Archive for August, 2017

What Have You Done for Me Lately?

What Have You Done for Me Lately?

“What have the Medical Association and ALAPAC done for me lately?”

It’s a question posed to me often, in various forms, by physicians whom I’m asking to join the Medical Association and contribute to ALAPAC. It’s a tough one to reply to – not for a shortage of answers – but for the difficulty, even for a seasoned communicator like myself, to encapsulate succinctly.

I like analogies, so here’s one to start: a legislative session is like a surgical procedure; hundreds of things can go wrong, and getting through one without incident is deemed a success. To reiterate: when nothing bad happens in a legislative session that is a victory. Preposterous? Allow me to elaborate.

It’s been attributed to everyone from Thomas Jefferson to Mark Twain, but the old adage “no one’s life, liberty or property are safe while the legislature is in session” certainly rings true. The Alabama Legislature may only be in session three days each week for three-and-a-half months (plus special sessions) a year, but just like with a surgical procedure, countless things can go wrong during that time.

Representing physicians at the legislature, the Medical Association is severely outnumbered. There are nearly 600 registered lobbyists in Alabama, many with clients – drug companies, health insurers, personal injury lawyers – interested in health care but whose corporate profits strategy or legislative goals are at odds with those of patients and physicians. I’ve heard physicians say they don’t like politics, that it’s dirty business. This is understandable but frankly, irrelevant. Feelings have no place here. Like it or not, politicians are in your business.

On average, a typical legislative session will see a combined 1,000 House and Senate bills introduced, with roughly 15 percent touching health care in some fashion. Over a four-year legislative cycle, that’s 600 “procedures” to get through with as few complications as possible. Some of these are initiatives the Medical Association supports, others will need tweaking through amendments or substitutes, still others will have no redeeming elements whatsoever and are outright opposed.

If that sounds simple in principle, it is not so in practice. To illustrate the complexity and unpredictability of an average legislative day, picture an emergency physician. At the State House, there is little warning of what daily catastrophes will present themselves or what will have to be triaged depending on severity. Committee testimony, one-on-one meetings with legislators, bill negotiations with opposing parties, these are all part of a typical legislative day. Getting through the day without any bad happenings is a success, even more so all 30 days of the session.

While it is the Medical Association’s role to lobby the legislature on issues important to physicians, it is the role of the Alabama Medical PAC (ALAPAC) to help elect candidates to office with whom physicians and the Medical Association can work on important health-related issues. Over just the past few legislative sessions alone, the Medical Association, with the help of ALAPAC-supported legislators, successfully saw passage of several important bills.

These include “virtual credit card” legislation to help medical practices from unknowingly getting hit with hidden processing fees in electronic payments from health insurers and RCOs; the chemical endangerment “fix” legislation protecting pregnant women and their doctors from prosecution for the issuance of legitimate prescriptions (after the courts issued a new interpretation of Alabama’s chemical endangerment of children law); and, direct primary care legislation, which ensures state government stays out of private contracts between physicians and their patients. The list also includes legislation related to increasing naloxone availability, establishing guidelines for interstate medical licensure, and preventing Medicaid cuts, to name but a few.

On the opposite end of the spectrum, other proposed legislation is so bad there is no “fixing” it, bills like the Patient Compensation System legislation from 2016. The PCS legislation would levy an $80 million tax increase on physicians to fund a new government-administered malpractice claims payout system that would deprive physicians and legitimately-injured patients of their legal rights, undo decades of medical liability reforms and make Alabama doctors appear – on the national claims database – to be practicing sub-standard medicine. This legislation was, with the assistance of ALAPAC-supported legislators, defeated.

In the same vein as the PCS bill, pharmaceutical legislation was introduced in 2017 that would (1) lower biologic pharmaceutical standards in Alabama law below those set by the FDA, (2) withhold critical health information from patients and their doctors and, (3) significantly increase administrative burdens on physicians. This legislation met the same fate as the PCS legislation, but both bills are expected to return in a future session. (Click here for a complete recap of the 2017 legislative session.)

Clearly, the Medical Association and ALAPAC have been hard at work for physicians and patients, from the primary care doctor to the sub-specialist. There is a natural tendency for physicians to associate and support their respective specialties, which they unequivocally should. At the same time however, the collective strength of a unified state medical society representing all physicians of all specialties and the patients they care for is much greater than any individual specialty on its own.

This article began with a question and so it is fitting to end with one: What have you done lately to help the Medical Association and ALAPAC succeed for you?

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Still the New Guy with Mayor Howard Rubenstein, M.D.

Still the New Guy with Mayor Howard Rubenstein, M.D.

SARALAND – A native of Chicago, Howard Rubenstein moved to Saraland in 1985 after he completed his residency. He dabbled in civic organizations at first before diving in head first as he learned just how much he enjoyed his community and the people in it. A thriving family practice, to the Lion’s Club, to the Chamber of Commerce, to team doctor, to the city council, and even the creation of a Boy Scout Explorer Post, Dr. Rubenstein’s mark on the community that he loves continues today as mayor. And yet…he’s still “the new guy.”

“Even though I’ve been in Saraland since 1985, I’m still the new guy. It’s part of the joy of a small community having patients ask about city council business or folks come up to me after a city council meeting and ask for medical advice. That’s just how things work. I still get phone calls from constituents who say, ‘Well, Mayor, I know you’ve lived here a few years but I’ve been a resident since 1946!’”

After all these years living in the Deep South, when Dr. Rubenstein speaks, you won’t catch him saying, “Y’all.”

“I’m working on it. Give me a few more years. I love living in Alabama. This state has some of the best people in it, but I’m still one of the new guys, I guess. I’ll take that,” he laughed.

He credits his love of public service to his residency director, who also served as mayor of his hometown. It was a philosophy of civic duty that resonated with the young physician.

“For three years during my residency, he hammered into us that it’s not enough to basically hang out a shingle and practice medicine. You have to get involved in your community. You have to become part of your community. You have to give back to your community. It’s a great philosophy I took to heart,” Dr. Rubenstein explained.

Once Dr. Rubenstein finished his residency and moved to Saraland, that philosophy followed him. He set up his practice…and then set out to get more involved in his community. Healing his patients was one thing, but doing as much as he could to help heal his community was one step further. More work needed to be done in this suburb of Mobile. He got involved with as many civic groups as he could until 1996 when a seat opened on the city council. That spark lit a new fire for Dr. Rubenstein.

“I told my wife I’d like to run for that, and she told me I was crazy,” he laughed. “But, after doing everything else I realized I really did want a little more input on how things were being done in the community. “I expected to lose that election, I was just so shocked! I think I won by just 72 votes. It was totally different than I thought it was going to be.”

A lot of parallels have been drawn between politics and medicine – about healing patients and healing communities. But, according to Dr. Rubenstein, nothing can be farther apart than the two.

“The difference between public service and being a physician is that as a physician you want to make every patient as happy as you possibly can make them. That’s your goal – to do the absolute best that you can for your patient. You can’t always do that as an elected official. With every decision you make as an elected official, you’re going to make someone happy and someone unhappy. So, it’s a different paradigm that you’re working in. You just can’t make everyone happy.”

Dr. Rubenstein is currently serving his second full term as mayor, and with 21 years in politics, he’s found a balance: He enjoys serving his community as a physician in a thriving practice and as a public servant.

“I’ve really enjoyed this opportunity to serve. We’ve done a lot of great things in our community of the last 20 years. Saraland has come a very long way in that time. We have our own city school system, which we started about 10 years ago…a brand new high school and elementary school, just built an early education center. There’s a lot of growth and a lot of new businesses and subdivisions coming into the area now. I think the favorite part is the enjoyment when a project that you’ve thought about and worked on is actually done. To go from ‘maybe we can do this’ to ‘now it’s done’…There’s such a sense of accomplishment in seeing a project from conception to completion.”

That doesn’t mean his days are short. They’re long and challenging. He begins each day in his practice around 7:30 a.m. seeing patients and ends sometimes as late as 9 p.m. working on city council business.

“I don’t enjoy sitting at home at night and watching television. That’s not my idea of fun, and I don’t think I’m missing anything anyway. I love seeing my patients and working with them…for the past four generations now. That’s the joy of family medicine!” he laughed. “And with the civic work, I’m helping my community grow. Here’s the thing – To me, every physician should be able to make time to do something they enjoy to prevent burnout. I’ve seen a lot of physician burnout cases, and it’s important to be able to do something different and exciting and fun! Being a physician is a challenging career that can take a toll with all the regulations and rules and stress, so even this work with the city helps break up my day.”

And, he has a hobby. As an avid scuba enthusiast, Dr. Rubenstein and his family have for the last 12 years visited their favorite spot in the Cayman Islands for some of the most spectacular diving in the Caribbean Sea.

As much as he loves his home in Saraland, it’s obvious the residents love and appreciate him and his family as well. In 2012 after the sudden passing of his son, Dr. Rubenstein said the outpouring of support and compassion was breathtaking.

“I have an amazingly supportive wife, Tammy, without whose support I couldn’t do what I do. We’ve been married for 34 years. In 2012, our 28-year-old son went to bed one night and didn’t wake up the next morning. We discovered he had a rare congenital heart defect. Our community was extremely supportive. Without their support, I don’t think we would have made it through,” he said.

Posted in: Physicians Giving Back

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CMS Cancels Some Bundled Payment Proposals

CMS Cancels Some Bundled Payment Proposals

CMS released a proposed rule that reduced the number of mandatory geographic areas for the joint bundled payment program and cancels the cardiac bundled payment program model.

In response to the cut, the American College of Cardiology released a statement indicating the ACC “will continue to work with CMS on opportunities for clinicians to participate meaningfully in Advanced Alternative Payment Models. As we move from volume-based care to value-based care, the path forward is challenging and we must work together to find solutions.”

The cardiac bundled program was set to begin in January 2018, but the bundled payment programs have been delayed multiple times. By eliminating the bundling programs, CMS also removes one of the ways providers can qualify for MACRA’s 5 percent advanced payment model bonus.

“Changing the scope of these models allows CMS to test and evaluate improvements in care processes that will improve quality, reduce costs, and ease burdens on hospitals,” said CMS Administrator Seema Verma. “Stakeholders have asked for more input on the design of these models. These changes make this possible and give CMS maximum flexibility to test other episode-based models that will bring about innovation and provide better care for Medicare beneficiaries.”

Moving forward, CMS expects to increase opportunities for providers to participate in voluntary initiatives rather than large mandatory episode payment model efforts, including additional voluntary episode-based payment models, the agency said.

The episode payment models and the cardiac rehab incentive models were designed as mandatory payment models to test the effects of bundling cardiac and orthopedic care beginning in 2018.

Read the proposed rule here

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Fewer Physicians Could Be Audited under a New CMS Program

Fewer Physicians Could Be Audited under a New CMS Program

Fewer physicians will undergo audits under a new Medicare claims review process, according to a Centers for Medicare & Medicaid Services announcement.

CMS will roll out a new approach to claims review nationwide targeting fewer providers and requiring review of fewer claims. The new policy, to take effect later this year, makes it less likely doctors who have sound billing practices will face a Medicare audit.

Under the Targeted Probe and Educate (TPE) program, Medicare Administrative Contractors will focus “only on providers/suppliers who have the highest claim error rates or billing practices that vary significantly out from their peers,” according to the CMS announcement. Providers/suppliers with continued high error rates after three rounds of TPE may be referred to CMS for additional action, which may include 100 percent prepay review, extrapolation, referral to a Recovery Auditor, or other action. Providers/supplier may be removed from the review process after any of the three rounds of probe review, if they demonstrate low error rates or sufficient improvement in error rates, as determined by CMS.

Read the full CMS announcement here

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Physicians Maintain High Standards

Physicians Maintain High Standards

By the time this article goes to print, a lot could change, so there’s no apparent use in guessing what will come of the next Repeal and Replace efforts or what’s happening at Main Justice. Nobody knows. The only certainties from Washington are that there will be change in the payment and insurance models, and that there will be more reports of arrests and prosecutions for alleged fraudulent schemes. Some practitioners express concern, but physician quality and innovation do not have to suffer because of these changes in law because physicians maintain high standards.

Neither Obamacare nor Ryancare nor Trumpcare nor the next iteration will actually change health care. Instead, they guide how health care services are paid. Payment certainly can influence quality, just as who pays for care can perhaps impact patient compliance. But quality care is neither guaranteed nor premised on any particular actual or proposed national structure. These laws do not provide anyone health care. You do, as physicians and nurses and hospitals. The Medical Association began with 30 physicians having a common goal of higher standards in an era with no insurance market at all, nor anesthesia like we know it today. It has always been appropriate for physician entrepreneurship to drive innovation and quality care with it, but there are limits.

The limits have always been there. Whether the changes of today will raise or lower the standard of care within any specialty, or chill entrepreneurship and innovation, is up to each provider. Understanding the legal bounds is often difficult for physicians, and sound legal advice is crucial to success because for every one announced prosecution or indictment there are untold stories of civil corporate misdeeds and aggressive strategies where specialized counsel could have maintained the high standard.

The Department of Justice under Attorney General Jeff Sessions announced in a July 13 news conference that 412 people were charged for participating in health care fraud amounting to more than $1.3 Billion. Pharmacists in Mississippi recently pleaded guilty to fraud charges, with one admitting” that he conspired with others to select compounded medication formulas based on profitability, rather than on effectiveness or patient need,” and that he dispensed medically unnecessary medications. The other pharmacist admitted to “soliciting physicians and other medical professionals to write prescriptions without seeing patients for medically unnecessary compounded medications dispensed by the pharmacy.”

In Virginia, “[a] medical doctor and entrepreneur was sentenced to [10 years] in prison . . . for defrauding his former company’s shareholders and for failing to account for and failing to pay employment taxes.” Ohio-based companies and their executives recently “agreed to pay approximately $19.5 million to resolve allegations pertaining to the submission of false claims for medically unnecessary rehabilitation therapy and hospice services to Medicare,” not that the therapy wasn’t performed or quality care – just that it was excessive and driven by profit over patients. Louisiana clinical psychologists were sentenced for a $25.2 million Medicare fraud scheme involving both unnecessary therapy and therapies never performed. A Florida physician pleaded guilty for his role in pain pill diversion and Medicare fraud scheme. An Alabama federal court enjoined a pharmacy from “distributing adulterated, misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.” A Tennessee physician settled false claims allegations of distributing and billing Medicare for drugs that had not been FDA-approved. This is all according to the Department of Justice in just the last month. Expect more, whether it’s from General Sessions or a successor.

These headlines should educate rather than frighten the physician entrepreneur with high standards. Each case can educate an intelligent professional that while billing guidelines and corporate laws may have positive or negative impacts on quality, usually indirectly, your standard of care owed to your patient and your business partners does not have to regress. These providers who fell into trouble with the Department of Justice may truly be outliers.

The Virginia “physician and entrepreneur” sentenced in July abused his investors’ trust, stole their money, and provided fraudulent financial statements. That’s an extreme case, perhaps, but consider the same case but where the physician and his investors lost trust in each other purely because of a lack of communication after a series of misunderstandings, and maybe some ego or fear. Perhaps the misunderstandings were fueled by further misunderstandings of medicine by the investors and misunderstandings of business by the physician. But I speculate on a hypothetical ripped from these DOJ headlines. Further, though, consider where the physician did not intend to steal anything but made blindly ignorant mistakes because he failed to ask for help or just maintained business as usual despite corporate changes. Consider the same story but where the financials were not intentionally fraudulent but in error or premised on aggressive billing practices, or an unwillingness to fully engage accountants for their services to pinch pennies. These seemingly more benign circumstances could be all too common, aggravated further by ego and competing visions or interests, and if unchecked and don’t make the DOJ alert then they could also lead to civil lawsuits.

A health care lawyer can answer questions and guide physicians to maintain high standards. The honest physician in need of compounded pharmaceuticals for patients could unwittingly become a co-conspirator like the Mississippi physician. The honest clinician is being driven to cut costs and increase revenue. The honest physician is brought into seemingly prudent arrangements that can turn sour. When a physician goes beyond medicine and into business, retaining legal counsel is critical to maintaining the same high business standards as physician strives for high standards in caring for patients. Specialists and trained sub-specialists are available.

Tom Wood is a partner in the Health Care Practice Group at Burr & Forman LLP and represents health care providers in regulatory and litigation matters. Buff & Forman LLP is a partner with the Medical Association.

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What If No One Was On Call…2017 Legislative Review

What If No One Was On Call…2017 Legislative Review

In times of illness, injury and emergency, patients depend on their physicians. But what if no one was on call? Public health would be in jeopardy. However, the same holds true during a legislative session. What would happen if the Medical Association was not on call, advocating for you and your patients at the Alabama Legislature? Keep reading to find out.

Moving Medicine Forward

Patients and their physicians want assurances about not only the quality of care provided, but also its continued availability, accessibility, and affordability. Patients want to make health decisions with their doctors, free from third-party interference. Continued progress toward these objectives requires constant vigilance in the legislative arena, where special interest groups seek to undermine physician autonomy, commoditize medicine and place barriers between physicians, their patients and the care their patients need.

If no one was on call… Alabama wouldn’t be the 20th state to enact Direct Primary Care legislation. DPC puts patients and their doctors back in control of patients’ health and helps the uninsured, the under-insured and those with high-deductible health plans. SB 94 was sponsored by Sen. Arthur Orr (R-Decatur) and Rep. Nathaniel Ledbetter (R-Rainsville).

If no one was on call… the Board of Medical Scholarship Awards could have seen its funding slashed but instead, the program retained its funding level of $1.4 million for 2018. The BMSA grants medical school loans to medical students and accepts as payment for the loan that student’s locating to a rural area to practice medicine. The BMSA is a critical tool to recruiting medical students to commit to practice in rural areas. As well, the economic footprint of every physician is at least $1 million, which improves both community health and local economies.

If no one was on call… Medicaid cuts could have been severe, possibly reducing access for patients within an already fragile system in which less than 20 percent of Alabama physicians participate. Due to work done during the 2016 second special session and the 2017 session, sufficient funds were made available for Medicaid without any scheduled cuts to physicians for 2018. Increasing Medicaid reimbursements to Medicare levels – a continued Medical Association priority – could further increase access to care for Medicaid patients.

Beating Back the Lawsuit Industry

Personal injury lawyers are constantly seeking new opportunities to sue doctors. While Alabama’s medical liability laws have fostered fairness in the courtroom and improved the legal climate, each year personal injury attorneys seek to undo parts of the very law that helps keep “jackpot justice” and frivolous suits in check.

If no one was on call… an $80 million tax increase on physicians to fund a new government-administered malpractice claims payout system called the Patients Compensation System could have passed. The PCS would administer damage claims for physical injury and death of patients allegedly sustained at the hands of physicians. Complaints against individual physicians would begin with a call to a state-run 1-800 line and would go before panels composed of trial lawyers, citizens and physicians to determine an outcome. In addition, any determinations of fault would be reported to the National Practitioner Databank. The Patient Compensation System would undo decades of medical tort reforms, which the Medical Association championed and is forced to defend from plaintiff lawyer attacks each session. The PCS deprives both patients and doctors of their legal rights.

If no one was on call… physicians could have been exposed to triple-damage lawsuits for honest Medicaid billing mistakes. The legislation would create new causes of civil action in state court for Medicaid “false claims.” The legislation would incentivize personal injury lawyers to seek out “whistleblowers” in medical clinics, hospitals and the like to pursue civil actions against physicians and others for alleged Medicaid fraud, with damages being tripled the actual loss to Medicaid. The standard in the bill would have allowed even honest billing mistakes to qualify as “Medicaid fraud,” creating new opportunities for lawsuits where honest mistakes could be penalized.

If no one was on call… physicians would have been held liable for the actions or inactions of midwives attending home births. While a lay midwife bill did pass this session establishing a State Board of Midwifery, the bill contains liability protections for physicians and also prohibitions on non-nurse midwives’ scope of practice, the types of pregnancies they may attend, and a requirement for midwives to report outcomes.

If no one was on call… the right to trial by jury, including jury selection and jury size, could have been manipulated in personal injury lawyers’ favor.

If no one was on call… physicians could have been held legally responsible for others’ mistakes, including home caregivers, medical device manufacturers and for individuals following or failing to follow DNR orders.

Protecting Public Health and Access to Quality Care

Every session, various pieces of legislation aimed at improving the health of Alabamians are proposed. At the same time however, many bills are also introduced that endanger public health and safety, like those where the legislature attempts to set standards for medical care, which force physicians and their staffs to adhere to non-medically established criteria, wasting health care dollars, wasting patients’ and physicians’ time and exposing physicians to new liability concerns.

If no one was on call… legislation could have passed to lower biologic pharmaceutical standards in state law below those set by the FDA, withhold critical health information from patients and their doctors, and significantly increase administrative burdens on physicians.

If no one was on call… allergists and other physicians who compound medications within their offices could have been shut down, limiting access to critical care for patients.

If no one was on call… numerous scope of practice expansions that endanger public health could have become law, including removing all physician oversight of clinical nurse specialists; lay midwives seeking allowance of their attending home births without restriction or regulation; podiatrists seeking to amputate, do surgery and administer anesthesia up the distal third of the tibia; and marriage and family therapists seeking to be allowed to diagnose and treat mental disorders as well as removing the prohibition on their prescribing drugs.

If no one was on call… state boards and agencies with no authority over medicine could have been allowed to increase medical practice costs through additional licensing and reporting requirements.

If no one was on call… legislation dictating medical standards and guidelines for treatment of pregnant women, the elderly and terminal patients could have been placed into bills covering various topics.

Other Bills of Interest

Rural physician tax credits… legislation to increase rural physician tax credits and thereby increase access to care for rural Alabamians did not pass but will be reintroduced next session.

Infectious Disease Elimination… legislation to establish infectious disease elimination pilot programs to mitigate the spread of certain diseases failed to garner support on the last legislative day.

Constitutional amendment proclaiming the State of Alabama’s stance on the rights of unborn children… legislation passed to allow Alabamians to vote at the November 2018 General Election whether to add an amendment to the state constitution to:

“Declare and affirm that it is the public policy of this state to recognize and support the sanctity of unborn life and the rights of unborn children, most importantly the right to life in all manners and measures appropriate and lawful…”

If ratified by the people in November 2018, this Amendment could have implications for women’s health physicians.

Coverage of autism spectrum disorder therapies… legislation passed to require health plans to cover ASD therapies, with some restrictions.

Portable DNR for minors… legislation establishing a portable DNR for minors to allow minors with terminal diseases to attend school activities failed to garner enough votes to pass on the last legislative day.

If the Medical Association was not on call at the legislature, countless bills expanding doctors’ liability, increasing physician taxes and setting standards of care into law could have passed. At the same time, positive strides in public health — like passage of the direct primary care legislation — would not have occurred. The Medical Association is Alabama physicians’ greatest resource in advocating for the practice of medicine and the patients they serve.

Posted in: Advocacy

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Association Voices Concern with MOC in Letter to ABMS

Association Voices Concern with MOC in Letter to ABMS

Earlier this year, the Association’s House of Delegates passed a resolution formally opposing additional Maintenance of Certification requirements as dictated by the American Board of Medical Specialties and the American Osteopathic Association. While it was agreed that the need for continuing medical education to improve the quality of care, the expense and clinically irrelevant process of MOC often proved overly burdensome. Now, the Association has joined with other state associations to send a message to ABMS expressing concerns about MOC and have requested a meeting later this year to discuss the issues.

As discussions concerning MOC mounted during the June AMA meeting, a small group of national medical specialty society and state medical society CEOs furthered the discussion with a high-level summit that recently took place to discuss these problems, and a meeting this December with the American Board of Medical Specialties, the Council of Medical Specialty Societies, and state medical societies to directly share our views and seek agreement on how to reshape the MOC process to the betterment of our physicians and the patients in their care.

In the letter to ABMS, the groups were quick to explain that the intention is not to diminish patient care or physician training. However, the letter addressed that not only had many state legislatures addressed the issue of maintenance of certification either successfully passing new laws or laws that were pending but that this trend of legislative interference was another threat to a physician’s right to professional self-regulation. Along with the exorbitant costs of the MOC process and the lack of transparent communication from certifying boards have damaged the integrity of the MOC brand, all of which presents an opportunity to realign the process.

The Medical Association has begun to address this situation, and with the formation of this new joint initiative, will continue to be active in discussions to create a long-term solution for MOC. The joint meeting is currently scheduled for early December.

Read the letter to ABMS

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Mylan Finalizes Settlement Agreement on Medicaid Rebate Classification for EpiPen® Auto-Injector

Mylan Finalizes Settlement Agreement on Medicaid Rebate Classification for EpiPen® Auto-Injector

The Centers for Medicare & Medicaid Services announced an agreement with Mylan regarding the classification of EpiPen in which Mylan will reclassify EpiPen as a brand name drug consistent with the Medicaid statute and regulations. In addition, Mylan has agreed to use the correct reference price of the 3rd quarter of 1990 for the purpose of calculating inflationary payment rebates under the Medicaid Drug Rebate (MDR) program, saving the Medicaid program hundreds of millions of dollars. These changes will be effective retroactive to April 1, 2017.

“Mylan’s agreement with CMS to correctly classify EpiPen is a huge win for Medicaid beneficiaries and American taxpayers,” said CMS Administrator Seema Verma. “Medicaid will no longer be overcharged for EpiPen, protecting access for Medicaid beneficiaries who rely on this life-saving drug while saving hundreds of millions of dollars. This announcement puts drug manufacturers on notice that CMS remains vigilant in our duty to protect the integrity of the Medicaid program.”

The settlement resolves claims relating to the classification of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector for purposes of the Medicaid Drug Rebate Program. The question in the underlying matter was whether the EpiPen products were properly classified with CMS as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.

The settlement provides for resolution of all potential Medicaid rebate liability claims by the federal government, as well as potential claims by certain hospitals and other covered entities that participate in the 340B Drug Pricing Program. The settlement allocates money to the Medicaid programs of all 50 states and establishes a framework for resolving all potential state Medicaid rebate liability claims within 60 days. In connection with the settlement, Mylan also has entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The settlement does not contain an admission or finding of wrongdoing. Mylan will reclassify EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of April 1, 2017.

Posted in: Advocacy

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Alabama Medicine Magazine Receives International Award

Alabama Medicine Magazine Receives International Award

apex award winnerAlabama Medicine magazine has received the 2017 APEX Award for Publication Excellence. APEX 2017 is the 29th Annual Awards for Publication Excellence based on excellence in graphic design, editorial content and the ability to achieve overall communications excellence. This international competition is sponsored by Communications Concepts.

There were 1,361 entries evaluated in 11 major categories but only 304 publications accepted in the category of Magazines, Journals & Tabloids. Of those entries, 543 Awards of Excellence recognized distinction in all 100 individual categories, but only 16 awards went to entries in Magazines, Journals & Tabloids.

States and territories represented in this category include California, Georgia, Illinois, Indiana, Kansas, Maryland, South Carolina, Virginia, Washington D.C., Canada and Singapore. Only four award winners were from Alabama, and Alabama Medicine was the only award headquartered in Montgomery.

Alabama Medicine is the official magazine of the Medical Association of the State of Alabama. It is in its third year of publication and is managed by Lori M. Quiller, APR, director of communications and social media. For more information about Alabama Medicine magazine, the APEX Award for Publication Excellence, or any other publication of the Medical Association, please email lquiller@alamedical.org.

Posted in: Official Statement

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Public Health Warns of Increased Pertussis Cases in Alabama

Public Health Warns of Increased Pertussis Cases in Alabama

The Alabama Department of Public Health’s Immunization Division is warning citizens that pertussis cases are significantly higher in Alabama and continue to be on the rise. Immunization data reveals an increase from 113 reported cases in 2016, to 151 reported cases thus far in 2017. Pertussis cases have occurred statewide in 2017, including multiple outbreaks in Calhoun and Chambers counties.

Pertussis, also known as whooping cough, is a highly contagious respiratory notifiable disease, which begins with symptoms such as a runny nose, low-grade fever and cough. After a week or two of the illness, pertussis progresses to violent coughing, making it difficult for those infected to breathe. After fits of many coughs, people with the illness often need to take deep breaths which result in a “whooping” sound.

“Alabama is not alone in the growth of pertussis cases. Nationwide we have seen an increase in pertussis cases, and while there are several factors that could contribute to this, one generally accepted reason from the Centers for Disease Control and Prevention is that although the pertussis vaccine is effective, it tends to decrease in immunity over time,” said Dr. Karen Landers, Assistant State Health Officer. “That’s why it’s so important that we educate Alabamians on this disease and let them know how they can prevent and treat it.”

During an outbreak of pertussis, Immunization Division staff collect specimens for testing, assess vaccine status, contact persons via phone who have been in places where exposure has occurred, and provide information for entities to share with those who may have been exposed. Those who are concerned that they may have been exposed to the disease, or feel that they are exhibiting symptoms, should consult their primary physician to be evaluated.

“Patients should be aware that this is a serious disease that can affect people of all ages. It can even be deadly for babies less than a year old. That’s why it’s especially important for parents and grandparents who are in close contact with infants to make sure they are up to date on their vaccinations,” said Dr. Landers.

According to CDC, the best way to protect against pertussis is by getting vaccinated. Pregnant women should also be vaccinated with Tdap (tetanus, diphtheria, pertussis) during each pregnancy as a way to protect infants.

For more information on signs and symptoms of pertussis, or vaccination please visit http://www.alabamapublichealth.gov/immunization and the division’s Facebook page Alabama Immunization Info at www.facebook.com/AlabamaImmunizationInfo.

Posted in: Health

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