Lawmakers ask FDA for information on US drug shortages

By Mary Van Beusekon, MS - In response to continuing US drug shortages, two lawmakers have asked the Food and Drug Administration (FDA) to provide information on the country's continuing drug shortages. Read Full Article…

VBA Article Summary

1. Congressional Concern over Drug Shortages: House Committee on Oversight and Accountability Chairman James Comer and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain have raised alarms over the Food and Drug Administration's (FDA) failure to prevent a widespread shortage of essential drugs. This shortage includes critical medications for infections, heart failure, psychiatric conditions, and cancer. They have cited a pre-existing problem, not solely attributable to pandemic-related supply chain issues, including the reliance on overseas manufacturing and the reduced production of generic drugs.

2. Request for FDA Accountability and Documentation: Comer and McClain have formally requested detailed information and a briefing from the FDA to gain a better understanding of the agency's involvement in monitoring and preventing drug shortages. They aim to scrutinize the FDA's strategies and actions in the face of 128 drugs currently listed as scarce, which impacts the treatment of various serious health conditions.

3. Concerns Over Future Shortages and Public Health: The lawmakers expressed apprehension that the Inflation Reduction Act's price controls might exacerbate drug shortages by deterring investment in domestic drug production and the development of new therapies. They warned of the potential rise of illegal pharmacies and counterfeit drugs as desperate consumers seek alternatives, highlighting the necessity for the FDA to proactively address and mitigate the risk of future shortages to safeguard American public health.

Bipartisan bills meant to streamline employers’ healthcare reporting requirements

By Kathleen Steele Gaivin - Two pieces of legislation meant to streamline employers’ healthcare reporting requirements are drawing support from the long-term care industry. Sens. Catherine Cortez Masto (D-NV), John Thune (R-SD), Mark R. Warner (D-VA) and Todd Young (R-IN) introduced the bills in the Senate on Thursday. Read Full Article…

VBA Article Summary

1. Legislative Modernization: The Employer Reporting Improvement Act and the Paperwork Burden Reduction Act propose to modernize the current compliance requirements by allowing electronic filing and reducing the need for physical forms. This initiative aims to simplify the process for both employers and employees, facilitating easier access to benefits without the complexity of extensive paperwork, as highlighted by Senator Warner's statement.

2. Industry Support: The proposed legislation has garnered support from key industry stakeholders. The American Health Care Association / National Center for Assisted Living recognizes the potential for these changes to alleviate administrative burdens, enabling providers to concentrate on urgent matters, such as addressing the workforce shortage and improving care for seniors, rather than navigating bureaucratic procedures.

3. Advocacy and Streamlining Effects: The National Association of Benefits and Insurance Professionals (NABIP) has praised the legislative efforts as a significant advancement in healthcare reporting. NABIP CEO Jessica Brooks-Woods acknowledges the decade-long push for such reforms, emphasizing that the legislation will eliminate obsolete and cumbersome mandates, ultimately contributing to a more efficient healthcare system that benefits all parties involved, including fostering a robust workforce.

Gag Clause: An Employer’s Perspective

By CBIZ - The Consolidated Appropriations Act (CAA) of 2021 includes a provision prohibiting a health plan and related service entities from entering into so-called gag clauses. The intent of this law is to ensure that interested parties, such as health plan participants, health providers and the like, have access to cost and quality care information allowing such parties to access the identified information and allowing the sharing of such information with business associates. Read Full Article…

VBA Article Summary

1. Introduction of Gag Clause Attestation and Deadlines: Health plans and vendor contracts are now mandated by law to remove any clauses that prohibit the sharing of information, while still retaining the right to restrict certain public disclosures. Compliance with this regulation is verified through an attestation process overseen by the Departments of Health and Human Services, Labor, and Treasury. The inaugural attestation is due by December 31, 2023, covering the period from the law’s enactment on December 27, 2020, up to the attestation date. Subsequent annual attestations must be submitted by December 31st of each year.

2. Entities Required to Attest and Exemptions: The attestation process is obligatory for a wide array of health insurers and health plans, such as insured and self-funded plans, government, and church plans, including those that are grandfathered and grandmothered. However, this requirement is waived for excepted benefits like dental and vision plans, as well as account-based plans, including health flexible spending accounts and health reimbursement arrangements.

3. Attestation Procedure for Plan Sponsors: Completing the attestation involves a relatively straightforward online process. Plan sponsors can undertake the attestation themselves or outsource it to a service provider. The process includes accessing the designated website, using a code sent via email, filling out a web form with specific details about the plan, and then signing to confirm the attestation. Both the attestation process and proof of submission must be meticulously documented and retained by the plan sponsor, ensuring that all regulatory requirements are thoroughly met.

Reposition your role as a benefits advisor

By Kevin Trokey - I work in a very dangerous place. No, it’s not dangerous in the way that may first come to mind; it’s dangerous because one of my favorite pizzerias is on the first floor of my building. Yeah, THAT kind of dangerous. Read Full Article…

VBA Article Summary

1. The Power of Perspective in Everyday Jobs: The article illustrates the story of Tony, a seemingly ordinary pizzeria worker who also has a profound job delivering donor organs to recipients, a role he describes as "saving lives." This comparison highlights how viewing one’s job with a different perspective can transform the mundane into the extraordinary. It prompts readers to reevaluate their own roles and the importance of their work, regardless of the industry.

2. Parallels Between Unrelated Professions: Drawing parallels between Tony's pizzeria job and his critical role in organ delivery, the article suggests that the essence of many jobs is similar—they involve transferring something valuable from one place to another. This insight serves as a powerful reminder that the value of work is not always in the task itself, but in the significance and impact it has on others.

3. The Impact of a Shift in Perspective: Encouraging a shift in perspective, the article calls for individuals to see beyond the surface of their job descriptions. By recognizing the broader impact of their work, like improving client's bottom lines or influencing their strategies, professionals can elevate their sense of purpose, boost their confidence, and enhance their relationships with clients, changing not just how they view their role but potentially transforming the role itself.

U.S. job growth slowed in October, except for Healthcare

By John Commins - Healthcare accounted for nearly 40% of the 150,000 jobs created in the U.S. economy in March, new federal data show. Overall job growth in the national economy slowed in October, well below the 258,000 monthly average for jobs gained over the past 12 months, according to the Bureau of Labor Statistics' monthly report on job growth. Read Full Article…

VBA Article Summary

1. Healthcare Job Growth: In October, the healthcare sector saw the creation of 58,000 jobs, surpassing the average monthly growth of 53,000 jobs over the past year. The increase was led by ambulatory care services with 32,000 new positions, followed by hospitals with 18,000 jobs, and nursing and residential care facilities with 8,000 jobs.

2. Employment Rates and Wages: The unemployment rate remained constant at 3.9%, with 6.4 million individuals unemployed, which is unchanged from the previous month. Average hourly earnings for private nonfarm payroll employees increased modestly by 7 cents to $34, marking a 4.1% increase over the past year. Earnings for production and nonsupervisory employees also rose by 10 cents to $29.19.

3. Comparative Job Gains and Losses Across Sectors: Other sectors also experienced job gains, with government adding 51,000 positions; leisure and hospitality, 19,000; professional services, 15,000; and social services, 14,000. In contrast, manufacturing jobs declined by 35,000, significantly impacted by the Auto Workers strike affecting the automotive parts manufacturing sector. All reported job numbers for October and September are considered preliminary and may be revised in future BLS reports.

Menopause: The next big benefits trend?

By Dawn Kawamoto - Although 75% of American women in their 40s and 50s are working, only a tiny fraction of U.S. employers currently offer accommodations for those experiencing the disruptive and sometimes debilitating symptoms of menopause that eventually hit most women in this age group. Read Full Article…

VBA Article Summary

1. Increasing Recognition of Menopause Accommodations in the Workplace: Presently, only 4% of U.S. employers provide specific accommodations for employees going through menopause, but a study by NFP reveals that a third are considering adding such benefits within the next five years. As the stigma around menopause decreases, thanks in part to public discussions by figures like Oprah Winfrey and legislative efforts such as the Menopause Research Act of 2022, more companies like Microsoft and Genentech are recognizing the productivity and financial benefits of supporting menopausal employees.

2. Business Case for Menopause Benefits: Companies are acknowledging the costly impact of menopausal symptoms on employees, which can result in up to $26.6 billion in lost work and medical costs. Experts argue that retaining experienced mid-career women by providing a supportive work environment is more cost-effective than recruitment. Bristol Myers Squibb exemplifies this approach, having initiated a menopause benefits program that includes consultations, personalized treatment plans, and educational resources.

3. Steps Toward Implementing Menopause Support Programs: Despite 64% of working American women expressing a desire for menopause-specific benefits, there is a significant gap in employer recognition of this need. Establishing such a program involves understanding the demographics of the workforce, soliciting input from women about desired support, and creating policies and training that address menopausal symptoms. Internationally, countries like the U.K. lead in employer support, with over half offering menopause support, and the interest in such benefits is gaining momentum globally.

New recommendations outline how Congress could lower ground ambulance costs

By Laura Santhanam - To lower costs and improve billing for patients who need ground ambulance services, federal lawmakers should ban surprise bills, limit patient cost-sharing and make bills easier to understand, according to a committee formed by Congress to explore how to tackle these issues. Read Full Article…

VBA Article Summary

1. Patient Protection Against Surprise Billing: The advisory committee recommended to Congress that health insurance plans should cover emergency transport, including out-of-network ambulance services, to protect patients from surprise billing. They argued for mandated insurance coverage that would extend to the transportation of patients between hospitals, especially as specialized services become more centralized due to hospital mergers.

2. Capping Copays and Simplifying Billing: To ease financial anxiety during emergencies, the committee suggested a cap on patient copays for ground ambulance services to $100 or 10% of the out-of-network service cost, whichever insurance covers. They also advocated for bills to be more understandable, with clear language indicating insurance coverage, dispute processes, and illegal billing practices, to alleviate the stress on patients who are often in vulnerable health states.

3. Fair Compensation and Dispute Resolution: Acknowledging the financial strain on ambulance services, the committee recommended that Congress ensure guaranteed payments for ambulance crews, even when the care provided at the scene prevents a hospital transport. Moreover, they advised against employing an independent dispute resolution process for ground ambulances, which is seen as a bureaucratic hassle, preferring a system that removes patients from payment disputes between insurers and ambulance providers.

The obesity drug effect: What medical device executives are saying

By Susan Kelly - Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices. The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector. Read Full Article…

VBA Article Summary

1. Market Correction and Medtech Perspectives: The introduction of weight-loss drugs like Ozempic, Mounjaro, and Wegovy, which also treat diabetes, has created concern within the medical technology (medtech) sector, causing a significant market correction and a loss of approximately $370 billion in market capitalization. Analysts like Anthony Petrone from Mizuho Securities view the concern as more of a perceived risk, highlighting the potential of these drugs to reduce the prevalence of weight-related diseases and, by extension, the need for related medical procedures.

2. Company Insights on Drug-Device Interplay: Executives from major medtech companies have shared varied insights on their earnings calls:
   Abbott - Abbott's CEO notes an increase in the use of their FreeStyle Libre glucose monitor alongside GLP-1 medications, suggesting a complementary relationship that improves diabetes treatment.
   Boston Scientific - Boston Scientific sees GLP-1 drugs as beneficial but with limited short-term cardiovascular impact, predicting minimal influence on procedure volumes in the long term.
   Dexcom and Johnson & Johnson - Dexcom and Johnson & Johnson observe an increase in device usage and potential long-term complementary effects with these medications.

   Intuitive Surgical - Intuitive Surgical acknowledges a temporary slowdown in bariatric procedures due to the drugs but expects continued growth and market share increase in this segment.
   ResMed - ResMed sees no change in the use of their CPAP machines among patients using GLP-1 medications, indicating a stable combined therapy cohort and a positive outlook for patient flow.

3. Long-Term Outlook and Adoption: Despite initial disruptions, there is an overarching sentiment that the rising use of GLP-1 weight-loss drugs could eventually lead to a symbiotic relationship with medtech products. Medtech executives project that it could take over a decade for these drugs to reach peak usage, and even then, a significant portion of patients might not adopt them due to various challenges such as cost, side effects, and compliance. This anticipated gradual integration, along with a percentage of patients who may not tolerate medication long-term, suggests an ongoing and potentially growing need for medical devices and procedures in the future.

Medicare cuts doctor and hospital payments

By Maya Goldman - Medicare administrators served doctors and hospitals a pair of big payment cuts late Thursday. Read Full Article…

VBA Article Summary

1. Decrease in Doctor's Medicare Pay: The final rule announced a 3.4% reduction in a crucial factor that determines baseline Medicare compensation for doctors in the coming year, remaining consistent with the proposed figure from earlier in the summer. This cut has raised concerns among medical professionals, with organizations like the American Medical Association labeling the payment plan as unstable for physicians' finances and the Medical Group Management Association warning that it could significantly hinder patient access to care.

2. Hospital Outpatient Service Cuts and Repayments: Starting in 2026, there will be a reduction in payments for hospital outpatient services amounting to $7.8 billion over approximately 16 years. This measure is to balance earlier cuts from a discount drug purchasing program deemed illegal by the Supreme Court, with affected hospitals receiving a one-time payment totaling $9 billion. The hospital repayment policy has been criticized by the Federation for American Hospitals, particularly for its potential negative impact on rural hospitals' ability to provide critical services.

3. Possible Interventions and Adjustments: While the healthcare sector has expressed significant concern over these policies, there have been some concessions, such as the delay of hospital payment cuts by one year and the extension of telehealth provisions for doctors. Family physicians anticipate benefits from a new billing code for complex office visits. The final ruling leaves room for potential legislative action before year's end, with professional associations immediately calling for Congressional intervention to prevent the cuts and possible legal challenges hinted by stakeholders like FAH's CEO against the repayment plan for safety-net hospitals. Additionally, a separate rule indicates a 3.1% increase in rates for hospital outpatient and ambulatory surgical centers in 2024.