Dr. Julia Harder, PharmD, CGP
The American Geriatrics Society (AGS) has released a second list of 5 tests or treatments that physicians and older adult patients or caregivers should question. Release of the evidence-based recommendations is a continuation of the AGS's participation in the Choosing Wisely® initiative, launched in 2012 by the American Board of Internal Medicine Foundation.
The new list, released online February 27, adds 5 tests or treatments to a previous Choosing Wisely® list by AGS that was published in the Journal of the American Geriatric Society in June 2013. To view AGS’s previous list, and also the lists submitted by the American Association of Hospice and Palliative Medicine (AAHPM) and other medical specialty societies, visit the Choosing Wisely website (www.choosingwisely.org), or view a copy of the April 2013 issue of our newsletter, The Clinician, in which we give a detailed overview of the AAHPM and AGS Top 5 lists.
The AGS’s new recommendations, along with implications specific to our hospice population (where appropriate), are:
1. Don't prescribe cholinesterase inhibitors for dementia without periodic assessment for perceived cognitive benefits and adverse gastrointestinal effects. Cholinesterase inhibitors include donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne). If a non-hospice patient is started on a cholinesterase inhibitor and treatment goals are not achieved after a reasonable time (e.g., 12 weeks), medication discontinuation should be considered. Once a patient is on hospice for dementia, cholinesterase inhibitors should be discontinued right away. Cholinesterase inhibitors are ineffective in end-stage dementia and, as this recommendation from AGS reminds us, they are not benign drugs. Cholinesterase inhibitors can cause troubling side effects, including nausea/vomiting and bradycardia (which can result in syncope and falls). For a more detailed discussion of this issue, please see our blog posts: “Hospice, End-Stage Dementia, & the Role of Drug Treatment” Part 1 and Part 2.
2. Don't recommend screening for breast or colorectal cancer, nor prostate cancer (with the prostate-specific antigen test) without considering life expectancy and the risks of testing, overdiagnosis and overtreatment.
3. Avoid using prescription appetite stimulants or high-calorie supplements for treatment of anorexia or cachexia in older adults; instead, optimize social supports, provide feeding assistance and clarify patient goals and expectations. No evidence exists that these stimulants and supplements improve quality of life, mood, functional status, or survival. They can be very costly, add to medication burden, and have side effects, some of which can be very serious (e.g., thrombosis from megestrol). The risks of using appetite stimulants and high-calorie supplements will outweigh benefits in the vast majority of hospice patients.
4. Don't prescribe a medication without conducting a drug regimen review. A review may reduce medication burdens by exposing unnecessary prescriptions. This is especially important in the hospice population, in whom we are consistently looking to reduce medication burden and potential medication side effects by discontinuing any medications which are no longer necessary for symptom management and comfort or are no longer contributing to the patient’s goals of care. In hospice, a drug regimen review can range from an informal review by the prescriber, ideally done each time a new medication is ordered, to a more formal Medication Review conducted as part of the hospice patient’s comprehensive assessment. Formal Medication Reviews are required by CMS as part of the Medicare Conditions of Participation for Hospice. For more information, see our blog post: Medication Reviews and Medicare CoPs: Is Your Hospice in Compliance?
5. Avoid physical restraints to manage behavioral symptoms of hospitalized older adults with delirium. Use physical restraints only as a last resort and discontinue as early as possible.
Esther Liu, PharmD, MSIA
Recently, CMS has issued some clarifications on the new CR 8358 reporting requirements for hospice claims. This clarification document is accessible on the CMS Website. Also see our previous article on CR 8358.
The following clarifications are provided for the prescription drugs reporting requirement:
1. Hospice agencies shall report injectable and non-injectable prescription drugs for the palliation and management of the terminal illness and related conditions on their claims. Both injectable and non-injectable prescription drugs shall be reported on claims on a line-item basis per fill, based on the amount dispensed by the pharmacy
2. When a facility (hospital, SNF, NF, or hospice inpatient facility) uses a medication management system where each administration of a hospice medication is considered a fill for hospice patients receiving care, the hospice shall report a monthly total for each drug (i.e., report a total for the period covered by the claim), along with the total dispensed.
3. Hospices shall report multi-ingredient compound prescription drugs (non-injectable) using revenue code 0250. The hospice shall specify the same prescription number for each ingredient of a compound drug according to the 837i guidelines in loop 2410. In addition, the hospice shall provide the NDC for each ingredient in the compound; the NDC qualifier represents the quantity of the drug filled (meaning the amount dispensed) and shall be reported as the unit measure.
4. When reporting prescription drugs in a comfort kit/pack, the hospice shall report the NDC of each prescription drug within the package, in accordance with the procedures for non-injectable prescriptions.
5. Hospice agencies shall report infusion pumps (a type of DME) on a line-item basis for each pump and for each medication fill and refill. The hospice claim shall reflect the total charge for the infusion pump for the period covered by the claim, whether the hospice is billed for it daily, weekly, biweekly, with each medication refill, or in some other fashion. The hospice shall include on the claim the infusion pump charges on whatever basis is easiest for its billing systems, so long as in total, the claim reflects the charges for the pump for the time period of that claim.
The effective date for the mandatory reporting requirement has not been changed and it will remain on April 1st, 2014. If your hospice has not taken advantage of the voluntary reporting period started January 1st, 2014, now is the time to start.
Contact Us Today to get more information on a partnership that will help your hospice meet the new requirements.
Julia Harder, PharmD, CGP
A question came up recently regarding what to do with a patient’s Hospice Comfort Kit (also known as an E-Kit) when he or she is either discharged alive, decides to revoke the hospice benefit, or otherwise terminates hospice service while still alive. The clinical pharmacists at Outcome Resources have put their heads together regarding this issue, and would like to share with you our thoughts.
• Encourage destruction of the Comfort Kit medications (by proper medication disposal) for the following reasons:
o The patient will probably no longer be followed by the physician who prescribed the Comfort Kit medications. In many cases, Comfort Kit medications are labeled with instructions for the patient/caregiver to “call hospice before using”, which the patient will no longer be able to do.
o The symptoms that these medications were initially prescribed for have probably abated if the patient is discharging from hospice or revoking the benefit.
o There is a high risk for misuse or inappropriate use, possibly resulting in drug toxicity since hospice will no longer be managing the patient.
• Keep in mind that the Comfort Kit medications, because they were prescribed for the patient, actually belong to the patient. The patient cannot be legally forced to destroy the medications, so if they refuse to destroy them the patient has the authority to keep them. In this type of case, it is important for the hospice to document that they did advise the patient to destroy the medications for their own safety.
• Even if the Comfort Kit has never been opened or used, the medications cannot be reused for another patient.
The above information would technically apply to ANY medication prescribed by the hospice physician which the patient will no longer be taking upon hospice discharge. There are strict regulations regarding proper drug disposal, especially concerning opioids (which are frequently present in Comfort Kits/E-kits). For more information on proper drug disposal, including the disposal of opioids, please review our previous blog posts on the topic of proper drug disposal.
Julia Harder, PharmD, CGP
Opioids, the most commonly used medications in hospice, are available in a wide array of dosage forms, strengths and combinations. As clinicians, it’s helpful to have a reference at our fingertips that tells us which dosage forms and strengths are available for any given opioid medication. Use our new Medication Reference Chart to help you make the most appropriate selection for your patient. This Opioid Analgesic Dosage Forms Chart details each opioid drug in terms of the formulations available (immediate-release, extended-release, liquid, suppository, and injectable), and the commercially available strengths of each formulation. We’ve included all of the most commonly used opioids, including many opioid/non-opioid combination products.
Please let us know in the Comments below if you found this to be a helpful resource for your hospice. As always, we are here for our hospice partners 24/7 for clinical consultation, opioid dose conversions, pharmacy claim and account support. Request your hospice pharmacy information kit today.
Dr. Julia Harder, PharmD, CGP
The Food & Drug Administration (FDA) has formally recommended that health care professionals stop prescribing and dispensing prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit. Prescribers are asked to stop writing prescriptions for these products, and pharmacists who receive a prescription for a combination product containing more than 325 mg acetaminophen per dosage unit are asked to contact the prescriber to discuss an alternative product. According to the FDA, there are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit to the patient that outweighs the risk of liver injury.
For a number of years, the FDA has been on a campaign to reduce the risk of severe liver injury resulting from acetaminophen overdose, which is the most common cause of acute liver failure in the US. In January 2011 the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. In addition, a Boxed Warning highlighting the potential for severe liver injury was added to the label of all prescription drug products that contain acetaminophen. In May 2011, the FDA pulled from the market the more concentrated children’s acetaminophen drops to reduce the risk of confusion and inadvertent overdose. Later in 2011, the FDA reduced the maximum daily dose on some over-the-counter acetaminophen products from 4000 mg per day to 3000 mg per day (see our previous blog posts on acetaminophen).
Even though the January 14, 2014 deadline has passed, products containing more than 325 mg of acetaminophen per dosing unit are still commercially available. However, the FDA has issued letters to all manufacturers of such products asking that they voluntarily withdraw the products from the market, and that the FDA intends to use its authority to initiate withdrawal proceedings for the products if they are not voluntarily withdrawn (though a specific time frame for this has not been given).
As health care providers, we should expect to see gradual discontinuation of these products, and should adhere to the FDA’s recommendations regarding prescribing and dispensing. In hospice, the products we need to be aware of are primarily hydrocodone/APAP and oxycodone/APAP combination products, both of which are still available in strengths containing more than 325 mg of acetaminophen per dosage unit and may contain as much as 750 mg of acetaminophen per unit. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen should be 650 mg (the amount in two 325 mg dosage units) or less. Be aware that the risk of severe liver injury is greater in patients who take more than one acetaminophen-containing product at the same time, or who drink alcohol while taking acetaminophen products.
Jim Joyner, Pharm.D., C.G.P.
There has been a palpable amount of confusion and anxiety percolating through the hospice community over the past year or more fueled by memorandums from the Centers for Medicare and Medicaid Services (CMS). The directives in these CMS memos have been primarily aimed at Medicare Part D plans focusing on concerns that the plans have been paying for drugs that should be covered under the Medicare Hospice Benefit. CMS directed the plans to communicate with their network pharmacies in order to ensure that hospice drugs are not billed to Medicare Part D.
The concern in the hospice community was ratcheted-up quite a bit following the latest CMS memo, dated December 6th 2013, which was sent to all the Part D plan sponsors as well as Medicare Hospice Providers. In this memo, CMS provides a brief overview of the Medicare Hospice Benefit which comports well with the actual statute, however, CMS then goes on to state the following:
“… hospices are required to provide virtually all the care that is needed by terminally ill individuals.”
In the section of the memo titled “New Clarification for Part D,” the memo states:
“As a general rule, hospice providers are expected to cover virtually all drugs for hospice beneficiaries during the hospice election.”
This new interpretation regarding medication coverage is what has many in the hospice community scratching their heads, wondering how they can comply and still remain viable with the current hospice benefit per-diem rate structure.
The recent CMS memo indicates that the agency presumes that it would be a very rare occasion when a hospice patient is prescribed a medication that would be completely unrelated to the terminal diagnosis; and therefore not covered by the hospice per-diem. This stance is not consistent with the current clinical reality, nor is it in keeping with the statutory and regulatory framework of the Medicare Hospice Benefit. There are numerous situations where hospice patients may have one or more disease states that are completely unrelated to the terminal diagnosis, and these conditions are not directly contributing to the patient’s terminal decline, and where medication treatment is clinically appropriate. One example might be a patient just admitted to hospice with a terminal diagnosis of breast cancer, who also happens to be an insulin dependent diabetic, and has moderately severe COPD. This patient may have a prognosis of 4 to 6 months. It is clinically appropriate to continue medication treatment for the COPD and Diabetes. The COPD and Diabetes are long-standing conditions which are unrelated to the terminal diagnosis, however, under the recent CMS assumptions some hospices feel their only options are those that follow below:
• covering the medications for COPD and Diabetes under the hospice benefit,
• or suggesting discontinuation of the medications,
• or asking the patient to pay out of pocket for these medications
None of these options seem to be appropriate. This is not a rare or unusual situation.
The Congress of the United States has identified the recent CMS activity as a radical departure from the status quo and responded to CMS on behalf of patients and hospices in their recent memo dated 12/16/13. Forty-two congress-persons have signed a letter notifying CMS that their recent presumptions are inconsistent with precedent as well as the current statute. The letter essentially requests that CMS curtail any substantive changes in the hospice benefit coverage. CMS is instructed to collaborate with all stakeholders (Part D plans, hospice communities, and others) to avoid disruption and confusion in the future. CMS is taking comments on this issue from interested parties through January 10, 2014. Hopefully this will result in a more rational approach by CMS that takes into account the needs of hospice patients, the hospice community, pharmacies, and the Part D plans.
Going forward it is essential that hospices maintain very complete documentation regarding the medication coverage decisions that they make. The statute has not changed. The view at Outcome Resources is that hospices should NOT be covering all medications that their patients are taking. Hospices should be covering all medications that are reasonable and necessary for managing the patient’s terminal illness and those which are reasonable and necessary for truly related conditions. Medications that are not reasonable and necessary need to be discontinued upon admission to hospice. Medications that are reasonable and necessary and clinically appropriate for managing an unrelated condition should be continued, but not covered by hospice (in most cases these would fall to the Part D plans). These are clinical decisions that need be made on a case- by- case basis. The individuals that are most suitable to make these decisions are of course the physician and interdisciplinary team of the hospice, taking into account the patient and caregiver wishes and the overall goals of care.
Outcome Resources will keep you posted as further developments surface.
Esther Liu, PharmD, MSIA
In 2013, there has been a market-wide cost hike for the dopamine antagonists. Among these medications, prochlorperazine (Compazine® /Compro®) and promethazine (Phenadoz®/Promethegan®) suppositories, both brand and generics, are impacted the most due to the limited availability of manufacturers. Promethazine is also commonly known as its brand name of the injectable dosage form, Phenergan®. The average cost of a promethazine suppository increased from $6 to $17, and the average cost of a prochlorperazine suppository increased from $4 to $13. Now it is not unusual to see a typical prochlorperazine/promethazine suppository prescription for a 15-day supply costing over $300, which is no longer a cost-effective first choice. Although there is also a price increase for the oral formulations, their prices still remain cost-effective in comparison to the suppository formulations.
In a hospice and palliative care setting, prochlorperazine and promethazine are some of the most common dopamine antagonists used as antiemetics. The dopamine antagonists are an attractive first choice due to their efficacy on the chemoreceptor trigger zone and the low cost associated with their generic availability. The suppository formulation especially comes in handy when managing patients who cannot tolerate oral medications due to severe nausea and vomiting. Many hospices would even order the suppositories in their comfort kit for patients to take home. Due to the recent price hike, many hospices have experienced a significant cost burden from routinely using the promethazine and prochlorperazine suppositories as the first choice to manage nausea and vomiting.
So now, with a prohibitive high cost, prochlorperazine and promethazine suppositories have become a less desirable option when managing patients with severe nausea and vomiting. As an alternative, haloperidol (Haldol®) is another common dopamine antagonist that can be used off label as an antiemetic. It has become a more favorable option because of the following:
1) It has a similar mechanism of action (dopamine antagonist, effect on chemoreceptor trigger zone)
2) It is very cost-effective (Download Comparison Table)
3) It can be absorbed sublingually
4) It is bio-available rectally per anecdotal reports ( although the suppository formulation is not commercially available)
a. The oral tablets can be wetted with water and used rectally
b. Suppositories can be compounded in the pharmacy with an extra compounding cost.
5) It has a favorable side effect profile with less anticholinergic effects than promethazine and prochlorperazine (However, just like other dopamine antagonists, haloperidol should be avoided for patients with Parkinson’s disease)
One of our local compounding pharmacies makes haloperidol 1mg suppositories for approximately $60 for a batch of 30, which is still more affordable in comparison to using the prochlorperazine and promethazine suppositories. The only drawback is that compounded medications are often not suitable for comfort kits because they have a relatively short shelf-life and the costs vary depending on the labor cost determined by each individual pharmacy. To maintain an affordable comfort kit for your hospice, antiemetic suppositories are no longer recommended to be included in the comfort kit due to their prohibitive high cost. As a substitution, haloperidol tablets or solution, used sublingually, is recommended. The suppository formulations of these dopamine antagonists should be reserved and ordered only for those patients no longer tolerating the sublingual route of administration.
Download This Comparison Chart for More Information.
Esther Liu, PharmD, MSIA
Centers for Medicare & Medicaid Services (CMS) has issued a Change Request (CR) 8358 which requires additional claim data reporting for hospices to support hospice payment reform as authorized by the Affordable Care Act, to be effective 2014. Hospices must report line-item visit data dates of service on or after April 1st, 2014, and they may voluntary begin this reporting as of January 1st, 2014. Hospices should make sure that the billing staff is aware of the changes. The additional data requested includes:
1) Visit reporting for general inpatient care (GIP),
2) Reporting of the service facility National Provide Identifier (NPI)
3) Reporting of infusion pumps and prescription drugs
These new requirements from CMS should come as no surprise because the Medicare Payment Advisory Commission (MedPAC), the Government Accountability Office (GAO), and the Office of the Inspector General (OIG) have all recommended over the past several years that CMS collect more comprehensive data in order to better evaluate trends in utilization of the Medicare hospice benefit. On several occasions, industry representatives have communicated to CMS that the required claims information was not comprehensive enough to accurately reflect hospice care. Industry stakeholders also commented that to understand hospice costs, CMS should consider non-labor costs, as these can be significant, and are largely comprised of data on drugs, Durable Medical Equipment (DME), and medical supplies. Finally, the Affordable Care Act gives CMS the authority to collect additional data as needed to revise payments for hospice care. The additional claims data collection is a step forward and will support the hospice payment reform that is coming down the pipeline.
New Reporting Requirement for GIP:
This includes visits reported by hospice nurses, aides, social workers, physical therapists, occupational therapists, and speech-language pathologists, on a line-item basis, with visit and visit length reported as is done for the home levels of care. It also includes certain calls by hospice social workers, with call and call length reported as is done for the home levels of care. CMS is not changing the existing GIP visit reporting requirements when the site of service is a hospice inpatient unit.
New Reporting Requirement for NPI:
This includes the NPI of any nursing facility, hospital, or hospice inpatient facility where the patient is receiving services, regardless of the level of care provided, when the site of service is not the billing hospice. The billing hospice must report the name, address, and NPI of the service facility where the service is being performed when the service is not performed at the same location as the billing hospice’s location.
New Reporting Requirement for drugs:
In most hospices, the requested information from CMS should already be recorded somewhere for administrative purposes. The heavy lifting work is about how to make it organized in a format that is ready for CMS claim submission. For some hospices, providing these data might mean additional billing staff to gather information and to file the CMS claim forms, or for the others, a change in IT infrastructure is needed to make sure the data are fed into the right places for billing. There is no unique solution for all hospices to follow; the bottom line is that your hospice needs to find a plan or protocol for your staff that will fit the work flow. And, the plan should also provide better coordination among all vendors involved in the data transmission process, such as your pharmacy benefit management (PBM) company, infusion pharmacy, the electronic medical record system and the Medicare contractor. For example, here at Outcome Resources, we provide invoices that package all the NDC coding for CMS submission and we work with our clients and their vendors to figure out a plan for data transmission if necessary. When your plan is in place, you should also take advantage of the voluntary reporting period and start testing your protocol for glitches on January 1st, 2014. That way, your hospice can resolve any issues now in order to avoid rejected claims later when data submission becomes mandatory on April 1st, 2014.
Do you want to further discuss your hospice's plan for achieving your goals in regards to the new reporting requirements for prescription drugs? Request More Information Today.
1) The official instruction, CR8358 issued to your Medicare contractor regarding this change may be viewed on the CMS website:
2) To view the Affordable Care Act, See the following:
Viibryd (vilazodone) was approved in 2011 by FDA for the treatment of major depression. The usual dosage is 40mg once daily with a titration schedule of 10mg for 7 days follow with 20mg for 7 days when initiating therapy. The manufacturer recommended titrating vilazodone when initiating therapy in order to reduce incidences of the most common side effects such as nausea, vomiting and insomnia. The efficacy of this product was established in an 8 week trial and the long-term effect of this product remains unknown. The vilazodone compound is structurally similar to trazodone, but its efficacy is thought to be related to its enhancement of serotonergic activity in the CNS through selective serotonin reuptake inhibition similarly to SSRIs (Selective Serotonin Reuptake Inhibitors). Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors like aripiprazole; however, the result of this action on serotonergic transmission and its role in vilazodone's antidepressant effect are unknown. Clinically, vilazodone is believed to share a similar side effect profile to the SSRIs (citalopram, sertraline, etc.), but with a lower incidence of sexual dysfunction. However, there is no head-to-head comparison between vilazodone and other antidepressants so the clinical advantage of vilazodone for patients is unclear. Due to the limited clinical experience with vilazodone, it is not recommended to be used as a first choice to manage depression because there are many similar low-cost alternatives with tremendous clinical experience available on the market. The recommended first choice for treatment of major depression should remain the generic SSRIs, such as citalopram. The application of vilazodone in hospice practice is limited at this time due to higher cost and very limited clinical experience with its use. Unless the patient came to hospice already stabilized on vilazodone, it would not be a likely choice for depression management in this population.
Outcome Resources considered it an honor to recently sponsor the 2013 Hospice Action Network Advocacy Intensive in Washington, D.C. Together with over 200 hospice professionals we had the opportunity to share positive, caring and supportive stories with nearly all of the nation’s Senators and State Representatives. In addition, this year, ten advocates whose hospice programs would otherwise be unable to afford it were able to attend the Hospice Action Network’s Advocacy Intensive thanks to Outcome Resources scholarships.
The support of our elected officials is crucial to protect and preserve the hospice Medicare Benefit and to support legislation that positively affects those patients and families facing end of life. We are grateful to the Hospice Action Network for providing all of us involved in hospice the forum and opportunity to speak with a unified message in support of our daily efforts. During the meetings on the Hill with Representatives, Senators, and Legislative Assistants, advocates focused on requesting support with the following issues and legislation:
To learn more about these issues or how you can help, please visit Hospice Action Network. Outcome Resources has been involved as hospice advocates for many years and will continue to support these efforts at every opportunity. We are honored to have Angie Truesdale, Vice President, Public Policy, and Tony Kudner, Manager, Grassroots Advocacy, presenting a session at the Outcome Resources Pathways to Success Conference by the Bay this November. To learn more about the Conference, visit the Conference Website or Download the Information Sheet.
View our photos of the HAN Advocacy Intensive on Facebook at http://on.fb.me/13eUw3N. Read more about Outcome Resources participation in the HAN Advocacy Intensive on NHPCO’s Blog at http://nhpco.blogspot.com/2013/08/outcome-resources-helps-bring-advocates.html.
Photo: The North Carolina Hospice Delegation with Senator Kay Hagan
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