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June 2018

CMS Releases FY 2019 IPPS Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) on April 24 released the fiscal year (FY) 2019 Medicare Inpatient Prospective Payment System (IPPS) proposed rule, which updates next year’s Medicare payment rates and coverage policies for patients when they are discharged from hospitals. Under the provisions proposed in this rule, CMS projects that total Medicare spending on inpatient hospital services will increase by approximately $4 billion in 2019.


The proposed rule renames the Electronic Health Record (EHR) Incentive program, known as Meaningful Use (MU), to Promoting Interoperability as part of CMS’ proposed overhaul of the MU program to reduce clinician burden and focus on measures that require the electronic exchange of health information between providers and patients. CMS also proposes new measures related to e-prescribing of opioids.


CMS proposes to reduce the required number of measures acute care hospitals must report across the agency’s quality value-based purchasing (VBP) programs and to remove measures if they are “topped out” (that is, an overwhelming majority of providers perform highly), duplicative, or excessively burdensome.


In addition, CMS is calling for several changes to documentation requirements to reduce administrative burdens for physicians and hospitals. Specifically, CMS proposes to remove the requirement that a written inpatient admission order be included in the medical record as a specific condition of Medicare Part A payment.  CMS also is planning to eliminate guidelines that require physicians to indicate the precise location of a statement in a medical record that certifies or recertifies the medical necessity of covered services.


The proposed rule is available for public review, along with a fact sheet.


Congress Takes Step to Address Physician Burdens

The House Energy and Commerce Health Subcommittee passed several legislative proposals last week, including the Standardizing Electronic Prior Authorization for Safe Prescribing Act, H.R. 4841.  This bipartisan legislation would allow for electronic prior authorization (PA) under Medicare Part D and allow for the creation of technical standards for the electronic transmission of PA.


CMS Releases Updated Tools to Track Trends in Drug Pricing and Prescribing

CMS recently released updates for two tools intended to help stakeholders track trends in drug pricing and prescribing under Medicare. The Centers for Medicare & Medicaid Services (CMS) released updated versions of its Drug Spending Dashboards, which are online tools that provide spending information for drugs in the Medicare Part B, Part D, and Medicaid programs. The dashboards now include information on annual trends in drug spending per dosage unit and identify manufacturers that have significantly increased the price of their products over time.


In addition to the new Drug Spending Dashboards, CMS updated the Part D Prescriber Public Use File (PUF) with data for 2016. The PUF includes summarized information on more than 1 million distinct health care providers who prescribed drugs under the Part D program in 2016. The Part D PUF is available for review on the Medicare Provider Utilization and Payment Data web page.


Senate Passes VA Choice Reform Legislation

The Senate passed S. 2372, the VA MISSION Act of 2018. The veterans’ health bill will provide $5.2 billion to extend the Veterans Choice program, which was scheduled to run out of money at the end of the month. The legislation would also expand veteran eligibility to receive care outside the VA through private doctors and hospitals. The bill passed the House last week in a 347 70 vote. It will now be sent to President Trump for his signature.


In related news, Chairman of the Senate Veterans’ Affairs Committee Johnny Isakson (R-Ga.) has signaled that his panel will convene a hearing next month on the nomination of acting secretary Robert Wilkie to serve as Secretary of Veterans Affairs. Ranking Member Jon Tester (D-Mt.) has indicated that he will support the nomination, stating that Wilkie is a strong candidate for the role.


Opioid Bills Update

The Senate Finance Committee has unveiled the 22 bills aimed at combating the opioid crisis that it plans to consider during a markup in the coming weeks. Most of the bills would make reforms to Medicare and Medicaid payment policies. It is still unclear how lawmakers plan to ultimately proceed with opioid response measures. While there is some overlap among House and Senate proposals, the two chambers are advancing separate legislation. The Senate Health, Education, Labor, and Pensions (HELP) Committee has also marked up opioid legislation this year. The House Energy and Commerce and House Ways and Means Committees reported out more than 60 bills to the floor for votes.


The House Oversight Committee has advanced bipartisan legislation to reauthorize the Office of National Drug Control Policy (ONDCP). H.R. 5925, the CRISIS Act, would retain the High Intensity Drug Trafficking Areas (HIDTA) and the Drug Free Communities (DFC) programs and expand responsibilities under the ONDCP. The Office has been a recent target for cuts by the Trump administration and is currently operating under an expired authorization.


The House Energy and Commerce Committee approved more than 20 opioid-related bills during a full committee markup. These bills focus on treatment, prevention, and safe disposal of opioids, as well as electronic prescribing for controlled substances under Medicare Part D.


Premiums Expected to Rise 15 Percent

Premiums in the individual market are expected to rise an average of 15 percent next year, according to the latest Congressional Budget Office (CBO) analysis released last week. The agency estimates that repeal of the Affordable Care Act’s (ACA) individual mandate will contribute to a 10 percent rise in premiums for 2019 because healthier people will drop out of the marketplace. CBO attributes the rest of the increase to rising health care costs and the absence of cost sharing reduction (CSR) payments. CBO estimates that the Obamacare market will be stable in most areas of the country over the next decade. Latest figures indicate that the number of uninsured people will increase by 3 million between 2018 and 2019.


Uninsured Rate Remains Flat

New data from the Centers for Disease Control and Prevention (CDC) indicate that the number of uninsured Americans has remained relatively flat over the past three years. The CDC estimates that 29.3 million people – 9.1 percent of the population – were without health insurance in 2017. In 2016 this figure stood at 9 percent; in 2015, it was 9.1 percent. The number of people covered by the Affordable Care Act (ACA) exchanges has also remained unchanged. The CDC did find an increasing gap between the uninsured rate in states that expanded Medicaid under Obamacare and states that did not. The uninsured rate in non-expansion states (19 percent) was more than twice as large as that of expansion states (9.1 percent).


GAO Freezes Rescissions Funds

The Government Accountability Office (GAO) has officially frozen the majority of funds included in the Trump administration’s $15 billion rescissions package. The money is frozen for a 45-day period to allow time for Congress to act on the rescission request. Congress has until June 22 to claw back the spending authority. If lawmakers fail to do so, the funds will be made available again for use.


Spotlight on Universal Flu Vaccine

Bill Gates is in talks with President Trump about the development of a universal flu vaccine. According to Gates, the two had an energetic conversation focused on global health security, innovation, and the possibility of a vaccine to provide protection against a range of seasonal and animal flu viruses. President Trump went on to discuss the idea with Commissioner of Food and Drugs Scott Gottlieb. The Gates Foundation is offering $12 million in seed money for products that would aid in the development of a universal influenza vaccine.


Insect Disease Transmission Increases Three-Fold

New data from the Centers for Disease Control and Prevention (CDC) shows that the number of disease transmissions caused by mosquito, tick, and flea bites has seen a three-fold increase over the past decade. The number of confirmed transmissions increased from 27,000 in 2004 to 96,000 in 2016, with more than 640,000 cases of illness attributed to insect transmission in that time span. The number of diseases spread by these bugs has increased as well; the CDC identified nine new pathogens over the 13 years. The agency warned that the nation is not fully prepared to combat a viral outbreak of bug-borne illness, and that public health departments need to do more to control mosquito, tick, and flea populations.


New Study Details Deaths Attributable to Synthetic Opioids

The Journal of the American Medical Association (JAMA) has published a new report detailing the emergence of synthetic opioids as the leading cause of opioid overdose deaths. Researchers found that 46 percent of such overdose deaths in 206 were the result of illicit synthetic opioids like fentanyl. This is a three-fold increase from 2010, when synthetic drugs were the cause of only 14 percent of opioid-overdose deaths.


Presidential Address on Drug Prices

President Trump delivered a highly anticipated address on his administration’s plan to lower drug prices, increase competition, and reduce the amount that people pay in out-of-pocket costs for medication. American Patients First is a mix of policies already laid out in the White House budget proposal for fiscal year (FY) 2019 alongside some new ideas. It is designed to address four major aspects related to the cost of prescription drugs: high list prices, a lack of negotiating tools in government programs, rising out-of-pocket costs for consumers, and foreign governments freeriding off of American innovation.


The blueprint includes both immediate actions and long-term strategies aimed at increasing competition, improving negotiation, incentivizing lower list prices, and reducing out-of-pocket costs. Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar stated that he believes the vast majority of the plan can be accomplished through administrative action rather than legislative change.


The plan proposes a number of changes to reshape the Medicare program, including offering free generic drugs to seniors, requiring Part D plans to pass on a portion of rebates to the consumer, and capping certain out-of- pocket costs for Part D beneficiaries. The blueprint would reform how drugs in Medicare Part B are paid for and potentially shift more treatments into Part D, where there is more competition. The Administration is considering fiduciary status for pharmacy benefit managers (PBMs) as well as reforms to the 340B drug discount program. The plan proposes to crack down on manufacturer gaming of regulatory processes and eliminate the use of gag clauses by insurers. The Food and Drug Administration (FDA) will also look into requiring the disclosure of prices in direct to consumer (DTC) advertising. Additionally, the President stated his intent to push other developed countries to loosen their price restrictions and pay treatments.


Take Back Day Collects 475 Tons of Medication

This year’s national Prescription Take Back Day resulted in the collection of nearly 475 tons of unwanted medications across 6,000 collection sites, the largest collection in the event’s nine-year history. The event, which was started to encourage people not to simply throw away or flush unused prescriptions, is now a part of the Drug Enforcement Administration’s (DEA) response to the opioid epidemic.


CMS Denies Medicaid Lifetime Limit Proposal

The Trump Administration will not allow states to impose lifetime limits on Medicaid coverage, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma announced last week. CMS rejected a request from the state of Kansas to limit coverage to a total of three years earlier this month, but four other states are currently pushing similar proposals. The Trump White House has prioritized state flexibility in the administration of the Medicaid program, and will continue to do so according to Verma. She stated that her main focus in the Medicaid program is sustainability. Under Verma’s leadership, CMS has approved four state waivers tying Medicaid eligibility to community engagement and work requirements. As many as 20 other states are exploring such requirements. CMS is also considering state proposals to require drug testing or to allow for partial expansion of Medicaid.


FDA Approves First Non-Opioid for Symptoms of Withdrawal

The Food and Drug Administration (FDA) has approved the first non-opioid for treatment of opioid withdrawal. Lofexidine, marketed as Lucemyra, is not a treatment for opioid use disorder, but can be used as a part of a broader treatment plan for management of the disorder and to help transition people into medication-assisted treatment (MAT), which may require that a person has already gone through detox. The drug is expected to become available in August.


President Signs Right to Try – Keep on Trying

President Donald Trump signed the “Right to Try” Act.The bill will allow the provision of unapproved, investigational drugs to terminally ill patients that have exhausted approved treatment options if they are unable to participate in clinical trials involving the innovative treatments. Only drugs that are in active clinical trials and have cleared initial preliminary testing may be considered. The legislation also requires the manufacturers of eligible investigational drugs to report annually to the FDA on usage under the law, a summary of which would be published online by the agency. The bill does not obligate drug makers to provide the treatments, nor does it prevent them from charging patients for associated costs if treatment is provided.