What Happened, What You Missed: June 12-16, 2023  

Health Spending to Make Up One-Fifth of US Economy 

National health expenditures will comprise 20% of the US economy, or $7.1 trillion, by 2031, according to the latest projections from the Centers for Medicare and Medicaid Services (CMS).  While health care spending actually grew at a slower rate than the national gross domestic product (GDP) in 2021 and 2022, the latest figures project that health care spending will once again outpace GDP growth starting this year, due to the aging population and people seeking medical services that were delayed during the pandemic.  CMS also found that the insured portion of the population reached a historic high of 92% in 2022, although that portion is expected to drop to 90.5% by 2031 due to people losing Medicaid coverage as the redetermination process resumes.   

Biden Administration Reaches Deal to Preserve Preventative Services Coverage 

The Biden administration finalized a deal with the 5th US Circuit Court of Appeals to preserve the federal mandate for health insurers to fully cover preventative care services like HIV prevention drugs and cancer screening.   The agreement thus keeps in place the Affordable Care Act’s (ACA) preventative services coverage mandate while a lawsuit that challenges the mandate proceeds.  Of note, the agreement allows the plaintiff in the case, Brainwood Management, to stop covering preventative services without co-payments for its employees.  Brainwood and other plaintiffs are challenging the mandate because they believe it challenges their religious beliefs by supporting homosexuality and drug use.  The Biden administration will continue to appeal the lawsuit. 

Sanders Blocks Bertagnolli’s Nomination over Drug Pricing 

Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) says he’ll oppose National Cancer Institute (NCI) Director Dr. Monica Bertagnolli’s nomination to lead the National Institutes of Health (NIH) until the Biden administration issues a plan to lower prescription drug prices.  Sanders’ support is critical for Bertangnolli’s nomination to move forward, as he chairs the Senate panel responsible for confirming the nomination.  In a statement, the White House pointed to the drug pricing provisions of the Inflation Reduction Act as a sign that the administration shares Sanders’ dedication to lowering drug costs without committing to releasing further plans.  Meanwhile, organizations in the medical research community are urging Sanders and other key Senate Democrats to quickly confirm Bertagnolli to ensure the nation does not lose momentum on scientific research. 

FDA Advisers Recommend Monovalent COVID-19 Boosters for Fall 

Members of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously on Thursday to recommend that the 2023-2024 formula of the COVID-19 vaccines be updated to a monovalent XBB Omicron subvariant.  According to the Centers for Disease Control and Prevention, XXB is responsible for nearly all COVID-19 cases in the US.  The decision to go with a monovalent vaccine is a departure from the bivalent vaccines that included both the original strain of COVID-19 and the Omicron variant.  The FDA advisers also opted to roll out the boosters in the fall to align with the availability of annual flu shots, despite a noted lack of certainty on the degree to which COVID-19 is seasonal.   

ICYMI: Senators Celebrate Seeksucker Day 

The Senate celebrated Seersucker Day last week as it has for years, with various senators and their staff donning seersucker suits.  Senators took the occasion to the next level this year by approving a resolution from Sen. Bill Cassidy (R-LA) to make June 7 National Seeksucker Day, the month of June as National Seersucker Month, and every Thursday in June through August as Seersucker Thursday.  Then-Sen. Trett Lott (R-MO) first introduced Seeksucker Day in 1996, and since Lott’s retirement, Cassidy has served as the “coordinator” of Seersucker Day. 

What Happened, What You Missed: April 10-14, 2023 

CMS Proposes 2.8% Bump for Hospital Inpatient Reimbursement 

Eligible hospitals could see a 2.8% increase in Fiscal Year (FY) 2024, according to the recently proposed Inpatient Prospective Payment Systems (IPPS) rule.  Other provisions of the rule would allow graduate medical education (GME) payments for training in rural emergency hospitals, boost reimbursements for hospitals treating unhoused patients, and lower payments for hospitals with excess readmissions and hospital-acquired conditions.  Provider organizations have so far been critical of the proposed rule.  The American Hospital Association (AHA) called the reimbursement increase “inadequate” due to the continued impact of inflation on hospitals, while the Federation of American Hospitals (FAH) said the rule could cause rural hospitals to pull back on some services.   

White House Launches Successor to Operation Warp Speed 

A new Biden administration initiative called “Project Next Gen” aims to accelerate the development of new COVID-19 vaccines and treatments.  The $5 billion program is essentially a continuation of Operation Warp Speed, a Trump administration initiative that resulted in the development of the first successful vaccines and treatments.  Among the areas Project Next Gen will focus on include the creation of long-lasting monoclonal antibody treatments, vaccines that deliver mucosal immunity, and a pan-coronavirus vaccine.  To fund the new agency, the administration shifted around funding that was initially earmarked for COVID-19 tests and other priorities.   

Juul to Pay $462 Million in Settlement over Youth Marketing 

Electronic cigarette manufacturer Juul Labs has agreed to pay $462 million to six states to settle claims that the company illegally marketed its products to young people, particularly through social media.  Attorneys general in those states argued that Juul executives were aware that their initial marketing persuaded adolescent users into its vaping pens but did little to address the problem as teenage use of e-cigarettes grew considerably. As part of the settlement, Juul will stop using people under the age of 35 in promotional materials, restrict the number of purchases consumers can make, and limit free or discounted promotions.   

CDC: STIs Hit Record-High in 2021 

Sexually transmitted infections (STIs) rose to their highest level in 2021 and show no signs of slowing down, according to data released by the Centers for Disease Control and Prevention (CDC).  Over 2.5 million cases of STIs were reported that year, with more than half of all cases attributed to chlamydia.  Of note, Syphilis spiked 32% in one year, while Gonorrhea increased by nearly 5%.  The data also showed a concerning jump in infections passed from pregnant moms to infants developing in the womb.  While the CDC said there are multiple causes behind the surge in STIs, pandemic-related delays in screening are one likely culprit.  To address the rise in STIs, the CDC is calling for increased access to public health services and more research into vaccines and post-exposure treatments.   

Senators in Key Battleground States Announce Bids for Reelection 

This week, Sens. Bob Casey (D-PA) and Tammy Baldwin (D-WI) separately announced that they will be seeking reelection next year.  Their announcements are a positive development for Senate Democrats, who will be relying on incumbents in battleground states to maintain their narrow majority in the Senate in what’s expected to be a difficult election cycle.  While no Republicans have announced a bid for Baldwin’s Senate seat, Rep. Mike Gallagher (R-WI) left the door open for a possible run in a recent interview.   In Pennsylvania, hedge fund CEO Dave McCormick and former Republican gubernatorial candidate Doug Mastriano are viewed as possible GOP challengers to Casey in 2024.   

ICYMI: Irish President’s Dog Ignores Biden in President Visit 

President and dog-lover Joe Biden got the cold shoulder from Irish President Michael Higgins’ dog Misneach when the commander in chief tried to beckon him.  Instead, the Bernese Mountain dog barked at the president, causing members of the press pool to chuckle.  The encounter occurred at the Áras an Uachtaráin, the official residence of the president of Ireland, where Biden inspected a military honor guard, planted an oak tree, and rang the Bell of Peace. 

What Happened, What You Missed: January 9-13

Number of ACA Marketplace Enrollees Reaches Record High 

A record-breaking 15.9 million people have enrolled for insurance coverage on the Affordable Care Act (ACA) marketplace through January 7, according to an announcement from the Centers for Medicare and Medicaid Services (CMS).  The new enrollment totals represent a 13% increase from the previous year.  In a press release, Health and Human Services (HHS) Secretary Xavier Becerra credited incentives in the Inflation Reduction Act (IRA) that expanded access to health care by lowering plan costs and offering more plan options for the enrollment boost.  The deadline to enroll in a plan on HealthCare.gov is January 15, although the deadline goes beyond Sunday in some states. 

Rep. Jason Smith Tapped to Chair Ways and Means 

Rep. Jason Smith (R-MO) prevailed over Reps. Adrian Smith (R-NE) and Vern Buchanan (R-FL) in his bid to chair the House Ways and Means Committee.  The committee’s jurisdiction over Medicaid and Medicare will give the Missouri congressman greater potential to affect health care policy.  Several factors helped Smith edge out his competitors, including his fundraising prowess and close relationship with Speaker Kevin McCarthy (R-CA). Known for his populist image, Smith has vowed to focus on rural health, telehealth, innovation, and price transparency.  He has also stated an interest in holding hearings to examine high health care costs.   

Medicaid Expansion Cause Post-Birth Hospitalizations to Decrease 

Medicaid expansion resulted in a 17% decline in postpartum hospitalizations in states that opted to expand the program, according to a new study from Health Affairs.  According to the data, the largest decrease in hospitalizations occurred during the first 60 days postpartum and a smaller decline in hospitalizations were observed for the period between 61 day and six months postpartum. Under the Consolidated Appropriations Act of 2023, the 12-month extended Medicaid postpartum coverage option has been made permanent. This has enabled 26 states and territories to expand Medicaid coverage for beneficiaries for up to one year postpartum. The results of the study are good news for the Biden administration, which is actively trying to improve maternal health. 

AHCA: 85% of Nursing Homes Face Staff Shortages 

Over eight in 10 nursing homes in the US are experiencing moderate to severe staffing shortages, according to a survey from the American Health Care Association (AHCA).  The survey also found that 96% of nursing homes are struggling to bring on additional staff.  Additionally, more than 60% of nursing homes said they’re worried about having to shut down due to the shortages.  To draw attention to the crisis, the ACHA launched a nationwide campaign to address staffing shortages that will help educate job seekers about opportunities in long-term care and help nursing homes recruit new employees. 

Porter, Lee Announce Bids for Senate 

Earlier this week, Reps. Katie Porter (D-CA) and Barbara Lee (D-CA) launched their campaigns for a Senate seat currently held by Sen. Dianne Feinstein (D-CA).  While the 89-year-old Feinstein filed paperwork in 2021 to run for re-election in 2024, the California senator has yet to publicly announce her bid for reelection.  Rep. Adam Schiff (D-CA) has also expressed an interest in running, although he has yet to make a formal announcement on his decision.  The likelihood of at least three House members seeking to represent California in the Senate will likely mean three competitive House races in the heavily Democratic San Francisco Bay Area and Los Angeles metropolitan area.   

ICYMI: Smoking Once Again Allowed in House Office Buildings 

House members are now allowed to use combustible tobacco products in their offices, according to new rules posted by the Speaker Pro Tempore on Tuesday.  While smoking is prohibited in nearly all office buildings in Washington, DC, the Capitol Complex is exempt from local rules.  However, smoking still remains off-limits on the House floor.  Since the rules were published earlier this week, noted cigar aficionado and new House Rules Committee Chairman Tom Cole (R-OK) has already been spotted smoking a cigar. 

What Happened, What You Missed: October 31-November 4 

CMS Finalizes Physician Fee Cuts for 2023 

Doctors face a nearly 4.5% payment cut from Medicare under the 2023 Physician Fee Schedule, which was finalized on Tuesday.  The final rule prompted strong criticism from provider organizations like the American Medical Association (AMA), who said the cuts “threaten patient access” to physicians who participate in Medicare.  The final rule will put pressure on Congress to enact legislation to counter the cuts in the coming months.  In addition to the payment cuts, the final rule will expand access to behavioral health care by allowing therapists to offer services under general supervision of a Medicare practitioner.  The rule will also allow Medicare to pay for opioid treatment programs that use telehealth to initiate medication-assisted treatment (MAT). 

Warner Lays Out Policy Options to Improve Health Care Cybersecurity 

Cyberattacks on the health sector affected 45 million Americans in 2021, according to a new report from Sen. Mark Warner (D-VA), who co-founded the Senate Cybersecurity Caucus.  To address the growing vulnerability of the health care sector, Warner offered several policy proposals, such as setting minimum security standards for health care providers, adding Medicare reimbursements for cybersecurity expenses, and creating a national stockpile with common equipment needed by hospitals facing cyberattacks.  The report is intended to solicit feedback from health care stakeholders on the proposed policy options.   

HHS Renews PHE for Monkeypox Outbreak 

Although new monkeypox case numbers continue to drop nationwide, Health and Human Services (HHS) Secretary Xavier Becerra renewed the monkeypox public health emergency (PHE) on Wednesday, which was initially declared on August 4th,  to ensure the continuation of vaccine effectiveness studies and to maintain data-sharing with states and jurisdictions.  Monkeypox case numbers peaked in early August and have since declined to about 30 new cases per day.  Over 28,000 monkeypox cases and six related deaths have been confirmed in the US since the outbreak began in the summer.  Public health experts say the drop in cases can be attributed to changes in behavior, particularly among men who have sex with men, a demographic that has been disproportionately affected by the outbreak. 

BPC Offers Ways to Make Employer-Sponsored Insurance More Affordable 

High unit prices for individual health care services and products are contributing to the rising cost of employer-sponsored health insurance, according to a report released this week from the Bipartisan Policy Center.  To ensure the viability of employer-sponsored insurance, which is the largest source of health care coverage in the US, the report calls on Congress to develop new legislation to spur use of biosimilars and to lower the threshold of what the Affordable Care Act (ACA) deems “affordable” for employer-sponsored plans.  The report also emphasized the need to create a mandatory federal all-payer health care claims database and full electronic access to health plan data for all employees to increase transparency.  

Pfizer’s RSV Vaccine Trial Shows Promise 

Pfizer announced this week that its vaccine candidate for respiratory syncytial virus (RSV) is 80% effective at preventing severe disease in infants.  The announcement comes as the US faces an unusual spike in RSV cases, likely due to delayed immunity to the virus since the start of the COVID-19 pandemic.  Unlike other RSV vaccine candidates, Pfizer’s is administered during pregnancy to allow antibodies to be transferred from mother to infant.  Pfizer said that it plans to submit data to the Food and Drug Administration (FDA) on the vaccine by the end of the year, with the hope of having it available by next winter.  If approved, Pfizer’s vaccine will be the first against RSV and the first new product related to the virus in over 20 years. 

ICYMI: Calls for Ouster of Architect of the Capitol Grow 

A growing chorus of lawmakers are calling on the Architect of the Capitol (AOC) J. Brett Blanton to step down after an AOC Office of the Inspector General (OIG) report found that Blanton had abused his power.  Released on Tuesday, the report found that Blanton had regularly used his official vehicles for personal purposes and even impersonated a police officer.  However, ousting Blanton could be difficult, as the AOC serves a 10-year term, and there is no explicitly described process for removing the AOC.  Then-President Donald Trump appointed Blanton to the post in December 2019. 

What Happened, What You Missed: September 26-30

Medicare Part B Premiums to Decrease Next Year 

Medicare beneficiaries will see lower Part B premiums in 2023, according to an announcement from the Centers for Medicare and Medicaid Services (CMS) on September 27. The upcoming premium drop follows a spike in 2022 premiums that was largely driven by the high projected cost of the new Alzheimer’s drug Aduhelm.  However, CMS was able to lower its estimates for 2023 after the cost of Aduhelm fell, paving the way for the agency to lower its Part B premiums for next year.  Lower-than-expecting spending on Part B services also factored into the agency’s decision to lower 2023 premiums.  CMS also announced earlier this week that Part A premiums will rise to $7 in 2023.  On Thursday, CMS also announced lower premiums for Medicare Advantage and Part D prescription drug plans in 2023.  

Pfizer Applies for EUA for Omicron Booster for Children Ages 5-11 

On Monday, Pfizer applied for an emergency use authorization (EUA) to the Food and Drug Administration (FDA) for its Omicron-targeted bivalent COVID-19 booster for children ages five to eleven years old.  The submission comes a week after Moderna filed an EUA application with the FDA for its own bivalent booster for children ages six to seventeen.  In a document released on September 20, the Centers for Disease Control and Prevention (CDC) said it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in children and adolescents, pending authorization by the FDA.  While human data on the efficacy of the new COVID-19 boosters won’t be available for another month or two, FDA and CDC officials are confident that the updated boosters offer better protection against infections and disease in the coming months. 

Experimental Alzheimer’s Drug Shows Promise 

Pharmaceutical companies Biogen and Esai announced on Tuesday that their experimental Alzheimer’s disease treatment slowed the rate of cognitive decline by 27% in a clinical trial.  The announcement increases the likelihood that the FDA could approve the drug as early as January 2023.  The clinical trial data also renews hope in the potential for anti-amyloid drugs, which work by clearing the buildup of amyloid proteins which are linked to development of Alzheimer’s disease.   The FDA greenlit Biogen’s first anti-amyloid drug known as Aduhelm last year, despite the little evidence demonstrating the drug’s efficacy.  According to both companies, the new drug began to show a benefit to patients about six months after they began taking it in clinical trial consisted of 1,800 participants with mild cognitive impairment or mild Alzheimer’s disease. 

White House Proposes Medicare-Covered Meals to End Hunger  

On Tuesday, President Joe Biden proposed Medicare coverage for medically tailored meals as a part of an overarching plan to end hunger that includes updates to nutrition labels and an expansion of food security programs.  The president also called for expanded access to nutrition and obesity counseling for people on Medicare and Medicaid as well as making the Medicare Diabetes Prevention Program a Medicare preventive services benefit.  However, many of the president’s proposals have an uncertain future, as most ideas would require the support of a polarized Congress.  

House to Vote on Stopgap Spending Bill Today 

The Senate voted 72-25 yesterday afternoon to approve a continuing resolution (CR) to keep the federal government open through December 16, setting the stage for the House to vote on the CR sometime today.  The CR notably includes a five-year extension of FDA user fee programs that lacks policy riders that were initially a part of previous user fee extension proposals.  Additionally, the CR includes disaster relief funding for Alaska, Florida, and Puerto Rico, as well as billions of dollars in aid to Ukraine.  Following today’s vote, lawmakers will return to the campaign trail for the 2022 midterm election.  While the House isn’t scheduled to return until after the election in November, the Senate will be reconvening in mid-October. 

ICYMI: Pop Star Performs with James Madison’s Flute 

At a concert in Washington, DC earlier this week, pop artist Lizzo performed with a crystal flute that once belonged to President James Madison. This was the first time the instrument had been played in over 200 years.  The flute was a part of a collection at the Library of Congress, which is allegedly the largest flute collection in the world.  A French flute designer originally gifted the fourth president the instrument in 1813 to commemorate Madison’s second inauguration.  Lizzo began training as a classical flutist at the age of 10 and had studied the instrument in college. 

Implicit Bias Is CMMI’s Latest Problem to Tackle

Advancing health equity is one of the five strategic objectives the CMS Innovation Center (CMMI) outlined in its Strategy Refresh back in November 2021.  It’s no surprise that health equity is becoming an increasingly important goal at CMMI as the Biden administration has made health equity a major priority since day one

However, CMMI has its work cut out for itself.  According to a July 2022 report, implicit bias is pervasive in at least three payment models, which signals challenges if CMMI is serious about advancing equity. 

Implicit bias is an involuntary bias that a person is unaware of.  Often times, negative attitudes and stereotypes can play a powerful role in shaping implicit bias, or “unconscious prejudice.”  Two top CMMI officials authored the report on implicit bias to analyze how implicit bias may be impacting beneficiary groups in payment models. 

In its analysis, CMMI only reviewed three models: the Comprehensive Care for Joint Replacement (CJR) Model, Kidney Care Choices (KCC) Model, and Million Hearts® Cardiovascular Risk Reduction Model.  CMMI selected these models because they represent a microcosm of CMMI models that vary by mandatory/voluntary status, financial methodology, and risk stratification. 

Overall, the report found that use of certain risk-assessment and screening tools, provider tools, and payment design and risk-adjustment algorithms has led to the exclusion of some beneficiaries from these models.  Here are some key findings:

  • The CJR Model tests bundled payment plans for participating providers that perform knee and hip replacements.  The report found beneficiaries receiving joint replacements were “less medically complex” than those receiving joint replacements at the same hospitals before model participation began.  The report also found that beneficiaries in the model are less likely to be dual-eligible, which indicates a lower socio-economic status.  It is also worth noting that Black Americans are likely to receive knee and hip replacements than White Americans. 
  • The KCC Model encourages nephrologists, dialysis facilities, and end-stage renal disease (ESRD) practices to focus on the total care of their patients and incentivizes kidney transplants for chronic kidney disease beneficiaries.  The analysis found that the model’s medical eligibility criteria may have inadvertently excluded Black American beneficiaries, despite the fact that Black Americans are over three times more likely to have ESRD. 
  • The Million Hearts Model provides financial incentives for practices to lower 10-year cardiovascular disease risk for the 30% of high-risk Medicare beneficiaries.  The evaluation found that despite being developed specifically for Black and White populations, the risk calculator used to predict risk scores underestimated risk among patients in other racial and ethnic groups that do not identify as White or Black as well as patients in lower-income households.   

CMMI acknowledged that its findings are “troubling” and underscore a need for a “more systematic evaluation of implicit bias in current and new models.”  As a next step, CMMI says it is working on a “step-by-step guide” to detect and address bias in current models and prevent bias from forming in future one.

While it’s encouraging to see CMMI has a plan to address implicit bias, the revelation that unconscious prejudice is prevalent in three key payment models only adds to the list of challenges CMMI needs to address.  According to an August 2021 report, only a handful of CMMI’s 40-plus models have met the center’s statutorily required goal of reducing costs or improving quality.  In addition to the Biden administration’s emphasis on health equity, the report’s findings likely catalyzed CMMI to lay out its strategic refresh in November 2021, which makes reducing costs and improving quality its “overarching goal.”  On top of CMMI’s difficultly of meeting its statutory obligations, the center now faces the challenge of addressing implicit bias, which may also be prevalent in additional payment models.

All in all, CMMI’s issues with reigning in costs, boosting quality, and stopping implicit bias could signal larger structural problems within the center.  Of note, CMMI’s problems are not lost on lawmakers, in May 2022, Sen. Cory Booker (D-NJ) and Rep. Terri Sewell (D-AL) introduced bicameral legislation to require the center to work with experts on health equity when developing and reviewing payment models.  

At least CMMI has acknowledged its challenges and is laying out plans to address them, including its strategic refresh and a forthcoming “step-by-step guide” on tackling implicit bias.  However, CMMI won’t be able to solve its problems overnight, and the center has a long way to go if it not only wants to achieve its statutory goals of bringing down costs and enhancing quality, but also take on new priorities like improving health equity.

What Happened, What You Missed: May 9-13

States Regain Authority to Pay for Home Health Aides’ Insurance 

State Medicaid agencies can once again directly pay for independent home health aides’ benefits, according to a final rule the Centers for Medicare and Medicaid Services (CMS) issued Thursday.  The final rule overturns a 2019 rule that required states to pay the full Medicaid rate to home health aides, which made health coverage and other benefits more costly and created administrative barriers to enrollment.  Under the new rule, state Medicaid agencies can now allow home health aides not working with an agency to have employee benefit premiums and union dues deducted from their paychecks.  According to CMS, boosting benefits for home health workers can help address the industry’s workforce shortage.

FDA Open to Moving Up Meeting Dates on Vaccines for Young Kids

A top Food and Drug Administration (FDA) official told members of the Select Subcommittee on the Coronavirus Crisis during a May 9 briefing that the agency will move up an advisory panel’s meeting dates on vaccines for children under 6 if the FDA finishes reviewing vaccine data sooner than expected.  The briefing was convened after reports emerged that the FDA was delaying its review of COVID-19 vaccines for young kids until both Pfizer and Moderna had submitted clinical trial data.  Additionally, the subcommittee was informed that the FDA would not withhold authorization for a pediatric vaccine solely because it did not reach a 50% efficacy threshold at blocking symptomatic infection, which was previously required for COVID-19 vaccines.  FDA advisory panel meetings on vaccines for young kids are currently scheduled for June 2022.

Administration Officials Still Tight-Lipped on End of PHE

The Biden administration on Tuesday sent a letter to state governors to urge them to make preparations for the end of the COVID-19 public health emergency (PHE).  However, the administration declined to give any indication as to when it will let the PHE expire, although the letter did reiterate the administration’s commitment to provide states 60 days’ notice before pulling the plug on the PHE.  The PHE is currently set to end of July 16, which means the administration would have to communicate that it will let the current PHE end no later than Tuesday, May 17.  Numerous policies tied to the PHE are immensely important to the states, including Medicaid redetermination and telehealth waivers. 

Reed Officially Resigns from Congress, Takes Job with Lobbying Firm

Rep. Tom Reed (R-NY) officially resigned from Congress on Tuesday, and he will soon start a new role at Prime Policy Group, a government relations firm.  Reed announced in 2021 that he would not seek an additional term following allegations of sexual misconduct.  In a final floor speech, Reed decried “the current focus on extremism” in politics, and he called for “petty political posturing to end.”  Reed was the top Republican on the Social Security Subcommittee of the powerful House Ways and Means Committee, and Rep. David Schweikert (R-AZ) is likely to replace Reed as the subcommittee’s top Republican.  Reed’s resignation will trigger two special elections this year to determine who will succeed Reed in representing New York’s Southern Tier region in Congress.

ICYMI: Paris Hilton Returns to Washington

This week, media personality and businesswoman Paris Hilton was spotted on Capitol Hill and in the White House, where she advocated for legislation to improve the oversight of youth treatment facilities.  Hilton endured psychological abuse at one such facility as a child, and in October 2021, she shared her experiences while testifying before a Utah State Senate panel.  In April, Hilton’s media company began working with a lobbying firm to advance legislation to regulate congregate care facilities for teens.

Tracking CMMI’s Shift to Health Equity

Health equity is the latest focus of the Center for Medicare and Medicaid Innovation (CMMI), which was launched a decade ago to develop and test health care payment models with the goal of saving money for Medicare.  This push for health equity goes back to the very beginning of the Biden administration when he first issued an executive order (EO) on advancing health equity in January 2021.  What steps has CMMI taken to push for health equity since then, and how will CMMI pull it off?

CMMI’s shift to health equity kicked off in October 2021, when the center released a white paper announcing a “strategic refresh” that would judge the success of its models not just on whether they save money but also whether they improve health equity.  Of note, the white paper found that only six models of the more than 50 models CMMI currently has generated substantial savings for Medicare.

CMMI followed-up this strategic refresh in February 2022 when it launched the Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model.  A key feature of the ACO REACH model is a requirement for model participants to develop a health equity plan that identifies underserved communities and outlines initiatives to reduce health disparities within their beneficiary populations. 

The ACO REACH Model won’t be the last CMMI model to make health equity a cornerstone.  In March 2022, CMMI Director Liz Fowler said creating a health equity plan will  likely be a requirement for future innovation center models.

CMMI took another bold step on health equity in March 2022 when Chief Medical Officer Dora Lynn Hughes announced in a Health Affairs blog post that the innovation center has added “Advancing Health Equity” as one its five strategic objectives.  In the blog post, Hughes outlines ways CMMI intends to achieve this new objective:

  • Developing new models and updating existing models to promote and incentivize health equity, as demonstrated by the ACO REACH Model.
  • Increasing the participation of safety net providers to ensure models reach underserved communities.
  • Increasing collection and analysis of equity data, primarily by coordinating with other offices in the Department of Health and Human Services (HHS).
  • Monitoring and evaluating models for health equity impact by analyzing beneficiary experience and equity assessments.

Can CMMI pull off its health equity goals?  After all, only a fraction of the center’s 50 models achieved the goal of saving Medicare money, which makes the center’s capability to tack on and carry out another goal seem overly ambitious.

Fortunately, CMMI has a plan.  In her blog post, Hughes stated that the center will have to collaborate with offices and agencies across HHS, particularly those focused on social determinants of health like food, housing, and transportation.  Outside of the government, Hughes said CMMI is already meeting with groups that have not previously engaged with the center, like community-based organizations and patient advocacy groups, and that CMMI is hosting roundtable discussions on health equity to help inform its work. 

On top of this, the Centers for Medicare and Medicaid Services (CMS) is working hard to advance health care interoperability, which CMS Administrator Chiquita Brooks-LaSure said in March 2022 is essential to addressing the “inequities in our health care system.”  Better data collection is one of the four ways CMMI hopes it will achieve its health equity goal, and Brooks-La Sure recently announced that CMS will soon publish a rule on health data exchange.  While CMMI’s success at creating models that reduce Medicare costs may be limited at best, the center has laid out some specific actions it hopes to take to achieve its new goal, increasing the odds this goal can become reality.    

What Happened, What You Missed: January 10-14

CMS Issues Narrow Coverage Determination for New Alzheimer’s Drug

On January 11, the Centers for Medicare and Medicaid Services (CMS) proposed a national coverage determination for Alzheimer’s disease medication Aduhelm that will limit Medicare coverage to patients participating in relevant clinical trials.  The Food and Drug Administration (FDA) approved the Biogen-developed drug last year, despite conflicting data regarding the drug’s efficacy.  Aduhelm attracted significant controversy after Biogen announced a launch price of $56,000, which was later halved due to public outcry.  CMS is holding a 30-day public comment period and will announce its final decision by April 11.

Supreme Court Blocks Vaccine Mandate for Employers, but Not Health Care Providers

On Thursday, the Supreme Court struck down the Occupational Safety and Health Administration (OSHA) mandate for private sector employers to require workers to be vaccinated or regularly tested, on the basis that OSHA lacks the authority to “regulate public health more broadly.”  The high court’s vote to invalidate the vaccine mandate was 6-3, along ideological lines.  However, the Supreme Court did vote to uphold a CMS regulation that requires health care provider that receive money from the federal government to mandate that employees be vaccinated.  According to the majority opinion, CMS was justified to mandate vaccinations because unlike OHSA, the agency has long-standing authority to issue health care mandates.

Sinema Doubles Down on Opposition to Filibuster Reform

Sen. Kyrsten Sinema (D-AZ) strongly expressed her opposition to changing filibuster rules to pass a voting rights bill in an impassioned speech she delivered on the Senate floor yesterday.  While Sinema said she supports the Democrats’ voting rights legislation, she’d prefer to see it advance through more collaboration between Democrats and Republicans.  Sinema’s speech came just before President Joe Biden met with Senate Democrats on Capitol Hill in order to stir up support for voting rights reform.  Both Sinema and her West Virginia Democratic colleague Sen. Joe Manchin’s continued opposition to creating a filibuster carve out for the voting rights bill means Democrats’ hopes of passing the measure are facing an uphill battle and may not get done.   

Johnson Announces Reelection Bid, Perlmutter Announces Retirement

In a Wall Street Journal op-ed, Sen. Ron Johnson (R-WI) announced on January 8 his plans to run for a third term in the Senate, putting an end to months of speculation regarding his plans.  Johnson initially pledged in 2016 to not seek reelection in 2022; however, encouragement from constituents and the nation’s “unsustainable path” caused him to reconsider.  The Senate race in Wisconsin is expected to be close, as President Biden narrowly won the state in 2020.  Later in the week, Rep. Ed Perlmutter (D-CO) announced that he will not be seeking reelection in November.  Representing the north and west suburbs of Denver, Perlmutter served in the Colorado Senate for eight years before his election to Congress in 2006.  In a statement, Perlmutter said he is stepping aside to “explore other opportunities,” but did not specify what those would be. 

ICYMI: Harry Reid Lies In State at US Capitol Building

On Wednesday, former Senate Majority Leader Harry Reid (D-NV) lied in state in the Rotunda at the US Capitol, where President Joe Biden, Vice President Kamala Harris, and dozens of other elected officials paid tribute.   Reid, who worked as a Capitol Police officer while studying law at George Washington University, served for years in the Nevada state government before being elected to the House in 1982 and the Senate in 1986.  Reid’s 30-year Senate career included a decade as Majority Leader, during which he led the Democratic caucus in voting to end the filibuster for most presidential nominations, including federal judges.  Reid retired in 2017 but continued to stay active in the public eye despite his diagnosis of pancreatic cancer in 2018.

What’s Changed for Open Enrollment 2022?

Open enrollment for 2022 kicked off on November 1, and it’s particularly consequential to President Joe Biden, who campaigned on building off the success of the Affordable Care Act (ACA) to expand access to health care coverage.  To deliver on these promises, open enrollment has undergone several key changes to make it more consumer-friendly for 2022. 

  • First off, open enrollment is a month longer than the previous four years.  While open enrollment last year ended on December 15, 2021, for the upcoming plan year, it ends on January 15, 2022.
  • Plan enrollees can also expect record-low prices, thanks to an extension of ACA premium tax credits made possible by the American Rescue Plan.  According to the Biden administration, four out of five people can now find a plan for $10 or less per month.
  • Additionally, 2022 sees a major boost to enrollment assistance.  Plan enrollees for 2022 can now look forward to over 5,000 enrollment assisters and navigators, plus nearly 50,000 brokers and agents.  Notably, the Centers for Medicare and Medicaid Services relaunched a program that engages with local organizations to provide outreach and education.
  • The current open enrollment has a new focus on health equity.  The administration is rolling out new efforts to people who previously lacked access to coverage, and advertising is being conducted in several new languages: Chinese (Mandarin and Cantonese), Korean, Vietnamese, Tagalog, and Hindi.
  • Finally, more Americans than ever will be eligible for open enrollment 2022.  That’s because three states (Kentucky, Maine, and New Mexico) transitioned from state-run coverage to the federal exchange for 2022, bringing the total number of state-based marketplaces on healthcare.gov to 18. 

What Do These Changes Mean for Enrollment?

For plan year 2021, enrollment reached a record high of 12.2 million people, which can be attributed to a special COVID-19 enrollment period that ended in most states in August 2021.  However, many Americans seem to be unaware of premium tax credits made possible by the American Rescue Plan.  According to an October 2021 poll by the Kaiser Family Foundation (KFF), only about a quarter of adults who are uninsured or buy their own insurance checked to see if there were eligible for ACA premium tax credits. 

KFF currently estimates that nearly 11 million Americans are eligible for but not enrolled in subsidized ACA plans.  Despite a record number of enrollees in 2021, it remains to be seen if new outreach efforts, longer enrollment periods, and other changes brought into play for 2022 will be enough to attract more enrollees and continue to lower the number of uninsured individuals in America.

Where Are We at with Medicare’s Temporary Telehealth Waivers?

Telehealth usage has exploded during the COVID-19 pandemic, thanks to legislation like the CARES Act that expanded Medicare coverage of telehealth services to make it easier for beneficiaries to access health care services while minimizing their exposure to COVID-19.  Now that the final stage of the pandemic is (hopefully) winding down, what are the implications for telehealth? 

It’s all about the PHE.  Expanded telehealth coverage is set to expire at the end of the COVID-19 public health emergency (PHE), which is currently January 16, 2021.  The Secretary of the Health and Human Services (HHS) has the authority to renew the PHE for 90-day increments, meaning the PHE could potentially extend through April 2022 – or longer.  Below are key Medicare telehealth coverage restrictions and rules that have been waived for the duration of the PHE.

  • Qualifying Technology: Medicare may now cover telehealth services conducted through devices like smartphones that offer audio-visual capabilities and can be used to facilitate two-way, real-time communication between a beneficiary and a practitioner.  Previously, this was limited to beneficiaries in rural areas.  Additionally, the requirement for visual capabilities is now waived for certain services, meaning some beneficiaries can now use audio-only telehealth services.
  • Geographic Location: Medicare will reimburse for telehealth services anywhere in the US, with no pre-existing patient relationship required.
  • Qualifying Service: Medicare can reimburse 238 telehealth services, compared to 101 prior to the PHE. 
  • Qualifying Originating Site Type: Telehealth services can be provided to all patients in all settings, including at a beneficiary’s home.
  • Qualifying Site Practitioner: Any health care practitioner who can bill Medicare may now furnish Medicare telehealth service.

All of these temporary changes expire once the PHE ends, but Congress could take action and can change that. Lawmakers from both parties have been pushing to take some of these temporary telehealth coverage extensions and make them permanent, beyond the PHE. 

  • Several bills (S. 368, S. 1988, H.R. 341, H.R. 1332, and H.R. 5425) would strike Medicare’s geographic site originating requirement and allow Medicare beneficiaries to access telehealth services in all settings. 
  • Another (H.R. 2168) would permanently allow audiologists, physical therapists, occupational therapists, speech-language pathologists, and other providers to provide telehealth services under Medicare.
  • Additional bills (H.R. 5425 and S. 1988) would ensure permanent Medicare coverage of certain telehealth services using audio-only technology.

However, none of these have bills have advanced in either chamber since their introduction, and the Build Back Better Act, Democrats’ social spending and climate package, does not contain any provisions that address Medicare coverage of telehealth services.

It would be amiss not to highlight a major barrier to continued telehealth coverage is reimbursement.  Under the PHE, telehealth services are reimbursed under Medicare at the same rate as in-person services, and lawmakers and stakeholders disagree over whether permanently expanded telehealth services should be reimbursed at or below the level of in-person services. 

So, what does the future hold for telehealth?  In summer and fall 2020, more than a quarter of Medicare beneficiaries used telehealth services, representing a massive increase in telehealth utilization since before the pandemic.  Given that the waiver of Medicare’s telehealth restrictions will expire once the PHE ends, the question of what telehealth coverage will look like post-pandemic looms large.  The numerous proposals on Capitol Hill to expand certain telehealth flexibilities suggest lawmakers want to ensure beneficiaries have continued access to telehealth services.  However, absent any serious progress on these proposals, Medicare beneficiaries are still staring down the very real possibility of losing popular, safe, and convenient ways to access medical treatment that they gained in the early days of the pandemic.   

After 10 Years, How Is the CMS Innovation Center Doing?

The Center for Medicare and Medicaid Innovation (CMMI), also known as the CMS Innovation Center, just celebrated its tenth birthday last year.  Tasked to address growing concerns about rising costs, quality of care, and inefficient spending, CMMI is a powerful tool for innovation in the US health care system.  After a decade, is CMMI delivering on its promise to innovate health care, or does the young agency still have much to accomplish?

All About CMMI

Created upon enactment of the Affordable Care Act (ACA) in 2010, CMMI is statutorily mandated to design, implement, and test new health care payment and delivery models for Medicare and Medicaid.  Managed by the Centers for Medicare and Medicaid Services (CMS), CMMI has launched over 40 new payment models since its inception, including accountable care organizations, medical homes models, and bundled payment models.  CMMI separately awards grants to state agencies, researchers, and other organizations for projects to design and implement new payment models with the same goals of improving care and lowering costs, and some of CMMI’s work includes multi-payer alignment models that impact patients with commercial insurance. 

2020 Report to Congress

Released on August 4, the 2020 Report to Congress provides an in-depth look at the performance of CMMI models and serves as a key indicator of how the center is doing in its effort to address rising costs and boost quality.  While the report focuses on CMMI’s activities from October 1, 2018, to September 30, 2020, it also highlights some actions taken from September 30 to December 31, 2020. 

In the 2020 Report, CMS estimated that over 27.8 million Medicare and Medicaid beneficiaries plus enrollees in commercial insurance plans have received care from over 500,000 health care providers or plans participating in alternative payment models under CMMI.  The 2020 Report analyzed a total of 38 active models within CMMI, including 11 new models announced since the 2018 Report and 27 active models that were launched prior to October 2018.

Summary of Findings

Unfortunately, only a handful of CMMI models met either goal of reducing costs or improving quality.   Furthermore, only the five following models delivered “statistically significant savings” to the Medicare Trust Fund according to the report:

Additionally, a few models led to improvements in quality but did not yield any noteworthy savings, including the Comprehensive End-Stage Renal Disease (ESRD) Care (CEC) Model and the Comprehensive Care for Joint Replacement (CJR) Model.

Saving money and raising quality aren’t the only metrics for a model’s success.  For CMS to consider permanently expanding a model for the federal health care entitlement programs, models must meet several additional criteria, including assurance from the CMS Office of the Actuary that a model’s expansion would not deny or limit coverage or provision of benefits under Medicare, Medicaid, and CHIP.   According to the report, only three models met the criteria:

How Can CMMI Improve?

While the 2020 Report to Congress does not explicitly offer recommendations on how to improve model performance, it does identify four issues that contributed to lower-than-expected model performance:

  • Selection bias created by voluntary models.
  • Benchmark inaccuracy.
  • Quality measure misalignment.
  • The need for greater data transparency.

These four issues identified in the report suggest a few ways CMMI models could produce better quality and provide for lower costs, mainly through mandatory model participation and more data transparency.  The idea of making more payment models mandatory is not a new idea.  In a July 2021 interview with Health Affairs, CMMI Director Liz Fowler explained that a shift towards mandatory models, which had already begun during the previous administration, will continue under the Biden administration and are likely to play a greater role in CMMI’s future.

The fact that CMMI models are underperforming is not lost on CMS leadership.  In a recent Health Affairs blog post, a few top agency officials including CMS Administrator Chiquita Brooks-LaSure and Fowler acknowledged only a handful of models have incurred savings and met the requirements to be expanded.  In addition to recounting a few recommendations from outside experts, such as MedPAC’s endorsement for streamlining and harmonizing models, Brooks-LaSure and Fowler offered several takeaways to inform how model performance could be improved.

  • CMMI needs to reevaluate how it designs financial incentives in order to boost meaningful provider participation.
  • Challenges in setting financial benchmarks have undermined models’ effectiveness, underscoring a need to ensure models are not resulting in overpayment and explore ways to improve or replace the current risk adjustment methodology. 
  • Since providers find it hard to accept downside risk if they lack the tools to change care delivery, CMMI should help ensure providers have options for managing risk, such as support in transforming care, waivers, and data. 

Despite dozens of underperforming models, CMS recognizes that the Innovation Center has room for improvement, and the agency’s leaders are keen on delivering a strategy that works.  Hopefully, through streamlining current models, implementing more mandatory models, boosting participation in voluntary models, improving financial incentives, and ensuring model participants have the tools they need to succeed, CMMI models could hopefully be in a better position to  both reduce costs and improve quality in time for the center’s 20th anniversary.