Health Care Checkup
January 15, 2021
THE BIG PICTURE
What Happened This Week
 
On January 13, the House of Representatives brought forward an article of impeachment against President Donald Trump, accusing him of inciting an insurrection based on his role in the deadly January 6 attacks on the Capitol. House Democrats, along with 10 Republicans, voted to impeach President Trump by a 232-197 margin. While it has been reported that Senate Majority leader Mitch McConnell (R-KY) is “pleased” with the House’s impeachment effort, he stated on Wednesday that he would not call the Senate back into session before January 19, eliminating the chance that the Senate will start the impeachment trial proceedings on President Trump before his term ends on January 20. President Trump is the first president in U.S. history to be impeached twice.

On January 14, President-elect Joe Biden gave a speech regarding his new plan, the “American Rescue Plan,” which is his $1.9 trillion COVID-19 response package. The plan includes provisions such as $1,400 direct stimulus checks for individuals, $160 billion to help fight COVID-19, $170 billion for schools, and $350 billion in emergency funding for state and local governments. The plan also includes goals to “mount a national vaccination program, contain COVID-19, and safely reopen schools.
 
On Tuesday, the Trump Administration announced various changes to its vaccine distribution strategy. At a press briefing, Health and Human Services (HHS) Secretary Alex Azar announced that states, who previously were told to vaccinate health care providers and long-term care residents, are now being advised to provide the COVID-19 vaccine to those 65 and older and those with underlying health conditions that increase their vulnerability to serious cases of the virus. There will also be a change in how the vaccines are allocated to the states.
 
President-elect Joe Biden and Vice President-elect Kamala Harris announced additional members of the incoming White House staff. The members announced include individuals who will comprise offices such as the Office of the Chief of Staff, Office of Scheduling & Advance, and the Office of Management and Administration. The Biden-Harris transition team also announced additional members of their COVID-19 response team.
 
On January 12, the Centers for Medicare and Medicaid Services (CMS) finalized a rule that aims to advance innovative technologies so Medicare beneficiaries can have access to the latest medical devices. On January 15, CMS issued its final rule for CY22 Medicare Advantage and Part D plans that it says aims to improve access to and coverage of prescription drugs for Medicare beneficiaries. The rule includes changes to the drug tiering system for Part D prescription drugs.
What to Expect Next Week: President-elect Joe Biden and Vice President-elect Kamala Harris will be sworn into office on January 20. There will be an unprecedented amount of security for Inauguration Day as federal officials prepare for additional protests and possible violence in the District of Columbia. President Donald Trump has stated that he will not attend the inauguration, but Vice President Mike Pence is expected to be in attendance.
 
Since the House impeached President Trump this week, the Senate will next hold an impeachment trial. However, the Senate will not reconvene until after President Trump’s term ends, so it will not occur before Inauguration Day. We will continue to monitor this as it continues to unfold.
DEEP DIVE
House Votes to Impeach President Trump for Incitement of Insurrection at U.S. Capitol
On January 13, the House of Representatives brought forward an article of impeachment against President Donald Trump, accusing him of inciting an insurrection based on his role in the deadly January 6 attacks on the Capitol. House Democrats, along with 10 Republicans, voted to impeach President Trump by a 232-197 margin. One of the most noteworthy Republican supporters of impeachment is Representative Liz Cheney (R-WY), who is the third-ranking House Republican. While it has been reported that Senate Majority leader Mitch McConnell (R-KY) is “pleased” with the House’s impeachment effort, he stated on Wednesday that he would not call the Senate back into session before January 19, eliminating the chance that the Senate will begin President Trump’s impeachment trial before his term ends. President Trump is the first president in U.S. history to be impeached twice.

President-elect Biden Announces COVID-19 Response: The “American Rescue Plan”
On January 14, President-elect Joe Biden announced his new plan, the “American Rescue Plan,” which is his $1.9 trillion COVID-19 response package. The plan includes provisions such as $1,400 direct stimulus checks for individuals, $160 billion to fight COVID-19, $170 billion for schools, and $350 billion in emergency funding for state and local governments. The plan also includes goals to “mount a national vaccination program, contain COVID-19, and safely reopen schools. The federal hourly minimum wage will also get a boost under the plan, increasing to $15 per hour. The plan also includes further assistance to those that are unemployed and economic aid for small businesses that have been hit hard by the pandemic. The President-elect has referred to December’s COVID stimulus package as a “down payment” and has stated that it fell short of the resources needed to effectively tackle the raging pandemic that continues to infect millions and kill thousands. The American Rescue Plan is the first step of Biden’s broader agenda to “Build Back Better. During his speech on Thursday evening, President-elect Biden said that the second step will occur next month in his first appearance before a Joint Session of Congress. He said that the second phase will “make historic investments in infrastructure and manufacturing, innovation, research and development, and clean energy.” President-elect Biden’s full speech can be found here.

Biden-Harris Transition Announces Additional White House Staff
President-elect Joe Biden and Vice President-elect Kamala Harris announced additional members of the incoming White House staff. The members announced include individuals who will comprise offices such as the Office of the Chief of Staff, Office of Scheduling & Advance, and the Office of Management and Administration. Some of these newly-announced members include Jeffrey Wexler, an Obama Administration alum, who will serve as the Director of COVID-19 Operations; Christen Linke Young, who will be the Deputy Director of the Domestic Policy Council for Health and Veterans Affairs; John McCarthy, who will serve as the Senior Advisor to the Counselor to the President; Zayn Siddique, who will be the Senior Advisor to the Deputy Chief of Staff; Thomas Winslow, who will be the Senior Advisor to the Deputy Chief of Staff; Lisa Kohnke, who will serve as the Director of Presidential Scheduling; Sarah Feldmann, who will be the Chief of Staff for the Office of the Management and Administration; Michael Leach, who will serve as the Chief Diversity and Inclusion Director; and Christian Peele, who will be the Deputy Director of Management and Administration for Personnel. More information can be found here and here
President-elect Biden and Vice President-elect Harris Announce Additional Members of the White House COVID-19 Response Team
On January 15, President-elect Biden and Vice President-elect Harris announced additional members of their COVID-19 response team. President-elect Biden said in a statement that “We are in a race against time, and we need a comprehensive strategy to quickly contain this virus. The individuals announced today will bolster the White House’s COVID-19 Response team and play important roles in carrying out our rescue plan and vaccination program.” Amy Chang will be a Policy Advisor, Abbe Gluck will serve as the Special Counsel, David Kessler will be the Chief Science Officer of COVID Response, Rosa Po will serve as the COVID Response Team Deputy Chief of Staff, Andy Slavitt, will be the Senior Advisor to the COVID Response Coordinator, Vidur Sharma will be the Policy Advisor for Testing, Ben Wakana will serve as the Deputy Director of Strategic Communications & Engagement, and B. Cameron Webb will be the Senior Policy Advisor for COVID-19 Equity. Additional information on the new members can be found here.
Trump Administration Makes Changes to COVID-19 Vaccine Distribution Guidelines 
On Tuesday, the Trump Administration announced various changes to its vaccine distribution strategy. At a press briefing, Health and Human Services (HHS) Secretary Alex Azar announced that states, who previously were told to vaccinate health care providers and long-term care residents, are now being advised to provide the COVID-19 vaccine to those 65 and older and those with underlying health conditions that increase their vulnerability to serious cases of the virus. There will also be a change in how the vaccines are allocated to the states. Currently, doses are given to the states based on their total adult population. However, beginning in two weeks, vaccines will be allocated to states based on the number of individuals over age 65 who live there, and based on the current rate of vaccine administration in the state. At the briefing, Secretary Azar stated, “We need doses going to where they'll be administered quickly and where they'll protect the most vulnerable.” Additionally, the Trump Administration is suggesting states begin creating more vaccination venues, such as convention centers, pharmacies, and auditoriums. The Administration’s new guidelines stand in contrast with the Centers for Disease Control’s (CDC) guidelines. The CDC has recommended that the next phase of inoculation should include non-health-related essential workers and those over 75 years of age. Some critics of the Administration’s distribution strategy claim that the changes will create mass public confusion and that attention is being unduly diverted from populations at the highest risk of COVID-19 complications.
CMS Finalizes Rule to Expedite Medical Device Coverage for Medicare Beneficiaries
On January 12, the Centers for Medicare and Medicaid Services (CMS) finalized a rule that aims to advance innovative technologies so Medicare beneficiaries can have access to the latest medical devices. CMS states that the current process for U.S. Food and Drug Administration (FDA) approval of devices is both “lengthy” and “costly” for Medicare coverage. The agency says that the “lag time between the two results in innovators first spending time and resources on FDA approval, and then subsequently on the Medicare coverage process.” Therefore, the Medicare Coverage of Innovative Technology (MCIT) final rule aims to remedy this lag time by creating a new, accelerated Medicare coverage pathway for “innovative products” that the FDA defines as “breakthrough.” Additionally, under this final rule, Medicare will be able to provide coverage concurrently with FDA approval for a period of up to four years. Once the coverage period is over, CMS will then reexamine the device based on clinical and “real-world” evidence of improvement in the health outcomes of Medicare beneficiaries. This process will help CMS determine which devices should be awarded permanent coverage. CMS hopes that this four-year timeline will “incentivize device manufacturers to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years.” Additional information can be found here.

CMS Approves New Financing Model for Tennessee’s Medicaid Program
On January 8, CMS approved a new Medicaid financing approach to Tennessee’s Medicaid program. In this new financing structure, Tennessee’s Medicaid funding would be in the form of a spending-capped block grant. If Tennessee spends less than the block grant amount, then the state would be permitted to keep 55 percent of the savings, but if Tennessee spends more, then the difference would need to be covered by state funds. If approved by the state’s legislature, the new financing model would be effective for 10 years. CMS has stated that the current financing approach focuses on volume instead of value. Therefore, the new approach aims to “shift [the] paradigm by aligning incentives across the state and federal government.” Proponents of the new Section 1115 waiver, known as “Tenn Care III” claim that it will provide Tennessee with “increased flexibility” in how funding can be used throughout the state’s Medicaid program. However, Tenn Care III has been highly controversial, as opponents claim that it will cause those in need to lose access to health care because they fear that the state will make cuts to its Medicaid program. CMS has responded to those fears, stating that “No reductions in benefits or coverage can be made by the state without an amendment and additional public comment processes.” Given that the Trump Administration has very little time left, it is unclear how the waiver will play out, as the Biden Administration will likely seek to reverse the decision. Additional information can be found here.

CMS Puts Patients Over Paperwork with New Rule that Addresses the Prior Authorization Process
On Friday, CMS finalized a rule that aims to “put patients over paperwork”. The final rule strives to reduce costs and administrative burdens associated with the prior authorization process by improving the electronic exchange of health care information among patients, providers, and payers. The rule requires that, starting January 1, 2023, state Medicaid and CHIP fee-for service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally facilitated Exchanges (FFEs) include claims, encounters, and prior authorization decisions in Patient Access application programming interfaces (APIs). Additionally, payers will need to create and “maintain a Provider Access API for payer-to-provider data sharing of claims and encounter data (not including cost data)”. The final rule also includes various prior authorization policies that will go into effect on January 1, 2024. Some of these policies include requiring payers to build Prior Authorization Support APIs to facilitate conducting prior authorizations electronically, mandating that payers include specific reasons for denials when denying prior authorization requests, and requiring that payers provide transparency by publicly reporting the operational outcomes of their prior authorization policies and practices. The final rule also calls for patients to have enhanced access to their health information through Payer-to-Payer APIs. More information can be found here.

CMS Issues Final Rule that Makes Changes to Medicare Advantage and Part D to Enhance Coverage and Access
On January 15, CMS issued its final rule for CY22 Medicare Advantage and Part D plans that it says aims to improve access to and coverage of prescription drugs for Medicare beneficiaries. Starting January 1, 2023, Medicare Part D plans will be required to provide beneficiaries with a “real-time” benefit comparison tool that they can use to comparison shop prescription drugs. There will also be changes to the drug tiering system for Part D prescription drugs. Currently, Medicare Part D drugs that are placed into a “specialty tier” have the same level of cost sharing. However, under the new rule, Part D plans will be allowed to create a second specialty tier, referred to as the “preferred tier,” which will have a lower level of cost sharing than the other specialty tier. CMS says that this change will allow Part D plans to better negotiate costs with drug manufacturers. The official rule will be published on January 19 and will be available here.

CMS Announces that the Geographic Direct Contracting Model (“Geo”) Request for Applications (RFA) is Now Available
On January 15, CMS announced that the Geographic Direct Contracting Model (“Geo”) Request for Applications (RFA) is now available. Geo is a new payment and service delivery model that CMS is testing. It will “test” whether taking a geographic-based approach to value-based care and care delivery can produce better health outcomes reduce costs for Medicare beneficiaries. Direct Contracting Entities (DCEs) in the Model will “assume financial risk in return for enhanced flexibilities, making it possible for these entities to offer Medicare beneficiaries an increased focus on care coordination through care delivery innovation.” DCEs will receive preferred provider networks, better care coordination and clinical management, and payment integrity. Medicare Beneficiaries will retain all of their Medicare benefits and all previously held appeal rights under Original Medicare. Some of the goals of Geo are to lower out-of-pocket costs, improve care, and provide stronger beneficiary protections. CMS will accept applications for Geo from March 1 – April 2, 2021. The Model itself will be tested over a six-year period in four-ten regions. Additional information can be found here.
SENATE HEARINGS AND EXECUTIVE SESSIONS
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HOUSE HEARINGS AND EXECUTIVE SESSIONS
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ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

National Institutes of Health
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