to the complexities of setting rates, including Maine Community Health Options v. United States, where it was ruled that the government must reimburse insurers for money owed under the risk corridors program. Risk corridors are federally run, so state regulators and the NAIC have no say in how those programs are operated, according to the group. (InsideHealthPolicy)

Additionally, the NAIC has suggested that states should be responsible for determining who is responsible for the costs, noting in their letter that testing for virus “infection and exposure is a critical means to understand and control the spread of the pandemic, especially as states begin the process of re-opening businesses.” The group has also urged CMS to operationalize its special enrollment period (SEP) on for individuals with minimal essential coverage who experience a change in income that makes them eligible for subsidized coverage. (InsideHealthPolicy)

Latest RAND Study Suggests Public Health Option Might Lower Rates, But Not Expand Coverage

According to a new RAND Corporation study, a government-sponsored health plan is less likely to help more Americans become insured without the assistance of additional financial help. The study found that while offering a public health plan with publicly determined payment rates could lower the cost of premiums, it would be unlikely on its own to increase the overall number of people with coverage.

Researchers in the study used four varying models available across the country and found that premiums for public plans could be 10% to 27% lower than private insurance plans because of lower provider payment rates in the public option.

“Since higher-income people pay the full cost of insurance on the individual market, they could receive substantial savings under a public option,” said Jodi Liu, the study’s lead author and a policy researcher at RAND. “But policymakers should consider how the design of a public option could decrease the tax credits lower-income enrollees receive under the ACA.” (InsideHealthPolicy)

The study also found, however, that in three of the four models, the number of uninsured people fell from 3% to 8% and determined that lower-income people are less likely to benefit from the public option because of the tax credit structure of the federal Affordable Care Act.

Researchers say the study will play a significant role in healthcare conversations as the country continues to battle the COVID-19 crisis and move into the final stages of the 2020 presidential election.

CMS Says Congress Would Need to Act to Extend Telehealth Wavers Beyond the COVID-19 Pandemic

As the country begins to examine policies that will continue to be in effect in the nation’s “new normal,” CMS has expressed that it’s in Congress’ hands to determine extensions for waived restrictions on telehealth Post COVID-19. While President Trump has already given an executive order for making some waivers permanent, CMS is feeling the pressure from stakeholders, and some lawmakers have expressed support for extending regulatory waivers and easing state licensing restrictions that affect telehealth across state lines, the agency told InsideHealthPolicy.

“CMS has already shown its commitment to expanding access to telehealth within our authority and is continuing to think carefully about what recent changes should be continued after the public health emergency is lifted. We will be assessing this fully after we get past the pandemic, with a focus on making sure that we are leveraging the latest technology and modernizing the Medicare program to provide high-quality care,” a spokesperson told the news service.

The Trump Administration had previously acknowledged that it might not be possible to continue to waive all restrictions beyond the public health emergency. CMS confirmed that many of the requirements that govern Medicare telehealth services “are statutory in nature and could only be revised through a change to the statute.”

Stakeholders are asking both CMS and lawmakers to retain access to telehealth after the emergency, with groups including the American Medical Group Association saying that the changes that have been implemented throughout the pandemic to expand telehealth have “fundamentally shifted” how patients interact with their providers in a way that would make it difficult to revert back. (InsideHealthPolicy)