May 17, 2018
Issue SpotlightTrump Administration releases drug pricing blueprint
On May 11, The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (Blueprint) was issued along with a request for information. The President framed the Blueprint as advancing four goals:
- Reducing list prices.
- Improving government's ability to negotiate better prices.
- Encouraging competition through rapid entry to market of generics and biosimilars.
- Lowering patient out-of-pocket expenses.
The Blueprint proposes a broad number of changes to prescription drug programs in several federal health care programs (Medicare, Medicaid, and other safety net programs) as well as Food and Drug Administration (FDA) policies that should impact commercial and federal health care program access to affordable prescription drugs.
While some of these proposals can be undertaken through immediate regulatory or subregulatory actions, others are still on the drawing boards at the U.S. Department of Health and Human Services and some will require congressional action to implement. Although the Blueprint proposes a select number of programmatic and design changes, there are a large number of questions for which the Administration is seeking feedback.
Based on a preliminary review, it appears that overall there will be increased access to lower-cost alternative generics. However, careful consideration by the AMA and Federation members will be needed on a number of proposed changes to the Medicare Part D prescription Drug Benefit program as well as the Part B drug reimbursement methodology.
One concern is that the proposed changes may limit patient access to medically necessary alternative brand or specialty treatments and result in additional administrative burdens on physicians and patients. Also of concern is the proposal to eliminate the requirement that Part D plans include a minimum of two drugs proven to be effective in each therapeutic category or pharmacologic class, if available.
The AMA will be preparing comments to the various proposals, but does applaud overall efforts to increase competition through a number of FDA proposals as well as proposed bans on gag clauses and ensuring a substantial portion of rebates are received by Medicare beneficiaries at the point-of-sale.
National UpdateHouse committee approves bills to address opioid abuse
On May 9, the House Energy and Commerce Committee held the first of two markups to address the opioid crisis. The committee favorably reported 25 bills by voice vote. The AMA submitted a letter to the Committee highlighting our positions on the considered bills; a second mark-up is scheduled for May 17.
House Majority Leader Kevin McCarthy, R-Calif., indicated that he intends to bring dozens of opioid-abuse bills from various committees with jurisdiction over the issue to the House floor in June. The AMA remains actively engaged in promoting policies that ensure patients access to opioid-use disorder (OUD) treatment as well as appropriate treatment for pain.
The House of Representatives passed H.R. 5674, the "Department of Veterans Affairs Maintaining Internal Systems and Strengthening Integrated Outside Networks (VA MISSION) Act," by a bipartisan vote of 347-70 on May 16.
This bill would streamline the VA's various community care programs into a single, cohesive program. The bill also includes funding for the VA Choice Program. Acting VA Secretary Robert Wilkie informed Congress that Choice Program funding could run-out as early as May 31, 2018. The Senate is expected to act swiftly on the bill.
The Department of Veterans Affairs (VA) issued a final rule on May 11 that allows its employed physicians to deliver telehealth services across state lines as long as they have a single valid medical license. The AMA strongly supports the VA's decision to only exempt employed physicians from multistate licensure requirements.
Contracted physicians or providers who are not directly controlled and supervised by the VA—and would not necessarily have the same training, staff support, shared access to a beneficiary's EHR and infrastructure capabilities—must continue to be licensed in the state where the patient is being treated.
As described in previous Advocacy Update articles, the Centers for Medicare & Medicaid Services (CMS) is in the process of mailing new Medicare cards to beneficiaries. The cards are being sent in phases by geographic location, but some mailings may be slightly delayed so that CMS can ensure all cards are sent to the correct address.
Practices should continue to remind their patients about the new Medicare card and encourage them to ensure that their address is up to date with Medicare by contacting the Social Security Administration. These tear-off sheets, available in English and Spanish, can be used to remind them to check their addresses. More information is available on the AMA's New Medicare Card page and the CMS New Medicare Card website.
At its 2017 Interim Meeting, the AMA House of Delegates established new policy to advocate against payment reductions for evaluation and management (E&M) codes appropriately reported with a Current Procedural Terminology (CPT) modifier 25.
In accordance with this policy, the AMA sent a letter to Anthem, met twice with the company's leadership, and was ultimately successful in convincing the insurer to not implement payment reductions for E&M services reported with modifier 25 on the same day as a minor surgical procedure code.
As part of its continued advocacy on this issue, the AMA recently sent letters to America's Health Insurance Plans (AHIP) and Blue Cross Blue Shield Association (BCBSA) urging the insurer organizations to encourage their member plans to halt CPT modifier 25 payment reductions. In the letters, the AMA addressed several arguments that plans have presented when implementing reductions for E&M codes reported with modifier 25, including overlap in payment between E&M and procedure codes, overuse/abuse of modifier 25, and the movement toward value-based payment models.
The AMA requested that AHIP and BCBSA share the letters with their member health plans and offered to further discuss modifier 25 policies with any interested individual insurers. The AMA will be having follow-up conversations with AHIP and BCBSA to further discuss this issue.
State UpdateAMA asks nursing boards to consider revising APRN Compact
In a letter to Katherine Thomas, president of the National Council of State Boards of Nursing, the AMA requested that NCSBN remove those provisions of the Advanced Practice Registered Nurse Compact (APRN Compact) that alter state laws related to the scope of practice of APRNs.
The AMA's letter was co-signed by more than 80 state and specialty medical associations. The AMA opposes the APRN Compact because it would inappropriately authorize APRNs who obtain an APRN Compact multistate license to practice and prescribe independent of physician supervision or collaboration in APRN Compact states, regardless of state laws that might require APRNs to have a supervisory or collaborative relationship with a physician.
To date, only three states (Idaho, North Dakota, Wyoming) have joined the APRN Compact; 10 states must join for the APRN Compact to start. Contact Kristin Schleiter (email@example.com), senior legislative attorney, for assistance in defeating APRN Compact legislation in your state.
A new survey of pain medicine specialists found that policies enacted by states, health insurers, pharmacy benefit managers and worker compensation programs are causing patients to go into withdrawal, experience anxiety, depression and increased pain.
The survey was conducted by the American Board of Pain Medicine (ABPM) to help identify how the nation's opioid epidemic is affecting patients with pain and the pain medicine specialists who treat them.
The survey found:
- 83 percent of pain medicine specialists said that they—or their patients—have been required to reduce the quantity or dose of medication they have prescribed;
- 93 percent of pain medicine specialists said that they have been required to submit a prior authorization for non-opioid pain care—with the physicians and their staff spending hours per day on such requests.
- 68 percent of pain medicine specialists said that they have had to hire additional staff to handle the prior authorization requirements.
"Prior authorization in some cases may be understandable to help ensure coverage benefits or coordinate complex care, but when it is used almost universally like this, it seems that the real purpose is to discourage physicians and patients from seeking non-opioid pain care," said ABPM President Mitchell J. Cohen, MD.
Respondents to the survey listed a wide range of non-opioid therapies that have been subject to prior authorization, including:
- Physical therapy limits, psychiatric services, occupational therapy.
- Pain creams and patches (e.g., lidocaine, Lidoderm, Voltaren, topical NSAIDs).
- Non-opioid prescription medications (e.g., Cymbalta, Lyrica, Celebrex).
- Non-opioid pain treatments (e.g., TENS, facet blocks, spinal cord stimulators, epidural injections).
For more information about the survey, contact Mike Slawny, executive director of ABPM at firstname.lastname@example.org.Medicaid waivers: work requirement OK'd in N.H.; lifetime limits denied in Kansas
On May 7, New Hampshire became the fourth state approved to implement a work requirement for certain Medicaid beneficiaries. The AMA opposes work requirements as a condition of Medicaid eligibility. As of Jan. 1, 2019, New Hampshire will require adult, non-elderly, non-disabled Medicaid beneficiaries to participate in 100 hours per month of "community engagement activities" such as employment, education, job skills training or community service.
Certain individuals, such as those who are pregnant, medically frail, or caring for a young child, are exempt. The work requirement was a key condition for state legislators who reauthorized the state's Medicaid expansion program this year.
Kansas also requested federal approval to impose a work requirement on certain Medicaid beneficiaries and additionally proposed to limit lifetime coverage eligibility to 36 months even if those work requirements were met.
On May 7, CMS notified the state that it would deny the state's request to impose a 36 month lifetime limit on Medicaid benefits. CMS did not render a decision on work requirements without a lifetime limit. Kansas has not expanded Medicaid under the ACA, and, to date, CMS has only approved work requirements in Medicaid expansion states (Arkansas, Kentucky, Indiana and New Hampshire).
Supporters of Medicaid expansion in Idaho report they have gathered enough signatures to place the measure on the November general election ballot. If approved by voters, Idaho would become the 33rd state to expand Medicaid eligibility to all adults with incomes under 133 percent of the federal poverty level, and approximately 62,000 individuals would gain coverage. Similar efforts to expand Medicaid via ballot initiative are underway in Utah and Nebraska. Montana is also seeking to reauthorize and fund its Medicaid expansion program by ballot this year.
Maine was the first state to pass a ballot measure to expand Medicaid in November 2017. Nearly 60 percent of voters approved the measure; however, Governor Paul LePage has refused to implement the program. On April 30, expansion supporters filed a lawsuit to compel the state to begin implementing the program. Approximately 80,000 low income individuals stand to gain coverage in Maine.
Please contact Annalia Michelman, senior legislative attorney, Annalia.Michelman@ama-assn.org for state Medicaid-related questions.
Judicial UpdateTop court to decide: Should doctors be held to lay standard?
Maryland physicians could see established medical liability law upended if the state's high court doesn't reject a trial court's instructions informing jurors that negligence could be defined by what a "reasonable" layperson would do.
For more than a century, negligence in Maryland medical malpractice cases has been guided by the "reasonably competent" physician standard of care—a standard that juries and judges learn through expert witness testimony.
But when a five-day trial in which a patient sued his neurosurgeon after developing an abscess and bacterial infection after an incision did not heal properly concluded, a Baltimore County Circuit Court judge instructed the jury that they could also consider what a layperson would consider reasonable. When the physician asked the court to have the standard of care measured solely based on the expectations for a neurosurgeon, the judge refused to modify the jury instructions in the case, Armacost v. Davis.
The result: The jury returned a verdict in favor of the patient plaintiff, Mark Armacost.
The physician, Reginald J. Davis, MD, appealed the decision to the Court of Special Appeals of Maryland, which ruled that the jury instructions were improper and ordered a new trial. The case now is before Maryland's highest court, the Court of Appeals of Maryland. Oral arguments are scheduled for late May.
The Litigation Center of American Medical Association and State Medical Societies joined the Maryland State Medical Society (MedChi) and the Medical Mutual Liability Society of Maryland in an amicus brief that urges justices on the high court to uphold the appellate ruling. Not doing so would have "cataclysmic consequences," the Litigation Center brief argues, including more meritless lawsuits, higher costs and implications for what standards other professionals "of every stripe and variety" are held to in court.
Read more at AMA Wire.
The Pennsylvania Supreme Court will decide whether Philadelphia can continue to collect a sugary-drink distribution tax—a levy that the AMA and others are urging justices to keep in place because it is a positive tool to help curb the obesity epidemic that is a major contributor to heart disease and type 2 diabetes.
Two lower Pennsylvania courts previously ruled that Philadelphia officials can levy a 1.5-cent per fluid ounce tax on sugar-sweetened beverages from distributors. The law, enacted in 2016, includes any drink with a sugar-based sweetener or artificial sugar substitute. The measure excludes products that contain more than 50 percent milk, fresh fruit or vegetables and some unsweetened drinks to which sugar is added later.
A coalition of retailers and retail groups that brought the lawsuit is appealing the Pennsylvania Commonwealth Court's decision in Williams et al. v. City of Philadelphia to the Pennsylvania Supreme Court, asking those justices to rule that the levy is duplicative of the general retail sales tax and, therefore, not allowed.
The Litigation Center of the American Medical Association and State Medical Societies, as it did in the lower court cases, recently filed an amicus brief supporting the sugary-drink tax.
More than a dozen organizations—including the American Heart Association and Pennsylvania Medical Society—joined the Litigation Center in the brief that attempts to rebut the legal argument that the tax is duplicative and explains to the court why the tax is important to the public's health.
Read more at AMA Wire®.
Other NewsGrowth in health spending slows in post-ACA era
A new Policy Research Perspective from EHPR provides a detailed examination of U.S. National Health Expenditures (NHE) through 2016 using data released by the Centers for Medicare & Medicaid Services.
In 2016, health spending in the U.S. was $3.3 trillion or $10,348 per capita. Health spending as a share of GDP increased from 17.7 percent in 2015 to 17.9 percent in 2016. However, spending grew more slowly in 2016 (4.3 percent) than in 2015 and 2014 (5.8 percent and 5.1 percent).
This slowdown was evident across most payers and types of spending, reflecting the stabilized enrollment and spending rates after the initial years of ACA implementation. In particular, physician spending grew more slowly over the 10-year period ending in 2016 (3.8 percent per year on average) compared to hospital, clinical services, and prescription drugs spending.
Read more at AMA Wire.
May 29–June 8: Telemedicine in practice
Telemedicine is transforming the way health care is delivered and is a strategy for many physician practices and health systems to provide more immediate access to care, improve care coordination, and decrease overall costs to organizations and their patients. If you are thinking about implementing telemedicine in your practice, this AMA Reinventing Medical Practice Community discussion is for you. Not only will you learn about relevant laws and licensure status; we will also focus on how to implement telemedicine in your practice by discussing such issues as cybersecurity, adoption and reimbursement. Join this discussion to learn more about implementing telemedicine in practice and where to go for resources to keep up with the latest legislative and payment changes in this space. Visit discussion page.
June 11, 8 a.m.: Value-based contracting
While at the 2018 AMA Annual Meeting, learn about the latest evolution of value-based payment contracts that include cost and quality metrics and risk-based payments. Through a presentation and dialogue moderated by an expert in health care legal and management consulting, this CME activity will enable you to learn from experienced physicians about the strategies used to ensure these arrangements work for your patients and your practice. This session qualifies for 1.0 AMA PRA Category 1 Credit™ and will take place on Monday, 8 a.m. CDT, in Crystal Ballroom A.
June 11, 9 a.m.: Transforming Clinical Practice: A step-wise approach
In this interactive session, we will describe the Transforming Clinical Practice initiative (TCPI), AMA's efforts and tools to help attendees assess their practice capabilities and identify pain points and to provide information/resources they can use in their practices. We will hear from a physician/practice on the front-lines of transformation who can share their performance story and offer valuable and practical tips for moving to VBC. Hosted by AMA's Professional Satisfaction and Practice Sustainability Strategy Group and held in Crystal Ballroom A.
June 11, 10 a.m.: Cost-sharing and preventive interventions
In this session, you will learn about the methods and processes used by the US Preventive Services Task Force (USPSTF) in making evidenced-based recommendations for preventive services and the ways insurance design can be used to align incentives. Coverage of preventive services was expanded under the Affordable Care Act (ACA) to include coverage, without cost sharing, of services rated as "A" or "B" by the USPSTF. Nevertheless, valuable preventive interventions are often outside the scope of the ACA preventive coverage and out-of-pocket costs can be a barrier for patients. A more precise benefit design can enhance patient-centered outcomes, while reducing the harm associated with high cost-sharing. Value-Based Insurance Design, consistent with AMA policy, applies the principle of "clinical nuance," to align patient cost-sharing with the value of the care to a specific patient. Crystal Ballroom A.
June 20: Health literacy solutions
There is a growing need to understand the socioeconomic issues surrounding patients and the lack of resources and assets on the topic of health literacy. In this AMA webinar, Dr. Mary Reeves, TCPI National Faculty, as well as several team members from HealthCare Dynamics International, will define health literacy and how it can have an impact on reporting and your practice overall, as well as discuss tools and resources that address clinician concerns regarding the social factors affecting their patient population and the impact of these factors on clinical outcomes. Register.