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Find our analysis on legislation, regulations, MedPAC meetings, and more. 

Week Ahead: The Fireworks Aren’t Done Yet

The fireworks are just starting in Washington, DC even if Independence Day celebration is over. Democratic offices on the Hill are still working out the best way to handle President Biden’s debate performance, his subsequent interview with ABC, and questions about his fitness for office. Additionally, there is a new framework on how to implement federal regulations with the repeal of the Chevron Deference doctrine. So don’t put away those lawn chairs and blankets just yet. Welcome to the Week Ahead!

The Administration

We are eagerly waiting for the release of the CY 2025 proposed rules for the Physician Fee Schedule and the Outpatient Prospective Payment System. While we expected them last week, don’t worry the rules aren’t late – they dropped mid-July last year.

The Centers for Medicare and Medicaid Services (CMS) did drop the CY 2025 Home Health Proposed Rule and the CY 2025 End Stage Renal Disease (ESRD) Proposed Rule on June 26 and June 27, respectively. The proposed home health rule included an overall rate reduction of -1.7%. The proposed ESRD rule increases the base rate to $273.20.

Don’t forget – the FY 2025 final rules for inpatient hospitals, skilled nursing facilities, and inpatient rehabilitation facilities are coming out soon.  They are under review at OMB right now.

But what about Chevron? The repeal of the Chevron Deference Doctrine by the Supreme Court on June 28 ends the long-held practice of giving deference to federal agencies when the laws they are tasked with implementing are not clear. This decision could complicate finalizing all sorts of rules, including health care provider payment rules. The Administration condemned the decision as one that will “block common-sense rules that keep us safe, protect our health and environment, safeguard our financial system, and support American consumers and workers.” Leading Democratic members of Congress, including Senate Majority Leader Schumer and House Judiciary Committee Ranking Member Nadler, have also criticized the decision.

The Senate

Nursing Home Staffing Rule Rebuke Possible

Speaking of rules, we are hearing rumors from within the Senate Democratic caucus that a Congressional Review Act vote may occur on the Biden Administration’s rule that would create a nursing home staffing mandate. This rule has come under fire from nursing homes and hospitals, and drawn bipartisan criticism on the Hill, especially in rural districts.

Although many Democratic senators are expected to vote against repealing the mandate, Democratic leadership may be looking to give a pass to vulnerable senators who face tough re-election campaigns in November. We expect the measure to pass in the Senate to pass this measure and to eventually make its way to President Biden’s desk where we expect he will veto the bill. We don’t see a scenario in which there is enough Democratic support to overturn the veto.

Health Care Hearings to Watch

  • July 9: Senate Health, Education, Labor, and Pensions Subcommittee on Children and Families hearing on the impact of high costs (not explicitly health care, but health care costs are certainly a concern members like to talk about)
  • July 11: Senate HELP Committee hearing on medical debt
  • July 11: Senate Special Committee on Aging hearing on health care transparency
  • July 11: Senate Appropriations Markup of Milcon-VA, Ag-FDA, and Legislative Branch Appropriations Acts and FY25 Subcommittee Allocations
  • July 11: Senate Homeland Security and Governmental Affairs Committee hearing on Oversight of Taxpayer-Funded High-Risk Virus Research

The House

Biden’s House Woes

More Democratic Representatives are calling for President Biden to step aside and let someone else face former President Trump in the 2024 election as the House returns from recess. So far, that list includes Reps. Craig, Quigley, Kuster (Nem Democat Coalition Chair), Moulton, Doggett, and Grijalva. The New York Times is also reporting that Reps. Nadler, Adam Smith, Takano, and Morelle have urged House Minority Leader Jeffries to get President Biden to end his reelection bid. These House Democrats join the Democratic Governor of Massachusetts in calling for Biden to let someone else run. Additionally, Sen. Warner of Virginia is reportedly working on building support among Senate Democrats to urge Biden to get out of the race.

Labor-HHS and FDA Appropriations Bills Set to be Marked Up

The House Appropriations Committee is scheduled to markup the Labor, Health and Human Services (HHS), Education, and Related Agencies Appropriations Bill for FY 2025 on July 10. It is also scheduled to markup other appropriation legislation, including its version of the Agriculture, Rural Development, Food and Drug Administration (FDA) Appropriations Bill for FY 2025. We will be watching for details on these bills as we move closer to the markup date, and to see if the bills that emerge include any controversial provisions on hot button issues like abortion.

Ways and Means Goes West

Much like the prospectors who went west during the California gold rush, the House Ways and Means Committee will be heading west for a field hearing in Utah on July 12. But unlike those prospectors looking for gold and silver, the Committee is looking for a different type of treasure. That is how to support medical innovation.

In theory, this is an area that could be a gold mine for bipartisan action. However, it remains to be seen if the committee can strike it rich or if things will be held up by partisan disagreements over how to best get the gold. We expect Republican members to criticize government interference in private-sector innovation, while Democratic members will likely highlight the importance of investing in research to make such innovations possible and the need to ensure those innovations are affordable.

There You Have It

Can you believe it’s already July? As if that was not hard enough to believe, the Republican National Convention begins July 15! Before you know it, summer will end, and the final push to the election will be upon us. So, soak up the sun and the speeches while you can. Make it a great week!

Week Ahead: Of Convictions and Congress

Donald Trump made history on May 30 as the first former President to be convicted of a felony. Congress now returns for the first time since that conviction, and many lawmakers will be focusing their attention on the fallout from the verdict. We won’t add to the pile of punditry that has already been printed but will instead focus on the latest health care policy news.  Welcome to the Week Ahead!

The Administration

ACLA Tests the Legal Waters with LDT Lawsuit

As the former president prepares his appeal, the Food and Drug Administration (FDA) is preparing for a legal fight of its own. On May 29, the American Clinical Laboratory Association (ACLA) announced it was filing a lawsuit against the FDA to stop the agency’s Final Rule to regulate laboratory-developed tests (LDTs) as medical devices. The ACLA argues that Congress never gave the FDA the authority to regulate these tests.

So what?  The lawsuit is just the latest effort by the ACLA to stop this rule from going into effect. We expect the lab industry to follow the lawsuit with increased lobbying. Some Republicans on the House Energy and Commerce Committee have expressed concerns about potential unintended consequences from the rule, but what will become of efforts to pull back the rule?

Senate

Multiplan Madness

Senate Finance Committee Chair Wyden (D-OR) and Senate HELP Committee Chair Sanders (I-VT) are looking to get answers from Mutliplan regarding concerns about certain practices the company uses when negotiating out-of-network payment rates for insurers. Specifically, the Senators are concerned these practices increase costs for patients and may be allowing insurers to skimp on fulfilling their obligations to patients. They requested a response by June 5. Here are some things to watch for:

  • Will the two Democratic chairs get any help from their GOP Ranking Members?
  • Will we see any corresponding action in the House?

Senate Health Care Hearings 

  • June 4: Senate HELP Committee hearing on the Impact of Abortion Bans on Women’s Health
  • June 5: Senate Special Committee on Aging and Senate VA Committee hearing on Services for Veterans and Their Caregivers

The House

Checking in with Ways and Means

Work continues behind the scenes at the House Ways and Means Committee on provisions that could find their way in a late year, post-election health care package:

  • Telehealth: It sounds like a 2-year extension of telehealth flexibilities is picking up steam and is likely before year’s end. While advocates would love action before the November elections, it’s unclear at best if Congress can agree on addressing the issue sooner than December.
  • Rural health: In addition to the bills passed out of the Committee at its May 8 markup, the Committee is hoping to move additional rural bills before summer’s end. Any measures cleared by the Committee will be in play to move in a larger health package during the lame duck session.
  • Medicare physician payment: With Congress waiting for the release of the Medicare physician fee schedule in late June, it’s hard to see any significant movement on Medicare payment legislation before the election. In addition, word is that there is growing interest among policymakers in H.R. 6371, the Provider Reimbursement Stability Act, which would address Medicare’s budget neutrality requirement.

House Health Care Hearings

  • June 3: House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing with Dr. Fauci
  • June 4: House Energy and Commerce Oversight and Investigations Subcommittee hearing on 340B Drug Pricing Program
  • June 4: House Natural Resources legislative hearing, including H.R. 6395, Recognizing the Importance of Critical Minerals in Healthcare Act of 2023

There You Have It

Summer is officially here! Have any big summer travel plans? Favorite summer- time activities? Let us know! Make it a great week!

Week Ahead: Congress Loves Rural

After a frenzied finish to last week that included a last-minute vote on legislation to reauthorize the Federal Aviation Administration in the Senate, and the bipartisan tabling of the motion to vacate House Speaker Mike Johnson in the House, the Congress reconvenes this week with only 2 work weeks before the Memorial Day break.  So, let’s get into it. Welcome to the Week Ahead!

The Administration

Cybersecurity Standards for Hospitals on the Horizon 

Deputy National Security Advisor for Cyber and Emerging Technology Anne Neuberger said that the Biden Administration plans to release a rule requiring hospitals to meet minimum cybersecurity standards in response to the Change Healthcare cyberattack in February, according to a Bloomberg News article republished on govtech.com.  She also said the administration plans to provide free training to small, rural hospitals who may have trouble meeting the standards.

Will the industry go along? We will be watching how stakeholders in the health care industry react to the news. An article published in the Record notes that Ms. Neuberger has argued that the industry has been asked to address cybersecurity concerns for more than a decade. But these arguments might be a moot point if the industry can find enough sympathy from members of Congress who have not been shy when it comes to pushing back on the administration’s rulemaking authority.

New DOJ Health Care Task Force Joins the Anti-Trust Parade

The Department of Justice (DOJ) Antitrust Division announced a new task force dedicated to addressing concerns about anti-competitive behavior in health care markets.  DOJ is also working with the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) to extend the comment period for an investigation into how corporate ownership affects health care.

One big question: Will this task force impact voters’ perceptions of Biden’s handling of the economy? As this task force gets going, we know President Biden must be aware of polls such as this one from Gallup that shows him fairing the worst of any president on the question of economic management since 2001. We expect the President to continue to tout his efforts to increase competition and break up trusts – including in health care. But will it be enough to capture the support of November voters?

Bird Flu on the Brain

HHS announced several actions it is taking actions to respond to a recent outbreak of the avian flu (H591) along with the U.S. Department of Agriculture (USDA). The actions announced by HHS to address the avian flu threat do not come cheap. According to the agency, the CDC and FDA investments announced on May 10  will cost more than $100 million.

What we will be watching for: Politico reported on discussions between FDA Commissioner Califf and Ranking Member Hoeven (R-ND) regarding a potential avian flu supplemental funding request.  If such a request comes, how will the President handle negotiations with a Republican House that has been skeptical of spending requests and public health proposals from this administration?

The Senate

Schumer Provides Update on AI Legislation 

When asked about the specific timelines for AI legislation, Senate Majority Leader Chuck Schumer (D-NY) shared at a recent event that the committees are all over the map:
•    Homeland Security, Commerce, and Rules committees are “pretty well along on this.”
•    The Senate committees with jurisdiction over health care and education as being “a little further back.”
He said the hope is to have legislation start to come out “within a few weeks throughout the summer and fall.”

Senate Health Hearings

The big hearing this week on health is at Senate Finance Committee entitled “Rural Health Care: Supporting Lives and Improving Communities on May 16.  Both the House and Senate committees have been working behind the scenes and with the administration on rural health policy, and this hearing will set the stage for further legislating this summer. Other hearings include:
•    May 15: Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies hearing entitled “A Review of the President’s Fiscal Year 2025 Budget Request for Indian Country.
•    May 15: Senate Veterans Affairs’ Committee hearing entitled “Frontier Health Care: Ensuring Veterans’ Access No Matter Where They Live.”
•    May 15: Senate Homeland Security and Government Affairs hearing to markup legislation, including S.4035, the FEHB Protection Act, which would direct the Director of the Office of Personnel Management to take certain steps to address concerns about improper enrollment in the health insurance program for federal employees.
•    May 16: Senate HELP Committee hearing entitled “Examining the Dental Care Crisis in America: How Can We Make Dental Care More Affordable and More Available?”

The House

Ways and Means Continues to Work on Rural  

House Ways and Means Committee took the first bite on a rural health package with the markup of telehealth and rural health legislation.  Telehealth was the only bill with a bipartisan vote, even though both Democrats and Republicans support improvements to rural health care.  Not to be outdone, House Energy and Commerce may be marking up telehealth legislation this week. Both the House and Senate would like to advance rural health legislation ahead of the August district work periods where they can tout legislative accomplishments to their constituents.
 
Becerra in the Hot Seat….Again 

HHS Secretary Xavier Becerra is once again returning to his old stomping grounds in the House when he testifies at a May 15 hearing at the House Education and Workforce Committee.   Other House health-related hearings include:
•    May 13: House Veterans’ Affairs Health Subcommittee field hearing entitled “Iowa: A Leader in Veteran Healthcare Innovation.”
•    May 16: House Oversight & Accountability Select Subcommittee on the Coronavirus Pandemic hearing entitled “Overseeing the Overseers: A Hearing with NIH Deputy Director Lawrence Tabak.” 

There You Have It

It’s going to be a busy one!  We want to join with those who have come to D.C. to honor our law enforcement officers for National Police Week and Peace Officers Memorial Day on May 15. Be sure to thank a police officer this week for what they do to keep our families and communities safe.

Here’s to a great week ahead – let us know your questions and feedback!

The Horses Are Not the Only Ones Racing

Over the weekend, fans of horse racing enjoyed an exciting Kentucky Derby that ended with a narrow win for Mystik Dan! As Congress returns, members are already lining up for their own race to the Memorial Day recess and looking ahead to the big race of the 2024 elections. Welcome to the Week Ahead!

The Administration

Medicare Drug Negotiation: Round 2

The Centers for Medicare and Medicaid Services (CMS) published a notice alerting the public about an opportunity to comment on the agency’s draft guidance for the 2nd round of Medicare price negotiations as authorized by the Inflation Reduction Act (IRA). This round of negotiations will add another 15 drugs to the 10 drugs currently moving through the negotiation process. These 15 drugs are scheduled to be announced by February 1, 2025, and any negotiated prices will be effective by 2027.

There are some potential roadblocks in the way even as the Biden Administration is moving confidently along with implementing the IRA, including:

•    Legal challenges: Pharmaceutical companies and trade associations have brought several lawsuits to stop the negotiations, claiming that the action is unconstitutional and leaves drug manufacturers with little bargaining power because they either have to accept the government’s price or choose not to participate in the Medicare program.
•    A 2nd Trump Administration: It’s not clear that Trump’s return to the White House would spell the death of Medicare price negotiations. After all, during his first administration, Trump signed an executive order to direct Medicare to pay no more than the lowest price at which the drug is sold in any other developed nation. However, a 2nd Trump Administration would face tremendous pressure from congressional Republicans to end the program.

The Senate

Health Care Stowaway on FAA Bill

This week, the Senate is scheduled to resume consideration of H.R.3935, a bill to reauthorize the Federal Aviation Administration (FAA) through FY2028. Obviously, this is not a health care bill, but a little bit of what might be considered health care policy managed to sneak aboard the bill before it passed the House. Specifically, the bill bans the FAA from imposing mask or COVID-19 vaccine mandates on passengers, air carrier employees, or FAA employees. Not too long ago, such a provision would have probably caused a bit more of an uproar among Democratic members of Congress. But it appears Captain Schumer is planning for clear skies ahead.

FDA Chief to Defend Budget

Food and Drug Administration (FDA) head Dr. Robert Califf, is scheduled to testify before the Senate Appropriations Ag-FDA Subcommittee on May 8. Although the hearing is about the President’s FY25 budget request, we will also be listening to other topics related to the FDA, such as the recently finalized rule that gives the FDA the authority to regulate lab-developed tests or the delayed rule to ban menthol-flavored cigarettes

Also on Our Radar

•    The Senate Budget Committee will hold a hearing on Administrative Burdens in Health Care on May 8.
•    The Senate Armed Services Subcommittee on Personnel will hold a hearing on May 8 where Assistant Secretary of Defense for Health Affairs Lester Martinez-Lopez will be testifying.

The House

To Legislate or Motion to Vacate?  

The House has a full agenda on the floor but the question is, will House Republican leadership be able to keep things on track, or will they be derailed by Rep. Marjorie Taylor Greene’s (R-GA) motion to vacate against House Speaker Mike Johnson (R-LA)?

The good news for the Speaker: House Democratic leadership has announced they will table Rep. Greene’s motion to vacate the Chair. So, he is probably safe. For now.

The bad news for the Speaker: If Rep. Greene or someone else brings up another motion to vacate, will House Democrats step up again, and if so, what will they ask for in return?

Ways and Means Makes a Way on Health Care

Last week, we saw a lot of health care action from the House Energy and Commerce Committee with subcommittee hearings on Medicaid and the Change Healthcare cyberattack. Not to be outdone, the House Ways and Means Committee is expected to hold a full committee markup this week to consider legislation to extend telehealth flexibilities initiated during the COVID-19 public health emergency, along with some additional reforms and flexibilities.

So what? The markup on telehealth legislation will be the first time this year that a committee has marked up legislation to extend the telehealth flexibilities granted during the COVID-19 pandemic.

Other Health Care Hearings in the House  

Just in case you thought Ways and Means was going to have all the fun this week, here are some other health care hearings we are tracking in the House this week:

•    May 8: House Small Business Committee hearing on regulatory burdens on small businesses in healthcare
•    May 8: House Homeland Security Subcommittee on Counterterrorism, Law Enforcement, and Intelligence hearing on foreign anomalous health incidents
•    May 8: House Natural Resources Indian and Insular Affairs Subcommittee hearing on the FY25 Budget Request for the Bureau of Indian Affairs, Indian Health Service, and Office of Insular Affairs

There You Have It

Did you watch the big race? If so, did you get dressed up? If you didn’t watch, how did you spend your Saturday? Reach out and let us know. Here’s to a great week!

Week Ahead: Congress Comes Back to Approps Season

Unseasonably cool weather in Washington last week left us feeling less than springy. However, we did see a thawing of relations between Republicans and Democrats on a foreign aid package. Additionally, the endorsement of Speaker Mike Johnson (R-LA) by former President Trump likely brings some feelings of rejuvenation to the embattled Speaker. The forecast this week calls for a return of Congress, a response to the Biden administration’s nursing home staffing mandate, and a possible rule on lab-developed tests (LDTs). Welcome to the Week Ahead!

The Administration

While Congress was out of session, the Administration dispatched several highly-anticipated final rules, including the nursing home staffing ratio rule, the Medicaid managed care rule, the Medicaid access rule, and an FTC ban on non-compete agreements, among others.

Banning menthol in cigarettes did not get finalized.  On April 26, Health and Human Services (HHS) Secretary Xavier Becerra acknowledged the need for more time, likely in part due to concerns that the rule would lead to increased law enforcement activity in minority communities.

4-1-1 on LDTs:  Despite all the regulatory activity, we are still waiting on a proposed rule granting the Food and Drug Administration (FDA) explicit authority to regulate LDTs. We expect that rule any day now.

The Senate

UnitedHealth Group CEO Comes to Town

United Healthcare Group CEO Andrew Witty testifies before Congress about the Change Healthcare cyberattack. His first stop will be a Senate Finance Committee hearing.

Some things we will be watching: 
•    Will GOP members use the hearing to criticize the Biden Administration’s response to the cyberattack, or will they focus their attention on UnitedHealth Group’s response?
•    Will any members discuss or propose legislative action to address broader concerns about cybersecurity? In particular, we will be watching to see if Sen. Mark Warner (D-VA) uses the hearing to advocate for legislation he introduced earlier this year that would tie federal payments to health care providers after a cyberattack to the adoption of cybersecurity standards.
•    How will Mr. Witty respond to allegations that United Healthcare has not done enough to help providers in the wake of the attack?

Other Notable Senate Hearings

  • April 30: Senate Armed Services Subcommittee on Personnel hearing on access to pharmaceuticals
  • May 2: Senate HELP Committee hearing on the shortage of minority health care professionals and the maternal health crisis

The House

Movement on Appropriations 

What’s happening: Last week, the House Appropriations Committee released guidance for members on FY 2025 Community Project Funding (earmarks). This comes as the House just finished FY 2024 appropriations only one month ago.

The House Labor, Health and Human Services Appropriations Subcommittee holds its Member Day on April 30.

What it means: The pace is quick: members must submit programmatic and language requests by May 1 and Community Project Funding Requests by May 3. We know how deadlines drive activity in DC!

House Energy and Commerce GOP Looks to Strike Back on Nursing Home Staffing Rule

What’s happening: On April 30, The House Energy and Commerce Health Subcommittee will consider the Protecting America’s Seniors Access to Care Act (H.R. 7513), which would block the implementation of the recently finalized minimum staffing rule during its legislative hearing entitled “Legislative Proposals to Increase Medicaid Access and Improve Program Integrity.”

Some Democrats have crossed the aisle to support this bill. Rep. Jared Golden (D-ME) is one of the bill’s cosponsors, and Rep. Terry Sewell (D-AL) supported the bill’s passage out of Ways and Means. That being said, most Democratic members are supporting the administration’s action. Given the small majority Republicans hold in the House, not to mention the Democratic majority in the Senate and Democratic President, getting this bill across the finish line may be a tall order.

In Other House Committee News 

  • The House Oversight Select Subcommittee on the Coronavirus Pandemic will hold a hearing on May 1 with the president of EcoHealth Alliance. EcoHealth Alliance has been accused by some House GOP members of funding risky gain-of-function research so this hearing will certainly be feisty.
  • After his appearance before the Senate Finance Committee on the morning of May 1, UnitedHealth Group CEO Andrew Witty will be crossing over to the House for an Energy and Commerce Oversight Subcommittee hearing about the Change Healthcare cyberattack.

There You Have It

What are your favorite springtime activities? Did you get to do any spring break traveling this year? Reach out to share and compare. Here’s to a great Week!

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