Insights

In today’s digital age, the protection of sensitive health information has become a priority for Congress. The Health Insurance Portability and Accountability Act (HIPAA), a federal law enacted in 1996, has long been the cornerstone of health data privacy in the United States. HIPAA sets the national standards for health data privacy and security, ensuring your health information is kept confidential and secure. It’s like your personal gatekeeper for medical records. However, as online data collection has grown, cyberattacks are increasing. Lawmakers and officials at the Department of Health and Human Services (HHS) have recognized the need for more comprehensive safeguards to protect health data privacy.

HHS & FTC Enforcement

HHS Office for Civil Rights (OCR) plays a crucial role in enforcing HIPAA; this office ensures that covered entities, such as health plans, health care providers, and health care clearinghouses, comply with HIPAA Privacy and Security Rules.

Additionally, the Federal Trade Commission (FTC) enforces the FTC Act and the Health Breach Notification Rule. The Health Breach Notification Rule applies to vendors of personal health records (PHR), PHR-related entities, and third-party service providers. This rule covers businesses not covered by HIPAA. The FTC Act prohibits deceptive or unfair acts or practices in commerce, including misleading consumers about health information handling. It enforces the idea that companies must ensure their health data practices do not cause more harm than good.

Gaps

However, despite regulatory efforts, gaps remain in HIPAA that can only be addressed by Congress. The law does not cover data collected by wearable devices, smart devices, health and wellness apps, and other digital health technologies that fall outside traditional healthcare settings. Companies may use this information for marketing purposes or share and sell your information to profit, depending on state law. In a House Energy and Commerce hearing in December of last year, witnesses discussed how Artificial Intelligence (AI) presents new challenges since AI models do not have HIPAA protection for the data they use, making it simple for an AI model to identify an individual patient

Congress is (kind of) Looking to Act

Congress has shown a growing interest in addressing health data privacy, particularly in the context of AI. President Biden issued an executive order on safe, secure, and trustworthy AI, emphasizing the need to protect Americans’ privacy, including from the risks posed by AI, and calling on Congress to pass bipartisan data privacy legislation. Yet, the urgency to tackle health data privacy has taken a backseat because of other congressional priorities and partisan disagreements on numerous matters.

Nevertheless, some Members of Congress, such as Senator Bill Cassidy (R-LA), are actively considering potential updates to HIPAA as evidenced by his request for input into potential updates to the legislation. As indicated by Sen. Cassidy’s persistence, ongoing consideration, and discussion regarding the expansion of health data privacy laws to encompass AI and other emerging technologies continues in earnest.

Advertisers’ Perspective

At least one group is happy Congress has not done anything to expand HIPAA – advertisers. The National Advertising Initiative (NAI) is an industry trade group that develops self-regulatory standards for online advertising for its members such as Google. The NAI states that Congress shouldn’t extend the federal health privacy law and that data-driven health advertising benefits consumers and health care professionals. They believe data-driven advertising serves to help consumers find the products they need, and it helps health care professionals optimize their products based on public needs.

Looking Ahead

As we have seen this year, Congress is struggling to pass anything right now. We will see if this year will be different, or if this becomes an issue for the next Congress to handle. Whatever happens, you can be sure we will be watching and providing in-depth analysis for our clients.

If you or your organization would like to receive this analysis, contact us!

 The KFF report on Health Coverage by Race and Ethnicity underscores the crucial role of health insurance coverage in accessing healthcare services and mitigating excessive medical expenses. This blog post summarizes the report’s findings.

Persistent Disparities in Coverage

The KFF report reveals that disparities in coverage have been entrenched over time and, in some instances, have widened despite previous gains under the Affordable Care Act (ACA).

• From 2010 to 2022, the uninsured rate among American Indian and Alaska Native (AIAN) individuals increased from 2.5 times higher than that of White individuals to 2.9 times higher.
• Similarly, Hispanic and Black individuals remained disproportionately more likely to be uninsured compared to their White counterparts.

Advancements during COVID-19 But Still Problematic

Notable improvements in health coverage were observed across various racial and ethnic groups between 2019 and 2022. These improvements primarily resulted from state and federal efforts to ensure affordable coverage during the COVID-19 pandemic.

• These efforts narrowed the gap in uninsured rates between Hispanic, Black, and AIAN individuals compared to their White counterparts.
• However, disparities in coverage persisted as of 2022, with nonelderly AIAN and Hispanic individuals exhibiting the highest uninsured rates.

High Uninsured Rates for Black and Hispanic Individuals Persist Even in Medicaid Expansion States

States that expanded Medicaid, as highlighted in the KFF report, witnessed lower uninsured rates across racial and ethnic groups than non-expansion states.

• However, the relative likelihood of Black and Hispanic individuals being uninsured as compared to White individuals remained consistent across both expansion and non-expansion states, underscoring ongoing systemic challenges.

Risks of Disenrollment from Medicaid Unwinding

The KFF report emphasizes concerns about potential disenrollment following the unwinding of Medicaid continuous enrollment post-pandemic. This raises concerns about its disproportionate impact on Hispanic, Black, AIAN, and NHOPI individuals, as highlighted in the report. Disenrolled individuals may face challenges accessing alternative coverage options, potentially exacerbating existing disparities.

Addressing Coverage Disparities

The report highlights the following to prevent coverage losses and narrow disparities:

• Policies that stabilize coverage
• Enhanced outreach and enrollment efforts
• Policies that provide continuous coverage for vulnerable populations, particularly children
• Increasing Medicaid expansion across states

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KFF Survey: Family Premiums in Employer Plans Up 7%

The average annual family premium for employer-sponsored coverage jumped 7% this year to reach nearly $24,000, according to the annual Employer Health Benefits Survey from the Kaiser Family Foundation (KFF).  The largely inflation-driven increase comes after a few years where family premiums for employer-sponsored plans generally remained stagnant.  While employers saw their share of the premium grow by a similar percentage, most employers are unlikely to shift growing premiums on to employees as the labor market remains tight.  However, 25% of employers reported in the survey that they are likely to increase employees’ premium contributions in the next 2 years.

HELP Committee to Vote on NIH Director Nomination on Oct. 25

The Senate Health, Education, Labor, and Pensions (HELP) Committee has scheduled an October 25 vote on Dr. Monica Bertagnolli’s nomination to lead the National Institutes of Health (NIH), which has been without a permanent director since December 2021.  The committee vote follows an October 18 nomination hearing during which Bertagnolli faced questions about prescription drug prices and gender-affirming care.  While Bertagnolli affirmed a commitment to making drugs more accessible, she declined to take a position on march-in rights that give the federal government the authority to take over a patent for a drugs it helped developed in order to lower drug costs.  Bertagnolli also expressed a commitment to improving the diversity of clinical trials and research staff.

New Study Links Low Serotonin to Long COVID

Lower levels of the neurotransmitter serotonin could be a contributing factor in the development and persistence of long COVID, according to a new study.  While estimates on the percentage of people affected by long COVID vary wildly, common symptoms include memory problems, fatigue, and headaches.  The study suggests that traces of COVID-19 remain in the gastrointestinal tract, where the majority of serotonin is produced.  The presence of COVID-19 could cause inflammation that depletes serotonin levels, which play an important role in mood and sleep regulation as well as transferring messages between brain cells and the rest of the body.  Researchers conducted the study by analyzing blood and stool samples from various clinical studies and in small animal models.

Insurers Call for Changes to Administration’s Mental Health Parity Rules

Organizations representing commercial health insurers say proposed rulemaking from the Biden administration to improve mental health parity could have unintended consequences that would limit access to care.  Released in September, the proposed rule would require plans to more closely evaluate their provider networks to ensure plan enrollees don’t face burdensome costs for out-of-network services, as well as would require a reevaluation of prior authorization protocols. However, stakeholders like the Blue Cross Blue Shield Association (BCBSA) argue that the proposed requirements could increase care that is not clinically recommended and limit a patient’s ability to choose care that best meets their needs.  The insurers’ concerns contrast with positive feedback from provider organizations and mental health advocacy groups.  As alternatives, BCBSA and America’s Health Insurance Plans (AHIP) are urging the administration to focus on workforce issues and licensure.

ICYMI: Senators Launch Bipartisan Mental Health Caucus

On Tuesday, a group of bipartisan senators launched the Senate Mental Health Caucus, which will focus on collaborating on mental health solutions, holding events to boost awareness of mental health issues, and reducing stigma.  During a press conference and subsequent reception to kick off, Sen. Tom Tillis (R-NC) spoke about how his experiences with mania and depression while he was on medication 16 years ago inspired him to work on mental health issues.  Similarly, Sen. John Fetterman (D-PA) discussed how his children became aware of his depression and his obligation to continue the conversation on mental health struggles.

2022 Uninsurance Rate Drops amid Concerns about Underinsurance

The uninsured rate in the US dropped from 8.3% in 2021 to 7.9% in 2022, according to the US Census Bureau.  Overall, 27 states saw their uninured rates decline, while Maine was the sole state to see its uninsured rate increase.  Per the Census Bureau, the increase in insurance rates can likely be attributed to Medicaid expansion in several states, economic growth, and enhanced marketplace premium subsidies under the American Rescue Plan Act.  However, remains unclear if trends towards lower uninsured rates will continue in 2023 as millions face potential coverage losses due to Medicaid redetermination.  Additionally, some state officials are concerned that Medicaid beneficiaries who lose their coverage could enroll in short-term plans that would render them underinsured.

White House Announces $240M Investment in Cancer Moonshot

The White House announced plans to award $240 million to researchers working on cancer-related projects as part of a larger initiative to advance the Cancer Moonshot.  The awards will be focused on projects that develop new tools that allow early detection of cancer, create new ways to visualize cancer cells during surgery, and produce devices that can deliver treatments directly to cancer cells and tumors more effectively.  The White House also announced development of a new program to transform data accessibility across cancer research, as well as new efforts and resources related to smoking cessation.  The administration is hopeful that the new investments will inspire the next generation of cancer researchers.

CDC Advisors Approve New COVID-19 Booster

A Centers for Disease Control and Prevention (CDC) advisory panel vote 13-1 on Tuesday on a recommendation for everyone ages 6 months and over to get the updated COVID-19 vaccine this fall.  Instead of recommending vaccines only for high-risk populations, as other countries have done, the advisors opted for a universal recommendation to allow for an easier vaccine distribution process and to ensure better access to vaccines.  The updated vaccines target the XBB.1.5 Omicron subvariant, which was the dominant subvariant in early 2023.  While other subvariants have since become more prevalent, recently published data has shown the new vaccines elicit strong protection against the newer subvariants.  The new shots could become available as soon as this week in some parts of the country.

HELP to Review Bertagnolli’s Nomination for NIH Chief in October

The Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a confirmation hearing next month on Dr. Monica Bertagnolli’s nomination for lead the National Institutes of Health (NIH), according to a recent announcement from Sen. Bernie Sanders (I-VT).  The announcement means the end of a months-long standoff where Sanders refused to move forward on the nomination until the White House released a plan on lowering prescription drug prices.  A surgical oncologist, Bertagnolli has been serving as the director of the National Cancer Institute since October 2022, and President Joe Biden tapped her for the top NIH role back in May 2023.  The NIH has been without a permanent leader since Dr. Francis Collins stepped down from the role in December 2021, and since then, Dr. Lawrence Tabak has been serving as acting director of the sprawling agency.

ICYMI: DC’s Coolest New Bar Is in…an Office?

The Distilled Spirits Council of the United States just moved its headquarters from downtown DC to Capitol Hill, and the organization’s latest digs feature an amenity nearly all advocacy organizations can’t claim: a 200-person capacity bar.  The council has already used the bar to host a meeting of the Congressional Bourbon Caucus and several fundraisers, and the organization plans to rent the space out for other events.  Of note, the bar contains an original George Washington-penned letter about the popularity of the first commander in chief’s whiskey.

Administration Proposes Fix to ACA “Family Glitch”

On Tuesday, the Treasury Department (USDT) and the Internal Revenue Service (IRS) issued a proposed rule to create a minimum value for family member of employees who are eligible for premium tax credits under the Affordable Care Act (ACA).  The rule aims to fix the “family glitch,” an ACA loophole that provides premium tax credits to individuals but not their family members.  According to the Kaiser Family Foundation, the family glitch has impacted about 5.1 million Americans.

CMS Limits Aduhelm Coverage to Clinical Trial Enrollees

On Thursday, the Centers for Medicare and Medicaid Services (CMS) issued a final coverage determination for Alzheimer’s drug Aduhelm that limits Medicare coverage of the drug to patients currently enrolled in clinical trials.  Aduhelm has been the subject of controversy since it was granted accelerated approval last summer due to its high out-of-pocket cost of $28,000 and mixed data on its efficacy.  In the coverage determination memo, CMS also outlined conditions of coverage for future drugs like Aduhelm that also target amyloid proteins.  For example, if the drugs were to go through the traditional approval process as opposed to accelerated approval, patients would not need to be enrolled in clinical trials to receive Medicare coverage.

CMS Proposes to Indefinitely Delay RO Model

On Wednesday, CMS issued a proposed rule that would indefinitely delay the implementation of the Radiation Oncology (RO) model, with no specific date for relaunching the model.  The proposed rule carries out legislation passed in December 2021 that required the RO model to be delayed until January 1, 2023.   The RO model was initially set to begin on January 1, 2021 but has been delayed multiple times.  The model, which would provide bundled payments for a 90-day episode of care to certain radiotherapy providers and suppliers, attracted controversy from radiology stakeholders over its mandatory status and reimbursement cuts.  In the proposed rule, CMS raised concerns over the costs of continually delaying the model’s implementation.

Republican Congressman Fred Upton to Retire

Rep. Fred Upton (R-MI) announced in a speech on the House floor Tuesday that he will not seek reelection in 2022.  Upton, who is among the 10 House Republicans who voted to impeach then-President Donald Trump in January 2021, cited Michigan’s new congressional map as a main reason for his decision to retire.  First elected to Congress in 1986, Upton forged a bipartisan reputation as chairman of the House Energy and Commerce Committee, where he was instrumental in advancing the 21^st Century Cures Act.

ICYMI: Lawmakers Defeat Lobbyists in Congressional Hockey Game

On Thursday night, the first Congressional Hockey Challenge in two years ended with the Lawmakers defeating the Lobbyists by a score of 4-2.  The Congressional Hockey Challenge began nearly a decade ago from a weekly pickup match consisting of congressional staff and lobbyists, and like all congressional sporting events, the game raises funds for a variety of charities.  Three members of Congress played for the Lawmakers this year: Reps. Tom Emmer (R-MN), Mike Quigley (D-IL), and Larry Bucshon (R-IN).  A prominent former member of Congress, who once laced up for the Lawmakers, is Sen. John Kerry (D-MA), who played on Yale’s varsity hockey team.

The administration’s latest interim final rule to implement the No Surprises Act dropped on September 30.  Here’s a look at the various reactions from stakeholders and why they are mixed.

What does it say?  The rule outlines a baseball-style, independent dispute resolution (IDR) process for settling payment disputes between out-of-network providers and commercial insurance plans.  Before the IDR process can begin, both parties involved must enter into a 30-day negotiation period to determine a payment rate.  If these negotiations fail, either party can initiate the IDR process.

Next, both parties submit their proposed payment rate with supporting documentation to a certified IDR entity, who then issues a binding determination by selecting one of the party’s proposed rates.  When making a determination on which rate to select, the IDR entity must “begin with the presumption” that the most appropriate rate is the median of contracted rates for a specific service in the same geographic region.

• Why? According to the rule, emphasizing the median in-network rate will help ensure that IDR outcomes are predictable and that stakeholders are not incentivized to overuse the IDR process.

In addition to the median-in network rate, other factors IDR entities may consider include the level of training, experience, and quality and outcomes measurements of the provider or facility that is furnished.

Insurers’ reactions have been favorable overall.  America’s Health Insurance Plans said the focus on the median in-network rate “is the right approach” to encourage all stakeholders to work together and negotiate in good faith.  And the ERISA Industry Committee said the IDR process will reinforce the intention of the No Surprises Act.”

But hospitals aren’t so happy.  The Federation of American Hospitals said the rule “misreads Congressional intent” on establishing a “fair and balanced” IDR process, while the American Hospital Association said the rule “unfairly favors insurers to the detriment of hospitals” and other providers.

Reactions from lawmakers are mixed, too.  Like hospital stakeholders, comments from members of Congress have focused on the rule’s prioritization of median in-network rates in the IDR process.  Ways and Means Committee Chair Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) said in an October 5 letter to the administration that the rule’s bias towards a median rate is not consistent with the law passed by Congress, which requires IDR entities to consider a range of factors when determining the appropriate rate.

However, House Education and Labor Committee Ranking Member Virginia Foxx (R-NC) commented that the rule is “consistent with congressional intent.” Both the Ways and Means Committee and the Education and Labor Committee played key roles in drafting the No Surprises Act.

When the No Surprises Act passed late last year, it was considered a win for hospitals, who favored settling out-of-network payment disputes with an IDR process.  In contrast, private health plans were advocating benchmark rates based on the median in-network rate as a solution.  By prioritizing median in-network rates in the IDR process, could the administration be attempting to balance the concerns of all health care stakeholders? 

What’s next: The administration will issue a rule later this year to implement the pharmacy and prescription drug reporting requirements of the No Surprises Act.  Despite a 60-day public comment period, the rule is final, and stakeholders will be required to comply with all of its provisions beginning January 1, 2022.  In the meantime, Reps. Neal and Brady have requested additional written justification from key administration officials on how the latest rule complies with the No Surprises Act, and stakeholders will continue to engage with the administration on upcoming rules.

ACA Survives Latest Legal Challenge

On June 17, the Supreme Court ruled 7-2 to overturn an appeals court ruling that found the Affordable Care Act’s (ACA) individual mandate to be unconstitutional.  The opinion by Justice Stephen Breyer was joined by the court’s two remaining liberal justices and four of the court’s six conversative justices, while justices Samuel Alito and Neil Gorsuch dissented.  In his opinion, Breyer argued that Texas and the other states that challenged the ACA’s individual mandate failed to show that they were harmed by enforcement of the mandate, which was zeroed out in 2017’s Tax Cuts and Jobs Act.  The ruling, which marks the third time the ACA has been reviewed by the Supreme Court, comes as the Biden Administration seeks to expand the ACA through financial subsidies and Medicaid expansion.

NIH Study Finds COVID-19 in US Earlier Than Initially Thought

A recent study by the National Institutes of Health (NIH) found COVID-19 may have reached the US as early as December 2019, nearly a month before the World Health Organization announced the discovery of a new coronavirus in Wuhan, China.  By testing for the presence of COVID-19 antibodies in blood collected via the All of US research program between January and March 2020, NIH researchers confirmed the results of a Centers for Disease Control and Prevention study of American Red Cross blood donations that found COVID-19 may have cropped up in the West Coast in December 2019.

Federal Government Purchases 200M Additional Moderna Doses

On June 16, Moderna announced that the US government purchased 200 million additional doses of its COVID-19 vaccine, bringing the total number of government-ordered doses to 500 million.  According to the company, the additional doses could be used as booster shots or primary vaccinations of children.    Moderna filed for full approval of its vaccine with the Food and Drug Administration (FDA) earlier this month and asked FDA last week to authorize its emergency use in adolescents aged 12 through 17.

McConnell Rejects Manchin’s Voting Rights Counteroffer

Senate Majority Leader Mitch McConnell (R-KY) said on June 17 that Republicans are likely to oppose Sen. Joe Manchin’s (D-WV) voting rights compromise, dashing any hopes for Democrats to advance comprehensive voting reforms.  Manchin introduced his proposal as a counteroffer to Democrats’ For the People Act that could potentially win the support of some moderate Republicans.  Manchin’s proposal includes some reforms which are already popular among Democrats, such as ending partisan gerrymandering and making election day a federal holiday, as well as others which are more appealing to Republicans, like a national voter ID law and allowing maintenance of voter rolls.  However, Senate Republican leaders say the proposal would undermine the authority of state legislatures, taking away their power to set congressional districts.

Administration Invests $3.2B in COVID Antivirals

On June 17, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci announced the Administration is investing over $3 billion to advance the development of antiviral pills that could be used to treat COVID-19.  The plan, known as the Antiviral Program for Pandemics, will provide support for clinical trials of promising COVID-19 treatments, with the goal of gaining FDA approval for some antivirals and making them available to the public within a year.  During a press briefing, Fauci said the antivirals could prove helpful for immunocompromised people for whom COVID-19 vaccines are less effective. While the federal government has invested billions of dollars in the development of vaccines, considerably fewer resources have been invested in COVID-19 treatments until now.

ICYMI: Amazon Pledges $125M for Workforce Housing in DC Area

Amazon announced on June 16 it will provide $125 million in financing to build or preserve approximately 1,000 units of affordable housing in the DC area on land owned by Metro, the region’s mass rail transit system.  The tech giant has already committed $2 billion to its Housing Equity Fund, which will finance affordable housing construction in regions that contain the company’s corporate offices, including the metropolitan areas of Seattle, Nashville, and Washington, DC.  Housing prices have notably climbed in the DC area since Amazon selected Arlington, Virginia as the site of its second headquarters.