Standard Operating Procedures (SOPs) are high-level written instructions for performing recurring procedures safely, accurately, consistently, and efficiently. In the Healthcare industry, SOPs help in meeting business and regulatory requirements and in achieving compliance with the law. Sections of regulations such as 21 CFR Part 58, 210, 211, 310, 314, 820 refers to well-written, reviewed, and revised SOPs in one way or the other. Most of the SOP related FDA-483s, revolve around absence of SOPs, failure to maintain or implement them, and/or ignorance of the companies to train employees properly on using SOPs. Many of the warning letters received by the pharmaceutical companies are because of inadequate, uncontrolled, and outdated procedures.

Consequently, there is a growing need for organisations to check the quality and effectiveness of their SOPs. Some of the checkpoints that might help in re-visiting and improving our SOPs require focus over the following areas:

SOP Development

• Use a well-defined template for writing including all the mandatory fields such as Title, Versioning, Effective date, Revision history (21 CFR Part 820.40)
• Write clear, short, simple, and user oriented sentences in active voice using an instructional tone
• Refer regulatory guidelines without copying the entire regulation (describe actual processes)
• Supplement the SOPs with Flowcharts, Job Aids, Notes, and Appendices
• Include all the required signatures and approvals (21 CFR Part 211, 820) with their meaning

SOP Testing & Implementation

• Get the SOPs peer-reviewed and quality checked
• Test the SOPs through new users ( experienced user might miss steps)
• Dry-run the SOPs
• Train all the required people on SOPs and maintain a training log
• Encourage employees to use SOPs for internal communication

SOP Control & Maintenance

• Keep SOPs in secure locations that can be accessed by the employees and reproduced during audits (21 CFR Part 58.81)
• Have a well-defined revision process including proper document management system to update SOPs against changes or mistakes (21 CFR Part 820.40)
• Update Revision history when there is a change in roles, responsibilities, requirements and processes; do not update for grammar or format changes
• Audit SOPs regularly based on company policy to ensure safe, updated, and effective procedures
• Remove obsolete SOPs

21 CFR Part 11 requires controlling and approving procedures that impact patient safety and product quality. Good SOPs not only ensure safety and quality but also facilitate internal and external communication, which prevents chaos and provides cross-functional insight within an organisation. Moreover, it can be used as a reference document, a checklist during inspections, and as a proof of sound business activities resulting in high quality and safe medicines and devices. Properly documented and controlled, SOPs can definitely prevent warning letters, legal actions, and recalls.

How do you manage Ms. Healthy Spender & Mr. Chronic Thrifty?

Member 0ADCF33F9A0F1642 (Ms. Healthy Spender) is a 40 year old healthy female whose annual health insurance payments total $67,742.  According to Kaiser Family Foundation the US per capita healthcare spend was $6,815 in 2009.  Upon further examination, Ms. Healthy Spender has no chronic conditions but complains of abdominal pain.  She has had one laparoscopic procedure performed on her and has medication spend of $63,561.  How do health insurance companies identify members like Ms. Healthy Spender and drive appropriate programs that will help her manage her health while reducing costs?

Member 0ADCF33F9A0F1642 Healthcare spend

Segmenting customers based on their behavior, understanding the needs of the various segments and then delivering programs to meet these needs has been the foundation of successful marketing strategy.  For health insurance customers, primary behavior is driven by the member’s health condition – whether they are healthy or have chronic conditions, the utilization of health services – the number of office visits, lab tests and hospitalization, and amount paid to consume these services – premiums, co-pays, out of pocket payments and claim payments.

Natural segments are members with multiple chronic conditions who are incurring high medical spend, healthy customers with low medical spend and members with life events (like pregnancy) who incur periodic medical spend.  From our analysis we have seen other segments like healthy members with high medical spend – like Ms. Healthy Spender above.  On the other hand are segments with members who have chronic conditions and low medical spend or utilization.  Member 0AC037393027DB82 (Mr. Chronic Thrifty) is a 58 year old male suffering from hypertension and cholesterol with annual spend of $303.

Category	Count	Amount Spent
Office Visits	1	$113
Lab Tests	2	$50
Other Procedures	0	$0
Rx Expenditure		$140

Member 0AC037393027DB82 Healthcare spend

Understanding behavior of unhealthy members with low spend is critical as they could develop complications over time resulting in higher spend.  Some common reasons for low spends have been lack of medication adherence, inadequate knowledge about their health conditions or financial condition.  Addressing these behaviors through care co-ordination, member education, care alerts/reminders or shifting to an appropriate plan might result in improved health outcomes.  Similarly healthy members with high medical spend could be due to undiagnosed or misdiagnosed health condition, member desire for periodic health check or possible waste and abuse.

Over time there has been a shift in responsibility to individual consumers for making decisions about their health and related spending.  Payers can help consumers in making these decisions by providing appropriate information.  More importantly decisions about health are prone to irrational behavior similar to what has been witnessed when consumers make decisions about their 401k or buying a car. Douglas Hough, a John Hopkins researcher, has conducted extensive research on anomalies around health behavior – why do patients insist on a prescription or having a procedure performed when visiting a doctor?  Patients do so because of an “action bias,” wherein people are predisposed to the idea that doing something is better than doing nothing, even though watchful waiting might be the most rational course. This is how patients with virus-based common colds end up with prescriptions for antibiotics that do nothing against viruses.

Behavioral segmentation is a powerful tool to understand customer behavior.  Understanding the possible psychology behind various behaviors and being able to develop programs that address customer needs is critical for delivering superior member experience.

Study Data Tabulation Model (SDTM) is defined by the Clinical Data Interchange Standards Consortium (CDISC) as a standard structure for human clinical trial (study) data tabulations that are to be submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

The SDTM data is the standard format recommended by the FDA. It has become a CDISC regulated content standard that describes how to organize subject information into variables and domains to be used as a standardized submission dataset format. The purpose of this model is to structure and format the tabulation data that are to be submitted to a regulatory authority. SDTM is based on the concept of observations (described by variables) made on the subjects who participate in a clinical study. The collected data is classified into a series of domains. The key idea of this model is that the domains are divided into Findings, Interventions, Events, and Special Purpose classes.

SDTM is a standard that improves process efficiency and a model that provides flexibility. It has the following advantages:

• Provides a uniform standard for clinical trial data study to ease data exchange
• Facilitates communication between CRO’s, sponsors, and regulators
• Improves viewing and analysis by streamlining the flow of data in a clinical trial process and facilitating data interchange between partners and providers
• Facilitates data management by consolidating the data collected from multiple CRFs
• Improves the effectiveness of reviewers with less time to prepare, by providing standardized datasets and standard software tools
• Ensures a more comprehensive, timely and efficient FDA review process, by providing the reviewer with standard tools and checks
• Facilitates meta-analysis of safety across new drug entities from multiple companies by enabling the FDA to develop a repository of all submitted data and standard review tools and to access, manipulate and view the tabulations using standardized datasets
• Reduces the number of submission queries to pharmaceutical companies by leveraging the standard structure provided by SDTM
• Allows companies to add additional domains and variables outside of the CDISC controlled domains and variables.
• Increases programming consistency and study efficiency by providing the same data structure to studies with different designs
• Assists in the creation of analysis data sets by developing macros
• Facilitates the development of commercial reporting and analysis tools
• Simplifies cross study analysis

While SDTM provides a standard and ample flexibility, it can also become tedious and lengthy. For instance, conversion of clinical database may be difficult due to the large number of CDISC domains and variables. Similarly, there may be errors and delays in data conversion as many ETL (Extract, Transform, Load) programmers lack the CDISC domain expertise. The converted data would also result in multiple lines of code that is difficult to understand and re-use. In addition, every sponsor company implements SDTM with some variation, because the model is subject to interpretation and allows some flexibility. Therefore, additional documentation like the ‘Define’ (metadata definitions) document is required to support the data sets. Moreover, the SDTM standard is an evolving one and new guidance updates may affect submissions and involve restructuring of data. Consequently, the conversion to SDTM format requires extra effort, time, and cost.

The SDTM standard has been endorsed by the FDA and embraced by the pharmaceutical industry. It has improved the FDA data submission and review process. Additionally, the Center for Drug Evaluation and Research (CDER) also encourages its use for ensuring efficient and quality reviews. The standard has improved data management, data integrity checking, data and cross-study analysis, as well as reporting. The widespread acceptance of SDTM will be beneficial for both the industry and the regulators in terms of efficient data conversion process and reduced related cost.

US Health Care is going through a major upheaval with the passage of Patient Protection and Affordable Care Act (PPACA), also known as Health Care reforms. PPACA includes several reforms like guaranteed health insurance, increased MLR limits, setting up of Health Insurance Exchanges, adoption of ICD-10 standards etc. These reforms will lead health plans to look for new initiatives and solutions to manage Health Care Fraud, Waste and Abuse (FWA) in post-reform scenario.

With PPACA, there is a potential of 30 million new customers entering the Health Insurance market which will result in high claim volume, creating a needle-in-a-haystack scenario for identifying fraud. Because of the sheer number of claims processed, erroneous claims can go undetected, easily bypassing rule edits in most claims adjudication systems.

Beginning in 2014, consumers including individuals and small businesses will be able purchase health insurance from the new health insurance exchanges established by the Act. This will drive up the customer acquisition cost of payers. The new Medical Loss Ratio (MLR) limits will also force payers to cut an average of 15-20% of administrative costs to maintain margins. As a result, health plans would look at reducing the amount of money lost in fraud, waste and abuse.

Health reforms also mandate replacing International Classification of Diseases-9 (ICD-9) with ICD-10 code sets. This transition from ICD-9 to ICD-10 code sets poses immediate challenges for Payer’ Special Investigation Units (SIU’s) due to confusions arising from code set mapping errors and increased risk of false positives from standard FWA analytics engines

Today, most of the health plans are focusing on deploying product solutions to manage fraud, waste and abuse cases. These analytics solutions rely only on the output of Rule Engine and/or Scoring Engine to identify suspected claims which leads to high false positive rates. Need of the hour is a shift in approach from only product centric model to a more services based model where services like claim validation, recovery, post-claim analytics, rules and model enhancement etc would complement FWA Analytic Engines to deliver more efficient outcomes.

“Ignorance is bliss” may be true in most cases; but it is a misnomer when it comes to health literacy.  A study conducted by Kaiser Permanente and published recently in the Journal of the American Medical Association found that patients with congestive heart failure and low health literacy are three times more likely to die in a given year than patients with better health literacy skills.

For instance, patients, with high deductible health plans, might be avoiding even basic preventive care like annual checkup, etc., simply because they do not know that preventive care does not attract any out of the pocket expenses as it is covered by the plan. It might also be because these patients have not  understood the benefits of their plan and hence avoid visiting the hospital.

Increasingly, stakeholders across the health care system have recognized the important link between health literacy and health status, and are advocating the necessity of  ‘clear communication’ to provide consumer health and benefits information that :

• Is easy to access, understand, and act upon
• Promotes consumer’s engagement in their own health
• Results in better health outcomes

So what are the health plans doing to improve health literacy of the consumers?

Some common strategies that could be employed by various health plans to promote health literacy are:

• Assessment of an organization to see if infrastructure exists to provide clear, easy to use information
• Awareness sessions for the personnel who are involved in either written or spoken communication to promote health literacy
• Adopt a target reading level for all communications, within and outside the organization
• Standardize the jargons and acronyms used across organizations. This would require a joint effort from multiple organizations

In our next blog post we will examine how improved health literacy among Americans will impact the health of the patients and reduce the overall cost of health care.

Healthcare fraud is an intentional deception or misrepresentation made by a person or an entity s, knowing that the misrepresentation could result in a payment to which the person or entity is not entitled. As healthcare fraud is seamless, it tends to blend making detection a challenge.

Fraud detection and prevention tools are no longer a “nice to have” but a critical element for sustaining the business. The damages incurred due to health care fraud has increased exponentially over the past few years. To reap the advantages of health care reform it is essential to strengthen fraud, waste and abuse protocols with strong processes, tools and services.

The National Health Care Anti-Fraud Association (NHCAA) estimates that the financial losses due to health care fraud are in tens of billions of dollars each year. As per the numbers provided by the Federal Bureau of Investigation[Ref], fraud, waste, and abuse account for 3 to 10 percent of the total health care expenditure. These losses lead to a causal system where increased health care costs are met by a surge in cost of coverage. The disproportionate surge of coverage as against income burdens the end customer.

The comprehensive solution to this issue is a two-pronged approach. Many organizations are not adequately staffed to review the high volume of claim activity that requires validation.

There is a need to provide aid in designing processes and services for claim validation, tracking, and recovery services to interpret the data output from their traditional tools, such as rule engine, scoring models. This would help in dealing with the volumes of claims that require validation leading to potential recovery of losses.

HCL offers an experienced professional claim validation and recovery management team that is capable of auditing high claim volumes. This team can either compliment a health plan’s current staffing or act as a completely outsourced unit for the plan.  If health plans do not have appropriate fraud detection tools in place, HCL along with its partner vendors can offer tools that aid in the identification and detection of FWA claims and links.

Find out more about our FWA solutions in our next blog…

ICD-10 Compliance date in healthcare industry is swiftly approaching and the ICD-10 steering committees of healthcare organizations are now rushing for the management of various tasks associated with ICD-10. The major areas of concern for the ICD-10 program managers include ensuring transactional neutrality with their trading partners and meeting timely compliance. It is absolutely essential that healthcare organizations assess the readiness of their partners and perform a round of testing with their partners transacting new ICD-10 code sets.

CMS set forth the key to success for ICD-10 compliance is to consider ICD-10 as a business initiative and not a code set update and compliance with ICD-10 simply means the ability to accept and send transactions.

ICD-10 noncompliance of trading partners would result in operational challenges necessitating them to make adjustments for reconciliation of billing codes. Also, the providers or clearing houses might face revenue shortfalls due to inability to process new ICD-10 codes.

Healthcare organizations today are looking for solutions to facilitate assessment of trading partners and track their ICD-10 readiness and perform end-to-end ICD-10 Testing with their partners.

Tracking partners for ICD-10 readiness calls for a solution or framework that can help them in the identification of problematic partners and drive better risk awareness among business partners. Also, healthcare organizations need to quickly start automating the tracking and testing process so that staff effort on monotonous everyday jobs can be reduced and better resolution of ICD-10-related issues can be achieved. Proper communication, coordination, transparency and multiple rounds of testing among the trading partners are critical to achieve compliance and mitigate compliance risks.

We all have been hearing about the issues, challenges, and bottlenecks in the US healthcare industry and the many approaches /solutions that have been discussed and designed to tackle them.

 

In order to initiate a reality check, I am outlining a few pointers  published online…

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• The congressional budget estimated that this legislation would cost around $900 billion with reduction in fiscal deficit of around $120 billion over a period of 10 years.
• It is also estimated that the act will reduce the number of uninsured by 32 million in 2019.
• This legislation will also result in 24 million people obtaining coverage through the newly created state health insurance exchanges or HIE.
• Approximately 16 million more people would be able to enrol in Medicaid and CHIP.
• Savings from Medicare/Medicaid, fees, taxes, etc. will offset the cost
• The act would also penalise insurance company for abuses, malpractices, etc.
• The legislation has already provided tax credits to small business health plans, allowed states to cover more people under Medicaid, ensured tough actions on health care fraud, expanded the coverage to retirees, and the coverage for pre-existing conditions.
• Insurance companies with excessive or unjustified premiums may not be able to participate in health insurance exchanges in 2014.
• The act also extends the coverage to young adults who are dependants or live with their parents and do not have dependants.

 

 

 

Interestingly these pointers have given rise to some more   questions:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• What are the execution/implementation strategies, which will play a crucial role in making this a historical act?
• How will the immense cost burden impact insurance premiums?
•  How willing are  the providers, payers, states, businesses, and members to adopt these guidelines?
• How to provide  the enormous training efforts that will be required to operate and adopt these legislatures?
• What about the information security/safety, quality check, and many more measures?

 

 

 

These questions require further examination…

With U.S President Obama getting re-elected for the second term, healthcare in the nation has been witnessing changes leading to increased access to affordable care.

The Patient Protection and Affordable Care Act became law on March 23, 2010, beginning a series of important, sweeping reforms to the healthcare system that will expand coverage, control health care costs and improve the healthcare delivery system. While the act’s provisions will continue to be implemented through 2016, its reforms are already benefiting millions of Americans in important ways.

One of the foremost important objectives of PPACA was to increase access to affordable healthcare. Let’s have a  look at what has happened with the help of some numbers and facts below:

• 2.5 million young adults gained health insurance.
  This is an example of the coverage gains for millions of people the Affordable Care Act is projected to provide. The Affordable Care Act allows young adults to stay on their parents’ insurance plans until age 26.
• More than 40,000 Americans with pre-existing medical conditions gained affordable coverage through the federally administered Pre-Existing Condition Insurance Plan.
  Those with pre-existing conditions, such as cancer or chronic disease, can access insurance to meet their health needs through the plan.
• The Department of Health and Human Services awarded more than $14 million in 2011 alone to school-based health centers across the country, increasing the number of children served by 50 percent.
  The Affordable Care Act provides a total of $200 million for school-based health centers, which provide primary care, dental health, mental health, substance-abuse counselling, and health and nutrition counselling.
• Across the country, 350 new community health centers were built and nearly 19,000 new jobs were created in 2011 alone to provide critical healthcare to the 50 million Americans living in medically underserved areas. 
  The Affordable Care Act provides a total of $11 billion to support and expand community health centers nationwide.
• Consumers are enjoying greater protection from unreasonable private-insurance premium hikes.
  The Affordable Care Act helped 42 states, the District of Columbia and five U.S. territories strengthen their rate-review laws, bringing greater transparency and accountability to private insurance rate increases. For example, Connecticut rejected a 20% rate hike by insurers, and Oregon halved the rate increase by one of its largest insurers, saving money for more than 60,000 people, and the Department of Health and Human Services recently deemed increases in five states “unreasonable.”

Taking the above facts in to consideration, I am pretty sure that the ‘Increased access to affordable care’ objective is on the perfect path to success. What do you think?

Next time, we will take a closer look at ‘Making Care More Affordable’!

The health insurance environment has gone through significant changes over the past few years and continues to evolve at a rapid pace. There is an industry-wide focus on ways to manage the rising cost of care, improving quality and achieving improved health outcomes. By 2014, millions of newly insured individuals will be joining the system and health plans will be under more pressure than ever before to improve the quality of services and deliver greater transparency to members, providers and other stakeholders.  Lack of a focused strategy that differentiates health plans in terms of enhanced customer service interactions and dedicated retention programs can significantly impact business growth.

Current statistics indicate no major improvement in member experience in the health insurance industry over the last five years. To make matters worse, member expectations continue to rise, with demand for fast, consistent and accurate information as well as the ability to communicate across different channels such as mobile, web, email, kiosks etc. All these call upon payers to collaborate better with members and become more proactive about improving member satisfaction.

Many health plans are yet to adopt innovative member engagement and technology strategies to determine how they are interacting with the members. These strategies focus on superior customer service and advanced, real-time member data profiling providing a 360-degree view of the health plan member interactions. Adopting such a model is a transformational change for payers and will require new technology investments, cultural and behavioral change and greater understanding of member preferences. These investments will play a big role in improving member enrollments, reducing costs and promoting overall member wellness.