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FDA Approves Evzio® (Naloxone Hand-Held Auto-Injector) For Opioid Overdose

Dr. Julia Harder, PharmD, CGP

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. Opioid overdose, in particular, has been steadily rising over the past decade, and has been the subject of intense FDA focus and regulation.

As we know, naloxone is an opioid receptor antagonist that rapidly reverses the effects of opioid overdose and is the standard of care. However, existing naloxone drugs require intravenous administration and are most commonly used by trained medical personnel in emergency departments and ambulances.

Yesterday, the FDA approved Evzio (naloxone HCl injection, manufactured by Kaleo, Inc.) for the emergency treatment of known or suspected opioid overdose. Evzio is a hand-held auto-injector that rapidly delivers a single 0.4 mg dose of naloxone as an intramuscular or subcutaneous injection into the thigh. The auto-injector, which is about the size of a cell phone, can be carried in a pocket or stored in a medicine cabinet, to be used by family members or caregivers in the case of suspected opioid overdose, as manifested by respiratory and/or central nervous system depression (e.g., extreme sedation or loss of consciousness). Evzio is approved for use in adult and pediatric patient (even infants).

Evzio is not intended to be a substitute for immediate medical care. The duration of action of most opioids exceeds that of naloxone, meaning that respiratory and/or CNS depression may recur after an initial improvement in symptoms. Therefore, the administrator should always seek immediate medical attention after giving the first dose of Evzio, and should repeat doses of Evzio every 2-3 minutes, depending on the patient’s response, while waiting for emergency medical assistance.

Evzio was reviewed under the FDA's priority review program and was also granted a fast track designation. Evzio is expected to be available this summer as a carton containing 2 prefilled auto-injectors and a single Trainer injector.


Vortioxetine (Brintellix™): A New Multimodal Antidepressant and its Place in Hospice Care

Dr. Julia Harder, PharmD, CGP

On September 30, 2013, a new antidepressant, vortioxetine (Brintellix™ -- Lundbeck and Takeda), was approved by the FDA. Vortioxetine is considered a “multimodal antidepressant”, which puts it in a class of its own. This blog post will summarize important points about the clinical use of vortioxetine, especially in the hospice population, in whom depression is very common.

Mechanism of Action

Vortioxetine is thought to work through a combination of both serotonin reuptake inhibition and serotonin receptor activity, including agonism at the 5-HT1A receptor and antagonism at the 5-HT3 receptor. As a result of this multimodal and partially novel mechanism of action, vortioxetine may hold promise for patients who have failed to respond to first-line treatment options. Vortioxetine may also have beneficial effects on cognition, which is currently being investigated further.

Efficacy Data

Data from both short- and long-term randomized controlled trials (RCTs) have demonstrated vortioxetine’s efficacy both in the treatment of major depression and in preventing relapse. International data have shown significant efficacy of vortioxetine in a dose range from 5 to 20 mg/day but most consistently at doses of 10-20 mg/day. Two low-dose studies, (2.5 mg/day and 5 mg/day of vortioxetine) did not show superiority over placebo. Furthermore, antidepressant efficacy has been demonstrated specifically in an elderly population (mean age, 70.6 years), which is unique among the antidepressants. An RCT of more than 450 elderly adults with major depressive disorder from 7 countries showed that those treated with vortioxetine showed significantly greater improvement on several depression rating scales and cognitive tests compared with those who received placebo.

Vortioxetine has also shown efficacy in patients who have already failed a first-line antidepressant. The REVIVE study compared the efficacy of vortioxetine with the most recently approved novel antidepressant in Europe, agomelatine, in a well-powered, head-to-head trial. Of note, the patients were non- or partial responders with a history of at least 6 weeks of treatment with an SSRI or SNRI who were then abruptly switched to 12 weeks of randomized treatment with either vortioxetine (10-20 mg/day) or agomelatine. In this "out of class" switch strategy for patients with insufficient response to first-line antidepressants, vortioxetine led to significantly greater improvement in depression scores at 8 weeks compared with agomelatine, with similar effects at week 12.

Finally, on the basis of its mechanism of action, vortioxetine is being studied for potentially beneficial effects on cognition. Initial data on the potentially procognitive effects of vortioxetine, independent of the drug's effects on symptoms of depression, have been generated in elderly patients with major depressive disorder. Other studies with cognition as a primary outcome are ongoing.

Safety Data

The most common adverse effects of vortioxetine across multiple studies were nausea, diarrhea, dry mouth, sweating, and headache – standard antidepressant side effects. Of these, nausea seems to be the most common. The potential benefits of vortioxetine include low rates of sedation/somnolence and insomnia, low weight gain in both short- and long-term studies, and less sexual side effects than the SSRIs.

Like other antidepressant medications, vortioxetine has an FDA boxed warning and a medication guide alerting patients and healthcare professionals that antidepressants can increase the risk for suicidal thought and behavior in children, adolescents, and young adults aged 18 to 24 years during initial treatment.


The recommended starting dose is 10 mg orally once daily, taken at any time and without regard to food intake. The dose should then be increased to 20 mg/day, as tolerated, with consideration being given to lowering the dose to 5 mg/day for patients who do not tolerate higher doses. Vortioxetine is currently available as brand-name only (Brintellix™), in 5 mg, 10 mg, and 20 mg tablets.


Vortioxetine has a favorable pharmacokinetic profile. It is metabolized by several different liver enzymes (rather than predominantly just one or two), which means that is does not have many drug interactions beyond the normal ones we are familiar with (tramadol, linezolid, methylene blue, monoamine oxidase inhibitors, triptans) that interact with all serotonergic antidepressants. Vortioxetine also has a long half-life of about 60 hours, which means that rebound or withdrawal will be unlikely if patients miss doses or have to abruptly discontinue the medication due to the loss of swallowing ability.


Currently, Brintellix™ is one of, if not the, most expensive antidepressants on the market, with an average wholesale price of $8.72 per tablet (same price for all strengths). By comparison, levomilnacipran (Fetzima™, another new antidepressant approved in 2013 that is still brand only) is $8.10 per tablet, escitalopram is about $4.50 per tablet, and citalopram is about $2.50 per tablet.

Place in Hospice Therapy

Vortioxetine has many positive characteristics, including a multimodal mechanism of action, demonstrated efficacy in the elderly, favorable pharmacokinetics, and a relatively short list of side effects. However, because of lack of clinical experience and very high cost, vortioxetine should not be used as a first-line agent for the treatment of depression in hospice. As a result of the diverse and partially novel mechanism of action of vortioxetine, this new multimodal antidepressant may hold promise for a very select group of hospice patients, including:

• Patients who have tried and failed other first-line therapies, including one or more SSRIs
• Patients who have experienced intolerable sedation/somnolence or insomnia with other antidepressants
• Patients with comorbid cognitive deficits

The broader picture of vortioxetine's clinical utility and place in the treatment of patients with depression will need to be established through its clinical use after approval and ongoing and future phase 4 trials. Future studies will hopefully examine whether vortioxetine has more robust efficacy in certain patient subgroups, including treatment-nonresponsive/resistant patients and those with comorbid cognitive problems, as this would be of particular interest to the hospice community.



CMS, Medicare Part D, and the Hospice Medication Coverage Debacle

Dr. Julia Harder, PharmD, CGP

CMS issued final guidance on the subject of Part D Payment for Drugs for Beneficiaries Enrolled in Hospice on March 10th, 2014. (Click to Download the full CMS Memo.) In this blog post, we will summarize the CMS memo and highlight the important points that you and your hospice need to know in order to most effectively sort through the mess that medication coverage has become in recent months.



On December 6, 2013, CMS issued a memorandum to all Part D plan sponsors and hospice providers clarifying the criteria for determining payment responsibility for drugs for hospice beneficiaries. In the memo, they stated: “In order for services to be covered under the Medicare hospice benefit, those services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. … To the extent that individuals seek and receive services outside of the hospice program, Medicare coverage is determined by whether or not the services are for treatment of a condition completely unrelated to the individual’s terminal condition. It is our general view that the statutory waiver of the right to payment of standard Medicare benefits for treatment of the terminal illness and related conditions is a broad one, and hospices are required to provide virtually all the care that is needed by terminally ill individuals. … Beneficiaries should only very rarely be taking drugs that are not covered under the hospice per diem.”

CMS urged Part D plan sponsors to “place beneficiary-level PA [prior authorization] requirements on all drugs for hospice beneficiaries to determine whether the drugs are coverable under Part D.” They went on to say that “The hospice provider will be responsible for coordinating with Part D plan sponsors for those drugs they believe are completely unrelated to the terminal illness and/or related conditions”. In such instances, CMS expects that “the hospice provider or prescriber will immediately provide, to the Part D sponsor, the written documentation necessary to satisfy the PA.”

In other words, CMS stated that hospices should be covering virtually all of a patient’s medications. Part D plans were instructed to reject outright any claim for a beneficiary enrolled in hospice and to use a prior authorization process for the very rare occasion that a beneficiary would be taking a medication not covered by the hospice per diem. CMS initially set an effective date of March 1, 2014.

Hospices and anyone affiliated with them have been in an uproar about this issue, as CMS’s memo is in clear disagreement both with the longstanding statutory and regulatory framework that has been in place since the inception of the Medicare hospice benefit, and with the clinical reality of hospice patients. Individual stakeholders and organizations such as the National Hospice and Palliative Care Organization (NHPCO) have lobbied tirelessly on behalf of hospice providers, asking CMS for clarification on many points and to reconsider implementation of this directive. CMS remained silent on the issue until March 10, 2014, 9 days after their initial implementation date of March 1, at which time many hospice pharmacies were already receiving rejected claims from Part D plan sponsors.

The March 10, 2014 Memo

On Monday, March 10, CMS issued the “Part D Payment for Drugs for Beneficiaries Enrolled in Hospice – Final 2014 Guidance.” This new memo reinforced many of the statements CMS made back in December of last year. The memo states: “We expect drugs covered under Part D for hospice beneficiaries will be unusual and exceptional circumstances”, and continues to recommend that the Part D plan sponsors place beneficiary-level PA requirements on ALL drugs for hospice patients. However, CMS did make some further clarifications and concessions. The following is a list of the most important points from CMS’s memo (however, we highly encourage that you read the memo in its entirety).

1. The implementation date was moved back to May 1, 2014 (although some Part D plans have already initiated the prior authorization process based on CMS’s earlier memo, and they are permitted to do so).

2. There is currently no standard PA form that CMS will require the Part D plans to use. However, CMS did compile a list of elements they would expect to see on a PA form, which can be found on pages 13-14 of the attached memo. Some Part D sponsors may choose to adopt that information list as their PA form. The best way to retrieve any particular Part D plan’s PA form is to contact them directly.

3. If the patient does not know who their Part D sponsor is, hospice providers can find that information through the patient’s primary pharmacy (NOT the PBM, but the dispensing pharmacy). Pharmacies can identify a beneficiary’s Part D plan by submitting a standard electronic eligibility (E1) query to the CMS Transaction Facilitator. The query response will give the name of the plan sponsor, the sponsor’s online billing information, and the sponsor’s pharmacy help desk telephone number.

4. Hospice providers may initiate the PA process prospectively (prior to the submission of any claims, such as upon initial hospice election) by initiating communication with the Part D provider, providing an explanation of why certain drugs are unrelated to the terminal illness, and submitting any necessary documentation. This proactive approach could speed up the process by avoiding rejected claims. This would also notify the part D sponsor right away of the patient’s hospice election, so that the Part D plan doesn’t continue to pay claims and then have to recoup those payments later.

5. Hospices may also initiate the PA process after a claim has been rejected. The rejection message will state “Hospice Provider- Request Prior Authorization for Part D Drug Unrelated to the Terminal Illness or Related Conditions” and should include the Part D sponsor’s 24-hour pharmacy help desk phone number. The pharmacy would contact the prescriber to pass along this information. The prescriber must then call the Part D plan to initiate the PA process. PAs can be completed either verbally or in writing. The hospice may provide a verbal explanation to the sponsor regarding why the drug is unrelated to the terminal illness or related conditions, or may complete the PA form and fax it to the sponsor. Hospices should be aware that the turn-around time for a PA is 24 hours for an expedited request and 72 hours for a standard request, with the clock starting once the Part D plan sponsor has received the completed PA from the hospice (either verbally or in writing).

6. In the case that a medication is prescribed by someone unaffiliated with the hospice (such as the patient’s primary physician), the prescriber and the hospice will need to coordinate their efforts. Either individual may complete the PA; if the prescriber unaffiliated with hospice completes the PA, the prescriber will need to attest that he or she has coordinated with the hospice provider and that the hospice provider concurs with the unrelated nature of the drug.

As mentioned before, many Part D plans are already starting to reject claims, so it is crucial that hospices become familiar with this issue and begin to develop procedures for incorporating this new PA process into their daily workflow. NHPCO has created an excellent Compliance Tool, “Incorporating Medicare Pare D into the Hospice Admissions and Medication Management Process.” We suggest that you download this document for assistance with how to implement this new CMS policy.

We look forward to your questions and comments on this highly controversial issue.


2013 Recap: New Hospice Drugs and Generics

Dr. Julia Harder, PharmD, CGP

Now that 2014 is underway, let’s review the major medication approvals related to hospice care that happened in 2013. These are medications that you will begin to encounter this year (or may have encountered already).

New Drugs Approved

For PAIN, Zohydro ER, a new formulation of extended-release hydrocodone (no acetaminophen), was approved in October 2013, and is now commercially available. Zohydro ER is the first hydrocodone-only medication and is classified as a CII. Zohydro ER is not formulated with any abuse-deterrant properties, which has caused some backlash due to concerns about opioid abuse. Concerned groups and individuals have pressured the FDA to withdraw Zohydro ER’s approval, or require that the manufacturer of Zohydro ER (Zogenix) reformulate the product to be resistant to abuse. Zogenix may consider reformulating Zohydro ER in the future (as Purdue did with OxyContin), but for now, it has been launched as is. Zohydro ER is fairly expensive, with an AWP in the range of $8 per capsule (depending on the strength). Currently available strengths are 10, 15, 20, 30, 40 and 50 mg.

On the topic of hydrocodone, expect all hydrocodone-containing products to be rescheduled from CIII to CII this year, and be prepared for the additional paperwork and restrictions on prescribing that will cause. The FDA formally recommended this change to the Department of Health and Human Services in October of 2013, as part of its campaign to reduce opioid drug abuse.

For COPD, two long-acting combination inhalers were approved in 2013 and are now commercially available. Anoro Ellipta (umeclidinium/vilanterol) contains a long-acting anticholinergic bronchodilator (umeclidinium) and a long-acting beta-agonist bronchodilator (vilanterol). It is the first inhaler to contain the two types of long-acting bronchodilator in combination, and it is available in only one strength containing 62.5 mg of umeclidinium and 25 mcg of vilanterol per actuation. The usual dose is 1 inhalation once daily. The AWP for a 30-actuation inhaler is $337, or about $11 per day – which is similar to other combination inhalers on the market. Breo Ellipta (fluticasone/vilanterol) was also approved in 2013. It contains a long-acting beta-agonist bronchodilator (vilanterol) and an inhaled corticosteroid (fluticasone). It is unique in that it is approved for once daily use, unlike its competitors Advair, Symbicort and Dulera, which must all be dosed twice daily. Breo Ellipta was approved in May 2013 and is currently available (see previous blog post here). Both Anoro Ellipta and Breo Ellipta are manufactured by Glaxo Smith Kline and are administered using the new Ellipta dry powder inhaler.

For DEPRESSION, two new medications are now available. Fetzima (levomilnacipran) is an SNRI antidepressant and was the subject of our October 2013 Newsletter. Brintellix (vortioxetine) is considered a new “multimodal” antidepressant, which puts it in a class of its own. This medication will be reviewed in detail in a future blog post. Both of these medications are currently available.

Drugs Now Available in Generic Form

Some commonly used hospice medications, previously available as brand-name only, are now available in generic form. Keep in mind, however, that generic availability does not always mean a dramatic drop in price. Desvenlafaxine, for example, is a single-source generic, manufactured by Ranbaxy, with an AWP of almost $6 per tablet. View this chart for drugs now available in Generic Form.

More information:


New “Choosing Wisely®” List from the American Geriatrics Society and Lessons for Hospice Care

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.


More information:


Hospice Compliance Alert: CMS Clarification on CR 8358

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.

More information:


What to do with a Patient’s Medications upon Hospice Discharge?

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.


Hospice Medication Chart: Opioid Analgesic Dosage Forms

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.

More information:


FDA Recommends Restricted Use of Acetaminophen-Containing Combination Products

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.


CMS and Hospice Medication Coverage

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.  

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