Esther Liu, PharmD, MSIA
Centers for Medicare & Medicaid Services (CMS) has issued a Change Request (CR) 83581 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
The FDA has updated the labeling for oral ketoconazole (Nizoral®), restricting its indications and adding warnings about serious liver injury, adrenal suppression and drug-drug interactions. A Medication Guide, which addresses these safety issues and should be handed out with each ketoconazole prescription, has also been added.
The FDA’s actions coincided with a similar announcement in Europe. On July 26, 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced their negative risk-benefit assessment for oral ketoconazole-containing medicines used to treat infections caused by Candida and dermatophytes. They recommended suspension of these medicines throughout the European Union, citing a high risk of liver injury associated with ketoconazole and the availability of safer alternative treatments.
In the United States, specific label changes include the following:
• Oral ketoconazole is no longer indicated for treatment of Candida or dermatophyte infections. It should not be used for any type of fungal infection of the skin or nails.
• Ketoconazole tablets are indicated only for the treatment of the following fungal infections: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis, and only when other therapies have failed or the patient does not tolerate other therapies.
• Ketoconazole should not be used for advanced prostate cancer or Cushing’s syndrome.
• Oral ketoconazole is now contraindicated in patients with any type of liver disease.
• An updated Boxed Warning with stronger language about hepatoxicity and a new warning about QT prolongation
• A new warning about adrenal suppression. Ketoconazole is unique in the ‘azole’ class in that it causes adrenal corticosteroid suppression at doses of 400 mg per day and higher. The recommended dose of 200 mg - 400 mg daily should not be exceeded. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress (major surgery, intensive care, etc.).
• Updated warnings about drug-drug interactions. Important drug-drug interactions in the hospice population include:
o Certain benzodiazepines. Ketoconazole is contraindicated with triazolam, midazolam and alprazolam because it can increase the activity of these benzodiazepines and result in profound sedation.
o Certain statins. Ketoconazole is contraindicated with lovastatin and simvastatin due to increased risk of myopathy and rhabdomyolysis.
o Fentanyl. Ketoconazole can increase the effects of the fentanyl patch.
o Other meds that may be increased by ketoconazole: calcium channel blockers like amlodipine and nifedipine, buspirone, carbamazepine, digoxin, methylprednisolone, warfarin, verapamil.
These new warnings do not apply to topical ketoconazole formulations, like creams, shampoos, foams and gels.
More information can be found on the FDA’s website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362672
In hospice, as many of our patients have difficulty swallowing, we are frequently faced with the question of whether or not medications can be crushed or capsules opened for easier administration. The Institute for Safe Medication Practices (ISMP) publishes a very helpful guideline entitled “Oral Dosage Forms That Should Not Be Crushed”, or the “Do Not Crush” list.
There are a number of reasons why a medication should not be crushed. By far the most common reason is when a medication has built-in extended-release properties. For these medications, crushing disrupts the extended-release formulation, resulting in a “dose dumping” effect in which the entire dose, meant to be released over a long period of time (like 12 or 24 hours), is released all at once, immediately. This can result in profound side effects and can even be fatal (such as with extended-release opioids).
Less frequently, medications can’t be crushed because they are too irritating to the stomach or esophageal lining, or because they are particularly toxic or teratogenic. Sometimes, the medication simply tastes bad.
The recently updated 2013 version of the ISMP’s Do Not Crush list can be found here. We recommend consulting this list as a useful reference when determining options for administering medications in a patient with swallowing difficulty.
Dr. Julia Harder, PharmD, CGP
In May of this year, the REDUCE study was published in JAMA (1). This important study provided evidence supporting the use of shorter steroid courses to manage acute COPD exacerbations.
Conventionally, we have recommended 10-14 day oral steroid courses, based on previous studies and international COPD guidelines. (For example, the 2013 GOLD Guidelines recommend 30-40 mg of prednisone for 10-14 days.) (2)
This study, by Leuppi and colleagues, investigated whether a 5-day steroid course was noninferior to a 14-day course. Reducing unnecessary steroid exposure is an important goal in hospice, as steroids lead to many short-term side effects, including steroid-induced psychosis, insomnia, hyperglycemia and fluid retention.
The REDUCE study was a randomized, noninferiority multicenter trial in 5 Swiss teaching hospitals, enrolling 314 patients presenting to the emergency department with acute COPD exacerbation. Patients were randomized to treatment with 40 mg of prednisone daily for either 5 or 14 days in a placebo-controlled, double-blind fashion. The primary endpoint was time to next exacerbation of COPD.
The cohort primarily included patients with GOLD stage IV disease (very severe) and many of the patients had experienced previous exacerbations.
When the investigators looked at time to reexacerbation (the primary endpoint), they saw no difference in one therapy group versus the other. Time to next COPD exacerbation was 43.5 days in the 5-day steroid group and 29 days in the 14-day steroid group. Furthermore, there was no difference between the two groups in time to death, quality-of-life measurements, rehospitalization rates, the subsequent need for corticosteroids or the subsequent need for mechanical ventilation. In conclusion, 5-day treatment with systemic glucocorticoids was noninferior to 14-day treatment, and these findings support the use of a 5-day glucocorticoid treatment in acute exacerbations of COPD.
1. Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013;309:2223-2231.
2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of COPD. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html Accessed July 23, 2013.
Dr. Julia Harder, PharmD, CGP
Two years ago, the FDA issued a warning that doses of citalopram (Celexa) exceeding 40 mg per day may cause prolongation of the cardiac QT interval, which can result in potentially fatal cardiac arrhythmias including Torsades de Pointes (please see our previous blog post on the FDA’s warning for more information). In addition, the maximum recommended dose of citalopram for patients greater than 60 years of age – most of the patients we treat in hospice – was reduced to 20 mg per day because of further increased risk of adverse cardiac outcomes in the geriatric population.
A recent study (see reference below) published in the American Journal of Psychiatry offers some evidence that contradicts the FDA’s warnings. In this study, doses of citalopram greater than 40 mg daily were not associated with increased risk of ventricular arrhythmia or all-cause mortality (cardiac and non-cardiac) as compared to lower doses.
This was a cohort study conducted using Veterans Health Administration data between 2004 and 2009. The study included almost a million depressed patients who were prescribed either citalopram (n = 618,450) or sertraline (n = 365,898). Sertraline was used as a comparison because it is also a selective serotonin reuptake inhibitor (SSRI), like citalopram, but does not have any warnings regarding adverse cardiac effects. Statistical analysis examined the association between antidepressant dosing and adverse outcomes including ventricular arrhythmia and all-cause (cardiac and non-cardiac) mortality.
The results were surprising in that higher doses of both antidepressants were actually associated with fewer adverse outcomes. Citalopram daily doses > 40 mg were associated with lower risks of ventricular arrhythmia (adjusted hazard ratio = 0.68, 95% CI = 0.61–0.76) and all-cause mortality (adjusted hazard ratio = 0.94, 95% CI = 0.90–0.99) compared with daily doses of 1–20 mg. Citalopram daily doses of 21–40 mg were associated with lower risks of ventricular arrhythmia (adjusted hazard ratio = 0.80, 95% CI = 0.74–0.86) compared with dosages of 1–20 mg/day but did not have significantly different risks of mortality. The sertraline cohort revealed similar findings, except there were no significant associations between daily dose and mortality. According to the authors, “these results raise questions regarding the continued merit of the FDA warning.”
The FDA’s warning was initially prompted by post-marketing reports of QT interval prolongation and Torsades de Pointes associated with citalopram. The FDA evaluated the results of a thorough QT study assessing the effects of 20 mg and 60 mg doses of citalopram on the QT interval in adults. In this randomized, multi-center, double-blind, placebo-controlled trial, 119 subjects received citalopram 20 mg per day, citalopram 60 mg per day, and placebo in a crossover fashion (meaning each individual received all three interventions for comparison).
Compared to placebo, maximum mean prolongations in the individually corrected QT intervals were 8.5 milliseconds (ms) for 20 mg citalopram and 18.5 ms for 60 mg citalopram. For 40 mg citalopram, prolongation of the corrected QT interval was estimated to be 12.6 ms. Let’s put these numbers in perspective. In adult males a QT interval greater than 450 ms is considered prolonged and between 430 and 450 ms is considered borderline. For females, a QT interval greater than 470 ms is considered prolonged and between 450 and 470 ms is considered borderline. So, you can see that a QT interval increase of nearly 20 ms (as may potentially be seen with the 60 mg dose) could be clinically significant.
As a result of this QT study, the FDA determined that citalopram causes dose-dependent QT interval prolongation and should no longer be used at doses above 40 mg per day. Safety information about the potential for QT interval prolongation and Torsades de Pointes with drug dosage and usage recommendations were added to the package inserts of Celexa and its generic equivalents.
How can we make sense of this conflicting data? While the recent Veterans Health Administration study looked at an incredibly large number of patients, it’s important to keep in mind that, as a cohort study, it can only demonstrate an association, not cause-and-effect. In other words, we cannot determine conclusively whether the antidepressant dose was the direct cause of the varying risks of arrhythmia and mortality, or whether other factors came into play. While the authors did attempt to correct for potentially confounding variables, it is impossible to completely do so with an observational study. Randomized controlled trials (RCTs), which more comprehensively account for confounding variables and are prospective (rather than retrospective) in nature, are considered superior forms of evidence to observational studies like cohort studies. The FDA’s study, though it looked at a much smaller number of patients, was an RCT using a crossover design to demonstrate conclusively the dose-dependent QT prolongation caused by citalopram. So, while the Veterans Health Administration data do raise questions, do not dismiss the FDA’s warnings about citalopram at this time. Especially in the hospice population, where many of our patients are already at an increased risk of QT prolongation and cardiac arrhythmia, it’s important to stick to the dosing limits currently included in citalopram drug labeling. For more comprehensive information about QT prolongation, including risk factors and which other medications may cause it, please see this blog post.
Zivin K, Pfeiffer PN, Bohnert ASB, et al. Evaluation of the FDA warning against prescribing citalopram at doses exceeding 40 mg. Am J Psychiatry. 2013; 170: 642-650.
Dr. Julia Harder, PharmD CGP
With so many different benzodiazepines available, each with its own distinct pharmacokinetic profile, it can sometimes be difficult to choose an appropriate agent to match a patient’s needs. We’ve developed this Benzodiazepines Chart to help you compare the benzodiazepines, understand their similarities and differences, and make patient-specific selections.
You will notice that the chart places emphasis on the pharmacokinetics of each agent. That’s because the pharmacokinetics are the main way in which the benzodiazepines differ from one another. Primarily, we focus on the half-life (which tells you something about the medication’s duration of action) and the speed of onset. In hospice patients, we want to avoid the benzodiazepines with very long half-lives, as these agents stick around for days, and many have metabolites that accumulate (especially in the elderly). We may also want to avoid benzodiazepines with very short half-lives (such as midazolam), except in specific circumstances.
Route of administration is frequently important in hospice. Most benzodiazepines can only be given PO, but a select few can be given sublingually or via injection, and diazepam can be given rectally. You will see on the chart which routes of administration, and which dosage forms, are available for each agent.
“Typical and Max Dosing” is there mainly to give you a feel for where most patients should be. But the therapeutic dose and the maximum daily dose sometimes depend on indication (anxiety versus seizure disorder, for example). For more precise dosing you may need to consult a comprehensive dosing reference, and always titrate to your patient’s needs.
We’ve also included a “Comparative Oral Dose” column to help you convert from one agent to another. Please keep in mind that these numbers are only estimates. In some cases, especially for those benzodiazepines that are not as well studied, the numbers vary widely depending on which reference you consult. In other cases (such as converting from lorazepam to alprazolam, for example), the conversion ratios are pretty consistent. But, each patient is unique and we can never completely predict how a specific patient will respond to one medication versus another. So, you will need to use your clinical judgment any time you convert a patient from one benzodiazepine to another, and should always monitor the patient very closely.
The chart does not include pricing information. Pricing is fairly consistent across this medication category, with a few notable exceptions which you will find in the “Comments” column.
We hope you find this chart useful in your hospice practice, and welcome any questions or comments here on the blog.
Dr. Julia Harder, PharmD, CGP
The hospice community is buzzing with the news of the Centers for Medicare & Medicaid Services (CMS)’s Proposed Rule, released on May 10, regarding the use of Debility Unspecified and Adult Failure to Thrive (AFTT) as primary hospice diagnoses. This blog post will update you on what the Proposed Rule is, what it will mean for your hospice if implemented, and what you can do now to prepare for the possible change. To read the complete Proposed Rule, go to: http://www.gpo.gov/fdsys/pkg/FR-2013-05-10/pdf/2013-10389.pdf.
What is the Proposed Change?
Debility and AFTT would not be allowed as principal hospice diagnoses on the hospice claim form. When reported as a principal diagnosis, these would be considered questionable encounters for hospice care, and the claim would be returned to the provider for a more definitive principal diagnosis.
According to CMS, Debility and AFTT are non-specific, symptom diagnoses, classified under the ICD-9 category of “Symptoms, Signs and Ill-Defined Conditions.” Codes under the classification “Symptoms, Signs, and Ill-defined Conditions” are not to be used as the principal diagnosis when a related definitive diagnosis has been established or confirmed by the provider.
The principal diagnosis listed should be the diagnosis which is determined to be most contributory to the terminal condition. Debility and AFTT could be listed on the hospice claim as other, additional, or coexisting diagnoses if needed to support prognosis.
Why is CMS Proposing this Change?
The Proposed Rule gives data showing the changes in diagnosis patterns among Medicare hospice enrollees, with a growing percentage of beneficiaries being admitted under the non-specific diagnoses of Debility and AFTT. In the past 10 years, Debility Unspecified has moved from the 3rd most common hospice diagnosis (6% of all patients) to the #1 most common diagnosis, accounting for 12% of hospice patients. AFTT has moved from #8 (3% of patients) up to #3 (7% of patients). In 2012, Debility and AFTT, the #1 and #3 most common hospice diagnoses, collectively accounted for about one in five hospice patients. See Chart here.
Simultaneously, the average lifetime length of stay for beneficiaries has increased, from 54 days in 2000 to 86 days in 2010, an increase of 59 percent. While this is undoubtedly partially due to the earlier identification of patients who are eligible for hospice services and increased awareness among Medicare beneficiaries of the availability of the hospice benefit, it is probably also due in part to the increased number of patients being admitted with Debility and AFTT, as these patients tend to have longer length of stays in hospice.
Furthermore, CMS expressed concern that if a nonspecific, ill-defined diagnosis is reported as the principal hospice diagnosis, a comprehensive, individualized plan of care may be difficult to accurately develop and implement, and, as a result, the hospice beneficiary may not receive the full benefit of hospice services. The comprehensive hospice plan of care should start with an accurate and thorough assessment and identification of the conditions contributing to the terminal illness and decline so that the patient will receive the best and most patient-specific care.
What Should Our Hospice Do Now?
It is important to understand that this is still a Proposed Rule and is not yet in effect, so you may still submit claims under Debility and AFTT. Because we do not yet know what the Final Rule will be, it may not be necessary to make sweeping changes now. However, many hospices have already reduced, or completely ceased, their use of Debility and AFTT as primary diagnoses, and some are even changing the primary diagnosis for existing beneficiaries currently admitted under Debility or AFTT. Your hospice will need to decide how you want to proceed at present. Consider making some changes now to prepare your hospice and reduce the impact when the Final Rule is released.
Try to reduce or even cease the use of Debility and AFTT as primary hospice diagnoses. Instead, select a primary diagnosis that is most contributory to the patient’s terminal disease trajectory. Reviewing the Plan of Care, the patient’s medical history, and the patient’s drug profile may help you determine which diagnosis is most contributing to the patient’s overall decline and will require the greatest amount of palliative interventions. List this medical condition as the primary diagnosis, and include Debility or AFTT as an additional diagnosis if needed to support prognosis.
CMS is accepting comments on the Proposed Rule until June 28, 2013. You may submit a comment:
• Online at http://www.regulations.gov. Follow the “Submit a Comment” instructions and refer to file code CMS–1449–P.
• By mail to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1449–P, P.O. Box 8010, Baltimore, MD 21244–8010.
And please leave us a comment here on the blog… What impact has this Proposed Rule had on your hospice?
The American College of Gastroenterology (ACG) released new treatment guidelines on the diagnosis and management of gastroesophageal reflux disease (GERD) in the March issue of The American Journal of Gastroenterology. This blog post will present highlights from the updated guidelines, particularly those that are most relevant to the management of GERD in the hospice setting. Some of the recommendations may surprise you, as many of these recommendations are not routinely followed in clinical practice.
Management of GERD
Risks Associated with PPIs
Reference: Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroeneterol 2013; 108: 308-328.
Access the complete guidelines here: http://gi.org/wp-content/uploads/2013/03/ACG_Guideline_GERD_March_2013.pdf
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Education Resources and Support for Hospices
Stay up-to-date on the latest hospice pharmacy benefits management information and tools with a variety of education resources and support at no extra charge. We offer presentations live at your facility, over the Internet or viateleconference, online service education programs, customized courses, and courses accredited for nursing continuing education credit.
Our palliative care experts provide clinical consulting on important medication management and care decisions. Our non-dispensing pharmacists provide focused attention and unbiased advice.
Why Use A PBM?
Contracting with multiple pharmacies, doing all the reporting, trying to stay current with medical practices and stay compliant while keeping costs down? There’s an easier and more effective way.