Domestic Sugar Wars

While my site tends to focus strictly on information regarding pharmaceutical compliance based in Florida, the FDA has recently made headlines for proposed changes to how added sugars are labeled in processed foods that we consume. While food labeling and drug labeling are different processes, it is interesting to observe the process and the reaction of the public on a non-pharma product.

The new proposed changes to the Nutrition Facts label began in March of 2014 and the supplemental rules were proposed in the July update of 2015. ONe of the points in particular of this second set of proposed changes has caused quite a stir and swept the headlines. With this proposed change, the FDA claims that the percent daily value for added sugars should be included on the nUtrition Facts label for foods that are packaged. This sort of additional information would arm consumers with more information about the nutritional value (or perhaps absence therein) of the sugar content added to these foods. Although this information is similar to that which consumers have been seeing for years, this sort of nutritional value expansion has never been included in packaging since the Nutrition Facts label was first mandated in the early ‘90s.

The %DV, or percent daily value reflects the how much a particular nutrient in a food serving contributes to the daily diet of the average consumer. Currently the %DV is based on a 2,000 calorie per day diet. With this added section revealing the amount daily value of sugars added, would also be a recommendation stating that a daily diet should not include more than 10% of daily calories from added sugars.
Though much has been written about this proposed change, the secondary amendment to the proposal regarding an updated footnote has not garnered nearly the same level of attention. In this proposed amendment , packaged foods would require that packaged foods include information regarding %DV in a form that is a bit more accessible in understanding to the average consumer.

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The Right to Try in Florida

Over the past year or so, Right-to-Try laws have become increasingly popular throughout the United States. These laws allow patients who are terminally ill to access experimental drugs, biologics and devices that have not yet secured the approvals necessary to be distributed widely. Florida recently approved a Right-to-try law for eligible patients.

 

Currently, the Right To Try is limited to patients afflicted with a terminal disease who have already tried the traditional treatments but are unable to enroll in a clinical trial. Essentially this is the last option for these terminal patients. However, it is important to keep in mind that all medications available to these patients must have successfully completed certain safety testing and be included in the FDA’s continuous approval process by law.

 

State Representative Ray Pilon and State Senator Jeff Brandes jointly sponsored the Florida Right to Try Act. Although this has not been approved on a national level, the cause has gained traction as a movement, with supporters expressing themselves on digital platforms.

However, it is important to keep in mind that Federal preemption laws prevent states from creating workarounds that supposedly supersede all of the regulatory infrastructure enforced by the FDA.

In the incidences of patients utilizing a treatment options through the RTT, both manufacturers and physicians will receive liability protection against claims based in adverse events caused by these non-traditional and unapproved treatment options.

Additionally, manufacturers might have the option to charge for the treatments – which are most likely outside of the coverage offered by health insurance.

Although these specifics have yet to be addressed within the acts themselves, support for this movement is quickly spreading, not just in Florida, but across the nation. The Goldwater Institute and a mother based in Indiana have joined forces to support the Right To Try and created a Change.org petition  that has already collected over 95,000 signatures, perhaps indicating the support to come.

 

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How to Reduce Pharma Drug Waste in Florida

According to the Florida Department of Environmental Protection, properly managing pharmaceutical waste products produced by different types of medical facilities can pose a real challenge. Not only do medical facilities need to comply with all required hazardous and solid waste regulations, but they must also ensure compliance with regulations from the Department of Health and the Board of Pharmacy, the Department of Transportation ( with particular attention to the Pipeline and Hazardous Materials Safety Administration). This particular waste stream also needs to conform to the Drug Enforcement Agency, the regulations set forth by the Occupational Safety and Health Administration as well as those standards set by local publicly owned water treatment facilities. Owing to the vast number of regulatory bodies that medical facilities are subjected to, in addition to staying up to date on the most current standards and guidelines, reducing the amount of pharmaceutical drug waste produced by the facility is one way to approach this mountain of regulations.

With this in mind, the Florida State Department released a set of guidelines to encourage waste reduction at these types of facilities.

 

Drug Sample Reduction:

To reduce the amount of sample drugs that go to waste, the document suggests the following: : 1. Ensure that drug reps sign in and list what they leave behind. This will help to maintain an accurate inventory of drugs on hand.

2. Only accept sample drugs you know will go to use soon.

3. Do not accept drugs with an expiration of less than 1 year.

4.Ensure that drug products are rotated on the shelves.

5. Consider moving to a voucher system (as many clinics already have) in order to eliminate samples.

Hospital drug waste reduction:

Some of the information originally appeared in; “Practice Greenhealth’s Managing Pharmaceutical Waste – A 10 Step Blueprint for Healthcare Facilities in the United States available at: http://ift.tt/1HOcddr

 

1.Lifecycle matters

a. Do not accept drugs with less than one year dating unless that is all that is available and the drugs will definitely be used.

b. Choose products that have less packaging, (particularly P-listed drugs). Packaging must be handled as hazardous if it comes into contact with a P listed drug.

c. Choose products without preservatives, especially Thimerosal or phenylmercuric acetate which must be handled as hazardous waste.

d. Choose single dose containers that don’t need preservatives.

 

2. GET the Maximum use out of OPENED CHEMOTHERAPY VIALS

3. LABEL DRUGS FOR HOME USE Medications must be returned to the pharmacy for destruction when the patient is discharged unless there is a discharge prescription from the doctor and proper labeling for the container(s). Because this causes delays in the discharge process, the prescriptions are often abandoned by the patient. a. Consider including pre-authorized discharge orders for maintenance medications. b. Produce labels in the units to avoid waiting for prescriptions from the pharmacy.

4. PRIME AND FLUSH IV LINES

a. Pharmacies should prep all chemotherapy IVs with saline before dispensing.

b. Ensure that nurses flush the tubing after administration to ensures that the patient receives the complete dose and decreases the chance of employee exposure.

c. Flushed IV lines can be managed as trace chemotherapy waste.

5. Review THE SIZE OF the CONTAINERS in relation to how they are used

a. Implement a survey of drugs that are routinely wasted because the prepared product is too large for complete administration.

b. Try purchasing different dosage formulations of these drugs to permit varied dosages to patients.

c. Inform your General Purchasing Organization if the appropriately sized product is unavailable.

 

Although minimizing drug waste does not absolve a medical entity of their responsibilities in properly following various protocols for medical waste disposal, but reducing the amount of waste to manage can have its advantages.

 

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Alameda County and Drug Disposal Regulation

If you have been paying attention to Pharma news over the past week you may have caught wind of a request for a lawsuit review denied by the U.S. Supreme Court filed by three industry trade groups against a drug take-back program based in Alameda County, California. The reason that this seemingly innocuous refusal to review a lawsuit is making waves has to do with it’s potential implications. Now many experts have weighed in saying that Pharmaceutical Companies needn’t panic yet since this is a very specific case, and that it is possible that in other circumstances the pharmaceutical companies would have come out victorious. However, this does set a precedent, and it’s possible that this specific case could incite action in other counties and cities.

 

The local law in question stems from an ordinance passed by the Alameda County, California Board of Supervisors in 2012. The Safe Drug Disposal Ordinance

is a first in the country and has been affirmed as not unconstitutional. This ordinance places the onus on drug manufacturers to safely dispose of drug products once these drugs have expired. The ordinance requires that manufacturers of these prescription drugs and drug products retrieve expiring drugs through creating and operating take back programs. According to this ordinance, not only are manufacturers responsible for footing the bill, but they are also tasked with administering the program. Through this “product stewardship organization” all prescription drugs must be accepted regardless of the manufacturer.

 

The roots of this ordinance rest in the county’s desire to reduce abuse of prescription drugs, and to keep drug and drug products out of the bay and the groundwater basin. Like many other counties across the country, prescription drug abuse has been on the rise, and in the Bay Area there has been an even more notable spike in this particular type of drug abuse in recent years. There has also been a link between the uptick in prescription drugs with the increase in heroin users. Noting these alarming numbers, officials spear-headed this effort to reduce the availability of prescription drugs.

 

In September of 2014, the office of Alameda County District Attorney Nancy O’Malley joined forces with a drug take-back event that collected 799 pounds of pills in just one day. The sheer volume involved in a response to this sort of effort speaks to the need within the county for this type of stewardship program.

 

There are discrepancies in the projected costs for pharmaceutical companies complying with these ordinances in years to come. These yearly costs range from $330,000 to $1.2 million per year, depending on who is reporting.

 

Regardless of the true costs incurred by this compliance with this ordinance, plaintiffs argue that this law interferes with the rights secured by the Interstate Commerce Clause in the Constitution. However, this argument has been repeatedly struck down.
Instead the plaintiffs will be held accountable for creating sustainable infrastructure that provides education and opportunity to give back prescription drugs at no cost to the taxpayers of Alameda County. This stewardship will continue to roll out over the next three years or so, so the trade representatives will have time to incorporate these new costs and need for resources into their budgets.

This whole incident exposes the importance of proper drug product disposal, as well as highlights the true costs of improperly executing or ignoring this step in the supply chain.

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How to Adhere to Pharmaceutical Waste Regulations

Pharmaceutical Waste Compliance

When considering how to properly manage pharmaceutical waste products, there are a few important areas of note. As of 2015, the Environmental Protection Agency has continued the process of outlining and proposing a new set of standards addressing how to handle both the management and disposal of pharmaceutical waste from healthcare facilities. This is meant to enhance the efforts proposed in 2008 when inclusion  of hazardous waste pharmaceuticals in the Universal Waste Program was proposed. Instead of finalizing that initial proposal, the EPA has continued to develop regulation requirements that address specific needs and concerns of entities that create, come into contact with or transport pharmaceuticals that would fall into the “Universal Waste Program”.

Recent Changes in FL

As we await finalized rulings regarding how to proceed with properly managing hazardous pharmaceutical waste products, the Florida Department of Environmental Protection has released a brief listing of protocols related specifically to hospital waste. This guidance document addresses how to properly determine whether or not this waste should be categorized as hazardous waste according to the Federal Resource Conservation and Recovery Act and relevant state laws.

In Florida, pharmaceutical waste that falls under the definition of “hazardous waste” (according to 40 CFR 261.33 and 261.24 as included in 62-730) may be treated indiscriminately from “Universal Waste” in terms of how it is managed. “P-listed waste” or “acutely hazardous waste” are other ways that this type of waste may be referenced.

In order to remain in compliance with the most current regulations, a facility must dispose of spills and unused preparations of these hazardous wastes as “universal waste”.

When reviewing current disposal practices for hazardous materials, consider the following guidelines to help ensure that your facility is indeed in compliance with the current regulations set forth by the RCRA, EPA and state laws that govern this domain.

1. Separate labeled container: Store all P-listed waste products in a separate container that is appropriately labeled as such. Take care to NOT store this waste in a biohazardous red bag. Do not store anything other than emptied syringes and needles in a red sharps box.
2. Pick up: FDEP registered hazardous waste transporters or another transporter who has notified the FDEP of its activities are the only types of transporters recognized as credible transporters. Take care to verify the credentials of the transporter.
3. The hospital is required to keep the manifest provided by the transporter on file for three years.
4. To qualify as an exempt Small Quantity Generator, a facility must generate less than 2.2 pounds of acutely hazardous waste or 220 pounds of non-acutely hazardous waste per calendar month. If a facility is categorized as a Small Quantity Generator, then it will be subject to less stringent regulation.

While these are all relevant and important key points of discussion found in the guidelines set forth by the Florida Department of Environmental Protection, it may be wise to consult with a local professional, to make sure that all of your information is up to date, accurate and comprehensive.

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Should you waive copayments for Medicare patients?

Should you waive copayments for Medicare patients?

The Importance of HIPAA

Most Medicare policies concerning the treatment of copayments and deductibles are included in the Health

Insurance Portability and Accountability Act of 1996 (HIPAA). Before HIPAA, Medicare treated copayments

and deductibles similar to private payers.

HIPAA concluded that free services are likely to influence a patient to receive some other paid services  and

should be considered a form of remuneration. Since offering remuneration to patients is illegal, waiving

copayments and deductibles are illegal. However, HIPAA did allow certain waivers to remuneration to patients

and allow practices to waive copayments and deductibles if:

• The waiver is not offered as part of any advertisement of solicitation.
• The practice does not routinely waive copayments or deductible amounts.
• The practice waives the copayments or deductible amounts after:
• The patient can show financial hardship. Financial Hardship should be defined by the practice in
• a written policy and must be applied equally to all patients.
• The practice fails to collect copay or deductible amounts after making reasonable collection
• efforts.
• A health plan type of waiver not applicable to individual or group providers.

So, under Medicare, if you occasionally waive copayments to those who can demonstrate financial hardship,

you will be within the law. But you cannot routinely waive copayments or advertise that you waive copayments.

So when a Medicare patient asks you to waive your copayments, you should inform them that this practice is

illegal

 

Should you waive copayments for Private Payer patients?

When Private Payer Insurance Companies set a copayment or deductible amount as part of their Insured’s

policy, they are counting on the copayment or deductible to cause a pattern of behavior. Simply stated, high

copays are designed to make sure the patient goes to the doctor when they have a real problem, not every time

they have an ache or pain. Similarly, high deductibles are designed to make sure the patient gets treated and

released from care instead of using their health insurance for maintenance treatments. If you agree to waive

copayments or deductibles, you are removing the incentives set by the insurance company and may be

increasing the amount of care to the patient and the cost to the insurance company. This might be considered

fraud based on your contract with the insurance company.

Most private payers do not allow you to waive copayments or deductibles. It is always best to check your

contract to see if you are allowed to waive these fees and under what circumstances you are allowed to waive

these fees. If you want to reduce the fees paid by the patient, the best way to do this would be to reduce your fee

so both the patient and the insurance company pay less. This will not reduce any copayments that must be

collected at full value. If the patient is truly having financial hardship, you may decide to treat the patient pro-

bono. Again, you should check your contract with the private payer to make sure this is allowed and you should

have written practice policy that is uniformly administered to all patients.

Conclusion – Do NOT waive copayments

When a patient asks you to waive their copayments or deductibles, it is best to inform them that this practice is

illegal and not endorsed by you nor your practice. If they threaten to go to another therapist who will waive

their copay or deductible, you are better off letting them go to another therapist. On top of the legal issues, you

are also working for free or greatly reduced fees when you waive copays and deductibles. Wouldn’t you rather

have a patient paying his fair share rather than a patient receiving free services? You owe it to yourself and your

practice to be fiscally responsible and protect it from possible fraud charges by refusing to waive copayments

unless it is justified by financial hardship.

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Welcome to My New Blog

Sharon Roberts, Attorney

Welcome to my new blog!

Sharon Roberts is a native of South Florida. She received her doctorate degree, with honors, in Pharmacy (Pharm. D.) in 1992 from Southeastern University. Upon passing her board exams, Dr. Roberts was licensed as a Registered Pharmacist.

Dr. Sharon Roberts continued to pursue her pharmacy education by way of a one year American Society of Health-Systems Pharmacy (ASHP) accredited residency program in Pharmacy Practice at the Veterans Administration Medical Center in Miami (VAMC). After a number of years of pharmacy practice, Dr. Roberts went on to attend Nova Southeastern University to obtain her Juris Doctorate, which she received in 1998. Sharon Roberts most recently earned a license as a Certified Designated Representative with the State of Florida.

For more, check out http://sharonrobertsattorney.com