Delegates generally agreed that making payments site-neutral would help private practices survive financially at a time when many physician groups are being bought out by hospital systems.
This article first appeared November 13, 2018 on Medpage Today.
By Joyce Frieden
NATIONAL HARBOR, Md. -- Site-neutral insurance payments are a good idea, American Medical Association (AMA) delegates agreed on Monday during their interim meeting here.
Currently, Medicare and other insurers pay physicians more for certain services if they are performed in a hospital, and pay less for the same procedures performed on outpatients, rather than paying the same amount regardless of the site of care. Monday's vote on the issue came after a discussion Sunday at an AMA reference committee meeting, in which delegates generally agreed that making payments site-neutral would help private practices survive financially at a time when many physician groups are being bought out by hospital systems.
Delegates approved a report by the AMA's Council on Medical Service that recommended that the AMA "support Medicare payments for the same service routinely and safely provided in multiple outpatient settings (e.g., physician offices, hospital outpatient departments, and ambulatory surgery centers) that are based on sufficient and accurate data regarding the actual costs of providing the same service in each setting."
The report also reaffirmed previous AMA policies on this issue; one policy "calls for equity of payment between services provided by hospitals on an outpatient basis and similar services in physicians' offices," the Council on Medical Service noted in its report on the matter. In addition, "AMA policy also supports defining Medicare services consistently across settings and encouraging the CMS [Centers for Medicare & Medicaid Services] to adopt payment methodologies that assist in leveling the playing field across all sites of service," the council said.
Delegates also agreed to reaffirm AMA policies that "encourage CMS to expand the extent and amount of reimbursement for procedures performed in the physician office, to shift more procedures from the hospital to the office setting ... and direct the AMA to aggressively promote the compilation of accurate data on all components of physician practice costs," as advocated by the council's report.
Delegates rejected a suggestion by Stephen Rockower, MD, of Rockville, Md., to refer the report to the board of trustees for further discussion. "There are accounting problems that can happen" when people try to tally up the costs involved in providing a particular service, Rockower said in explaining his proposal. "I would prefer ... to get proper accounting input to get the proper wording to make it [correct]."
But Charles Wilson, MD, a delegate from Greenville, N.C., disagreed. "I believe the council got it right," he said. "There will be further tweaks of this issue as time goes on, but right now this is quite adequate."
Steve Kanig, MD, a delegate from Albuquerque, N.M., speaking for the New Mexico delegation, agreed, pointing out that CMS is currently considering regulations on site-neutral payment. "This is a timely and urgent matter ... and we really don't want to put off further consideration of this report," he said.
The delegates also said No to a sentence added by the reference committee suggesting that "Site-neutral payments should be based on the actual costs of providing those services and not defined as equal payments or reducing all payments to the lowest amount paid in any setting."
"I speak against this amendment," said Andrew Kleinman, MD, of Rye Brook, N.Y., on behalf of the New York delegation. "Although the intent of the amendment, I think, is admirable, the actual effect could be the opposite of what was intended and could actually increase the difference and increase the amount a hospital would get as opposed to a physician's office."
In other results from Monday's session, AMA delegates also:
Approved a resolution asking AMA to continue advocating for the rejection of step therapy in Medicare Advantage plans
Rejected a resolution asking AMA to advocate for correction of underpayments by public and private payers for office-based DXA tests
Approved a resolution asking the AMA to educate state and federal policymakers and legislators on, and advocate for policies addressing, the medical spectrum of gender identity to ensure access to quality healthcare
Approved a resolution opposing FDA's decision to approve Primatene Mist HFA for over-the-counter use
A resolution on developing sustainable solutions to discharge of chronically homeless patients was referred to the board of trustees for further consideration. The reference committee that considered the resolution noted that it heard mixed testimony on the resolution, and that "speakers stressed that the resolution could have unintended consequences and amount to an unfunded mandate."
A patient's overdose made Jeoffry Gordon, MD, recognize he didn't know everything.
This article first appeared November 02, 2018 on Medpage Today.
By Cheryl Clark
Decades ago, California Gov. Jerry Brown twice named San Diego physician Jeoffry Gordon, MD, to sit on the board that licenses -- and disciplines -- the state's physicians. During those 8 years, his "DocSwat" agency aggressively went after narcotic overprescribers. It even manually searched pharmacy triplicates to proactively identify the worst offenders.
Gordon, 76, retired from his solo beach-area practice 4 years ago. He went to work part-time for a large federally qualified health center and its population of complex, low-income, and very difficult patients, many of whom had a history of substance abuse.
With 5 decades of experience, Gordon prided himself on being able to treat his patients with heart disease or diabetes -- as well as chronic pain -- all by himself, without referring them out. He'd taken the state-mandated course on managing pain and kept up with his CME.
But this summer, Gordon was criticized by his medical director and peer reviewers for his prescribing practices. As careful as he thought he was, one of his pain patients was hospitalized with a heroin overdose.
It wasn't easy for Gordon to accept. But after a period of anger and embarrassment, he acceded to his director's suggestion that he go through Physician Assessment and Clinical Education (PACE), a set of physician re-education classes offered by the University of California San Diego (UCSD).
PACE launched the classes Gordon took -- "Physician Prescribing" and "Medical Record Keeping" -- about 20 years ago in response to requests from state medical boards, hospitals, risk management groups, and peer review committees to address common errors in prescribing, charting, and billing. Those two classes have enrolled some 5,000 clinicians -- mostly physicians -- and most take it as a condition to keep their license. Since PACE enrollment is often ordered by the medical board or peer review committees, the program is not something doctors are eager to discuss.
Gordon told MedPage Today he was not under investigation. But he, along with about 20 other clinicians in each class, checked his ego at the door of a downtown hotel for a week. He found it worth his time and the $3,000-plus cost. He hadn't known what he didn't know.
He volunteered to describe the experience in the hope it will help other providers subdue the nation's opioid epidemic.
The following has been edited for brevity and clarity.
What was it about this clinic population that was so challenging compared with your solo practice?
Gordon: Virtually all -- 90% -- of my patients were high risk. That is, most had mental illness and many had well-documented substance abuse. Some were ex-cons. Many had broken bodies from collisions or violence and presented with acute or chronic pain. Most were also homeless, and pretty much all were in capitated Medi-Cal [Medicaid] managed care. Many pain patients if they did not get relief from one dose, might take two or three, and then bump into a friend who would give them an unknown pill or a packet of heroin. Or whatever.
What happened that prompted the suggestion that you attend PACE?
Gordon: One patient in particular -- a man age 50 years plus. He'd spent 12 years in prison, used to be a drug runner, was on methadone, and his initial drug screen was positive for cocaine. He came to me for multiple non-healing MRSA [methicillin-resistant Staphylococcus aureus] abscesses in his legs due to skin popping heroin.
I put him on clonazepam to keep him from drinking alcohol, tapered his methadone, and gave him talk therapy. Then he fell off his bicycle and got a herniated disc in his neck, which I documented with MRI. He complained of excruciating pain radiating down his arm. I told his methadone clinic to raise his methadone, and gave him Norco [hydrocodone-acetaminophen] on top of that.
It didn't control his pain. I arranged neurosurgery for him, but due to his anxiety he avoided it three times. I was tapering his pain meds. Then he was admitted to the hospital with a heroin overdose.
Did that patient die?
Gordon: No, thank God.
But that's the type of patient that I felt I could handle. I mean, no clinic patient ever got a prescription from me for any narcotics without having (1) a full exam documenting the pain and the problem, whether a fracture or arthritis; (2) appropriate imaging; (3) a pain contract; and (4) a urine screen.
Other patients came to me because their former doctors decided not to prescribe narcotics anymore, and I felt that was unprofessional and unethical.
I thought I could make good clinical judgments.
But I needed to learn how to deal with patients like that. My clinic's medical director recognized the complexity of my patients, and knowing that one overdosed on heroin, suggested PACE was the way to go.
But you were reluctant. At first you were angry.
Gordon: I didn't want to be embarrassed. Earlier, I stood up in a CME course -- in front of PACE instructors I knew -- and said that as a former member of the Medical Board of California, I knew that if you document your exam, have a contract, and do urine testing, you can continue your practice of prescribing narcotics. I'm embarrassed because while that's true, it's too simplistic. Also, PACE's founder was my chief resident when I was a resident at UCSD.
Treatment protocols have evolved. But I had not kept up.
Many doctors will refer these patients to pain management specialists or psychiatrists. Why didn't you?
Gordon: In my experience, the vast majority of pain management doctors weren't interested in a patient's psychosocial circumstances or their psychiatric needs, their depression, or dysfunctional families. And they managed pain by imposing strict or arbitrary limits that didn't address these patients' core problems.
Or they would be procedure-oriented and do epidurals or joint injections.
In several cases, my patients got markedly worse in their hands: an injection made the pain worse. One patient with back pain got epidurals and was immobilized. Or they refused medication even though I felt that person could use more.
I generally had to pester pain management doctors to give me their consult, and then it was mostly repetitive, cut-and-paste, similar, cloned reports, even for different patients. Very disappointing.
What about psychiatry?
Gordon: In my experience, psychiatrists are overworked and underpaid and didn't have time to sort out issues for my complex patients.
What pain drugs did you most frequently use?
Gordon: Mainly four: Norco or morphine sulfate, extended release, and sometimes fentanyl and sometimes hydromorphone -- and all in appropriate amounts.
You mentioned your patients sometimes surprised you in bizarre ways.
Gordon: I've been blown away by several elderly ladies who came to me complaining of pain. When their urine test results were incompatible with their prescribed medicines, I ordered a blood tox screen, stat. They refused and left the clinic. That confirmed for me they'd been selling their meds.
PACE directors said most people who go to PACE may have faced investigations that threatened their license to practice. Who else took the classes, and were they resentful or bitter about having to go? Was there a lot of anger?
Gordon: There were about 20 in each class, mostly primary care physicians in private practice. I assumed that there was anger, but the participants didn't show it.
Dr. [David] Bazzo [one of the course leaders] and his team treated the students with dignity and respect. It was not like traffic school. Rather, the atmosphere was educational and participatory, not punitive.
The classes were dense and highly educational. Two telephone book-sized binders of study points.
Who made up the faculty for the pain course?
Gordon: An anesthesiologist, an addiction treatment specialist, a pharmacist who talked about sedative hypnotics, and a psychiatrist/family medicine doctor who talked about the seductive, manipulative patient. Speakers also discussed drug interactions and newer federal and state prescribing rules dealing with chronic pain.
One impressive speaker, an administrative law judge for the medical board, was extremely reassuring and sensitive. He recognized we were all there because something went wrong, and we were probably angry. Well don't be angry, he said. There's a lot of benefit that can come from this. His attitude was, you know you can do better. That was in sharp contrast to our expectation that we would get a bunch of drill instructors.
What did you learn?
Gordon: There was good data on how ordinary patients who are not mentally ill and not substance abusers can get in trouble on opioids, and that it's correlated with higher doses and longer durations. Also, if a person goes on vacation and forgets the bottle and is hurting when they return, they might go back to a fairly strong dose and they can overdose.
One of the more interesting things I learned: you don't give the same patient benzodiazepines and opioids at the same time, because they're both respiratory depressants. Also, the safer benzos that are less likely to be abused and addictive can be more dangerous when combined with opioids because they're slowly metabolized and cause more respiratory depression.
That's something that, I guess, I'm impressed after going to the class that it's a "never do it" combination. And opioids have more side effects than the medical literature had previously revealed.
What else?
Gordon: Also, if you have groups of people with the same kind of knee or hip arthritis, and you give opioids versus an NSAID like Advil or Aleve, at the end of the year their pain relief and functionality is the same. But those on opioids will have 20% more all-cause mortality. Long-term maintenance on opioids is not the same as [long-term] metformin for diabetes. I never considered it that way before.
I generally went to both classes thinking I was more knowledgeable than most about hustling patients, proper charting, and regulatory oversight. I was wrong on all counts. I generally need to have my humility tank replenished from time to time. This worked.
What did you learn from the medical records class?
Gordon: I was mandated to take this course, but I did not know why until I did.
I learned a lot about how my record keeping could be improved to document not just the multiple diagnoses and drugs for each patient, but to be precise about my assessment and treatment plan.
Was there anything you think the classes missed or didn't do well?
Gordon: They talked about headache, back pain, fibromyalgia, without once mentioning those unbelievably difficult patients who believe they can't be relieved by anything but narcotics. They didn't go there, though they had an opportunity before a bunch of eager students. Also, this class was taught without regard to one socioeconomic consideration at all. That is, there was no discussion about how to manage pain patients when so many of them are ex-cons, low income, or mentally ill.
What will you change about your practice going forward?
Gordon: Some family doctors are like quarterbacks. They see the problem and throw it to the specialist. I was different; I didn't make a lot of referrals. I had no trouble assuming responsibility for heart failure, diabetes, irritable bowel, psychiatric, and chronic pain patients, except for the few patients with cancer or rheumatic disease.
Now, I'm not sure this old family doctor should be taking care of chronic pain. I feel compelled, given all the information in this class, to refer them to pain management, or psychiatry, or somebody else.
But you said you don't have confidence that you can get good referral care?
Gordon: This speaks to my dilemma. I will recommend that my managers develop a competent team within our clinic for pain management, or my clinic should designate a specialist to see them all.
This has been a reality check. Though I feel morally and ethically obligated to help these difficult patients, I can no longer take responsibility in this strict regulatory environment, which is so intense, we are motivated to just drop these patients. I fear patients will suffer more in the end.
Unwillingness to provide my patient's medications resulted in an escalation of care, from stable outpatient management to emergency services and hospital admission.
This article first appeared November 01, 2018 on Medpage Today.
By Andrew Perry, MD
I knew I had seen him before. Or was it that he looked like one of the actors from "The Office"? Either way, he did not look very happy, laying there on the stretcher in the emergency department.
"I went into atrial fibrillation [Afib] again," he said.
He ran out of medication about a month ago. The medication was too expensive for him. While at work today, he felt the palpitations return accompanied by shortness of breath. He came to the ER and had Afib with rapid ventricular response. He was getting a diltiazem infusion and would need to be admitted.
"It's not that I don't have a job, doc," he told me, "It's that my job doesn't pay me enough to cover these medications."
What kind of job does this guy have? I wondered. This is a familiar story: a patient with a chronic illness shows up in the emergency department for issues that could have been prevented if he or she had access to affordable medications. This guy probably works part-time at a fast food chain or something like that, I thought.
"Where do you work?" I asked him.
"Here in the hospital [food services]," was the reply. "I'm actually a really good chef," he said, "but nobody needs that skill anymore."
Unwillingness to provide my patient's medications resulted in an escalation of care, from stable outpatient management to emergency services and hospital admission.
This story highlights how employers and insurers attempt to "pass the buck" of healthcare costs to someone else, resulting in an overall increased cost of care. Since we, as a country, have decided we are morally obligated to provide emergency care, eventually these costs will come back to us -- the buck stops here.
Is it financially advantageous for the hospital (acting as both employer and healthcare provider) to behave this way? If we assume that the hospital charged him what it charges the Centers for Medicare & Medicaid Services, he was charged between $14,057 and $23,509 for the admission (For DRGs with "cardiac arrhythmia." Information available here). If the patient had Medicare, the hospital would receive between $3,360 and $8,133. Compare that to the estimated monthly cost of his medications: $430 a month (for diltiazem ER and apixaban, from GoodRx). If he had been prescribed warfarin instead of apixaban, his monthly cost would be $13 a month.
How much will the hospital recoup for this admission? Probably not much. This will become part of the hospital's sunk costs, and the hospital will receive some small reimbursement for being a safety-net hospital. By not providing the medications he needed a month ago, the hospital will spend more money on a hospital admission that could have been avoided.
This is not a unique story, but one that plays out every day in hospitals across the country. Have you noticed ironic disparities like this in your daily practice, too?
But Barbara McAneny, MD, applauds the recently signed legislative ban on pharmacy gag clauses.
This article first appeared October 17, 2018 on Medpage Today.
By Shannon Firth
WASHINGTON -- A single-payer healthcare system in the U.S. would break her practice, said the president of the American Medical Association (AMA), who argued that Medicare and other government programs as currently structured simply don't pay enough.
"We need a payment system that the country can afford," said Barbara McAneny, MD, AMA president, and a practicing oncologist/hematologist in New Mexico.
McAneny pointed out that in the portion of her practice that serves the Navajo Nation, 70% of payments are from governmental payers, and "I have struggled for the last 10 years to keep that practice breaking even."
Medicare payments are designed to cover about 80% of the cost of doing business, McAneny said. If all her commercial patients were to pay Medicare rates, there would be no other place from which to shift coasts, she explained. "My doors would be closed. I would no longer be able to make payroll."
Moving to a single-payer healthcare system won't fix what's broken, she said during a meeting with reporters Tuesday to discuss a variety of issues, including drug pricing, value-based payments, and turf battles.
While she said she strongly supported Medicaid expansion in New Mexico, McAneny expressed skepticism about the possibility of a Medicaid "buy-in," which would allow people to purchase Medicaid-based public insurance plans.
She pointed out that only about a quarter of the population in New Mexico has commercial insurance, and "Medicaid and Medicare do not cover the expenses of providing care." With fewer patients to cost-shift from, independent practices and small rural practices "would not be able to keep the lights on."
AMA policy supports patients buying "individually selected health insurance," subsidized with advanced or refundable tax credits, that corresponds inversely to income, McAneny said.
McAneny also discussed the Trump administration's recent efforts to curb drug prices, and to the challenge of transitioning from fee-for-service to value-based care.
She called the latest bill banning pharmacy gag clauses "really important. When patients discover that they can pay less than the co-pay to buy the drug, they need to know that because patients are going broke out there, trying to buy their drugs."
Gag clauses prevent pharmacists from telling customers whether paying for their prescription might be cheaper if they paid the cash price instead of using their insurance.
Earlier this week, the Department of Health and Human Services (HHS) announced that drug makers would need to include the list price of any drug paid for by Medicare or Medicaid in their TV advertisements. In an AMA press release, McAneny stated that the HHS move seemed like "a step in the right direction," although the AMA is opposed to direct-to-consumer advertising in general.
McAneny said greater transparency was a "first step" toward addressing such high drug costs.
"There's so much the public doesn't understand about the market, including the true costs of research and development and the role of middlemen, like pharmacy benefit managers and insurance mark-ups , she said.
"Before we suggest any sort of treatment, we think it' s a good idea to make the diagnosis, and that means really understanding that entire process, which means they're going to have to pull back the curtain and let us, the healthcare community, really take a look at that and figure out what adds value and what doesn't," she said.
McAneny was less supportive of changing the way Part B drugs are bought and paid for. In May, HHS Secretary Alex Azar suggested moving some Part B drugs administered in a physician's office into the Part D program, in an attempt to negotiate more competitive prices.
"People cannot afford a 20% co-insurance on a drug that costs $5,000 a month," she said.
In terms of value-based payment, McAneny said she's excited about the work the physician-focused Payment Model Technical Advisory Committee (PTAC) is doing. Doctors are well-positioned to help design alternative payment models, she noted.
"We see all the time places where healthcare dollars get wasted, and patients don't get what they want," she said, so allowing doctors to come up with new methods of care delivery, which incorporate things they've always wanted to do for their patients, has "tremendous potential."
McAneny said she hopes Azar will test as many pilots projects as possible, and see what works, but not penalize groups who fail. "If you're trying something innovative ... sometimes you're going to be wrong, and those people shouldn't have to lose their practices... they should be allowed to fail quickly, and move on to something else," she stated.
McAneny said she will present an alternative model to the PTAC in December.
Another challenge in healthcare is scope of practice, with some physicians expressing concern that nurse practitioners and physicians assistants (PAs) are encroaching on their territory.
McAneny acknowledged that concern, noting that primary care physicians must be "incredible diagnosticians," she said. "They need to know when a sore throat is a sore throat and when it's really cancer."
"In my own practice, where we have everyone working to the top of their license, I value my nurse practitioners and I value my PAs immensely, but I don't expect them to be oncologists, and I don't really expect them to be primary care doctors," she added.
"Everybody has a place in healthcare," McAneny stressed, "but I do not feel that a nurse practitioner who has gone to nursing school and done one extra year... and has not practiced in that post-doc process, has the same level of expertise to be that diagnostician."
A study found the shot offers 'moderate' protection. Only about half of pregnant women got their flu shot last year.
This article first appeared October 14, 2018 on Medpage Today.
By Molly Walker
The influenza vaccine offered pregnant women moderate protection against flu-related hospitalizations, researchers found.
Adjusted influenza vaccine effectiveness was 40% (95% CI 12%-59%) against influenza-related hospitalization during pregnancy, reported Mark G. Thompson, PhD, of the CDC, and colleagues.
Moreover, from 2010 to 2016, 13% of pregnant women who tested positive for influenza were vaccinated compared with 22% of pregnant women who tested negative, according to the study in Clinical Infectious Diseases.
Recent CDC data suggest that only about half of pregnant women got their flu shot last year, but the authors cited the "paucity of data" on influenza vaccine effectiveness in preventing severe influenza-related outcomes, given that randomized trials would be "unethical."
Researchers examined data from pregnant women ages 18-50 with records of live births or stillbirths with gestations ≥20 weeks, whose pregnancies overlapped with influenza seasons from 2010 to 2016.
The team analyzed records from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which contained laboratory, medical, and vaccination records in Australia, Canada, Israel, and the U.S. The authors estimated influenza vaccine effectiveness using the test-negative design, and adjusted for confounders.
A discharge diagnosis of "acute respiratory or febrile illness" was identified using ICD-9 and ICD-10 codes, and the authors noted that acute respiratory or febrile illness hospitalizations were included only if a clinician ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for influenza within 3 days prior to admission through the discharge date.
Overall, there were a little under 19,500 hospitalizations with an "acute respiratory or febrile illness" discharge diagnosis, and of these, only 6% had rRT-PCR influenza virus testing.
Thompson and co-authors noted that most acute respiratory or febrile illness hospitalizations were among women younger than 35, two-thirds were in their third trimester, and two-thirds had no high-risk medical conditions. Acute respiratory or febrile illness was the primary discharge diagnosis for around half of the hospitalizations, the authors wrote.
Among these hospitalizations, about 60% were positive for influenza virus infection. The authors found that compared with influenza-negative pregnant women hospitalized with acute respiratory or febrile illness hospitalizations, influenza-positive pregnant women were more likely to be in their third trimester and less likely to have a high-risk medical condition.
The researchers also found an influenza vaccine effectiveness rate of 55% among women who were hospitalized in their first or second trimester. This could contribute to discussions about the benefits of early maternal vaccination, particularly in the first trimester, the investigators noted.
The authors also said that the findings were potentially relevant to "several public health policy and research debates," including the lack of evidence for influenza vaccine effectiveness against severe laboratory-confirmed influenza during pregnancy, which has been "described as an obstacle to the expansion of maternal influenza vaccination programs" in low- and middle-income countries.
The study was supported in part by the CDC. Thompson disclosed no conflicts of interest; other co-authors disclosed support from Johnson & Johnson (Jannsen Pharmaceuticals), Pfizer, MedImmune/AstraZeneca, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science, Novartis (now GSK), and Dynavax.
The legislation includes telehealth provisions, a partial repeal of the Institutions for Mental Diseases (IMD) exclusion under Medicaid, and more.
This article first appeared October 03, 2018 on Medpage Today.
By Joyce Frieden
WASHINGTON — By a vote of 98-1, the Senate approved a package of bills Wednesday to address the opioid crisis, sending the bill to President Trump, who is expected to sign it.
"We have an urgent bipartisan consensus ... to deal with the most urgent public health epidemic facing our country today in virtually every community," said Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor, & Pensions Committee. "Including the appropriations bill passed in March and the bill approved last week, we'll have directed $8.5 billion toward the opioid crisis ... We're not pretending a single act here can fix the problem [but] we want to do everything we can do to provide tools for parents and patients and doctors and nurses and governors and anyone we can find to deal with this crisis."
"The final opioid package represents a critical component" of the fight against opioid addiction, said Sen. Edward Markey (D-Mass.) "But this should not and will not be the end of Congress's efforts." Markey said there were still some "outstanding" issues, "like mandating provider education and labeling opioid bottles on the risk. There are a lot of physicians out there prescribing opioids who have never had [that education] and don't understand what the consequences are. In the absence of that, the cap of the opioid bottle should have a warning."
Some of the provisions in the bill, which the House passed last week, include:
Giving Medicare beneficiaries more information on alternative pain treatments, and expanding treatment options for enrollees who are addicted to opioids, while expanding treatment options for opioid-addicted beneficiaries.
Partially repealing the the Medicaid Institutions for Mental Diseases (IMD) exclusion, which will allow state Medicaid programs to cover inpatient treatment in residential facilities.
Allowing mothers undergoing addiction treatment to have their young children stay with them, and increasing accessibility of family residential treatment programs, which allows more parents to get help while still caring for their children in a supervised setting.
Requiring state Medicaid programs to have safety edits in place for opioid refills, to monitor concurrent prescribing of opioids and certain other drugs, and to monitor antipsychotic prescribing for children.
Directing the Centers for Medicare & Medicaid Services to issue guidance to states on options for providing services via telehealth that address substance use disorders under Medicaid.
Accelerating the development and use of drug management programs for at-risk beneficiaries within the Medicare program by mandating that all prescription drug plans use such a program by 2022.
Requiring FDA to develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain.
The American Society of Addiction Medicine (ASAM) was particularly pleased with several provisions in the legislation, including a provision giving new and extended buprenorphine prescribing authority for physician assistants and nurse practitioners, as well as adding pathways for practicing physicians to obtain waivers to prescribe medication-assisted treatment; and loan repayment relief to addiction treatment professionals who practice in high-need areas. The group also welcomed the IMD exclusion's partial repeal.
"ASAM applauds Senate leaders for passing this legislation, which is an important step in ensuring individuals with substance use disorder are able to get the help they need," said Kelly Clark, MD, president of ASAM, in a statement. "Addressing the opioid overdose epidemic will require bold action, including a radical transformation of our treatment system into one that universally teaches, standardizes, and covers evidence-based addiction treatment. We commend Senate leaders for moving us closer toward that goal with today's historic vote."
The American Psychiatric Association also expressed support for the bill, but tempered it with concerns about what was left out. "The APA is grateful to see bipartisan support for increased access to treatment for substance use disorders, including expanded access to residential treatment and medication assisted treatment. We are also pleased to see provisions in H.R. 6 to deter opioid abuse," said APA President Altha Stewart, MD, in a statement.
"However, we are disappointed that the final bill did not include critical reforms to ... improve care coordination and patient safety for the treatment of substance use disorders while preserving patient privacy. This much-needed legislation passed the House earlier this year with overwhelming bipartisan support. We urge the Senate to hold a separate vote on [that legislation] to ensure that these enhanced patient safety, care coordination and consumer protections become law."
The National Community Pharmacists Association (NCPA), a trade group for independent pharmacies, also praised the bill's passage. "The opioid epidemic is a complex, heartbreaking problem requiring an all-hands-on-deck response," said Douglas Hoey, the organization's CEO, in a statement. "We are grateful to congressional leaders for their work on this vital relief package and for engaging with NCPA and other stakeholders throughout its development."
"Among other provisions, the final package includes the NCPA-endorsed Empowering Pharmacists in the Fight Against Opioid Abuse Act, introduced by Reps. Buddy Carter (R-Ga.) and Mark DeSaulnier (D-Calif.), which would require federal agencies to develop and distribute materials to train pharmacists on the circumstances in which they are allowed by law to decline to fill a prescription for a controlled substance," he said. "These circumstances may include the suspicion of fraud, forgery, or other forms of modification."
Coverage was highest among healthcare personnel working in hospital settings, followed by those working in ambulatory care, then other clinical settings.
This article first appeared September 27, 2018 on Medpage Today.
By Molly Walker
Over three-quarters of healthcare personnel received an influenza vaccination during the 2017-2018 flu season, researchers found.
Similar to the previous four flu seasons, 78.4% of healthcare personnel reported receiving the flu shot, with coverage around 95% for those whose employer required them to be vaccinated, while coverage was less than half of those working in settings where vaccination was not required, promoted, or offered on-site, reported Carla L. Black, PhD, of the CDC, and colleagues, writing in the Morbidity and Mortality Weekly Report (MMWR).
The researchers examined data from an internet panel survey of healthcare personnel conducted for the CDC by both Medscape and Survey Sampling International. Overall, the sample included 2,265 healthcare personnel.
The authors noted that coverage was similar to that in the 2016-2017 season, and similar to the results in previous seasons, it was highest among healthcare personnel working in hospital settings (91.9%), followed by those working in ambulatory care (75.1%), "other clinical settings" (74.9%), and finally, long-term care settings (67.4%).
Examining the personnel themselves, the researchers found that over 95% of physicians were vaccinated, as well as over 90% of pharmacists and nurses. Coverage rates were lowest among non-clinical health personnel (72.8%) and assistants and aides (71.1%).
Around 44% of healthcare personnel reported a requirement to be vaccinated -- including over two-thirds of those working in hospitals. Less than 40% of those working in ambulatory care were required to be vaccinated, as well as less than 30% of those working in long-term care.
The researchers noted that influenza vaccination coverage among healthcare personnel working in long-term care settings "continues to be consistently lower" than those working in all other healthcare settings. "Influenza vaccination among healthcare personnel in long-term care settings is especially important because influenza vaccine efficacy is generally the lowest among the elderly, who are at increased risk to severe disease."
About Half of Pregnant Women Received Flu Shot
A second study in the same issue of the MMWR found that about 49% of 1,171 pregnant women in an internet panel survey who were pregnant during "peak influenza vaccination period" (October 2017-January 2018) reported that they received the influenza vaccine before or during their pregnancy.
Two-thirds of women reported receiving a provider offer for influenza vaccination, wrote Katherine E. Kahn, MPH, of the CDC, and co-authors. Not surprisingly, of the women who reported receiving this offer, 63.8% received the vaccine. Among women who reported that their provider recommended the vaccine but did not offer influenza vaccination, 42.1% received a referral to get vaccinated. The most commonly reported reason for not receiving the flu shot before or during pregnancy was "belief that the vaccine is not effective" (20.2%).
The survey also found that among 700 respondents who had a recent live birth, 54.4% reported receiving the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during pregnancy. Similarly, a little over two-thirds of women reported receiving an offer from their provider of Tdap vaccine, and when the provider recommended but did not offer the vaccine, 52.9% received a referral, Kahn and colleagues said.
They emphasized the results of a recent survey conducted by the American College of Obstetricians and Gynecologists (ACOG), which found that while "providers believe they are giving a recommendation for vaccination, the recommendation might not be strong enough to be remembered by patients."
The team noted that CDC has resources to assist providers about effectively communicating about the importance of vaccination, and also cited the ACOG immunization toolkit as another resource.
Pharmacists should be able to freely tell patients that a drug will cost less out-of-pocket.
This article first appeared September 05, 2018 on Medpage Today.
By Shannon Firth
WASHINGTON -- Members of the House stumped for a healthcare bill that they said will improve transparency for patients at the pharmacy counter, and reduce their out-of-pocket costs, during a hearing Wednesday.
"Gag clauses" prevent pharmacists from informing patients that a drug will cost less out-of-pocket than it would using the patient's insurance, unless the patient requests the information directly, explained Rep. Michael Burgess, MD, (R-Tex.), chair of a subcommittee to the House Energy & Commerce Committee.
Rep. Buddy Carter (R-Ga.) put forth a draft version of a bill that would ban Medicare and private health plans from including gag clauses in contracts. Burgess called the bill "essential in both lowering drug costs for individuals and freeing the pharmacists to do what many consider the right thing."
At the hearing, Hugh Chancy, RPh, a member of the board of directors for the National Community Pharmacists Association, described a situation where gag clauses on patient-pharmacists discussions directly impacted his work. Chancy owns multiple pharmacies in South Georgia.
Chancy said a pharmacy customer, the mayor of a city in Georgia, was told that his co-payment for a single medication had increased from $7 to $26, after his city changed insurance providers.
Chancy said he told the customer that paying out-of-pocket for the medication would be less than the co-payment through insurance. The mayor then complained to the insurance company about the cost difference, according to Chancy.
The insurance plan contacted its pharmacy benefits manager (PBM) who issued a "verbal warning," claiming that Chancy had violated a contract by discussing the drug's cost without insurance and "disparaging the plan," he told the subcommittee.
"We were told [that] if my pharmacy were to do so again, there would be consequences," Chancy said, including being cut out of certain PBM networks.
David Yoder, PharmD, MBA, executive director of Member Care and Benefits for Blue Cross Blue Shield Association (BCBSA) Federal Employee Plan, said BCBSA does not support gag clauses, and even recommended that pharmacists go a step further in advising patients on generic substitutions, while stressing the need for "direct communication" with the prescribing physician.
He noted that he's "unaware of any Blue Cross and Blue Shield company or contracted pharmacy benefit managers to have gag clauses in place with pharmacies."
But Yoder's support for banning gag clauses was tempered by a warning regarding potential drawbacks of patients' not using their insurance to pay for prescription drugs. He noted that drugs purchased without insurance won't count towards a patients' deductible or out-of-pocket limits, "which may reduce the value of their insurance coverage."
Rep. Jan Schakowsky (D- Ill.) said she supported ending gag clauses, but noted that the committee needs to be doing more, such as advancing bills to allow Medicare to negotiate directly with drug companies.
Congressional members discussed a few other key pieces of legislation at the hearing:
The ACE Kids Act that would allow states the option to create "health homes" for children with medically complex conditions, and to improve care coordination including allowing states to coordinate care with out-of-state providers.
An amendment to title XIX of the Social Security Act aimed at broadening the authorities of State Medicaid fraud and abuse units, and allowing them to investigate and prosecute incidents where Medicaid beneficiaries may have been abused or neglected in any setting.
The EMPOWER Care Act, which would reauthorize the Money Follows the Person Rebalancing Demonstration Grant. This allows states to help residents transition from institutions, such as nursing homes, into home and community settings using supplemental benefits not traditionally provided by Medicaid.
When asked about the consequences of not passing the EMPOWER Act, hearing witness Matt Salo, executive director of the National Association of Medicaid Directors, said "Without extension of Money Follows The person, what you're going to have is a definite subset of people who are in an institution ... who don't want to be there, who don't need to be there, and are going to have an enormous difficulty making the transition out."
Witness Rick Merrill, president and CEO of Cook Children's Healthcare System, expressed support for the ACE Kids Act, noting that some states don't have a children's hospital or lack access to high-level services. This legislation would help these children with very complex illnesses get care.
In 2020, plans will have the option to exclude certain drugs for certain indications.
This article first appeared August 30, 2018 on Medpage Today.
By Shannon Firth
WASHINGTON -- Beginning in 2020, Medicare Part D plans will be allowed to cover prescription drugs for some indications but not others for which they're approved, the Centers for Medicare and Medicaid Services (CMS) announced on Wednesday.
Under current Part D rules, if a plan covers a drug it must cover that drug for all its FDA-approved indications. In the private sector, this isn't always the case -- plans are allowed to use indication-based formulary design, explained an agency press release.
"By allowing Medicare's prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries," said CMS Administrator Seema Verma in the press statement.
Indeed, some drugs may not be the best choice or the most affordable option for certain indications, agreed John Rother, president and CEO of the National Coalition on Healthcare and chair of the Campaign for Sustainable Rx Pricing.
"The idea is that this will put a little more pressure on the pharmaceutical industry to lower costs and have more careful utilization that makes sure that only the most appropriate drugs are used when people need them," he said in a phone interview with MedPage Today.
CMS issued a memo to Part D sponsors explaining what it sees as the benefits of the new Part D formulary options. It noted that any sponsor that chooses to limit its formulary, and opt for an indication-based design, must include a "therapeutically similar drug" for any indication that has been excluded, or the plans will fail to meet certain anti-discrimination requirements.
The agency cited the example of a tumor necrosis factor (TNF) blocker that is FDA-approved for both Crohn's disease and plaque psoriasis. A Part D plan could include the TNF blocker on the formulary for plaque psoriasis only, but would then have to include another TNF blocker for Crohn's disease on its formulary.
Overall these new "flexibilities" would encourage plans to broaden their formularies, the agency said.
"Since this policy provides sponsors the flexibility to add a drug to their formularies for specific indications, as opposed to leaving the drug off of the formulary altogether, patients in need of the drug will have access to the negotiated price and will have to rely less on the appeals process," noted a CMS fact sheet.
"This formulary approach will help ensure Medicare beneficiaries receive individualized drug treatment that is targeted to meet their needs," the agency fact sheet continued.
The Right Approach
Rother described the change as "a fairly small step, but it's a step in the right direction."
More aggressive actions the administration could take include importing drugs from other countries, limiting year-to-year increases of drug prices (as is done in Medicaid), or reviewing the value of each new drug compared to existing therapies and pricing it based on whether it represents a significant advance over current therapies.
"Those would all be really important bigger steps that we could take towards more affordable pharmaceuticals," Rother said.
He believes action could be seen on each of these approaches in the near-future, though in some cases only at the state level, he said.
Others saw the value, in theory, of bringing commercial approaches into Medicare, but weren't as optimistic about their viability in practice.
"It makes a lot of sense to borrow some of the tools that are used in commercial plans," said Marsha Simon, PhD, president of Simon & Co., a firm specializing in health policy development.
But she warned that allowing plans to exclude certain drugs for certain indications could make formularies too complex and sow confusion for beneficiaries.
Unintended Consequences
"We've all seen Medicare Part D beneficiaries get to the counter in the pharmacy and they're told, 'That will be $1,000,' and they just walk away," Simon said. Often, the reason they can't afford their medication is because it isn't on the formulary, she continued.
And the Annual Notice of Change (ANOC), a beneficiary document in which plans must explain any new indication limitation, has "serious deficiencies," she added.
Another stumbling block is that the Medicare Part D appeals process is next to impossible for beneficiaries to negotiate. And it lacks mechanisms found in other parts of the program -- such as an automatic review by an independent contractor.
"There's no question that adding this additional option for plans makes the program even more complex and even more difficult to understand and more likely to result in a doctor prescribing a drug that's not going to be on the formulary, if the doctor even has the information to parse it."
The American College of Rheumatology also expressed concern, saying in a press release that the change "takes clinical decision making out of the hands of providers and puts insurance companies in control of patient treatment plans."
"Furthermore, the proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy," the group said. "Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together."
Lance Grady, a vice president at Avalere Health, was more enthusiastic, saying these new options represents "another lever" for price negotiations with drug manufacturers.
While changes in formulary design may not affect the list price of the drug, they could alter net pricing.
"I think we could see a range of rebates or discounts," he said, depending on any one products range of indications.
In cases where one product is more effective for one indication than another, "that's where I think we could see differential net pricing," Grady said.
He noted, however the possibility of "operational challenges" and suggested that changes to pharmacy claims adjudication and to the granularity of the information that's collected relating to patient information or the clinical indications of use might be needed.
"If you're making coverage decisions based on an indication or clinically focused data ... [there's a] level of granularity that would need to be carried through the claims adjudication system" as well as through any prior authorization requests, he said.
'Fiddling Around the Edges'
Steve Knievel, the access to medicines advocate for the consumer advocacy group Public Citizen, said he expected only "a mild impact" on drug prices.
While distinguishing between different indications when a drug is more effective for one than another make sense from a policy perspective, "it's a far cry from what President Trump promised voters and what we actually need to provide relief to Americans that are struggling with high prescription drug prices."
"Rather than putting forth meaningful robust reforms that get to the root problem of the high drug prices that are set by the pharmaceutical corporations, the Trump administration is putting forward an approach that's fiddling around the edges."
Remarks came during a call that the agency convened to mark 100 days since President Trump released his plan to lower prescription drug costs for patients.
This article first appeared August 20, 2018 on Medpage Today.
By Joyce Frieden
WASHINGTON -- Congress and drugmakers should be doing more to lower the cost of prescription drugs, Health and Human Services (HHS) Secretary Alex Azar said Monday on a conference call with reporters.
"The industry and Congress can and should take specific action in the months to come," said Azar. For example, "The industry could move further to a fixed price discount system at the point of sale. There's nothing stopping them. There's nothing stopping pharmacy benefit managers [PBMs] from changing the contracts they have with their plans or their employers to enable discount pricing or to move to net pricing regimes and away from guaranteed rebate structures that lock in existing incentives toward ever higher list prices."
"The pharmaceutical industry can and should voluntarily begin disclosing the cost of their drugs in direct-to-consumer advertising," he continued. "Congress can and should act to preclude 'gag clauses' in private insurance as well as Medicare." Azar was referring to contract clauses that prohibit pharmacists from letting customers know when it would be cheaper to pay for a drug out-of-pocket than to go through their insurance.
"Congress can and should repeal the Obamacare giveaway to pharma by limiting the rebates in the Medicaid program for those actors who increase list prices faster than the rate of inflation, and Congress can and should act to get rid of the abuse of the 180-day generic exclusivity window currently being abused by generic and branded pharmaceutical companies to delay entry of competitive generic products," he added.
Azar's remarks came during a call that the agency convened to mark 100 days since President Trump released his plan to lower prescription drug costs for patients. "We have taken a significant amount of action in these 100 days, but this is just the beginning of a fundamental transformation," he said.
Azar cited actions the administration had taken in this area, including accelerating generic drug approvals, launching a work-group to consider ways to safely import certain sole-source branded drugs, launching a biosimilars action program, and publicizing companies who had used the FDA's Risk Evaluation and Mitigation Strategy (REMS) program to deny access to generic companies requesting samples of brand-name drugs for the purpose of developing generic versions.
He also lauded drugmakers for their actions so far. "Fifteen companies have made significant announcements on drug prices by either reducing prices ... or freezing prices at least," he said. "And a new analysis from the [HHS] Assistant Secretary for Planning and Evaluation finds that there have been 60% fewer brand-name price increases than the same period in 2017, and 54% more brand-name and generic price decreases."
However, some media outlets have reported that the drug companies' announcements were "largely symbolic" and would not greatly affect the companies' bottom lines. "Of the few companies that actually cut prices, for instance, most targeted old products that no longer produce much revenue -- such as Merck's 60% discount to a hepatitis C medicine that had no U.S. revenues in the first quarter," Politiconoted in its story on the topic. "Others volunteered to halt price increases for 6 months -- in some cases, just weeks after announcing what is normally their last price hike for the year."
When asked by MedPage Today about this, Dan Best, the secretary's senior advisor for drug pricing reform, responded that "Our focus is getting the work done that we laid out in the blueprint; how manufacturers have decided to support or go in this direction -- it's something we're appreciative of. It does have an impact on what consumers would pay, but at the end of the day, the only way we're going to achieve our objective is to deliver on the blueprint as outlined on May 11th."
Congressional Democrats are also talking about the topic -- but in a different light. On Tuesday, Senate Democrats are holding an event featuring patients and their families who have been adversely affected by high prescription drug prices.
