During the unwinding of the pandemic continuous enrollment provision in Medicaid, states are required to report monthly data on renewal outcomes. While these required data are valuable for tracking how many people are renewed and disenrolled, they lack the detail required to assess renewal outcomes for different populations. Additional demographic data can shed light on who is losing coverage, which can help to identify areas for potential outreach, assistance, or systems solutions to address issues that may be disproportionately affecting certain groups. Because people of color are more likely to be covered by Medicaid, there has been particular interest in the effects of unwinding by race and ethnicity. While data on renewals by race and ethnicity are limited, this policy watch examines which states are posting data and presents findings on disenrollment patterns by race and ethnicity based on available data.

As of September 2023, nine states are reporting data that allow for analysis of disenrollment patterns by race and ethnicity. Five states (Arizona, California, Indiana, Minnesota, and Oregon) provide data on disenrollment rates by race and ethnicity. Four states (Nevada, Oklahoma, Virginia, and Washington) report the distribution of disenrollments by race and ethnicity that can be compared to the distribution of overall Medicaid enrollment in each state by race and ethnicity. An additional two states (New York and North Dakota) provide data on redeterminations that have been completed by race and ethnicity but do not break out the share of people who were disenrolled or had their coverage renewed, preventing analysis of disenrollment patterns by race and ethnicity. In addition to differences in the metrics states are reporting, the number of months of reported data differ across states, as does data quality, with the share of data with unknown or not reported race and ethnicity ranging from 7% in Oklahoma and Washington to 37% in Oregon. Higher shares of data with unknown race and ethnicity can affect the validity of the findings. States also vary in their racial and ethnic classifications, and while all states report data for Hispanic people, some states report Hispanic and non-Hispanic ethnicity separately from race.

Across the five states reporting disenrollment rates by race and ethnicity, there are not large differences in disenrollment rates by race and ethnicity. Although the overall disenrollment rates vary from 12% in Oregon to 51% in Arizona, within states, the disenrollment rates for people of color are similar to those of White people (Figure 2). (Note: Arizona reports data for its COVID override population—enrollees who were flagged as potentially no longer eligible.) Overall, there are no consistent trends across states that point to disparities for certain groups of color. However, in some states, some groups have higher rates of disenrollment compared to their White counterparts. For example, in Minnesota, disenrollment rates for AIAN, Black, and Hispanic enrollees are higher than those for White and non-Hispanic enrollees.

In the four states that are reporting the distribution of disenrollments, the racial and ethnic composition of people losing coverage generally mirrors that of the overall Medicaid population. The share of disenrollments people of color make up varies across states from 36% in Oklahoma to 64% in Nevada, reflecting state differences in the overall share of Medicaid enrollees who are people of color. In general, the share of disenrollments for people of color is within one or two percentage points of their share of total Medicaid enrollment, suggesting that they are not being disproportionately disenrolled (Figure 3). For example, in Oklahoma, people of color account for 36% of disenrollments and represent 35% of total Medicaid enrollment. However, in Virginia, people of color are less likely to be disenrolled than White people; people of color comprise 46% of total Medicaid enrollment but account for only 41% of total disenrollments.

While available data on Medicaid disenrollments by race/ethnicity suggest people of color are not at greater risk of being disenrolled, the data reported to date are limited, and the experiences of people of color in the reporting states may not be similar to those of people in non-reporting states. Compared to the national average, these states have a higher share of Medicaid enrollees who are people of color, including a higher share of Hispanic people but a lower share of Black people. Data from a larger number of states, including more states in the South and Midwest, would provide a more complete picture of disenrollment patterns by race and ethnicity and would show whether some groups are being disenrolled at disproportionate rates. In addition, more standardization of reporting of race and ethnicity data would allow for better comparisons of disenrollment patterns across states.

Continued monitoring of disenrollment data, including by race and ethnicity, will be important to identify shifts in current trends and other potential issues. While states are not required to report demographic data on Medicaid renewal outcomes during the unwinding period, these data provide valuable insights into who is losing coverage and whether certain groups are at greater risk of being disenrolled, both within and across states. This information can help focus outreach efforts where needed or suggest strategies to address disparate impacts. In the absence of state reporting during the unwinding period, Medicaid claims data and survey data that could provide similar information will not be available for years. Overall, 60% of Medicaid enrollees are people of color, and the large number of disenrollments to date, particularly procedural disenrollments, has led to millions of people of color losing Medicaid coverage. Consequently, the unwinding of the Medicaid continuous enrollment provision is likely to have a greater impact on changes in health coverage for people of color, which, in turn, has important implications for their ability to access care and their health outcomes.

The recently released KFF/Washington Post Trans Survey, the most in-depth, representative survey of transgender adults living in the U.S., was aimed at providing a deeper understanding of trans people’s experiences in the U.S. over the life span including during childhood, through gender transition, and present wellbeing. Building on that report, and using the survey data, this analysis provides the most comprehensive representative profile of trans Americans ever complied, while also offering insights on their experiences in the health care system. While some federal surveys include a representative share of trans people, demographic questions tend to be fairly general and do not allow for more in depth analysis of the experiences and identities of trans people, particularly related to health access. At a time when issues around LGBTQ rights, including in health care, are at the forefront of national conversations, understanding trans people’s experiences and wellbeing is especially timely.

The survey included interviews with 515 trans and gender non-conforming individuals and a comparison sample of 823 cisgender adults. Trans adults include those who identify as transgender or as a trans adult; cisgender (non-trans) adults include those do not identify as trans and their gender is the same as their sex assigned at birth. For more information about sampling and method of recruitment, see the methodology section in the full report.

Identities

Gender Identity. Gender identity is based on one’s intrinsic sense of who they are, be that male, female, transgender, non-binary, or some other identity. When one’s gender identity aligns with their sex assigned at birth they are considered cisgender. When one’s gender identity does not align with sex assigned at birth, they are often described as being transgender, though many people use other terms to describe themselves, including being gender nonconforming or nonbinary, among others.

When asked how they think of themselves, a plurality of trans adults identify as non-binary (40%), with about one in five identifying as trans women (22%) or gender non-conforming (22%), and a smaller share identifying as trans men (12%). Others say they identify in some other way (2%). Some use one term and others use multiple terms. Those who described themselves in “some other way” commonly described themselves as agender or genderfluid when asked to specify. Those aged 18 to 34 are more likely to identify as non-binary than those aged 35 or older (47% v 32%).

Sex assigned at birth. Sex assigned at birth differs from gender identity because it is based on phenotypic sex characteristics and is the sex stated on an individual’s birth certificate. It may or may not align with gender identity. Trans and non-trans adults are equally likely to have been assigned either male or female at birth.

Sexual orientation. Sexual orientation is separate from sex assigned at birth (being biologically male, female, or intersex) and gender identity (which is based on an internal sense of being such as being cisgender or transgender, among other identities). Sexual orientation refers to the gender or genders someone experiences sexual, emotional, or romantic attraction or attachment to. Heterosexual/straight, lesbian, gay, bisexual, and queer are examples of sexual orientations. Most (70%) trans adults considered themselves to be lesbian, gay, bisexual or queer while just 8% of non-trans adults did so. However, three in ten (29%) trans adults do not identify as lesbian, gay, bisexual, or queer.

Pronoun use. Pronouns are a shorthand way of referring to an individual without using their name. Often, pronouns connote gender as is the case with he/him or she/her. Some adults, especially LGBTQ adults, and trans or nonbinary adults in particular, use a pronoun that would not traditionally be associated with their sex assigned at birth or does not reflect the historic gender binary (male/female), such as they/them. In addition, some adults use multiple pronouns or are comfortable with any pronouns.

Nearly half (48%) of trans adults use they/them pronouns, with those ages 18-34 being more than twice as likely to use these terms than those 35+ (64% vs. 28%). About half of trans adults use she/her (49%) pronouns and almost four in ten (37%) use he/him pronouns. About one-third of trans adults say they use a combination of they/them and she/her or he/him pronouns. (Note: Percentages do not sum to 100% as respondents could select multiple genders).

General Demographics

Age. Trans adults are a younger population than non-trans adults. Over half (53%) of trans adults are under 35 years old compared to just over a quarter of non-trans adults (28%). Just a small share (8%) of trans adults are seniors, those over the age of 65, compared to 22% of non-trans adults (not shown in chart).

Race/Ethnicity. Similar shares of trans and non-trans adults are White, Hispanic, Black, and other races/ethnicities.

Income. A larger share of trans adults have incomes below $50,000 per year than non-trans adults (57% v. 45%), potentially reflecting younger age, lower levels of education, and higher unemployment (see below).

Education. Trans adults have lower levels of education when compared to non-trans adults. More than 8 in 10 (84%) have less than a college degree compared to 65% of non-trans adults. Non-trans adults are more than twice as likely to have graduated college than trans adults (35% vs. 15%). This finding held true even when controlling for age, and despite having similar incomes at most levels.

Employment. A larger share of trans adults report being unemployed (14% vs. 8%) or being students (8% vs. 4%) than non-trans adults and smaller shares report being retired, likely due the fact that the trans adult population is younger in age than the non-trans adult population. Similar shares report being employed, being on disability, or being a stay at home parent/home maker.

Partisan identification. Four in ten trans adults (42%) identify as a Democrat, a larger share than non-trans adults (29%) and few, just one in ten (10%), identify as a Republican compared to almost one-third (31%) of non-trans adults. Trans adults are also more likely to say their political identity is something other than Republican, Democrat, or independent (20% vs. 14%).

Marital Status. Trans adults are about half as likely to be currently married than non-trans adults (26% vs. 49%) and also less likely to have ever been married (25% vs. 38% ) which likely reflects, at least in part, their younger age. However, they are twice as likely to be living with an unmarried partner (20% vs. 10%). The share of trans adults who are widowed or divorced is similar to that of non-trans adults.

Parenthood. Overall, similar shares of trans adults are a parent or guardian to a child under the age of 18 living in their household (27% vs 26%). However, looking at younger adults, there are significantly fewer trans parents under the age of 40 than non-trans parents under 40 (23% vs. 40%).

Healthcare Access

Insurance Coverage. Larger shares of trans adults report being uninsured than non-trans adults (15% vs. 10%). The share of trans adults who report not having health insurance is similar across age groups and racial and ethnic identities, but larger among those with lower household incomes compared to those with higher incomes.

About half of both trans adults and non-trans adults report having private insurance (55% vs. 51%), although trans adults are three times as likely to report having such coverage through a parent (10% vs. 3%), likely reflecting their younger age. Smaller shares of trans adults have Medicare (6% vs. 25%), likely reflecting the younger age of the population, and about one in four have Medicaid (21%), a larger share than non trans-adults (14%).

Care location. Trans adults use different types of health care settings to access care than non-trans adults. They are more likely to get their usual care at clinics including health centers, pharmacies, and urgent care (36% vs. 21%) and less likely to get this care at a doctor’s office (48% vs. 64%). Trans adults of color, those under age 35, and those earning less than $40,000 per year were more likely to say their usual source of care is the ER than White, older, or higher income trans adults. Among trans adults, those ages 35 and older and those earning more than $40,000 per year are more likely to receive care at a doctor’s office than trans adults who are younger or who have lower incomes. Like non-trans adults, about one in ten have no place they get care.

Health and Well-being

Physical Health. Despite being a younger population, trans adults report poor physical health more so than non-trans adults. Looking back across the past 30 days, on average, trans adults had more days when their physical health, including physical illness and injury, was “not good”. Smaller shares of trans adults than non-trans adults had zero days when their physical health was not good in the preceding 30 days (27% vs. 41%) and nearly double the share of trans adults said their health had not been good for 21-30 days (17% vs. 9%). Among trans adults, there were minimal differences when looking across demographic factors including, race/ethnicity, age, and income.

Mental Health. Similarly, while four in ten (39%) non-trans adults say there were zero days in the past month when their mental health, including stress, depression, and problems with emotions, was not good, just about one-in-ten trans adults (13%) said so. Conversely, nearly one quarter of trans adults (23%) say their mental health had been not good 21-30 days in the preceding 30. Notably, trans adults who reported having had a happy childhood reported fewer not good mental health days. Among trans adults, there were minimal differences when looking across demographic factors including, race/ethnicity, age, and income. In our main report on this survey, we find specifically that trans adults report higher rates of anxiety, depression, and loneliness than non-trans adults.

Nearly half of adults say that they will “definitely” or “probably” get the newly recommended COVID-19 vaccine, though most parents are not planning to get the shot for their children, according to the latest KFF COVID-19 Vaccine Monitor poll.

Among all adults, 23% say they will definitely get the new vaccine, 23% say they will probably get it, while 19% say they will probably not get it and 33% say they definitely not get it.

The share of the public who intend to get the new COVID-19 vaccine is higher than the share who have received previous booster shots, but not as high as initial vaccine uptake back in 2020.  Almost four in ten (37%) people who previously received a COVID-19 vaccine say that they probably or definitely won’t get the new shot. Reflecting patterns from earlier vaccine rollouts during the pandemic, the groups most likely to say they definitely or probably will get the new vaccine include people at least 65 years old (64%) and Democrats (70%).

While the new COVID-19 vaccine is recommended for children ages 6 months and up, fewer than four in ten parents say they expect to get the vaccine for their children ages 12-17 (39%), ages 5-11 (36%), and ages 6 months through 4 years (34%). More than half of parents with children in each age group say they probably or definitely won’t get their children vaccinated.

The latest survey also shows that somewhat larger shares of eligible people expect to get an annual flu shot and a newly recommended vaccine for RSV (respiratory syncytial virus) than plan to get the COVID-19 vaccine. For example, most adults (58%) say that they have already gotten or expect to get a flu shot, and most adults ages 60 and older (60%) say they have already gotten or expect to get the new RSV vaccine (recommended for their age group).

As has been true throughout the pandemic, a much smaller share of Republicans (24%) than Democrats (70%) expect to get the new COVID-19 vaccine – 46 percentage point gap.

There are smaller, but still considerable, partisan divisions in intentions for these vaccines than for the COVID-19 shot: for example, 76% of Democrats and 51% of Republican expect to get or have already gotten a flu shot this fall (a 25-point gap), while among those ages 60 and older, 79% of Democrats and 41% of Republicans expect to get or having already gotten an RSV vaccine (a 38-point gap)

Republicans are also less likely than Democrats to be confident that each of three vaccines are safe, with the biggest divide for the COVID-19 vaccine (84% of Democrats and 36% of Republicans are confident it is safe).

The partisan divides persist across a wide range of measures related to vaccines and the COVID-19 pandemic. Some examples:

• Trust in public health agencies. Overall, 63% of the public trust the Centers for Disease Control and Prevention (CDC) a great deal or a fair amount when it comes to providing reliable information about vaccines, and 61% trust the Food and Drug Administration (FDA). Much larger shares of Democrats than Republicans have at least a fair amount of trust in vaccine information from the CDC (88% vs. 40%), their local public health departments (87% vs. 51%), and the Food and Drug Administration (86% vs. 42%).
• Perceptions about threat. Three quarters (77%) of Democrats say that there is a new wave of COVID-19 infections across the country. In contrast, similar shares of Republicans say there is (48%) and isn’t (51%) a new wave.
• Taking precautions. Democrats are more than three times as likely as Republicans (58% vs. 16%) to say that news about the new COVID-19 wave has led them to take extra precautions, including being more likely to wear a mask in public or avoid large public gatherings, or being less likely to travel or to dine indoors at restaurants.
• Getting tested. Republicans are half as likely as Democrats (9% vs. 19%) to say that they were sick in recent months and got a COVID-19 test.

“The poll shows that most of the nation still trusts the CDC and the FDA on vaccines – but there is a partisan gap, and most Republicans don’t trust the nation’s regulatory and scientific agencies responsible for vaccine approval and guidance,” KFF President and CEO Drew Altman said.

One area where partisans agree is that their personal doctors, including their children’s pediatricians, are their most trusted sources of vaccine information.

Most adults (68%) also say they normally keep up-to-date with the vaccines that are recommended by their own doctor, including 82% of Democrats and 61% of Republicans. Large majorities of parents – regardless of partisan identification – say they keep their children up to date on recommended childhood vaccines, with just 10% saying they delayed or skipped some vaccines.

Other poll results include:

• Following the end of the COVID-19 public health emergency in May, most insured people now say they are unsure whether their health insurance covers either in-home, rapid COVID-19 tests (55%) or PCR COVID-19 tests that are sent to a lab for results (61%).
• In addition, one in seven (15%) say they’ve wanted to get a COVID-19 test but were not able to find or afford one. Those most likely to report difficulties obtaining a COVID-19 test includes at least one in five Black adults (25%), Hispanic adults (21%), and people with household incomes under $40,000 annually (21%).
• Most adults (68%) and parents (55%) – say that healthy children should be required to be vaccinated against measles, mumps, and rubella to attend public school; fewer adults (31%) and parents (43%) say that parents should be able to decide not to vaccinate their children even if that may create health risks for others.

Designed and analyzed by public opinion researchers at KFF, the survey was conducted from September 6-13, 2023, online and by telephone among a nationally representative sample of 1,296 U.S. adults. Interviews were conducted in English and in Spanish. The margin of sampling error is plus or minus four percentage points for the full sample. For results based on other subgroups, the margin of sampling error may be higher.

Telehealth use surged with the COVID-19 pandemic as patients sought access to services while providers implemented social distancing protocols. An ongoing question is how the growth of telehealth will affect health spending. If payers reimburse services provided through telehealth at a lower rate, there could be cost savings. Alternatively, if telehealth encourages the use of more services, total spending could increase.

This analysis compares payments for physician medical service claims delivered via telehealth and in-person in 2021 using data from the Health Care Cost Institute (HCCI). It finds that private insurers paid similarly for telehealth and in-person physician claims for evaluation and management and mental health therapy services, on average, in 2021 as well as 2020. This is after accounting for variation across regions, providers, and severity level, among privately insured. Among providers who offered both telehealth and in-person care, the majority received similar payments for service provided in-person or through telehealth.

The analysis is available through the Peterson-KFF Health System Tracker, an online information hub that monitors and assesses the performance of the U.S. health system.

Medicare recently announced the first 10 Part D drugs selected for negotiation under Medicare’s new drug price negotiation program. These drugs were identified as the 10 top spending drugs covered under Medicare Part D without generic or biosimilar equivalents that have been on the market for at least seven years and also meet other selection criteria. The 10 drugs selected for the first round of negotiations include treatments for several medical conditions, including diabetes (Farxiga, Fiasp/NovoLog, Januvia, Jardiance), blood clots (Eliquis, Xarelto), heart failure (Entresto, Farxiga), psoriasis (Stelara, Enbrel), rheumatoid arthritis (Enbrel), Crohn’s disease (Stelara), and blood cancers (Imbruvica) (Appendix Table 1). Between June 2022 and May 2023, 8.3 million Medicare Part D enrollees used one or more of these medications. Negotiated prices for these 10 drugs will be available on January 1, 2026.

Much of the discussion around Medicare’s new drug price negotiation program has been about the details of the negotiation process, whether or not it will impact future drug development, and the several lawsuits that have been filed by drug manufacturers seeking to block its implementation. But scant attention has been paid to the ways in which the new negotiation program could affect access to and utilization of selected drugs for Medicare Part D enrollees:

• The law requires all Medicare Part D plans to cover each of the selected drugs, including all dosages and forms, when negotiated prices take effect in 2026.
• The Centers for Medicare & Medicaid Services (CMS) will require Part D plans to justify formulary placement of selected drugs on non-preferred tiers, where cost sharing is typically higher than for preferred tiers.
• CMS will scrutinize plans’ use of utilization management tools, such as prior authorization requirements, applied to selected drugs, which could remove administrative barriers to accessing these medications.
• Along with improved access, Part D enrollees could see lower out-of-pocket costs due to lower negotiated prices, particularly for drugs with coinsurance requirements, which could increase utilization.

This brief examines how Part D enrollees’ access to and utilization of the first set of 10 selected drugs could be affected by the new Part D coverage and formulary requirements for selected drugs established by the Inflation Reduction Act and in CMS guidance, as well as the potential for lower out-of-pocket costs, based on analysis of current (2023) Part D formulary coverage, tier placement, and utilization management requirements for these 10 drugs.

The Inflation Reduction Act requires Part D plans to cover all selected drugs, including all dosages and forms, when negotiated prices are in effect

Not all Medicare Part D enrollees have coverage of each of the 10 selected drugs in 2023. The statutory coverage requirement will have the effect of improving access to the selected drugs that are not currently universally covered, in particular the insulin product Fiasp/NovoLog and the psoriasis drug Stelara. The share of Part D enrollees with coverage of any form of these 10 drugs ranges from less than 60% for Fiasp/NovoLog and 66% for Stelara to 100% for Eliquis, Entresto, Imbruvica, Jardiance, and Xarelto (Figure 1). (Imbruvica is an antineoplastic, a type of medication used to treat cancer, which is one of six so-called protected classes where all or substantially all drugs are required to be covered by all Part D plans.)

For Part D enrollees with coverage of the selected drugs in 2023, plans generally cover all or nearly all dosages and forms, but there is a small amount of variation in coverage for seven of the 10 selected drugs. For example, the blood thinner Xarelto is covered in tablet form for virtually all Part D enrollees, but the share of enrollees with coverage of the oral suspension falls to 78%. For the cancer drug Imbruvica, all enrollees have coverage of the 140mg oral capsule but that share drops to 77% for the 280mg oral tablet (Appendix Table 2).

CMS will require Part D plans to justify formulary placement of selected drugs on non-preferred tiers

As of 2023, placement of the 10 selected drugs on non-preferred tiers is not common (although whether CMS will consider the specialty tier a non-preferred tier for this purpose is unknown); if coverage of selected drugs shifts to preferred tiers, that could lower Part D enrollees’ out-of-pocket costs. In 2023, three of the 10 selected drugs – the rheumatoid arthritis drug Enbrel, the cancer drug Imbruvica, and the psoriasis drug Stelara – are placed on the specialty tier in virtually all Part D plans that cover these drugs, with median coinsurance of 30-33% in the initial coverage phase (Figure 2, Appendix Table 3). This coinsurance rate is applied to the price of each drug to determine an enrollee’s monthly out-of-pocket cost. Currently, list prices, which do not take into account manufacturer rebates or other price concessions, are generally used in determining patient out-of-pocket costs for drugs with coinsurance. This means that a lower negotiated price would result in lower out-of-pocket costs for selected drugs with coinsurance requirements. In turn, lower out-of-pocket costs could lead to higher utilization of selected drugs.

Six of the 10 selected drugs (Entresto, Eliquis, Farxiga, Januvia, Jardiance, and Xarelto) are more commonly placed on a preferred brand tier in 2023, with a median copayment of $47 per month – an out-of-pocket amount that is fixed rather than being a percentage of the drug’s list price (Figure 2, Appendix Table 3).

But some Part D enrollees with coverage of these six drugs in 2023 have coverage on a non-preferred tier, where cost sharing is higher than for drugs on preferred tiers, and enrollees may face coinsurance of up to 50% rather than fixed copayments. For example, roughly 13% of Part D enrollees whose plans cover the blood thinner Eliquis have coverage on a non-preferred tier and face coinsurance of 50% (9.5% of enrollees) or a monthly copayment of $100 (3% of enrollees). If coverage of these drugs shifts to preferred tiers, that could lower Part D enrollees’ out-of-pocket costs.

For the insulin product Fiasp/NovoLog, the most common tier placement in 2023 is on a preferred brand tier, but regardless of tier placement, monthly cost sharing is capped at $35 in plans that cover this product. This is due to a provision of the Inflation Reduction Act, where, starting in 2023, Part D plans are not allowed to charge a copayment of more than $35 per month for covered insulin products.

CMS expects Part D plans to provide justification if more restrictive utilization management is applied to selected drugs relative to non-selected drugs in the same class

Most Part D enrollees face some type of utilization management restriction on the 10 selected drugs in 2023. Prior authorization requirements are applied to virtually all Part D enrollees who have coverage of Enbrel, Imbruvica, and Stelara in 2023, meaning that nearly all enrollees would need to get prior authorization from their plan prior to initiating treatment with any of these three drugs (Figure 3, Appendix Table 4). The most common utilization management restriction applied to the 10 selected drugs is quantity limits, ranging from around 2% of Part D enrollees who have coverage for the insulin product Fiasp/NovoLog to nearly all enrollees with coverage of Januvia and Jardiance. Step therapy requirements are rarely applied to these 10 drugs.

This analysis did not examine utilization management restrictions applied to other drugs in the same classes as selected drugs to assess whether utilization management applied to selected drugs in 2023 is comparatively more restrictive. But if CMS’s justification requirement leads to less frequent application of utilization management tools on selected drugs by Part D plans, utilization could increase.

Conclusion

While Medicare’s new drug price negotiation program is projected to lower Medicare spending on drugs selected for negotiation, less attention has been given to its potential to expand access to and utilization of selected drugs for Part D enrollees. In part, this could result from a requirement in the Inflation Reduction Act that all Part D plans cover all selected drugs once negotiated prices take effect. This requirement will have the effect of expanding coverage for the selected drugs that are not currently universally covered by all plans, in particular Fiasp/NovoLog and Stelara. This requirement could have a larger impact in future years, depending on formulary coverage of drugs selected for price negotiation in the future. CMS has also stated that it intends to use the annual formulary review process to ensure that all Part D plans cover all dosages and forms of selected drugs during the year that the negotiated prices apply. This level of coverage currently is not standard.

CMS has stated that it will also require plans to justify formulary placement of selected drugs on non-preferred tiers, where cost sharing is typically higher than when drugs are on preferred tiers. As of 2023, placement of the 10 selected drugs on non-preferred tiers is not common, but some Part D enrollees have coverage on a non-preferred tier and face higher cost-sharing requirements than for drugs on preferred tiers. If coverage of selected drugs shifts to preferred tiers, that could lower Part D enrollees’ out-of-pocket costs. And for drugs with coinsurance requirements, a lower negotiated price would result in lower out-of-pocket costs. In turn, lower out-of-pocket costs could lead to higher use of selected drugs.

Finally, CMS has stated that it expects plans to provide a justification if more restrictive utilization management is applied to selected drugs relative to non-selected drugs in the same class, or if utilization management restrictions that are not based on medical appropriateness are applied to selected drugs. If CMS’s justification requirement leads to less frequent application of utilization management tools on selected drugs by Part D plans, utilization could increase.

It should be noted that if manufacturers of selected drugs do not want to participate in price negotiations, they are required to withdraw their drugs from coverage under Medicare and Medicaid or face an excise tax on sales of the selected drug to Medicare beneficiaries. Withdrawal of products from coverage under the Medicare and Medicaid program would affect access to these medications, but would also mean that manufacturers would forfeit the revenue from sales of all of their products in these programs.

Taken altogether, the formulary and coverage requirements for selected drug in the Inflation Reduction Act and CMS guidance are likely to increase access to selected drugs for Medicare Part D enrollees and could also lower Part D enrollees’ out-of-pocket costs, which could increase utilization of these drugs and revenues for their manufacturers.

Appendix

Jennifer Kates, senior vice president and director of the Global Health and HIV Policy Program at KFFCynthia Cox, vice president and director of the Program on the ACA at KFF

On September 11, 2023, the FDA approved and authorized updated COVID-19 vaccines from Pfizer and Moderna. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended them for everyone from the ages of 6 months and older on September 12 and the CDC Director adopted this recommendation on the same day. This marks the first time that COVID-19 vaccines will be commercialized – that is, transitioned to the commercial market for their manufacturing, procurement and pricing. Up until this point, the federal government had purchased all COVID-19 vaccines and provided them free of charge to anyone, regardless of insurance coverage or ability to pay. The commercial price being charged by Pfizer and Moderna is $115 to $128 per dose, respectively, about 3-4 times higher than the price paid for by the federal government. In addition to the cost of the vaccine, there may be a cost associated with administering the vaccine and/or the cost of a provider visit.

With commercialization, the way in which vaccines are paid for and whether they are covered by insurance will now be dictated by insurance market rules and regulations. Because of the Affordable Care Act and laws passed during the COVID-19 pandemic, COVID-19 vaccines will continue to be free of charge to virtually everyone with private and public insurance coverage, although uninsured adults will have no guarantee of free vaccines. This cheat sheet provides details on coverage rules by insurance type and for people who are uninsured.

LEGAL BASIS

Private:

ACA: Requires private insurers to cover any ACIP recommended vaccine once the CDC Director adopts recommendation no later than one year later.

CARES Act: Expedited coverage requirement to 15 business days for COVID-19 vaccines

DOL FAQs: The 15-day requirement was already satisfied 15 days after first COVID-19 vaccine recommended in December 2020. As of January 5, 2021, any COVID-19 vaccine that is approved or authorized by the FDA must be covered immediately.

Medicaid:

ARPA: Requires no cost-sharing through September 2024

IRA: Requires Medicaid coverage of ACIP-recommended vaccines for adults with no cost sharing permanently.

Medicaid covers ACIP-recommended vaccines for children at no cost through the Vaccines for Children Program.

Medicare:

CARES Act: Requires no cost-sharing

Uninsured Adults:

There is no federal guarantee of free recommended vaccines for adults. Section 317 of the Public Health Services Act created a discretionary program that provides some limited support for recommended vaccines. The Biden administration has proposed creating a mandatory Vaccines for Adults Program, modeled on the Vaccines for Children Program

Uninsured Children:Section 1928 of the Social Security Act created the VFC program. Vaccines are automatically included in program if recommended by ACIP and included on the CDC’s vaccine schedule. COVID-19 vaccines were added to the vaccine schedule on October 19, 2022.

SOURCES

Affordable Care Act, March 23, 2010, Section 300gg–13: https://t.co/Q5ySrwDFSB

Coverage of Certain Preventive Services Under the Affordable Care Act, Federal Register, Vol. 80, No. 134, July 14, 2015: https://www.govinfo.gov/content/pkg/FR-2015-07-14/pdf/2015-17076.pdf

CARES Act, March 27, 2030, Section 3203 and Section 3713: https://www.congress.gov/116/plaws/publ136/PLAW-116publ136.pdf

Department of Labor FAQ, October 4, 2021: https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf

Department of Labor FAQ, March 29, 2023: https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf

ARPA, March 11, 2021, Section 9811: https://www.govinfo.gov/content/pkg/PLAW-117publ2/pdf/PLAW-117publ2.pdf

Vaccines for Children Program: https://www.cdc.gov/vaccines/programs/vfc/index.html

HHS Bridge Access Program: https://www.cdc.gov/media/releases/2023/p0914-uninsured-vaccination.html and KFF, https://www.kff.org/policy-watch/covid-19-vaccine-access-for-uninsured-adults-this-fall/.

Vaccines for Adults Program proposal: https://www.cdc.gov/budget/documents/fy2024/FY-2024-CDC-congressional-justification.pdf#page=79

As Congress considers reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) for a fourth time, KFF explores the debate over abortion policy that has stalled the legislation and the potential implications if Congress does not reauthorize the program. PEPFAR spans more than 50 countries and has been reported to have saved 25 million lives since President George W. Bush created it in 2003. Funding for the program in FY 2023 was $6.9 billion, including funding for the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

Despite a long history of broad and bipartisan support—and in the wake of the U.S. Supreme Court’s overturning of the constitutional right to abortion—the U.S. government’s signature global health effort in the fight against HIV has been drawn into a broader political debate about abortion, even though U.S. law prohibits the use of U.S. foreign assistance, including PEPFAR funding, for abortion.

In this new analysis, KFF provides an overview of the current debate and answers key questions about the role of the abortion debate in PEPFAR’s reauthorization, including:

• What concerns about abortion have been raised?
• What has been the response by PEPFAR and the U.S. government?
• What U.S. government laws and policies regarding abortion apply to PEPFAR?
• What are the implications if PEPFAR is not authorized?

Read “PEPFAR Reauthorization and Abortion” for more information and access “PEPFAR Reauthorization 2023: Key Issues”, which discusses top issues related to PEPFAR’s authorization and funding. You can also find a variety of resources about the program in our PEPFAR Policy Resource Hub.

Despite a long history of broad and bipartisan support, reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) is currently being held up by congressional debate around abortion. PEPFAR, first created in 2003 by President George W. Bush and reauthorized three times thus far, is the U.S. government’s signature global health effort in the fight against HIV. Widely regarded as one of the most successful programs in global health history, PEPFAR reports having saved 25 million lives due to its efforts, and KFF analyses have found a significant impact of the program beyond HIV, including large reductions in both maternal and child mortality and significant increases in some childhood immunization rates. Still, its fourth reauthorization has been drawn into broader U.S. political debate about abortion, in the wake of the Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision (which overturned the nationwide right to obtain an abortion), even though U.S. law prohibits the use of U.S. foreign assistance, including PEPFAR funding, for abortion. This policy watch provides an overview of the current debate and issues.

What concerns about abortion have been raised?

Abortion was publicly raised as one of the discussion points in PEPFAR reauthorization in early May after a coalition of organizations opposed to abortion rights, a conservative think tank’s report, and a member of Congress raised their concerns that PEPFAR may be supporting abortion. Among the criticisms leveled were that the Biden administration had restored funding to the United Nations Population Fund (UNFPA), signaled its support for sexual and reproductive health and rights globally in the September 2022 Reimagining PEPFAR’s Strategic Direction strategy document and February 2023 PEPFAR operational guidance, and funded various recipients who expressed support for abortion generally. There was also a call for Congress to reinstate and apply the “Mexico City policy” to PEPFAR. The Mexico City policy – first instituted in 1984 but not currently in effect – is a policy that required foreign non-governmental organizations (NGOs) to certify that they would not perform or promote abortion as a method of family planning using funds from any source as a condition for receiving certain U.S. funding. Typically put in place through executive order, it first applied to PEPFAR in 2017 under an expanded version of the policy instituted by President Trump, which was rescinded by President Biden in 2021 (prior to that time, when it was in place, PEPFAR was not subject to this policy).

What has been the response by PEPFAR and the U.S. government?

There has been no evidence produced that PEPFAR has supported any prohibited abortion activities. In June, Ambassador John Nkengasong, the head of PEPFAR, publicly stated that PEPFAR does not provide a platform for abortion in Africa and that it is “implemented strictly within the context of the laws it was created [by].” PEPFAR also sent official communication to all its implementers regarding current law and policy in this area. Additionally, the PEPFAR program revised its earlier September 2022 document, Reimagining PEPFAR’s Strategic Direction, to clarify that “sexual and reproductive health services” has a specific meaning in the PEPFAR context and reiterated that “PEPFAR does not fund abortions, consistent with longstanding legal restrictions on the use of foreign assistance funding related to abortion.” The U.S. government also has training and compliance processes in place to monitor the adherence of funding recipients and sub-recipients with U.S. requirements.

What U.S. government laws and policies regarding abortion apply to PEPFAR?

PEPFAR is governed by several legal, policy, and programmatic requirements related to abortion (see the KFF fact sheet on these and other requirements), including:

• the Helms Amendment (in place since 1973) – a legal ban on the direct use of U.S. funding overseas for the performance of abortion as a method of family planning or to motivate or coerce any person to practice abortion;
• the Leahy Amendment (in place since 1994) – a legal requirement that clarifies the Helms Amendment language that uses the term “motivate” by stating that “motivate” shall not be construed to prohibit, where legal, the provision of information or counseling about all pregnancy options; and
• the Siljander Amendment (in place since 1981) – a legal ban on the direct use of U.S. funding overseas to lobby for or against abortion.

In addition, while not currently in effect, the Mexico City policy was applied to PEPFAR for the first time during the Trump administration.

what are the implications if PEPFAR is not reauthorized?

If PEPFAR is not reauthorized this year, or in the near future, the program won’t end, but there are several practical and symbolic implications for the program and the people it serves.

PEPFAR is a permanent part of U.S. law and will continue, provided funds are appropriated. PEPFAR operates largely under permanent authorities of U.S. law that allow for ongoing funding and the continuation of the major structures of the program, such as the Office of the Global AIDS Coordinator at the Department of State as well as the position of Global AIDS Coordinator, U.S. participation in the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), and annual reporting on PEPFAR efforts.

Some requirements, however, are time-bound and would “sunset.” There are eight requirements that will end (seven after FY 2023 and one after FY 2024) if not addressed through PEPFAR reauthorization or another legislative vehicle. These include requirements related to Global Fund support, a funding directive for orphans and vulnerable children (OVC), and others.

The lack of reauthorization would mark a significant departure from PEPFAR’s long-time bipartisan support. PEPFAR has enjoyed strong bipartisan support across multiple Congresses and administrations. This has enabled the program to operate outside some of the policy debates that have stalled agreement on other issues related to both health care and foreign assistance in Congress. Despite the fact that funding for PEPFAR could continue absent reauthorization, the program may be more vulnerable in future funding debates.

Failure to reauthorize the program could send a message to partner countries and the people served by PEPFAR. Despite vocal administration support for the program as well as former President Bush and others calling on Congress to reauthorize PEPFAR, the lack of a congressional reaffirmation of the program may undermine efforts to demonstrate the depth of the U.S. government’s commitment to the global fight to end AIDS and broader leadership role in global health. It could also weaken PEPFAR’s partnering and diplomatic efforts, particularly conversations with partners about longer-term planning, financial sustainability, and country leadership of efforts.

The annual blitz of ads for Medicare Advantage plans has become a rite of fall, as health insurers, brokers and other third parties seek to court enrollees for these private plans, which are offered to the 65 million people with Medicare during the program’s open enrollment season.

In advance of the open enrollment period starting on October 15, KFF reviewed more than 1,200 unique television ads that aired more than 643,000 times last year to examine these marketing strategies in depth.

Based on its research, KFF found a heavy reliance on celebrity endorsers, liberal use of what appear to be official hotlines and images of government-issued Medicare cards, and suggestions that seniors who do not sign up for a plan could miss out on benefits to which they are entitled.

More than 85 percent of airings, or 9,500 ads per day, were for Medicare Advantage, the private plans that now enroll more than half of all eligible people with Medicare. Most of the remaining ads were for Medicare drug plans or Medicare supplemental insurance (Medigap).

Ads rarely mentioned traditional Medicare, or potential limitations with plan coverage, such as provider networks or prior authorization requirements, leaving beneficiaries with an incomplete view of their coverage options and the tradeoffs among them. Open enrollment runs annually from Oct. 15 to Dec. 7, with advertising permitted to begin on Oct. 1.

“There’s no question that Medicare has become a lot more complex. As enrollment in Medicare Advantage plans has grown, the annual marketing madness can create confusion for people who are trying to make difficult decisions about coverage,” said KFF President and CEO Drew Altman. “We heard directly from seniors in focus groups that the ads were often perceived as misleading and left them feeling overwhelmed. This isn’t a good basis on which to make a choice that will affect your health and pocketbook.”

Key insights from the research include:

• More than a quarter of all airings of Medicare Advantage ads (27%), included an official Medicare card or an image that resembled it. Additionally, more than 80% of airings sponsored by brokers and other third parties urged viewers to call a toll-free number described as “Medicare” hotline. But the number was not the official 1-800-Medicare hotline, and the entities behind such messages did not represent the government. New CMS rules in effect for the upcoming open enrollment period prohibit misleading use of the Medicare name, logo, or card in private marketing and communication materials, or any use of the Medicare card without prior approval from CMS.
• Some ads suggest that seniors may miss out on financial savings, or benefits to which they are entitled, if they don’t sign up for a Medicare Advantage plan. While Medicare Advantage plans do typically offer extra benefits, that can leave viewers with the impression that they have incomplete coverage if they have traditional Medicare, and that they have an entitlement to extra benefits under Medicare Advantage.
• Nearly all Medicare Advantage ad airings emphasized extra benefits, such as dental, vision, and hearing (92%) or the potential for lower out-of-pocket spending (85%). Less than 4 percent of airings referenced quality star ratings, even though CMS created the ratings in part to help shoppers compare Medicare Advantage plans.
• One-in-four Medicare Advantage ad airings (26%) showed physically robust seniors engaging in activities such as hiking, yoga, tennis, and even bouncing on a trampoline. This may suggest that they are targeting relatively healthy, lower cost enrollees. Few ads showed people with visible disabilities (4%) or the appearance of serious illness (1%), though one-fifth of Medicare beneficiaries are in fair or poor self-reported health.
• Celebrity endorsers, including actor William Shatner, comedian J.J. Walker and former Arkansas governor Mike Huckabee, appear more often in Medicare Advantage ads sponsored by brokers and other third-party entities than in ads sponsored by insurers. The celebrity endorsers are almost always men. Ex-NFL star Joe Namath was the most prolific, appearing in ads that aired nearly 56,000 times over the period, or about 10 percent of all airings of Medicare Advantage ads that season. More than two-thirds of ad airings sponsored by brokers and other third parties mentioned getting money back in your Social Security check, even though just 17% of Medicare Advantage plans offered in 2023 include this benefit.

As part of this research, KFF also released a second report that was based on focus groups conducted in fall 2022, which confirms that many Medicare beneficiaries and their family members feel overwhelmed by the annual onslaught of TV ads and are sometimes confused about whether the government or private companies are behind them.

In the focus groups with beneficiaries and other Medicare plan shoppers, many participants thought TV advertisements were misleading and said they did not trust the content of the ads, particularly those that marketed a slew of “free” benefits. Many participants said they relied on agents and brokers when making coverage decisions. Few used government resources, such as the Medicare Handbook or 1-800 Medicare, but those who did generally found them helpful.

The two KFF reports come at a time when lawmakers in Congress, state insurance regulators and officials in the Biden administration are taking steps to address rising consumer complaints about deceptive marketing practices in Medicare ads. Such complaints, which numbered fewer than 16,000 in 2020, increased to nearly 40,000 in the first eleven months of 2021, according to the Centers for Medicare and Medicaid Services (CMS). The rise has coincided with an increase in advertising by third-party marketing organizations such as agents, brokers, lead generation businesses and media firms in recent years.

Finally, a third new KFF resource answers key questions about the Medicare open enrollment period. It addresses topics such as what sorts of changes beneficiaries can make during open enrollment; how features of traditional Medicare compare to Medicare Advantage; how supplemental coverage like Medigap plans or retiree health benefits factor into Medicare coverage decisions.

The Medicare ad study by KFF analyzed TV ad data that was compiled by the Wesleyan Media Project, which collaborated with KFF on the research. Ads were obtained from Vivvix (formerly Kantar) CMAG, a data analytics and consulting firm, and were coded by the Wesleyan Media Project and analyzed by KFF.

KFF also worked with PerryUndem to conduct focus groups with Medicare beneficiaries and other Medicare plan shoppers in the Fall of 2022, during the annual Medicare open enrollment period.

The full reports are available collectively here or individually at:

“How Health Insurers and Brokers Are Marketing Medicare: An Analysis of Medicare Advantage, Medigap and Prescription Drug TV Ads For the 2023 Open Enrollment Period”

“What Do People with Medicare Think About the Role of Marketing, Shopping for Medicare Options, and Their Coverage?”

“What to Know about the Medicare Open Enrollment Period and Medicare Coverage Options”