Category Archives: Womens Health

10 Key Medtech Themes for 2023

Posted on by • Posted in Aging Population, Antitrust, Artificial Intelligence, Chronic Care Management, Chronic Diseases, Competition, Data Privacy, Data Security, Digital Health, European Medicines Agency (“EMA”), the Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), Federal Trade Commission, Federal Trade Commission (FTC), Food and Drug Administration (FDA), Market Consolidation, Medicines and Healthcare Products Regulatory Agency (MHRA), Medtech, Mergers & Acquisitions, Private Equity, Tech-Enabled Care, Telehealth - Remote Monitoring, Virtual Care Strategy, Virtual Healthcare, Virtual Office, Virtual Visit, Womens Health, Workforce Shortages • Leave a comment

https://medcitynews.com/2023/01/10

We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.

The combination of rapid developments in novel healthcare technology and heightened demand for integrated tech-enabled care has continued to fuel innovation in the medtech industry.  At the same time, medtech innovators – whether in digital health, wearables and AI-driven offerings in healthcare, or diagnostics, telemedicine and health IT solutions – continue to face a patchwork of laws, rules and norms across the world. Life sciences and healthcare innovators and regulators are also looking to medtech to increase access to care and health equity. Here are ten global medtech themes we are tracking in the coming year:

Focus on digital tuck-in acquisitions in medtech M&A

Despite continued uncertainty in the overall financial market, medtech M&A activity continued at a steady pace in 2022.  This year witnessed a rise in tuck-in acquisitions of smaller companies that can be easily integrated into buyers’ existing infrastructure and product offerings, as opposed to significantly sized takeovers of businesses that aren’t squarely aligned with buyers’ existing businesses lines.  Medtech acquirers have been particularly focused on developing their digital capabilities to innovate and reach customers in new ways.  As digitization continues to transform the industry, we expect acquirers to continue to prioritize the value of digital and data assets as they evaluate potential targets.

Continued interest by private equity and other financial sponsors

Private equity firms, healthcare-focused funds and other financial sponsors have continued to display a strong appetite for investing in Medtech companies, with top targets in subsectors such as diagnostics and healthcare IT solutions.  Later-stage medtech companies in particular are gaining a larger share of venture capital funding, as later-stage investments allow financial sponsors to focus on businesses with higher yields, as well as less time to market and capital reimbursement.  Demographic trends, including an aging population and the increasing prevalence of chronic diseases, coupled with healthcare technology advancements have created robust demand for medtech-enabled solutions.  Additionally, medtech offerings have broad applications that can extend beyond stakeholders in a specific therapy area, product category or care setting, offering the ability to satisfy unmet needs with large patient bases.

Strategic medtech collaborations as the new norm

Strategic medtech collaborations and partnerships have become the new norm in our increasingly connected digital healthcare ecosystem.  In response to heightened consumer demand for tech-enabled care, pharmaceutical and medtech companies are collaborating to use digital technologies to engage with consumers, unlocking a vast range of treatments such as personalized medicine.  Additionally, as the market rapidly evolves towards data-driven healthcare, we expect medtech companies to continue to work collaboratively to address existing barriers to data sharing and promote interoperability of healthcare data.

Continued scrutiny by antitrust and competition authorities 

As expected, global antitrust and competition authorities continued to focus on the tech, life sciences and medtech sectors in 2022.  The US, UK and EU authorities have stepped up efforts to investigate and challenge conduct by large pharma and technology companies pursuing mergers and acquisitions.  We expect these authorities to assess similar concerns in the digital health context in an effort to account for the value of combined datasets and the interoperability of various offerings that could be derived from digital health mergers and acquisitions.  Furthermore, geopolitical tensions have resulted in new and expanded foreign investment regimes to improve the resilience of domestic healthcare systems.  Notably this year, the UK government implemented the National Security and Investment Act that allows it to restrict transactions that may threaten national security, including in the AI and data infrastructure sectors.  Sensitive data continues to be a recurring theme for foreign investment review for Committee on Foreign Investment in the US  and that of the EU as well.

Growing importance of data privacy and security

Increasing regulatory attention to sensitive health data and the escalating rise of ransomware attacks has made data privacy and security more important than ever for medtech innovators.  The Federal Trade Commission has issued several statements about its willingness to “fully” enforce the law against the illegal use and sharing of highly sensitive data.  Additionally, several state privacy laws coming into effect in 2023 create new categories of sensitive personal data, including health data, and impose novel obligations on innovators to obtain data-related consents.  As ransomware continues to pose security-related threats, the US Department of Health and Human Services renewed calls for all covered entities and business associates to prioritize cybersecurity.  New standards, such as cybersecurity label rating programs for connected devices, aim to address security risks.  In the EU, medtech providers will need to consider how the launch of the European Health Data Space and newly proposed data regulation, such as the Data Act and AI Act, could impact their data use and sharing practices.

More active engagement with FDA/EMA/MHRA

We expect companies active in the medtech sector, particularly those that make use of AI and other advanced technologies, to continue their conversations with the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) and other regulators as such companies grow their medtech business lines and establish their associated regulatory compliance infrastructure. Given the unique regulatory issues arising from the implementation of digital health technologies, we expect the FDA, EMA and MHRA to provide additional guidance on AI/ML-based software-as-a-medical device and the remote management of clinical trials.  2022 saw stakeholders in the life sciences and medtech industries collaborate with regulatory authorities to push forward the acceptance of digital endpoints that rely on sensor-generated data collected outside of a clinical setting.  As the industry shifts to decentralized clinical trials, we expect both innovators and regulators to work together to evaluate the associated clinical, privacy and safety risks in the development and use of such digital endpoints.

Increasing medtech localization in the Asia Pacific region

2022 saw multinational companies (“MNCs”), including American pharma/device makers make an active effort to expand their medtech business lines in the Asia Pacific region.   At the same time, government authorities in the region have been increasingly focused on incentivizing local innovation, approving government grants and prohibiting the importation of non-approved medical equipment. In light of MNCs’ market share of the medical device market in the Asia Pacific region, especially in China, we expect the emergence of the domestic medtech industry to prompt discussions among MNCs, local innovators and government authorities over the long-term development of the global market for medical technology.

Long-term adoption of telehealth and remote patient monitoring technologies 

The Covid-19 pandemic saw the rise of telehealth and remote patient monitoring technologies as key modes of healthcare delivery.  The telehealth industry remains focused on enabling remote consultations and long-term patient management for patients with chronic conditions.  Looking forward, we expect to see increased innovation in non-invasive technologies that can provide early diagnostics and ongoing disease management in a low-friction manner.  At the same time, we anticipate telehealth companies to face increasing scrutiny from regulatory authorities around the world for fraud and abuse by patients and providers.  Consumer and patient data privacy and security in connection with telehealth and remote patient monitoring continue to remain top of mind for regulators as well.

Women’s health and privacy concerns for medtech

We expect to see increased consumer health tech adoption for reproductive care, especially in light of the U.S. Supreme Court’s decision to overturn Roe v. Wade.  Following the Dobbs decision, a number of states introduced or passed legislation that prohibits or restricts access to reproductive health services beyond abortion.  In response, women’s health-focused companies are expanding their virtual fertility and pregnancy, telemedicine and other services to patients.  At the same time, such companies need to assess the legal risks stemming from the collection and storage of their customers’ personal health information, which could then be used as evidence to prosecute customers for obtaining illegal reproductive health services.  We expect companies active in this space to take steps to navigate the patchwork of data privacy and security laws across jurisdictions while establishing clear digital health governance mechanisms to safeguard their customers’ data privacy and security.

Addressing inequities in the implementation of digital healthcare technologies

Medtech innovators and regulators have been increasingly focused on addressing inequities in the healthcare system and the data used to train AI and ML-based digital healthcare technologies.  In 2022, a number of medtech companies collaborated to provide technologies that result in improved patient outcomes across all populations, as well as boost participation of diverse populations in clinical trials.  In parallel, we are seeing increased interest from regulators to reduce bias in digital health technologies and the accompanying datasets, as evidenced by the EU’s proposed AI Act and the UK’s health data strategy. In the US, which currently lacks comprehensive government regulation of AI in healthcare, there have been increasing calls for institutional commitments in the area of algorithmovigilance.  Because of the inaccurate conclusions that may result from biased technologies and data, MedTech companies must prioritize health equity in the implementation of digital healthcare technologies so that everyone can benefit from the latest scientific advances.

In conclusion, the medtech industry has remained resilient amidst the challenging macroeconomic environment.  We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.  At the same time, the rapidly changing legal and regulatory landscape will continue to be a key issue for medtech innovators moving forward. Adopting a global, forward-thinking regulatory compliance strategy can help MedTech companies stay competitive and ultimately, achieve better outcomes for patients.

Biden Administration says that all hospitals must provide abortion care in emergencies

Posted on by • Posted in Abortion, Dept of Health and Human Services (HHS), Dept of Justice (DOJ), Emergency Care, Emergency Medical Treatment and Labor Act (EMTALA), Executive Orders, Health Policy, Womens Health • Leave a comment

https://mailchi.mp/30feb0b31ba0/the-weekly-gist-july-15-2022?e=d1e747d2d8

This week, federal health officials sent hospitals clarification that the federal Emergency Medical Treatment and Labor Act (EMTALA) protects the provision of abortion care during medical emergencies, regardless of state laws. The guidance also offers EMTALA as a possible legal defense for providers against state enforcement of antiabortion laws. Texas Attorney General Ken Paxton has already sued the Department of Health and Human Services (HHS) to set aside the guidance, claiming the agency is exceeding its authority.   

The Gist: This latest federal action follows President Biden’s recent executive order directing federal agencies to protect access to reproductive care, and HHS’s warning that pharmacists refusing to dispense medications used to induce abortions could be violating federal civil rights laws. The Federal Trade Commission and Justice Department have also announced that they will enforce data privacy rules and pursue legal action against states that look to restrict patients from traveling to obtain abortion care. 

These quick federal actions, while limited, are an attempt provide clarity for providers trying to deliver lifesaving care in a timely manner, without running afoul of state laws. Some Democrats, however, argue that they don’t go far enough, and are pushing for the President to declare a public health emergency on abortion, though it’s not clear that would provide much patient benefit.

Meanwhile, reports from Texas and other states with restrictive abortion laws reveal physicians are already delaying care for ectopic pregnancies and other life-threatening conditions, setting up all-but-certain legal action when patients experience adverse outcomes.

Threats of prison time put gynecologists in impossible circumstances

Posted on by • Posted in Abortion, Dilemma, Ethics, Health Policy, Legal Challenges, Legal Jeopardy, Legal Liability, Physician, Pregnancy Care, Prison Sentence, Uncertainty, Unclear Laws, Womens Health • Leave a comment

https://mailchi.mp/9e0c56723d09/the-weekly-gist-july-8-2022?e=d1e747d2d8

In states with laws that criminalize performing abortions, physicians are facing the dilemma of having to wait until a pregnant patient’s death is imminent to perform a potentially lifesaving procedure. Reporting from STAT News reveals how these laws are disrupting care. A physician in Missouri, which outlaws all abortions unless the life of the mother is in danger, described having to spend hours getting clearance from a hospital ethics team to perform the procedure on a patient with an ectopic pregnancy.

Even non-pregnancy care is being impacted. An arthritis patient taking methotrexate, which can also be used for abortion, was told by her doctor that all prescriptions for the drug are on pause due to legal uncertainty.

The Gist: Doctors and hospital legal counsel are dealing with a new legal landscape, marked by restrictive, ill-defined anti-abortion laws that fail to clarify what constitutes a medical emergency.

Physicians are forced to interpret unclear laws, often written without help from medical professionals, and many feel compelled to wait until patients are in dangerous, life-threatening situations to provide care—the opposite of what was instilled in them during years of training.   

Businesses face major benefits questions amid Roe uncertainty

Posted on by • Posted in Abortion, Employee Benefits, Health Insurance Benefit Design, Health Insurance Coverage Adequacy, Health Policy, Recruiting, Reproductive Health Benefits, Roe v. Wade, Supreme Court, Talent Competition, Talent Management, Womens Health • Leave a comment
https://www.axios.com/2022/05/13/businesses-face-major-benefits-questions-amid-roe-uncertainty?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Corporate America is facing a flurry of questions about how it provides health benefits in the wake of a leaked U.S. Supreme Court draft that indicates the federal right to abortion could be overturned.

Why it matters: Businesses hoping to use reproductive health benefits as part of efforts to recruit and retain employees would have to be careful not to run afoul of laws should states be allowed to ban abortions.

  • The balancing act over the next several months could get messy, experts warn.

What they’re saying: “It’s a serious issue for employers,” said Candice Sherman, the CEO of the Northeast Business Group on Health. The group represents roughly 80 large companies such as American Express, Colgate, Moderna and Pfizer.

  • Limits on abortion coverage have the potential to impact the physical and mental health of the workforce and could come as many employers are addressing equity and inclusion for women, people of color and LGBTQ employees, Sherman said.
  • That is often communicated by companies through benefit design.

State of play: Some large companies like Amazon, Apple and Lyft have already announced plans to provide workarounds in those states with abortion restrictions.

  • But many others are still on the sidelines as they tease out employees’ priorities on abortion-related benefits, as well as the potential costs and legal risks.
  • Eleven states restrict insurance coverage of abortion in all private insurance plans written in the state, including those offered through Affordable Care Act markets, according to the Guttmacher Institute. Six other states require abortion coverage in private health insurance plans.

Zoom in: One of the most immediate questions is what kind of employer-sponsored abortion coverage — as well as enhanced benefits like travel stipends — might create legal liabilities for companies in states that ban abortion.

  • “There’s a question as to whether providing transportation benefits could be construed, or at least alleged by the states in enforcement, as aiding and abetting,” said Garrett Hohimer, director of policy and advocacy for the Business Group on Health. That group counts corporations like The Walt Disney Co., Walmart and General Motors among its members.
  • Companies like Citigroup that pay for out-of-state abortions have already been threatened with the loss of business.

Yes, but: In the case of a challenge, companies would have a strong argument that federal protections for providing abortion care benefits preempt state laws, Emily Dickens, the head of government affairs for the Society for Human Resource Management, told Axios.

  • Dickens pointed specifically to the Pregnancy Discrimination Act which specifically says an employer is permitted to provide health insurance coverage for abortion, as well as protections under ERISA law.

But, but, but: It’s not a sure thing. For instance: “ERISA is not a get out of jail free card,” Hohimer warned, saying there is some question about how the law would be interpreted.

  • While experts largely believe the Affordable Care Act would provide protections for birth control coverage, it’s unclear how fertility benefits such as egg freezing, surrogacy or in vitro fertilization might be affected, Sherman said.

What to watch: Many large companies already offer health benefits allowing workers to travel to Centers of Excellence for procedures like joint replacements or cancer care.

  • Those kinds of benefits will likely gain more attention because of the attention surrounding reproductive health, Hohimer said.
  • Sherman said this may also raise questions about whether there’s flexibility in the tax code to expand the scope of Flexible Spending Accounts or Health Savings Accounts to cover travel for any health care issues.

The bottom line: “Assuming this discussion comes down the way we think it may, organizations are going to have to work very hard,” Sherman said.

The Association Between Continuity of Marketplace Coverage During Pregnancy and Receipt of Prenatal Care

Posted on by • Posted in ACA, Health Insurance Coverage Adequacy, Health Policy, Open Enrollment, Pregnancy, Prenatal Care, Qualifying Life Event, Womens Health • Leave a comment
The Association Between Continuity of Marketplace Coverage During Pregnancy and Receipt of Prenatal Care
The Association Between Continuity of Marketplace Coverage During Pregnancy and Receipt of Prenatal Care | The Incidental Economist

Pregnancy is a significant life event, one that typically leads to substantially more interaction with the health care system than average. In the United States (US), pregnant people usually have about one health care visit per month of pregnancy, during which they receive a myriad of services. However, access to high quality prenatal care — and enough of it — is often limited by one’s health insurance coverage.

When the Affordable Care Act was enacted, it established the individual Marketplaces from which those who are ineligible for Medicaid, Medicare, and/or employer-sponsored insurance can purchase coverage. However, pregnancy is not considered a qualifying life event, so an individual cannot just sign up for coverage once they find out they’re pregnant; they must wait until the next open enrollment period or the birth of their child, whichever comes first. Thus, they may be stuck without coverage during pregnancy. This can have a significant impact on access to appropriate prenatal care.

New Research

A recent study in Health Affairs looked at Marketplace enrollment patterns for pregnant people and the impact of Marketplace insurance coverage on their health and care utilization.

The authors are Sarah Gordon and Melissa Garrido from Boston University School of Public Health (BUSPH) Health, Law, Policy, and Management Department (HLPM) and VA Boston Healthcare System; Charlotte Alger from BUSPH HLPM; and Eugene Declercq from BUSPH Community Health Sciences Department.

The authors used data from the Pregnancy Risk Surveillance and Monitoring System (PRAMS) from 2016 to 2018. Developed by the Centers for Disease Control and Prevention, PRAMS is a self-reported survey within 40 states and New York City and is representative of 83 percent of all US births. State health departments pull a representative sample of recent births from birth certificate registries and reach out via mail and telephone to the selected mothers. The survey asks respondents about health status and behaviors, health care use, and insurance coverage.

With these data, they studied two questions. First, they assessed how likely pregnant people were to be enrolled in Marketplace insurance coverage preconception, during pregnancy, and/or postpartum. Sample size for this question was 6491 and the authors used simple descriptive analysis techniques.

Second, they studied how Marketplace enrollment impacted individuals’ receipt of prenatal care, such as the number of prenatal visits, receipt of care within the first trimester, and receipt of specific health care services like flu shots and screenings for intimate partner violence and depression. The sample size for this question was 3443, limited to individuals who reported Marketplace coverage during pregnancy. The authors used logistic regression models and inverse probability of treatment weights to conduct these analyses.

Findings

For enrollment, the authors found that about one third of respondents had continual Marketplace coverage, from preconception to postpartum. Of those who were only enrolled in the Marketplace preconception, over 70 percent reported Medicaid coverage during pregnancy. Of those who were only enrolled in the Marketplace postpartum, almost 50 percent reported Medicaid coverage and one third reported employer-sponsored insurance coverage during pregnancy.

For impact of enrollment during pregnancy, the authors compared those with continuous coverage (preconception to postpartum) to those who only enrolled in the Marketplace during pregnancy. Those with continuous Marketplace coverage were more likely to have “adequate” or “more than adequate” prenatal care use. (The authors defined these classifications using the Adequacy of Prenatal Care Utilization Index which measures timing and quantity of care.) Those with continuous coverage were also more likely to initiate prenatal care in the first trimester, though over 80 percent of respondents in both groups did so. The authors did not find any significant differences in the likelihood of receipt of particular prenatal services, such as flu shots or social/mental health screenings.

Limitations

There were several limitations to this study due to the nature of the PRAMS data set. For example, PRAMS is self-reported, subject to both recall bias and response bias. Plus, the survey is not conducted in all states and, thus, assumptions must be made about generalizability. Lastly, PRAMS simply includes a finite set of questions; this is certainly understandable but does limit researchers’ analyses.

Discussion

With the connection between insurance coverage and access to care clear, several notable policy questions arise from this study. Classifying pregnancy as a qualifying life event is perhaps the most obvious. As mentioned previously, pregnancy is not a qualifying life event, though the birth of a child is. (Only two states have implemented policies to the contrary.) Allowing an individual to sign up for health insurance coverage once pregnant, rather than waiting until birth or the next open enrollment period, could improve access to prenatal care and even improve maternal and child health outcomes.

Another related policy implication is determining what type of insurance is ideal for pregnant individuals. The authors found that individuals without Marketplace coverage often have other types of coverage, at least temporarily. What type of insurance is best or most cost-effective for pregnant people — and the benefits of coverage continuity regardless of type — could be studied further.

The study did not touch on the quality of prenatal care but that is also worth discussion. In the US, pregnant people tend to receive far more prenatal care than other countries but that doesn’t mean the quality is better, nor do maternal health outcomes suggest that’s true. In fact, the US’ maternal health outcomes are some of the worst in the industrial world.

Pregnancy is full of changes, expenses, and challenges. Determining how Marketplace insurance coverage — which has been around for a decade — access to care, and maternal and child health outcomes all interact from preconception to postpartum warrants more study.

Medicare finalizes its hospital payment policy for next year

Posted on by • Posted in Health Equity, Health Inequity, Health Policy, Health System, Hospital, Hospital Industry, Maternal Care, Maternal Mortality, Medicare, Medicare Advantage, Medicare Payment, Price Transparency, Quality Measures, Quality of Care, Womens Health • Leave a comment

https://mailchi.mp/ef14a7cfd8ed/the-weekly-gist-august-6-2021?e=d1e747d2d8

CMS finalizes $2.3B pay bump for hospitals in federal fiscal 2022 | FierceHealthcare

The Centers for Medicare & Medicaid Services (CMS) issued its final payment rule for inpatient hospitals for FY22 this week, giving providers a 2.5 percent pay increase, and implementing a number of other regulatory changes. Of particular note, the rule puts in place a requirement for hospitals and long-term care providers to report on COVID vaccination rates among their workers, amid growing calls for healthcare organizations to mandate vaccines.

The final rule will also extend additional payments to hospitals for delivering COVID care until the end of the public health emergency is declared.

On top of a number of changes to quality reporting programs aimed at reducing the adverse impact of the pandemic on hospital metrics, CMS also used the final inpatient rule to begin acting on the Biden administration’s stated desire of improving health equity by adding a maternal morbidity measure to hospital quality reporting requirements.

The measure will require hospitals to report whether they participate in initiatives to improve perinatal health, an area in which unequal treatment has led to disproportionately adverse outcomes for women of color. In what will surely be welcome news for hospitals, CMS will no longer require disclosure of the contract terms providers strike with Medicare Advantage insurers, which was a key provision of Trump-era transparency regulations.

Nevertheless, based on earlier proposed changes to physician and outpatient surgery payment rules, and the President’s recent executive order on competition policy, we’d anticipate the Biden administration will continue to boost efforts to increase transparency of provider pricing.

First things first, however: there’s a pandemic to get through, and this final inpatient payment rule should largely come as good news to hospitals who are increasingly feeling the strain of a fourth surge of COVID cases.

Biden’s Broader Vision For Medicaid Could Include Inmates, Immigrants, New Mothers

Posted on by • Posted in ACA, Access, Access & Quality of Healthcare, Health Insurance Coverage Adequacy, Health Policy, Medicaid, Medicaid Expansion, Social Determinants of Health, Uninsured, Womens Health • Leave a comment

https://www.npr.org/sections/health-shots/2021/06/23/1009251576/bidens-broader-vision-for-medicaid-could-include-inmates-immigrants-new-mothers

Hospitals, health care advocates launch campaign to authorize Medicaid expansion through statewide vote

The Biden administration is quietly engineering a series of expansions to Medicaid that may bolster protections for millions of low-income Americans and bring more people into the program.

Biden’s efforts — which have been largely overshadowed by other economic and health initiatives — represent an abrupt reversal of the Trump administration’s moves to scale back the safety-net program.

The changes could further boost Medicaid enrollment — which the pandemic has already pushed to a record 80.5 million. Some of the expansion is funded by the COVID-19 relief bill that passed in March, including coverage for new mothers.

Others who could also gain coverage under Biden are inmates and undocumented immigrants. At the same time, the administration is opening the door to new Medicaid-funded services such as food and housing that the government insurance plan hasn’t traditionally offered.

“There is a paradigm change underway,” said Jennifer Langer Jacobs, Medicaid director in New Jersey, one of a growing number of states trying to expand home-based Medicaid services to keep enrollees out of nursing homes and other institutions.

“We’ve had discussions at the federal level in the last 90 days that are completely different from where we’ve ever been before,” Langer Jacobs said.

Taken together, the Medicaid moves represent some of the most substantive shifts in federal health policy undertaken by the new administration.

“They are taking very bold action,” said Rutgers University political scientist Frank Thompson, an expert on Medicaid history, noting in particular the administration’s swift reversal of Trump policies. “There really isn’t a precedent.”

The Biden administration seems unlikely to achieve what remains the holy grail for Medicaid advocates: getting 12 holdout states, including Texas and Florida, to expand Medicaid coverage to low-income working-age adults through the Affordable Care Act.

And while some of the recent expansions – including for new mothers — were funded by close to $20 billion in new Medicaid funding in the COVID relief bill Biden signed in March, much of that new money will stop in a few years unless Congress appropriates additional money.

The White House strategy has risks. Medicaid, which swelled after enactment of the 2010 health law, has expanded further during the economic downturn caused by the pandemic, pushing enrollment to a record 80.5 million, including those served by the related Children’s Health Insurance Program. That’s up from 70 million before the COVID crisis began.

The programs now cost taxpayers more than $600 billion a year. And although the federal government will cover most of the cost of the Biden-backed expansions, surging Medicaid spending is a growing burden on state budgets.

The costs of expansion are a frequent target of conservative critics, including Trump officials like Seema Verma, the former administrator of the Centers for Medicare & Medicaid Services, who frequently argued for enrollment restrictions and derided Medicaid as low-quality coverage.

But even less partisan experts warn that Medicaid, which was created to provide medical care to low-income Americans, can’t make up for all the inadequacies in government housing, food and education programs.

“Focusing on the social drivers of health … is critically important in improving the health and well-being of Medicaid beneficiaries. But that doesn’t mean that Medicaid can or should be responsible for paying for all of those services,” said Matt Salo, head of the National Association of Medicaid Directors, noting that the program’s financing “is simply not capable of sustaining those investments.”

Restoring federal support

However, after four years of Trump administration efforts to scale back coverage, Biden and his appointees appear intent on not only restoring federal support for Medicaid, but also boosting the program’s reach.

“I think what we learned during the repeal-and-replace debate is just how much people in this country care about the Medicaid program and how it’s a lifeline to millions,” Biden’s new Medicare and Medicaid administrator, Chiquita Brooks-LaSure, told KHN, calling the program a “backbone to our country.“

The Biden administration has already withdrawn permission the Trump administration had granted Arkansas and New Hampshire to place work requirements on some Medicaid enrollees.

In April, Biden blocked a multibillion-dollar Trump administration initiative to prop up Texas hospitals that care for uninsured patients, a policy that many critics said effectively discouraged Texas from expanding Medicaid coverage through the Affordable Care Act, often called Obamacare. Texas has the highest uninsured rate in the nation.

The moves have drawn criticism from Republicans, some of whom accuse the new administration of trampling states’ rights to run their Medicaid programs as they choose.

“Biden is reasserting a larger federal role and not deferring to states,” said Josh Archambault, a senior fellow at the conservative Foundation for Government Accountability.

But Biden’s early initiatives have been widely hailed by patient advocates, public health experts and state officials in many blue states.

“It’s a breath of fresh air,” said Kim Bimestefer, head of Colorado’s Department of Health Care Policy and Financing.

Chuck Ingoglia, head of the National Council for Mental Wellbeing, said: “To be in an environment where people are talking about expanding health care access has made an enormous difference.”

Mounting evidence shows that expanded Medicaid coverage improves enrollees’ health, as surveys and mortality data in recent years have identified greater health improvements in states that expanded Medicaid through the 2010 health law versus states that did not.

Broadening eligibility

In addition to removing Medicaid restrictions imposed by Trump administration officials, the Biden administration has backed a series of expansions to broaden eligibility and add services enrollees can receive.

Biden supported a provision in the COVID relief bill that gives states the option to extend Medicaid to new mothers for up to a year after they give birth. Many experts say such coverage could help reduce the U.S. maternal mortality rate, which is far higher than rates in other wealthy nations.

Several states, including Illinois and New Jersey, had sought permission from the Trump administration for such expanded coverage, but their requests languished.

The COVID relief bill — which passed without Republican support — also provides additional Medicaid money to states to set up mobile crisis services for people facing mental health or substance use emergencies, further broadening Medicaid’s reach.

And states will get billions more to expand so-called home and community-based services such as help with cooking, bathing and other basic activities that can prevent Medicaid enrollees from having to be admitted to expensive nursing homes or other institutions.

Perhaps the most far-reaching Medicaid expansions being considered by the Biden administration would push the government health plan into covering services not traditionally considered health care, such as housing.

This reflects an emerging consensus among health policy experts that investments in some non-medical services can ultimately save Medicaid money by keeping patients out of the hospital.

In recent years, Medicaid officials in red and blue states — including Arizona, California, Illinois, Maryland and Washington — have begun exploring ways to provide rental assistance to select Medicaid enrollees to prevent medical complications linked to homelessness.

The Trump administration took steps to support similar efforts, clearing Medicare Advantage health plans to offer some enrollees non-medical benefits such as food, housing aid and assistance with utilities.

But state officials across the country said the new administration has signaled more support for both expanding current home-based services and adding new ones.

That has made a big difference, said Kate McEvoy, who directs Connecticut’s Medicaid program. “There was a lot of discussion in the Trump administration,” she said, “but not the capital to do it.”

Other states are looking to the new administration to back efforts to expand Medicaid to inmates with mental health conditions and drug addiction so they can connect more easily to treatment once released.

Kentucky health secretary Eric Friedlander said he is hopeful federal officials will sign off on his state’s initiative.

Still other states, such as California, say they are getting a more receptive audience in Washington for proposals to expand coverage to immigrants who are in the country without authorization, a step public health experts say can help improve community health and slow the spread of communicable diseases.

“Covering all Californians is critical to our mission,” said Jacey Cooper, director of California’s Medicaid program, known as Medi-Cal. “We really feel like the new administration is helping us ensure that everyone has access.”

The Trump administration moved to restrict even authorized immigrants’ access to the health care safety net, including the “public charge” rule that allowed immigration authorities to deny green cards to applicants if they used public programs such as Medicaid. In March, Biden abandoned that rule.

Are new moms really the key to health system loyalty?

Posted on by • Posted in Consumer Marketing, Consumer Preferences, Consumer Research, Consumer Segmentation, Consumerism, Investment, Investments, Market Segmentation, Marketing, Strategy, Womens Health • Leave a comment

https://mailchi.mp/d88637d819ee/the-weekly-gist-march-19-2021?e=d1e747d2d8

Healthcare Marketing Blog for Hospitals and Health Systems | BPD Advertising

It’s long been accepted as a truism that “moms” make most of a family’s healthcare choices. This has led many health systems to invest in high-end women’s services, especially labor and delivery facilities, with the hope of winning the entire family’s long-term healthcare loyalty.

This conventional wisdom has existed since the middle of the last century, when the postwar Baby Boom coincided with the rise of commercial insurance. But it’s hard to find real evidence that these investments deliver on their intent—and we think the argument deserves to be reexamined.

An expectant mother is likely years away from her family’s major healthcare spending events. Giving her a fantastic virtual care experience, or taking great care of her teenager who blows out a knee playing soccer, is likely to engender greater loyalty to the health system when she’s looking for her first mammogram, than her labor and delivery experience from a decade earlier. That’s not to say that top-notch obstetrics isn’t important—but market-leading labor and delivery facilities are likely more critical for wholesale purchasers, such as an employer considering a narrow network, or for physicians choosing where to build an OB practice.

Direct-to-consumer strategies should be built on more sophisticated consumer research that takes into account the preferences of a new generation of consumers, for whom not all healthcare choices are equal—that same consumer will be in different “segments” and make different choices for different problems over time, not all pre-determined by one memorable birthing experience.

Trump Unveils Healthcare Agenda

Posted on by • Posted in 2020 Election Issues, Abortion, ACA, Employer-Based Health Insurance, Essential Health Benefits, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Medicaid, Medicaid Expansion, Medicare, Out of Pocket Expenses, Pandemic, Personal Protective Equipment (PPE), Pharmaceutical Industry, Preexisting Conditions, Prescription Drugs, Social Security, Supreme Court, Surprise Bills, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vaccine, Vague, Womens Health • Leave a comment

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What's in, and out, of Biden's health care plan

List of bullet points prompts debate over lack of detail, potential for actual achievement.

Health policy scholars critiqued the Trump campaign’s broad strokes healthcare agenda for his potential second term. While some found it overly vague, even dishonest, one suggested it was precisely what voters want.

Released Sunday night as a list of bullet points, the “Fighting for You” agenda will apparently serve as the Republican platform for the 2020 election. The GOP’s platform committee voted over the weekend to dispense with the customary detailed policy document for this cycle, in favor of simply backing President Trump’s agenda.

That agenda, which the Trump campaign promised would be fleshed out in future speeches and statements, included the following points relevant to healthcare:

Eradicate COVID-19

  • Develop a vaccine by the end of 2020
  • Return to normal in 2021
  • Make all critical medicines and supplies for healthcare workers
  • Refill stockpiles and prepare for future pandemics

Healthcare

  • Cut prescription drug prices
  • Put patients and doctors back in charge of our healthcare system
  • Lower healthcare insurance premiums
  • End surprise billing
  • Cover all pre-existing conditions
  • Protect Social Security and Medicare
  • Protect our veterans and provide world-class healthcare and services

Reliance on China

  • Allow 100% expensing deductions for essential industries like pharmaceuticals and robotics who bring back their manufacturing to the U.S.
  • No federal contracts for companies who outsource to China
  • Hold China fully accountable for allowing the virus to spread around the world

Joseph Antos, PhD, a resident scholar in healthcare and retirement policy at the American Enterprise Institute, characterized Trump’s strategy as “Don’t explain it. Just say what your goals are.”

He applauded the brevity of the document, 6 pages in total, covering 10 different policy areas from jobs to healthcare to immigration, as a “smart strategy.”

Voters don’t want to read lengthy policy briefs and gave the “Biden-Sanders Unity Task Force Recommendations” which were over 100 pages long and “unbelievably complicated stuff” as an example of how not to reach voters.

“I think [Trump] got it right. He’s not running a think tank…. He’s running for office. He does have a keen eye for what the average voter could stand to listen to.”

Gail Wilensky, PhD, an economist and senior fellow at Project Hope in Bethesda, Maryland, and CMS administrator under President George H.W. Bush, agreed that a platform packed with policy details doesn’t sway many voters.

This election, she said, is about one thing only: “Trump or not Trump.”

Whither the ACA?

Nevertheless, the Trump campaign’s goals merit attention, often for what they don’t include as well as what they do.

As for the substance of the agenda, the key difference between the Trump administration’s proposed agenda and that of the Democratic nominee, former Vice President Joe Biden, is that the latter aims to expand access to health insurance using the Affordable Care Act’s (ACA) framework, said Wilensky.

While Trump’s 2016 healthcare agenda centered around repealing the ACA, his second-term agenda doesn’t mention the law by name.

Wilensky said she’s glad that Trump did not include ACA repeal among his goals, given that “there’s no historical precedence” for eliminating the core benefits of such far-reaching legislation, now on the books for 10 years and fully implemented for 6.

Kavita Patel, MD, a primary care physician and Brookings Institution scholar in Washington, D.C., who was an advisor on the Democrats’ platform, said, “This is all just posturing and politics and almost a continuation of things [Trump’s] been saying without any real details behind it.”

Many of these items — such as ending surprise billing, lowering health insurance premiums, and cutting prescription drug prices — would have Democrats’ support “but they would get there in a different way,” Patel said.

One thing she was surprised not to see in the agenda were references to abortion or other reproductive health issues, she noted.

Insurance Coverage Neglected

Rosemarie Day, founder and CEO of Day Health Strategies and author of Marching Toward Coverage: How Women can Lead the Fight for Universal Healthcare, was dumbfounded by the overall lack of substance in the agenda, and particularly by the absence of a plan to deal with rising rates of uninsurance related to the pandemic.

Day thought the Trump campaign could have at least included a plan for returning to the “baseline” on the number of uninsured. Another administration might have chosen to promote Medicaid coverage or encourage unemployed workers to enroll on the health insurance exchanges, but not this administration, she said.

“So, they’re really just leaving people out in the cold,” Day said.

Wilensky, too, suggested it would have been “useful” for the Trump campaign to have “talked about how they envision getting more people covered.”

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy, said much of the agenda is “just aspirations.”

“‘Put patients and doctors in charge of our healthcare system’? … I don’t know what the policy is, [but] who’s going to quarrel with that?”

Lowering healthcare premiums also sounds “nice” but how that would be achieved is unclear, he said.

One agenda item in the document that really really irked Day was the Trump administration’s pledge to protect people who have pre-existing conditions.

“I consider the ‘covering all pre-existing conditions’ an outright lie,” she said. “I find it incredibly upsetting that [Trump] continues to say that” because he spent his first term attacking the ACA, which does protect pre-existing condition coverage.

Day also noted that the administration has repeatedly promised an ACA replacement without ever delivering an actual proposal.

Responding to the Pandemic

The Trump campaign agenda lists “eradicate COVID-19” on its bullet list, but Patel said it’s “probably not an achievable goal.” A more realistic target is to control it better.

“We have deaths every year and hospitalizations from influenza, but we have a vaccine and we have … strategies to protect people like seniors and young children,” Patel said. “That’s exactly the kind of attitude we have to take” with regard to COVID-19.

For both Patel and Ginsburg, “return to normal” is another aspiration that’s beyond the government’s power to deliver.

“So much depends on a vaccine and its acceptance and how quickly it can be produced,” Ginsburg said.

As for making all critical medicines and supplies for healthcare workers in the United States, Ginsburg acknowledged that it’s theoretically doable, but still unrealistic because it would be “way too expensive.”

“Brand name drugs are routinely produced in other countries as well as the U.S.; I wouldn’t want to upset that supply chain, especially for drugs that are in shortage,” he said.

 

 

 

Trump sidelines public health advisers in growing rift over coronavirus response

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Data Integrity, Dept of Health and Human Services (HHS), Economic Crisis, Economy Reopening, Evidence-Based Care, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, False Hope, False Narrative, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Integrity, Intimidation, Leadership Culture, Leadership Decentralized, Mislead, Misleading, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Physician, Public Health, Public Safety, Retaliation, Scientists, Transparency, Trust, Truth, Womens Health • Leave a comment

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The Health 202: Health officials promise to ramp up pandemic ...

The June 28 email to the director of the Centers for Disease Control and Prevention was ominous: A senior adviser to a top Health and Human Services Department official accused the CDC of “undermining the President” by putting out a report about the potential risks of the coronavirus to pregnant women.

The adviser, Paul Alexander, criticized the agency’s methods, and said its warning to pregnant women “reads in a way to frighten women . . . as if the President and his administration can’t fix this and it is getting worse.”

As the country enters a frightening phase of the pandemic with new daily cases surpassing 62,000 on Wednesday, the CDC, the nation’s top public health agency, is coming under intense pressure from President Trump and his allies, who are downplaying the dangers in a bid to revive the economy ahead of the Nov. 3 election. In a White House guided by the president’s instincts, rather than by evidence-based policy, the CDC finds itself forced constantly to backtrack or sidelined from pivotal decisions.

The latest clash between the White House and its top public health advisers erupted Wednesday, when the president slammed the agency’s recommendation that schools planning to reopen should keep students’ desks six feet apart, among other steps to reduce infection risks. In a tweet, Trump — who has demanded schools at all levels hold in-person classes this fall — called the advice “very tough & expensive.”

“While they want them open, they are asking schools to do very impractical things. I will be meeting with them!!!” Trump tweeted Wednesday. Within hours, Vice President Pence had asserted the agency would release new guidance next week.

“The president said today we just don’t want the guidance to be too tough,” Pence told reporters. “And that’s the reason next week the CDC is going to be issuing a new set of tools.”

Analysts say the deepening divide is undermining the authority of one of the world’s premier public health agencies, which previously led fights against malaria, smallpox and HIV/AIDS. Amid the worst public health crisis in a century, the CDC has in recent months altered or rescinded recommendations on topics including wearing masks and safely reopening restaurants and houses of worship as a result of conflicts with top administration officials.

“At a time when our country needs an orchestrated, all-hands-on deck response, there is simply no hand on the tiller,” said Beth Cameron, former senior director for global health security and biodefense on the White House National Security Council.

In the absence of strong federal leadership, state and local officials have been left to figure things out for themselves, leading to conflicting messaging and chaotic responses. Trump’s decision to pull the U.S. out of the World Health Organization further undermined efforts to influence global strategies against the coronavirus, including how vaccines will be distributed.

The CDC, meanwhile, is increasingly isolated — a function both of its growing differences with the White House and of its own significant missteps earlier in the outbreak.

Those stumbles include the botched rollout of test kits likely contaminated at a CDC lab in late January, which led to critical delays in states’ ability to know where the virus was circulating. And the CDC’s initial decision to test only a narrow set of people gave the virus a head start spreading undetected across the country.

During a May lunch with Senate Republicans, Trump told the group the CDC “blew it” on the coronavirus test and that he’d installed a team of “geniuses” led by his son-in-law Jared Kushner to handle much of the response,” according to two people familiar with the lunch who spoke on the condition of anonymity.

“There is a view the CDC is staffed with deep state Democrats that are trying to tweak the administration,” said one adviser who also spoke on the condition of anonymity to reveal private conversations.

White House officials, who see the president’s reelection prospects tied to economic recovery, also say they’ve been deeply frustrated by what they view as career staffers at the agency determined “to keep things closed,” according to a senior administration official who spoke on the condition of anonymity to reveal internal deliberations.

Trump believes the CDC is “ineffective” and a “waste of time,” but doesn’t blame CDC Director Robert Redfield and generally likes him, said another official speaking on the condition of anonymity. “He just thinks he is a poor communicator,” the official added.

Joe Grogan, former head of the White House Domestic Policy Council, said Redfield had fans inside the White House who work on “addiction issues, on life issues, on HIV issues,” among other topics.

But he said Redfield has few political appointees to help him run a complex agency. “How do you run a place like that with … [few] appointees?” Grogan asked.

HHS Secretary Alex Azar called the director “a key scientific guide for the President and his administration, a trusted source for the American people, and a closely engaged partner of state and local governments.”

But Redfield is not a voice in coronavirus task force meetings, and “is never really in the Oval [Office] with the president,” said another senior administration official, who also spoke on the condition of anonymity to discuss the internal dynamics.

Even Redfield’s supporters say he has failed to be an effective advocate for the agency.

“Bob Redfield’s commitment to public health is completely strong,” said William Schaffner, a veteran infectious-disease specialist at Vanderbilt University. But he said Redfield lacks the standing, deftness, and communication capacity to persuade skeptical audiences, including those in the White House, that protecting public health and fostering economic recovery are not opposing goals.

Redfield, for his part, downplayed Trump’s criticism of the CDC school reopeniing guidelines after a coronavirus task force briefing Wednesday, saying the agency and the president were “totally aligned.”

“We’re both trying to open the schools,” he said.

White House spokesman Judd Deere also disputed big differences, saying in a statement the White House and the CDC “have been working together in partnership since the very beginning of this pandemic to carry out the President’s highest priority: the health and safety of the American public.

“The CDC is the nation’s trusted health protection agency and its infectious disease and public health experts have helped deliver critical solutions to save lives. We encourage all Americans to continue to follow the CDC’s guidelines and use best-practices they have learned, such as social distancing, face coverings, and good hygiene, to maintain public health and continue our Transition to Greatness.”

But some health experts were indignant the agency had been ordered to rewrite guidance to reopen schools to “make it easier and cost less” — a demand that effectively “turns science on its head,” said Tom Inglesby, director of Johns Hopkins University’s Center for Health Security.

“CDC should be giving their best judgments on how to lower risks to make schools safer,” he said. “That’s their job. If they aren’t allowed to do that, the public will lose confidence in the guidance.”

Why are they ‘not shouting “fire”?’

The diminished role of the 74-year-old agency has bewildered infectious-disease experts, as well as members of the public seeking guidance.

After six states set one-day case records on July 3, Carlos del Rio, executive associate dean at Emory University’s School of Medicine, tweeted at Tom Frieden, a former CDC director, “Tom, where is @CDCgov ? Why are they not out there shouting ‘fire’?”

Frieden shot back: “They are still there, still doing great work, just not being allowed to talk about it, not being allowed to guide policy, not being allowed to develop, standardize, and post information that would give, by state and county, the status of the epidemic and of our control measures.”

Jeffrey Duchin, the health officer at Seattle and King County health department, added: “Agree. Muzzled, neutered and exiled.”

The agency has been largely invisible. After more than three months of silence, it resumed briefings for the public last month. There have been two.

By comparison, when the H1N1 swine flu pandemic hit the United States in the spring of 2009, the CDC held briefings almost every day for six consecutive weeks.

During this outbreak, the agency’s regular briefings ended abruptly after White House officials were angered when a top CDC leader warned that Americans could face “significant disruption” to their lives as a result of the virus’s spread to the United States.

CDC officials say they are still getting their message out, pointing to more than 2,000 documents providing pandemic-related information about reopening and staying safe for dozens of groups and venues, including funeral home directors, amusement parks, and pet owners. Each Friday, the CDC also posts CovidView, a weekly report of selected data and trends on testing, hospitalizations, and reported deaths.

But the information is posted without additional explanation or analysis.

“I want to hear a real person give me three minutes based on these findings,” said del Rio, also a global health and infectious-disease professor at Emory. “I want to see them in the news, being interviewed, giving us the data.”

Scientists at the CDC and former colleagues speak of deep frustration and low morale over its inability to fully share and explain scientific and medical information.

Researchers are fearful for their jobs and want to protect the integrity of the data they release. “If you want to say something, you’re thinking, ‘what’s the White House going to say and how are they going to use it,’ ” said one longtime scientist who spoke on the condition of anonymity for fear of retaliation.

The lack of briefings has fostered misunderstandings at times. In early April, for instance, when the agency reversed its position and recommended the use of cloth face coverings, CDC scientists gave no public briefings explaining why they made the change.

“It’s not rocket science,” said Nancy Cox, a virologist and former CDC official who led the influenza program for 22 years and was part of the agency’s response during the 2009 H1N1 swine flu pandemic. “But the reasoning behind those changes should be explained as clearly as possible and then you can get everyone on board.”

In the CDC’s absence, academic medical centers, public health and professional disease groups have filled the void by holding coronavirus briefings and providing analysis of key issues, data and research studies. Frieden, the president of Resolve to Save Lives, a New York nonprofit, has also been posting long Twitter threads analyzing the weekly CDC data released on Fridays.

Speaking ‘with an unfettered voice’

Alarmed at the agency’s diminished role, nearly 350 public health organizations sent a letter Tuesday to Azar urging him to advocate for the CDC. The agency must be allowed to speak based on the best available science “and with an unfettered voice,” said John Auerbach, president and chief executive of Trust for America’s Health, a public health nonprofit that led the effort.

House Democrats echoed those concerns in a separate letter to Azar last month. Reps. Diana DeGette of Colorado and Frank Pallone Jr. of New Jersey, who chairs the House Energy and Commerce Committee, said they were troubled by reports that administration officials are considering narrowing the CDC’s mission and embedding more political appointees at the Atlanta-based agency.

Traditionally the CDC has one political appointee, the director. Now it has Redfield and five other political appointees, including two advisers who were added in recent weeks.

“Now more than ever, the American people need a robust and effective CDC that is not repeatedly undermined by others in the administration, including the President and the Vice President,” the letter said.

White House Chief of Staff Mark Meadows views the agency as a problem and has criticized the CDC repeatedly to other administration officials, said a senior administration official.

White House and HHS officials are discussing what the CDC’s “core mission needs to be,” said one adviser familiar with the talks who spoke on the condition of anonymity to comment on policy deliberations. The discussions were first reported by Politico.

Over the years, the agency that was founded to fight malaria now works on virtually every aspect of public health. “It has tried to be everything to everyone,” the adviser said, suggesting the agency might need to refocus more narrowly.

On the global front, administration officials are also weighing a $2.5 billion initiative called the President’s Response to Outbreaks that would move a significant portion of national and international pandemic responses to the State Department, according to a draft obtained by The Post. Details were first reported by Devex.

“There is no clear leadership role for CDC” in this plan, said Jennifer Kates, a senior vice president for global health and HIV policy at the Kaiser Family Foundation. “In global health, you need an engaged CDC.”

Taken together, the administration efforts seem “designed to position CDC to the margins,” said one federal health official who spoke on the condition of anonymity for fear of retaliation.

‘Boogeyman where there aren’t any’

The report that drew the email attack, accusing the agency of undermining the president, had provided detailed but incomplete information about pregnancy risks related to the coronavirus. It found pregnant women with covid-19 were more likely to be hospitalized, admitted to an intensive care unit, and to need ventilator support than infected women who are not pregnant.

The sender, Alexander, a specialist in health research methods, is a senior adviser to Michael Caputo, a longtime Trump ally who was recently appointed assistant HHS secretary for public affairs , which includes the CDC.

The email was directed to Redfield and Caputo.

Even amid the intense criticism of the agency, the email “crosses the line,” said the official, who was aware of the content.

Like all of the CDC’s reports, the analysis itself noted several limitations. One key one that researchers acknowledged was that they did not have data to indicate whether the pregnant women were hospitalized because of labor and delivery, or because they had covid-19.

Administration officials are “seeing political boogeymen where there aren’t any,” the federal health official said, adding that such narratives could further hamper the U.S. response.

“It could feed the fire to limit the flow of scientific data and communication to the general population,” the official said. “People are getting sick and dying. Can we just focus on the science?”

Alexander said in his email that the lack of data about why women were hospitalized was a “key issue.”

“The CDC is undermining the President by what they put out, this is my opinion and sense, and I am reading it and can see the subtle and direct hits,” he wrote.

Alexander, also a part-time assistant professor at McMaster University in Hamilton, Ontario, did not respond to emails and telephone calls seeking comment.

Caputo said in an interview that he agreed with Alexander. The CDC represents itself as the gold standard for public health agencies, he said, “but in the case of pregnancy analysis, it wasn’t even bronze.”

He called CDC’s track record “spotty” and “questionable,” pointing to Zika diagnostic testing errors in 2016.

“In many cases over the years, regardless of administration, the CDC has undermined presidents and themselves,” Caputo said, referring to leaked drafts of CDC guidances. “Who says the CDC is the sole font of wisdom when it comes to detecting and fighting deadly pathogens?”

Experts say that even with some big unanswered questions, the pregnancy findings represent the best available evidence and are important. The lack of data reflects decades of long-neglected national surveillance on pregnancy.

“I don’t think this is frightening women,” said Denise Jamieson, who heads the obstetrics and gynecology department at Emory University and Emory Healthcare. True, the report “suffers from completeness of data,” she said. But now doctors can be more confident that pregnant women are more likely to have severe disease and use “this really important information” to counsel patients, she said.