Nov. 10, 2016
Issue SpotlightPatients give voice to call for drug pricing transparency
A Texas patient who takes medication for her heart every day wonders how drug prices are set. A Missouri man cannot understand why drugs that often cost so little to manufacture can be priced so highly. These are just two of the tales arising from a new website that aims to bring needed transparency to skyrocketing drug prices and give patients the opportunity to tell their stories.
Housing or medicine? Food or medicine? With prescription drug prices rising, patients are increasingly facing these kinds of terrible dilemmas. From 2013 to 2015, spending on prescription drugs in the U.S. rose nearly 20 percent. And the recent 400-percent price increase for lifesaving EpiPens that came without any justification has caught Congressional attention from both sides of the aisle.
TruthinRx.org is an interactive website that lends an ear to patients who want to share their stories of how rising prices are affecting their health and finances. The grassroots campaign, launched this month by the AMA, will use patient and physician voices to urge Congress to take action on these growing price increases on medications that, for some people, could mean the difference between life and death.
The site will be continually updated with a gallery of curated videos and testimonials and ways for the public to take action or send a message to Congress. TruthinRx.org lays bare alarming figures, such as the 92-fold rise in price for an antibiotic that went from $20 for 500 tablets to $1,849 for the same quantity in just seven months.
The issue of prescription drug pricing is on the table for the AMA House of Delegates at the upcoming 2016 AMA Interim Meeting. A report of the AMA Council on Medical Service proposes policy for value-based drug pricing programs and support for direct purchasing mechanisms to assure patient access to prescription drugs.
Patients share stories on drug pricing
More than 62,000 people have signed the petition asking representatives to increase pricing transparency.
Patients have already shared hundreds of personal stories and comments, which will be added to the site in the coming weeks. Here are a few of the responses so far:
- "Now that I'm a senior, the stories of seniors having to choose between food and medication hits closer to home. Stop the obscene profits made by the drug companies and bring prices to within reach of seniors already struggling." – Nancy S., Greenfield, Ohio
- "Because both me and my wife are on a lot of different medicines and being on a fixed income, it really makes it hard to try and buy our meds. And to be able to eat and keep our house cool in the summer and warm in the winter." – Jerrie B., Sarcoxie, Mo.
- "All my medication prices keep rising and now insurance companies are making it more difficult to get coverage as well due to the increased pricing. These drugs are needed to keep myself and others leading productive, healthy lives." – Christina C., Newberg, Ore.
- "Why does a drug that costs the company less than three dollars to produce cost the American people over six hundred dollars?" – Dennis M., Skidmore, Mo.
- "Many of these drugs are for a 'life and death' situation and people should be able to afford them." – Beverly C., Beverly Hills, Fla.
- "People spend so much money on medicine and don't know why we are paying it besides the pharmacy saying that's what it costs." – Brandon T., Lenoir, N.C.
- "I am a cardiac patient required to take daily drugs. I want to know how the prices for drugs are set." – Phyllis M., Lockhart, Texas
- "My patients cannot afford their medications and therefore are not taking what they need." – Fran V., Hollywood, Fla.
The stories above reflect the concerns of millions of Americans as drug pricing becomes one of the top issues across the nation. Since there is little information on how prices are negotiated or the role of industry players, the AMA is asking the public to join the initiative to uncover the truth about prescription drug prices.
Visit TruthinRx.org to tell your story and get involved.
National UpdateMedicare releases 2017 Physician Fee Schedule final rule
The Centers for Medicare & Medicaid Services (CMS) set the 2017 conversion factor at 35.7751, a slight increase over what was proposed, with the release of the Physician Fee Schedule final rule last week. The final rule also addressed policies dealing with diabetes prevention, global surgical reporting requirements, add-on payments for primary care and telehealth services.
Due to strong advocacy from the AMA and other physician groups, CMS finalized its proposal to establish the Medicare Diabetes Prevention Program (MDPP) as a preventive service with no cost sharing. The MDPP is a 12-month program that consists of at least 16 weekly core sessions during the first six months, followed by additional core maintenance sessions over the remaining six months. The MDPP provider network will be scaled up next year with service delivery to Medicare beneficiaries set to begin Jan. 1, 2018.
CMS finalized a claims-based data collection process on the frequency of and inputs involved in global surgical services that is much less burdensome for physicians than CMS' earlier proposal. Key changes include:
- CMS' decision to use 99024 for reporting post-operative services rather than the proposed set of time-based G-codes
- Reporting is no longer required for pre-operative visits
- Reporting is only triggered for services that meet certain minimum thresholds annually—CPT codes billed by more than 100 practitioners over 10,000 times or have allowed charges in excess of $10 million
The final rule increases payments for Chronic Care Management services by accepting CPT and RUC recommendations urging CMS to ease the administrative burden and expand the opportunities for physicians. CPT codes 99358 and 99359 for non-face-to-face prolonged E/M services will also be billable under Medicare beginning in 2017.Medicare finalizes changes to site of service and Meaningful Use program
The release of the 2017 Outpatient Prospective Payment (OPPS) rule sets the stage for changes in how Medicare pays hospitals for care provided in offsite hospital-owned physician practices, referred to as Provider-Based Departments (PBD).
With a few exceptions, the Centers for Medicare and Medicaid Services (CMS) finalized virtually all of its proposals to eliminate the site-of-service payment differential that has incentivized hospitals to purchase physician practices. CMS, however, did not finalize its proposal to apply reduced payment to exempted PBDs that expand service lines.
In direct response to AMA advocacy, CMS eliminated the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey questions concerning pain management from the Hospital Value Based Purchasing (VBP) program. Over the years, physicians have expressed deep concerns about the unintended consequences pain questions have had on opioid prescribing practices and patient care. Under HCAHPS, there was a link between high scores on the pain questions and higher payments to hospitals. The AMA looks forward to working with CMS as it develops alternative questions related to pain and the patient experience and quality measures related to opioid prescribing to ensure the measures and questions are clinically appropriate.
CMS also announced Meaningful Use reforms that will help physicians meet reporting requirements—policy changes for which the AMA advocated directly to CMS. The agency is allowing physicians to report Meaningful Use for 90 days in 2016. This is a much-needed reform of the earlier proposal requiring a full year of reporting.
CMS has developed a hardship exception that allows first time Meaningful Use participants to report once in 2017 to satisfy both Meaningful Use and the Advancing Care Information performance category in the Merit-based Incentive Payment System track of the Medicare Access and CHIP Reauthorization Act.
State UpdatePennsylvania joins Interstate Medical Licensure Compact
Pennsylvania Gov. Tom Wolf in late October signed House Bill 1619, authorizing the Commonwealth of Pennsylvania to join the Interstate Medical Licensure Compact. Pennsylvania is now the 18th state to join the Compact and many more states are slated to join in 2017.
The AMA strongly supports the Compact and is working to support state medical association advocacy efforts in support of Compact legislation. If your medical association is interested in pursuing Compact legislation in 2017, contact Kristin Schleiter of the AMA to learn more.
The New Hampshire Board of Medicine last week adopted final opioid prescribing guidance for acute and chronic pain care, as well as requirements to register and use the state prescription drug monitoring program (PDMP) based on the adoption of House Bill 1423 in late June.
The new board rules, which go into effect Jan. 1, apply to initial Schedule II-IV opioid prescriptions self-administered by an individual patient for the management or treatment of pain. Excluded from the new rule is the supervised administration of opioids in a health care setting.
"The Medical Society worked collaboratively with the New Hampshire Board of Medicine and bill authors to produce more reasonable approach to help mitigate misuse and diversion of opioids, while ensuring appropriate care for patients with chronic pain and terminal conditions," said NHMS President John Butterly, MD.
For chronic pain, the rule requires opioid prescribers to re-evaluate treatment plans and query the PDMP at least twice a year, as well as document the consideration of a specialist consultation when a patient receives 100 mg morphine-equivalent dose for longer than 90 days.
Among the new provisions for acute pain in an emergency department, urgent care setting or walk-in clinic, the rule states that physicians and physician assistants shall not prescribe for more than seven days unless the medical condition is documented and appropriate clinical rationale included in the patient's medical record.
Exceptions are also provided in the new rule for PDMP queries for administration in a health care setting, technological problems and in an emergency department that would materially delay care. Opioid prescribing guidance patterned after the Board of Medicine rules is expected to follow shortly for other New Hampshire professionals such as advanced practice registered nurses (APRN), dentists and podiatrists.
"We'll continue to closely monitor, help educate physicians for the new law's effective implementation, and be prepared to press for modifications, if concerns about continuity of care persist, particularly in EDs and primary care settings," Dr. Butterly said.
For detailed information about the new provisions, visit the New Hampshire Board of Medicine website or contact the New Hampshire Medical Society at (603) 224-1909.
Four new laws were signed by Pennsylvania Gov. Tom Wolf last week ranging from opioid prescribing limits in emergency departments (ED) and for minors to new requirements to check the state prescription drug monitoring program (PDMP) and more.
The new laws include provisions that will:
- Limit the prescribing of an opioid to an individual seeking treatment in certain settings—EDs, urgent care centers or while in observation status in a hospital—to no more than a quantity sufficient to treat that individual for up to seven days. Some exceptions apply. (Act 122)
- Require prescribers to query the PDMP system each time a patient is prescribed an opioid or benzodiazepine. Some exceptions apply. (Act 124)
- Mandate prescribers and dispensers to complete continuing medical education (CME) in pain management, identification of addiction and prescribing or dispensing practices of opioids. Two hours of CME are required as a condition for license renewal, while four hours are required for individuals applying for initial licensure or certification, to be completed within 12 months of obtaining an initial license or certification. (Act 124)
- Limit the number of opioids that may be prescribed to a minor to no more than a seven-day supply unless a prescriber determines that more than a seven-day supply is needed to stabilize the minor's acute medical condition. Some exceptions apply. Prescribers are also required to obtain written consent from a minor's parent, guardian or an authorized adult in order to prescribe an opioid to that minor. (Act 125)
- Require the licensing boards to implement curriculum regarding safe prescribing practices for controlled substances containing opioids. This curriculum may be offered by medical schools, medical training facilities, dental schools and other providers. This education will not be mandated as a graduation requirement but will instead be left up to each educational institution to determine whether it will be required for graduation. (Act 126)
- Direct the state Department of Health to create a voluntary non-opioid directive form, which may be used by a patient to deny or refuse the prescribing or administering of a controlled substance containing an opioid by a practitioner. (Act 126)
Read more about these new laws, including effective dates and exceptions, in a blog from the Pennsylvania Medical Society.Back to Top
Judicial UpdateJudgment on life expectancy at issue in Medicare fraud case
Determining life expectancy is not an exact science, but over a million Americans each year who turn to hospice care depend on a physician's clinical judgment so they can live their remaining time in relative comfort. The Medicare hospice benefit, created in 1982, helps patients transition to end-of-life hospice care. A case before the 11th U.S. Circuit Court of Appeals is threatening physicians' ability to exercise their judgment.
At stake in United States of America v. GGNSC Administrative Services is this question: When can a physician's clinical judgment regarding a patient's life expectancy—based on the normal course of a terminal illness—be considered false under the False Claims Act?
In this case, the government alleges that a hospice care center violated the False Claims Act by billing Medicare for services that did not qualify for reimbursement.
Two conditions must be met for a patient's care to qualify for payment under the Medicare hospice benefit:
- A physician must certify that the patient's medical condition is such that it appears the patient has less than six months to live
- The medical record must support the physician's evaluation
The patients in question had the required physician certifications and their doctors testified that their medical records supported this evaluation. However, the government introduced testimony from another physician who claimed that the medical records did not support the certifications stating the patients had less than six months to live.
The trial court found that "something more" than a mere second opinion from another physician was needed to prove that the first doctor's terminal illness certification was false. On appeal, the government maintained that it only had to show that a physician disagreed with the certifying physicians as to the adequacy of the medical record, and it would be for the jury to determine who was telling the truth.
In defense of the hospice center physicians, the AMA and four hospice and palliative care organizations filed an amicus brief stating that for a physician's opinion to be deemed false, it must be proved that no reasonable physician could hold that opinion.
Clinical judgement or opinion?
"This case does not involve something as simple as a patient's weight or body temperature," said the brief filed by the AMA. "Nor does it involve something as comparatively straightforward as how to lower a patient's cholesterol. Rather, this case involves something far more complicated."
When it comes to how long a patient is expected to live, the range of reasonable conclusions can be quite broad, the brief said.
Read more at AMA Wire®.
A case before the Supreme Court of Iowa holds the confidentiality of peer-review materials in the balance. Will the court uphold an Iowa statute meant to maintain confidentiality of such documents in order to reduce errors leading to morbidity and mortality and improve public health?
What happened in Iowa
At stake in Willard v. State of Iowa is whether the Iowa Morbidity and Mortality Study Law (MMSL), a type of peer-review statute meant to keep peer-review information and materials confidential, created a privilege against legal discovery of a hospital's patient safety network incident report (PSN) and related documents.
Dennis Willard was injured in a motorcycle accident and taken to a hospital in Davenport, Iowa, for treatment. Because of the seriousness of his injuries, Willard was transferred to the University of Iowa Hospital—an agency of the State of Iowa. Willard was under heavy sedation at the time of the transfer and sued the State of Iowa alleging he was handled negligently during the transfer process and suffered further injuries as a result.
During discovery, Willard sought production of various documents pertaining to his care, including the hospital's incident report. The hospital objected to the discovery, claiming the requested documents were privileged under MMSL.
After hearing testimony from the hospital regarding the nature of the contested documents and ordering an in camera review—review of the hospital's documents by the judge without their disclosure to Mr. Willard's attorneys in order to determine the validity of the hospital's privilege claim—the trial court ordered the production of the PSN report. The hospital filed an Interlocutory Appeal.
In a report, "To Err is Human: Building a Safer Health System," the National Academies of Sciences, Engineering and Medicine (formerly the Institute of Medicine) determined that at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of preventable medical errors.
The report states that the majority of errors do not result from individual recklessness or the actions of a particular group. This is not a "bad apple" problem; more commonly, errors are caused by faulty systems, processes and conditions that lead to mistakes or failed prevention. The report said that mistakes are best prevented by designing the health system at all levels to make it safer. A key first step to a safer health system is identifying error so that it can be studied.
Iowa's MMSL advances vital public health and patient safety interests in dynamic, robust review and analysis of how medicine can do better in treating and curing disease and preventing death.
"In order to be able to identify error, everyone—physicians, nurses, hospital staff, etc.—must be willing to report the error," the Litigation Center of the AMA and the Iowa Medical Society (IMS) said in an amicus brief supporting the hospital's objection. "The only way people will be willing to do so is if there is a system of protection in place for such reporting."
Read more at AMA Wire.
Other NewsMedicare announces new RAC contracts
Last week, Medicare announced the new Recovery Auditor contracts, which sets limits for the post-claims review process and dictates when Recovery Audit Contractors (RAC) will be eligible to receive their contingency fees.
Among the changes specified in the new contracts, RACs will no longer automatically receive contingency fees for each identified overpayment. This new policy requires the RACs to pass the second level of a five-level appeals process before receiving their contingency fee. The new RAC contracts also establish new audit timelines—the RAC lookback period for inpatient claims is reduced from three years to six months—and the two midnights rule will continue to be exempted from RAC audits.
These changes are in addition to Medicare's recent pilot program that directs RACs to consider as a low-priority reviewing claims from providers participating in Advanced Alternative Payment Models under the new Quality Payment Program.
The Physician-Focused Payment Model Technical Advisory Committee (PTAC) is the committee charged with soliciting proposals from specialty societies and other stakeholders for physician-focused alternative payment models under the Medicare Access and CHIP Reauthorization Act. The PTAC recently held a webinar providing an overview of the Committee.
The PTAC is preparing to receive proposals of physician-focused payment models from stakeholders. In order to submit a proposal, stakeholders must first provide a non-binding letter of intent (LOI) at least 30 days in advance of their anticipated model submission. The Committee will use LOIs to appropriately plan the time and resources needed for prompt review of proposals. Instructions for submission are available. There is no deadline for submitting an LOI. Full proposals may be submitted beginning Dec. 1.
The Center for Medicare and Medicaid Innovation (CMMI) also released its Alternative Payment Model Design Toolkit. PTAC encourages all interested stakeholders to review this new resource, which will soon be added to the PTAC website.
Advocacy staff from the AMA and several specialty societies that have been designing alternative payment models have outlined their ideas to PTAC members and interacted with the Committee about challenging issues such as risk adjustment, attribution of costs and access to data analysis.
Watch the PTAC overview webinar.
Nov. 21 and Dec. 6: MACRA Educational Webinars
The AMA will host two educational webinars to help physicians prepare for the new Medicare Quality Payment Program created by the Medicare Access and CHIP Reauthorization Act. Both sessions will cover the same material. Registration is open for the first webinar on Nov. 21, at 7 p.m. EDT, and the second webinar on Dec. 6, at 8 p.m. EDT. Physicians and medical society staff are welcome
Dec. 1: MACRA Regional Seminar, Atlanta
The Medical Association of Georgia, the Medical Association of Atlanta, the Cobb County Medical Society and the DeKalb Medical Society invite physicians and medical staff to attend an educational session to help physicians understand what the Medicare Access and CHIP Reauthorization Act final rule means for their practices and what they need to do as part of the new Medicare Quality Payment Program. It will be held at Cobb Galleria Centre, Two Galleria Parkway, at 6:30 p.m. EDT. The seminar is also available to stream or by webinar. Register and learn more.
Dec. 10: MACRA Regional Seminar, San Francisco
The AMA and California Medical Association will host an educational seminar similar to the Atlanta seminar, to be held at the Marriott Marquis, Nob Hill Ballroom, 780 Mission St., at 9:30 a.m. PST. This seminar is also available to stream or by webinar. Register and learn more.