DOL Audit Fights Cyberterrorism

DOL Audit Fights Cyberterrorism

Of the many responsibilities Employee Retirement and Income Security Act (ERISA) plan sponsors, fiduciaries, and recordkeepers must uphold, one of the most challenging relates to cybersecurity to protect plan assets and plan participants’ information. The US Department of Labor (DOL) upped the ante associated with cybersecurity last year when it issued first-of-a-kind new guidance in April and, within several weeks, started auditing for compliance.

With cyber threats and attacks on the rise, in April of 2021 the DOL issued a three-part guidance package (Cybersecurity Program Best Practices; Tips For Hiring a Service Provider; and Online Security Tips) and specified plan fiduciaries are obligated to mitigate cybersecurity risks within their own operations, vendors’ operations and prospective vendors’.  To reinforce this guidance, the DOL began requesting information and documents to audit compliance.

According to the Employee Benefits Security Administration, as of 2018, there were an estimated 34 million defined benefit plan participants in private plans and 106 million plan participants in defined contribution plans with estimated American retirement assets exceeding $9 trillion. That’s an attractive target for cyber criminals and threats. The American Society of Pension Professionals and Actuaries indicates that while the April 2022 guidance was the first related to cybersecurity, it complements regulations on electronic records and disclosures to plan participants and beneficiaries about protecting personally identifiable information.

The DOL wasted no time reinforcing cybersecurity is one of its top priories. Within two months of issuing the guidance, it began requesting documents and information about plan cybersecurity policies and practices as part of retirement plan audits.

According to the Society for Human Resource Management (SHRM), the DOL asks for “all documents relating to any cybersecurity or information security programs that apply to the data of the Plan, whether those programs are applied by the sponsor of the Plan or by any service provider of the Plan.” This may include policies, procedures, and guidelines for access controls and identity management; processes for business continuity, disaster recovery and incident response; third-party providers’ management; cybersecurity training; data encryption; documents and communications about past incidents; service providers’ documents and communications regarding cybersecurity capabilities and procedures and how plan data is used, and more.

Bloomberg Tax created a cybersecurity audit checklist for plan fiduciaries based on the DOL guidance, and an action plan to promote compliance. It suggests fiduciaries should get informed about cybersecurity governance; get expert support when needed; identify data flow and storage; and assess fiduciary conduct to date.

Going forward, many sources indicate that while the immediate focus is on retirement plan assets and participants, fiduciaries and plan sponsors may want to prepare to uphold the same guidance for their health and welfare plans.

If you’re unsure about anything related to compliance with the guidance or audits, it’s always a good idea to consult your benefits legal counsel. For assistance with benefit plan accounting, taxes, and audits, you can trust RBT CPAs – a leading provider in the Hudson Valley for over 55 years.

Clamping Down on Anti-Competitive Behavior in Healthcare

Clamping Down on Anti-Competitive Behavior in Healthcare

Last July, President Biden issued Executive Order 14036 to promote competition (and eliminate anti-competitive practices) across a number of industries, including health care, with the hopes of lowering prices, increasing growth and wages, and promoting innovation. The order includes 72 initiatives, including four specifically focused on health care.

In this post, we explore what has happened since the executive order was issued and what’s expected to happen next in relation to the health care initiatives.

Lowering prescription drug costs

Two months after the executive order was issued, the Department of Health and Human Services (HHS) released, “A Comprehensive Plan for Addressing High Drug Prices.” A recent Congressional Budget Office report on prescription drug costs and spending indicate cost increases are slowing but that’s only after seeing spending increase from $30 million in 1980 to $335 million in 2018.

In 2021, 20 states enacted 43 laws to lower costs that included establishing Prescription Drug Affordability Boards (PDABs); regulating Pharmacy Benefit Managers (PBMs); limiting out-of-pocket  insulin costs; and promoting cost transparency. According to the National Conference of State Legislators Bill Tracking Database, New York State introduced 69 bills related to lowering prescription drug costs last year; another 20 have been introduced since the start of this year.

Allow hearing aids to be sold at drug stores

The Food and Drug Administration (FDA) proposed a rule creating a category of hearing aids that could be sold over-the-counter at drug stores without a prescription. The rule was up for public comment during a 90-day period ending January 18 of this year.  According to Harvard Health, approval is expected some time this year and manufacturers are already moving ahead with production that will give consumers access to a $600 on-average device (versus the $5,000 average at a doctor’s office).

Still, 42 states are asking that as part of the rule the FDA preserves related state consumer protection laws. At the same time, the Federal Trade Commission  indicates that, in part, some of those laws hurt competition and access to affordable hearing aids. Several governors are asking that the FDA finalize the rule without delay. 

Stop the negative impacts of healthcare industry consolidation

The Justice Department and Federal Trade Commission (FTC) are encouraged to review merger guidelines to ensure patients are not harmed by hospital mergers, which have traditionally driven up prices and left rural areas without adequate access to care. As a first step, the FTC restored a policy where it could restrict two merging parties from moving forward if it would have anti-competitive impacts on the community. Courts seem to align with this position. However, the American Hospital Association disagrees, asserting current practices actually boost competition and help the economy. Also, a study by the American Medical Association shows mergers actually result in better patient outcomes – something the medical community asserts the political establishment is ignoring.  The FTC is currently soliciting public comments on the issue. So, stay tuned.

Address surprise bills from hospitals

Even before President Biden’s executive order, actions were underway to promote hospital price transparency and eliminate surprise bills for care. This past January 1, new rules took effect under the No Surprises Act requiring uninsured patients receive good faith estimates for the cost of care and insured patients don’t receive surprise bills for emergency care and treatment by an out-of-network provider at an in-network facility.

What’s more, with the Consolidated Appropriations Act of 2021, health plans and health plan issuers are required to track and submit certain prescription drug and health care costs starting December of 2022 (for 2020 and 2021 data) and every June thereafter to help promote price transparency.

Going forward

For decades, addressing escalating health care costs in the U.S. has been the focus of legislation, corporate board rooms, and individuals, and it looks like it’s going to remain a hot topic with both the FTC and the HHS identifying actions related to Executive Order 14036 a priority for 2022.

We’ll keep you updated as the story continues to unfold. In the meantime, RBT CPAs does have staff specializing in accounting and taxes for health care. Should you need advice or assistance, please give us a call.

NOTE: RBT CPAs is an accounting and tax firm – not a law firm. In no way should information in this article be construed as legal advice or direction. For that type of assistance, we encourage you to contact your legal advisor.

Limited-Scope Audits Expand Auditor and Plan Sponsor Responsibilities

Limited-Scope Audits Expand Auditor and Plan Sponsor Responsibilities

Effective December 15, 2021, new standards apply to audits of financial statements for employee benefit plans subject to the Employee Retirement Income Security Act (ERISA). While this primarily expands what’s required of an auditor, plan sponsors have some new responsibilities as well.

Employee retirement and health plans are legally required to undergo an audit – by a qualified accountant – at a plan’s year end to help protect plan participants. The auditor inspects financial accounts and issues a report on the plan. The audit helps hold those managing and controlling a plan accountable in their fiduciary responsibilities. After a United States Department of Labor assessment showed these audits had major deficiencies, new standards were issued.

The new standards apply to “limited-scope audits,” which are now called Statement on Auditing Standards (SAS) No. 136 ERISA Section 103(a)(3)(C) audits. Under the new standards, an employee benefit plan’s annual reporting obligations are expanded. Along with Form 5500, the auditor’s report must include an opinion on financial statements, schedules, and accounting principles and practices.

To start, a plan sponsor must provide a letter confirming eligibility for a Section 103(a)(3)(c) audit and acknowledge responsibility for plan administration (including maintaining the plan document and amendments; ensuring plan transactions are consistent with plan provisions; and maintaining accurate records to determine participants’ plan benefits). The letter must state the audit is permissible; investment information was prepared by a certified bank, insurance carrier or similar institution; and the certified investment information meets the new requirements, and is appropriately measured, presented, and disclosed.

In addition, the plan sponsor must provide a substantially complete draft Form 5500 – with forms and schedules that may affect the audit — to the auditor before he/she can move ahead with the engagement.

In turn, the auditor will evaluate the plan and use a new format to report findings. The report provides more transparency by requiring more details about the auditor’s opinion and basis for that opinion, as well as financial statements and the audit of those statements. The audit must include reportable findings that include noncompliance or suspected noncompliance with applicable laws and regulations; findings relevant to those who oversee financial reporting and governance; and/or an indication of deficiencies in internal controls warranting attention. Any reportable finding must be communicated in writing to those responsible for governance so it can be addressed in a timely manner.

While they require a bit more work, the new standards are a positive for plan participants and sponsors by promoting transparency and compliance, while uncovering potential issues when they are easier to rectify.

To ensure compliance, plan sponsors should start the process earlier than usual, so they can be sure to select a qualified, experienced auditor (like RBT CPAs), and have the time to gather and complete required paperwork and forms.

Your RBT CPAs partner is ready to walk you through the new process and conduct an audit to ensure compliance with the new standards. Give us a call so we can help you get started today.

SOURCES: SHRM, RSMUS, Employee Benefit Plan Audit Quality Center (EBPAQC), Plansponsor.com

Patient Satisfaction & Your Financial Future

Patient Satisfaction & Your Financial Future

Healthcare and the delivery of healthcare services is often a matter of life and death and there has been an increased intensity of those in need of medical help and, as a result, a significant increase in the demanding workload on the healthcare workforce.

Patients deserve quality care and healthcare employees deserve on-the-job satisfaction to provide quality care.  Thoughtful considerations must go into how stressful and challenging the work of a healthcare provider is and how it impacts patients with either a negative or positive outcome as it links to public investment in hospital care. To succeed in 2022, healthcare organizations must address this concerning connection to sustain high-quality healthcare readiness and the funding that makes access possible.

According to News: Medical Life Sciences, 2021 studies show that there is a critical link between hospitals’ healthcare compensation, healthcare workers’ well-being, and patient satisfaction surveys. It is impossible to separate this idea from The Center for Medicare and Medicaid Service (CMS), whose goal is to empower consumers and hold hospitals accountable for improving care by implementing the Medicare payment system that ties patient care experiences with hospital reimbursement rates.  Since 2008, CMS endorses the publishing of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scoring system that provides qualitative data to rate patient experiences using Value Based Performance Standards (VBP). Specifically, all the dimensions surveyed are consumer-driven factors that contribute to well-being and satisfaction, such as the conditions of the hospital environment (noise level, cleanliness), the social climate (interactions, responsiveness), and information access (discharge, care transition). When any of these factors are receiving unsatisfactory or poor scores, it can negatively affect healthcare employees’ job satisfaction due to significant stressors, thereby affecting customer satisfaction–and hospital funding. Let’s face it, there are billions of dollars from Medicare at stake.

Certainly, the stressors of the still raging pandemic in the healthcare field highlight the need to address and prevent undue burdens on our healthcare professionals as we move into 2022. The real burdens of occupational pressures on the healthcare providers on the front lines translate into their ability to provide quality care experiences.  Patient experiences of care across the nation certainly reflect the caregiver’s burden in the HCAHPS VBP scores so healthcare leaders can utilize this data in practical and useful ways. Healthcare organizations have an obligation to fundamentally do good by their healthcare professionals and consequently increase positive outcomes for patients.

What steps can you take to boost patient satisfaction and secure healthcare funding?

  • Ensure adequate funding and allocate funding resourcefully
  • Elicit feedback from healthcare professionals to allow for emerging new ideas
  • Provide empowerment opportunities to those who feel a lack of control over their work
  • Be transparent; share knowledge
  • Establish systems or support from senior staff
  • Let employees know they are valued
  • Create equitable engaging training to keep up to date
  • Foster healing and recovery for healthcare providers
  • Approach care from an honest, open, empathetic stance
  • Encourage healthcare professionals to invest in patients

The satisfaction of the patients is largely dependent upon the healthcare workforce they encounter in adverse situations.

The perceptions of patients are key to acknowledge as it influences healthcare funding as we head into 2022. KFF offers an overview and funding facts on Medicare spending, showing that Medicare was 15% of the total federal spending in 2018 which totaled $605 billion; further, Medicare spending is projected to rise to 18.3% percent from 2019 to 2029, increasing spending to $1.3 trillion in 2029. By enhancing the well-being of healthcare workers, hospitals will be better able to retain and recruit healthcare workers, provide quality care, increase customer satisfaction, and plan to respond to future public health threats.

Here at RBT CPAs, we understand the diverse and complicated world of healthcare. Our team of healthcare experts brings industry expertise in reimbursement, regulatory compliance and audit, accounting, and tax services. We will continue to keep you notified of timely news that matters to you and your team, but if you’d like to connect and receive individualized services, please contact us today. If you would like to submit feedback or topic ideas for future articles our team produces, please feel free to contact us at TLideas@rbtcpas.com.

Sources: News-Medical, News-Medical, CMS, CMS, Relias, AMA, News-Medical, KFF

How to Fix the Healthcare Trust Problem

How to Fix the Healthcare Trust Problem

With December just one calendar page turn away, it’s a good time to consider ways your organization excelled this year, as well as areas your team fell short of. Reflecting on the past year, healthcare workers across the state were tested beyond limits and proved that this industry is more resilient than any of us could have imagined. Just like at RBT, the people you hire to be a part of your team are truly the lifeblood of your organization – they are what make your operation remarkable. But while the threat of the COVID-19 pandemic may finally be waning, other threats are lurking. With escalating cyberattacks on hospitals and health systems and the continued spread of health misinformation online, the healthcare industry is headed for an exit from the “trusted category” next year, according to a recent Forrester report. Why is distrust eroding the healthcare industry and what can your team do to protect your brand as we enter 2022?

Forrester examined the state of healthcare in the U.S. and how threats like misinformation and increasing cyberattacks will affect public trust for its Predictions 2022: Healthcare report. Misinformation has permeated social media and even platforms built for clinicians, and the true industry cost just might be immeasurable. The spread of false health information, shortcomings in data integrity, and the politicization of science will unseat healthcare from its standing as a trusted industry according to Forrester’s 2022 projections. Continued erosion of trust in healthcare institutions will force more clinics to close and threaten population health as patients avoid treatment for their conditions.

As far as cybersecurity is concerned, the report indicates that healthcare is the most attacked industry and has the highest average cost of a data breach as well as the slowest incident response time. Cybersecurity investment initiatives are expected to hit $125 billion between 2021-25 in response to the increasing number of threat actors and weak digital systems.

What can your team do today, to stay protected? The financial risk and the health of your patients are at stake if you don’t have full control over the information being shared with the public. Righting the ship in 2022 will require an all-hands-on-deck approach, including coordination between those working in public health research and practice, public policy, and cybersecurity. Ensuring you have a reliable communications department is key to getting your patients access to accurate, reliable information about your organization. Think about your social media strategy. When was the last time you updated the way you connect with clients? On the cybersecurity front, make sure you reassess your 2021 defense plan and determine whether or not your team is doing enough to protect your data. Ensure that everyone on your staff is up to speed on the plan. Simple team-wide reminders, like creating complex, unique passwords with frequent updates, encrypting patient data and medical files to avoid data leaks in ransomware, and using a VPN for a safe internet connection can help to avoid outside risks. Like misinformation, cybersecurity awareness and education will help your team recognize problems before they evolve into crises. As always, we are rooting for your success. Our trusted team of healthcare specializing RBT professionals are here for you, to navigate the diverse and complex world of healthcare. If you would like to submit feedback or topic ideas for future articles our team produces, please feel free to TLideas@rbtcpas.com.

Source: Forrester

Need to Know: DOL Cybersecurity Guidance

Need to Know: DOL Cybersecurity Guidance

Cyber-attacks are on the rise.

As you’re aware, plan sponsors, administrators, and service providers maintain electronic information that can be extremely vulnerable to cyber-attacks, including personally identifiable information (PII), participant enrollment data, and of course, electronically protected health information (EPHI). Responsible plan fiduciaries must safeguard against cybersecurity risks, but not everyone is prepared. This year, The Department of Labor (DOL) issued a new cybersecurity guidance package and has already begun including this in its enforcement efforts. Ask yourself this important question: does your team have internal cybersecurity policies that already meet updated standards? If not, it’s time to draft new policies or risk falling behind and falling victim to an attack.

What prompted this action?

Earlier this year, the Government Accountability Office (GAO) released cybersecurity issues and risk findings. The GAO issued an urgent recommendation that the DOL affirmatively state whether cybersecurity is a fiduciary obligation and provide guidance for plan sponsors and service providers regarding mitigation of this cybersecurity risk. In response, the DOL issued a three-part cybersecurity guidance package containing:

Best Practices.

The first document, Cybersecurity Program Best Practices supports information technology security protocols for Employee Retirement Income Security Act (ERISA)-covered benefit plans. The memo outlines 12 points for cybersecurity risk mitigation, including conducting cybersecurity risk assessments on at least an annual basis and conducting third-party audits of system security controls. In regards to conducting a third-party audit, EBSA indicated that if it were to review an audit program it would expect to see evidence of audit reports, penetration test reports, and documented corrections of any identified weaknesses. The document also calls for a plan sponsor’s cybersecurity program to be managed at the executive level, and annual cybersecurity awareness training. EBSA further instructs plan sponsors and fiduciaries to utilize a secure system development life cycle program (SDLC) to ensure that new systems are designed to prioritize cybersecurity considerations. For example, EBSA suggests certain events (like when a participant wants to change their account information) should automatically trigger two-factor authentication or other additional protocols.

Tips for Hiring Service Providers.

The second document, Tips for Hiring a Service Provider With Strong Cybersecurity Practices, is aimed at helping plan sponsors and fiduciaries protect their cybersecurity interests when working with a third party. In this guidance, EBSA lists six core points that plan sponsors and fiduciaries should follow in order to meet their responsibilities under ERISA. EBSA suggests asking potential service providers whether they have cybersecurity insurance coverage and reviewing public information regarding the provider’s cybersecurity track record and potential liabilities. Entering into a new contract? Time to read the fine print. Plan sponsors should carefully review the contract, ensuring it includes protections addressing access control policies, encryption policies, and a cyber threat notification procedure. Finally, EBSA recommends that service provider contracts include a clause requiring ongoing compliance with evolving cybersecurity information and standards.

A Model Notice offering Cybersecurity for Participants.

The third piece of guidance, Online Security Tips, is directed at participants and provides a list of best practices to reduce the risk of fraud and cybersecurity threats to retirement accounts. This guidance provides best practices for maintaining a secure online presence, such as using multi-factor authentication where possible, changing passwords regularly, and avoiding public Wi-Fi.

Since releasing this guidance, the DOL began ramping up its cybersecurity audit protocols by contacting plan sponsors and fiduciaries and inquiring as to their cybersecurity practices.

This means it’s a good idea to be prepared to produce cybersecurity and data privacy policies, information, and documentation related to past incidents, and risk assessment reports. Whether or not it’s been a priority in the past, cybersecurity considerations should become part of your regular administrative process. Please note that this DOL guidance likely applies to all plans governed by ERISA, not just retirement plans. To stay protected and prepared, a cybersecurity review should also be performed for ERISA-covered health and welfare plans. If you have any questions about the new guidance, please reach out to our team of dedicated professionals.

Source: DOL, GAO, Benefits Pro, Security Magazine

How Selecting the Right Audit Professionals Can Save You Millions

How Selecting the Right Audit Professionals Can Save You Millions

With the current administration aiming to significantly boost the Department of Labor’s (DOL’s) funding for 2022 and over the next 10 years, more DOL audits could be on the horizon for employers. The Employee Benefits Security Administration (EBSA), a DOL agency, is responsible for ensuring the security and integrity of private employee benefits plans throughout the country. And if employers are not prepared, a DOL audit or investigation carries significant risk. Organizations can be identified for audits for several different reasons, including:

  • Participant complaints
  • Referral from another agency
  • Errors or omissions in Form 5500 filings

Typically there isn’t much advance notice when an employee benefit plan is audited. Organizations can’t stop an audit, whether it is random or for a specific reason. If an audit uncovers violations, then corrective action may be required including paying penalties. By ensuring compliance in advance of an audit, organizations can prevent costly fines and save thousands, if not millions, of dollars.

What traits should you look for when interviewing auditors?

There are a variety of professional firms you can choose to work with and it’s important to take the time to connect with each option and determine which best fits your company’s needs. As a general rule, the firm you select should be able to discuss how their policies and procedures provide your company with reasonable assurance that the firm and its personnel comply with relevant ethical requirements. The American Institute of Certified Public Accountants (AICPA) Code of Professional Conduct establishes the fundamental principles of professional ethics, which include responsibilities, public interest, and integrity, objectivity, due care, scope, and nature of services.

What are “red flags” to look out for?

Generally speaking – accounting, auditing, and DOL rules are not static. While it’s not your job to keep up with accounting, auditing, and regulatory changes, it certainly is the job of the firm you trust with your audit. Missed changes in reporting requirements or upcoming deadlines could mean irrevocable damage to your company. If you get the sense that the firm members you meet with are at all disorganized, or fail to regularly revise firm checklists, programs, and other materials each year to reflect any new accounting, auditing, or regulatory requirements – it’s a major red flag. In fact, the DOL regularly reviews hundreds of audits annually and releases a report describing the most common “major audit deficiencies” for reference. A recent DOL audit quality study found that nearly 40% of plan audits had deficiencies (a copy of this study can be found here).

What’s an important question to ask potential firms you may work with in the future?

You should ask the firm what their criteria are for accepting and taking on new clients. The firm you select should establish policies and procedures for the acceptance and continuance of client relationships and specific engagements. Does the firm consider the integrity of the client? The identity and business reputation of the client’s principal owners, key management, related parties, and those charged with its governance are all important factors. There are real risks associated with providing professional services to a range of clients, and it’s important to know you’ll be in good company. You may learn that the firm is eager to take on any and every client that walks through their door (another red flag). Whatever the response you get, you’ll be able to gather a lot of valuable insight when you ask this simple question, so you can make an informed decision. Additionally, be sure to ask to obtain the auditor’s most recent peer review letter.

Ultimately, while you have a thousand other things on your to-do list, it’s important to find an auditor that maintains consistent teams, demonstrates industry knowledge, and keeps disruption to a minimum. While selecting a qualified audit firm won’t prevent you from having a plan selected for an audit, it can prepare and protect your plan. RBT CPAs, LLP’s audit team has developed guidelines that help us perform audits as efficiently and effectively as possible. We assign experienced staff, so you don’t need to teach new auditors your business every year. We gather industry knowledge from Firm resources and market research, to identify and target issues significant to your business. Finally and perhaps most importantly, we maintain as transparent a presence as possible during fieldwork, to minimize disruption and utilize your employees’ time efficiently. Contact us to set up a primary consultation to learn more about what we can do for you.

Sources: AICPA, DOL

The Harsh Reality Facing Healthcare Workers and Vaccination Mandates

The Harsh Reality Facing Healthcare Workers and Vaccination Mandates

It feels like bad déjà vu, but the reality is that once again the majority of New York healthcare systems are battling the perfect storm of challenges amid a resurgence of COVID-19 cases statewide. The rising risk of the delta variant, combined with staffing shortages, and mounting mandate pressure to get vaccinations in the arms of more staff members are creating a mess for officials. Over 450,000 New York hospital workers became eligible for vaccination under Phase 1A of New York’s COVID-19 vaccination program. Hospital worker vaccination progress is self-reported by individual hospital facilities weekly via the New York State Department of Health’s HERDS survey. Currently, 79% of Mid-Hudson area hospital workers have received a complete vaccine series, with the highest percentage reported in Westchester County (85%) and the lowest (55%) reported in Putnam County. With so much information constantly fluctuating, what do you need to know about state and federal vaccination mandates, and what are the financial implications for your healthcare system?

New York State’s public health and health planning council approved emergency regulations on August 26 requiring that hospital workers be vaccinated for COVID-19, while removing religious exemptions. Vanessa Murphy, a DOH attorney said they are not constitutionally obligated to provide a religious exemption, which is also the case for the Measles and Mumps vaccine. This will be in effect for 90 days before it’s either renewed or expires.

So, what is a valid medical reason to make an accommodation for a medical worker?

For a valid medical exemption, a licensed physician or certified nurse practitioner must certify that immunization with a COVID-19 vaccination is detrimental to the health of a member of a covered entity’s personnel, based upon a preexisting health condition, and ceases to be effective if it is later found that vaccination would not be detrimental to that personnel member’s health. The nature and duration of the medical exemption must be documented in the personnel file of the member of the organization in accordance with the same timeline for the vaccination requirements, along with documentation of whatever reasonable accommodations are granted in conjunction with the exemption.

What entities does this apply to in New York State?

The requirement approved by the public health and health planning council applies to hospitals, nursing homes, diagnostic and treatment centers, adult care facilities, certified home health agencies, hospices, long-term home health care programs, AIDS home care programs, licensed home care service agencies and limited licensed home care service agencies. So, who falls under New York State’s definition of health care “personnel” in the new regulation requirements? It’s pretty all-encompassing, covering employees, students, volunteers, and any other affiliates of the organization who “engage in such activities such that if they were infected with COVID-19, they could potentially expose other covered personnel, patients or residents to the disease.” According to the state health department, these institutions are tasked with developing a plan for implementation of the mandate and any actions it will take regarding non-compliant employees. This could include firing non-compliant workers.

What’s the COVID-19 vaccination deadline for staff?

Healthcare workers at hospitals and nursing homes must receive their first vaccine dose by Sept. 27. Workers at additional entities covered by the mandate, including diagnostic and treatment centers, home health agencies, long-term home health care programs, school-based clinics, and hospice care programs, must have at least one dose by Oct. 7. Documentation of proof of vaccination must be maintained in the personnel files of each employee/affiliate of the organization.

What about federal updates?

In a bold move, President Joe Biden announced in August that he is directing all nursing homes to require their staff to be vaccinated against COVID-19 in order to continue receiving Medicare and Medicaid funding. Over 130,000 nursing home residents and 2,000 employees died due to COVID-19, according to the most recent CDC data. However, vaccination rates among nursing home workers remain low. As of mid-August, about 60% of staff per facility were vaccinated, compared to 82.8% of residents per facility.

What are the financial and emotional consequences your system could face?

Here at home, HealthAlliance of the Hudson Valley, a three-hospital system in the Westchester Medical Center Health Network, laid off an undisclosed number of workers on June 14, according to the Daily Freeman. This is just one local example of shrinking medical staff at a time when facilities are overloaded with cases and patients. Tension is running high for medical professionals on both sides of the issue. The New York State Nurses Association (NYSNA) representing more than 42,000 members in New York State, last issued a statement in mid-August. “Overall, we are seeing a crisis in hospital emergency departments that indicates a general lack of preparedness. The DOH should listen to the frontline this time not just hospital CEOs. Our healthcare workers are exhausted and traumatized. Their voices should be heard – not denied or characterized as vectors of infection- which is exactly what we are trying to avoid. When healthcare workers document what they are experiencing they must be believed. Hospitals must also ensure that new mandates do not contribute to already problematic staffing shortages. We do not want a situation where patient care is compromised because the pool of nurses and other healthcare workers continues to shrink.” Only time will tell whether or not our care system can sustain itself if healthcare organizations continue to face the arduous task of firing staff for vaccination refusal.

Sources: Daily Freeman, CDC, Health.ny.gov

Can We Fix Our Drug Supply Chain Problem?

Can We Fix Our Drug Supply Chain Problem?

The COVID-19 pandemic highlighted the critical importance of a resilient U.S. healthcare manufacturing sector.

While healthcare leaders have made remarkable scientific strides to combat the pandemic by developing and distributing lifesaving vaccinations, critical issues remain. In fact, some issues existed long before the pandemic, but we have recently been confronted with the gravity of the challenges we face. the United States remains critically dependent on imports for a range of key pharmaceutical products and APIs—the primary ingredients of generic drugs—which represent 90 percent of all prescription medications filled. About 87 percent of API facilities for generic drugs are located overseas which has left U.S. supply chains of essential medicines vulnerable. The lesson? Instead of waiting for the next crisis to strike, leaders should act now to identify strategies and solutions for their organizations.

China and India are estimated to control substantial parts of the supply chain where there have been issues with shortages because of disruptions that have impacted supply as well as quality, and safety.

The drive toward lower costs as well as unfair trade practices has led to a hollowing out of domestic production. The Food and Drug Administration (FDA) has been tracking and reporting to Congress on the drug shortage crisis since 2014, in response to drug shortages that had impacted hospitals for years. In 2019, the FDA created an inter-agency task force to study the problem, determine the root causes and recommend solutions. The report recommends enduring solutions:

  • Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages
  • Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities
  • Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs

Earlier this month, the Biden-Harris Administration announced the first step in a whole-of-government effort to strengthen domestic competitiveness and supply chain resilience.

To address vulnerabilities in the supply chain, the Biden-Harris Administration will immediately support the domestic production of critical medicines. The Department of Health and Human Services (HHS), under the Defense Production Act (DPA) and building on current public-private partnerships, will establish a public-private consortium for advanced manufacturing and onshoring of domestic essential medicines production. The consortium’s first task will be to select 50-100 critical drugs, drawn from the FDA’s essential medicines list, to be the focus of an enhanced onshoring effort. HHS will make an initial commitment of approximately $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies to increase domestic manufacturing capacity for API. The goal? Greater API production domestically will help reduce reliance on global supply chains for medications that are in shortage, particularly during times of increased public health need.

Many within the healthcare field believe this is the moment to reimagine and rebuild a new American healthcare system, not go back to the way things used to be.

The current system is not sustainable, and to ensure more resilient supply chains we need to develop an approach that includes improving transparency, building emergency capacity, and investing in domestic production. At RBT, we pride ourselves on assisting healthcare professionals to build more sustainable organizations with our comprehensive services. But most importantly, we aim to pass along useful, relevant information to help our communities succeed, grow, and prosper. As we continue to dedicate time and resources to help our healthcare clients achieve success, we look forward to connecting with you and your team.

Sources: The White House, HFMA, FDA

Blockchain: The Next Healthcare Breakthrough?

Blockchain: The Next Healthcare Breakthrough

The COVID-19 pandemic highlighted many cracks in our healthcare system. If we take the “glass-half-full” approach, we can appreciate how the pandemic exposed our industry-wide weaknesses, so we can get to work making efficient and effective improvements for future public health crises. One healthcare game-changer that’s emerging as the dust begins to settle, is Blockchain technology. While Blockchain is still in its early stages of development and implementation, (think “the internet” in the late 1990s) you can expect to hear more about strides in Blockchain technology. It’s already transforming the financial world, and health authorities like the Centers for Disease Control (CDC) have been advocating the benefits of this modernization tool for years. The application of Blockchain in healthcare represents the potential to reduce costs, streamline business processes, and improve access to information across diverse stakeholders working toward a common goal: patient-centered care.

Wait, what is Blockchain again?

Blockchain is a system of recording information in a way that makes it difficult or impossible to change, hack, or cheat the system. A Blockchain is essentially a digital ledger of transactions and it is ideal for delivering information because it provides immediate, shared, and completely transparent information that can only be accessed by permission network members. It is also the underlying technology behind the cryptocurrency known as Bitcoin.

What are examples of how it can impact healthcare?

  • Identity Management – Patients, Providers
  • Medical Record Management
  • Medicaid Management Information Systems
  • Benefits Administration
  • Data Security
  • Reimbursement
  • Clinical Trial Management
  • Pharmaceutical Supply Chain

What are some important factors to consider when implementing Blockchain technology?

Reducing Costs: While organizations can expect some added upfront technology costs that are common in the adoption of any new technology, Blockchain can streamline the supply chain and administrative processes in healthcare, which may decrease costs.

Increasing Patient Control: Blockchain technology may have the potential to empower patients with greater control of their data and privacy. For example, the technology could enable patients’ access to their medical records across providers.

Improve Transparency/Security: While Blockchain is transparent it is also private, concealing the identity of any individual with complex and secure codes that can protect the sensitivity of medical data. The decentralized nature of the technology also allows patients, doctors, and healthcare providers to share the same information quickly and safely.

Security Vulnerabilities: While the technology provides resilience to certain types of attacks, nothing is ever entirely secure. It is still susceptible to zero-day attacks and technical bugs. Also, because this technology is almost always accessed by people, it is susceptible to one of the greatest risks in information technology: social engineering.

So, where does New York stand with this technology?

This past March, The New York Department of Financial Services (NYDFS) organized a techsprint (a sort of extended hackathon with participation by both industry and regulators) to learn how to become better at regulating crypto companies. That the techsprint occurred at all is a signal of the evolution of the crypto industry, said Sandra Ro, the CEO of the Global Blockchain Business Council and one of the event’s judges. Ro said it was significant that NYDFS is not only looking at how it can parse information it collects but also how it can integrate technologies like Blockchain into its supervisory process. “I think it is a testament to how far the crypto community has come from an industry standpoint to work with regulators and legislators and various bodies, to solve for critical problems in order for the industry to grow and scale, and become mainstream within regulation and guidelines,” Ro said.

Final Thoughts

Ultimately, the healthcare industry is constantly evolving and improving, and putting the patient in control with Blockchain technology would also make switching between healthcare providers a far simpler process than presently while ensuring that any information provided is complete and verifiably accurate. Reflecting on the pandemic, this could be incredibly transformative for future illness prevention, vaccination campaigns, wellness programs, and health training. At RBT, we understand the diverse and complicated world of healthcare, and we understand the first step to a brighter financial future is having important conversations about industry-specific topics that matter to you. Feel free to contact our team today, we hope to help your team succeed.

Sources: CDC, Coindesk, NYDFS, BuiltIn