Life Science Compliance Update

March 31, 2016

MACRA Progress Report: Subcommittee on Health Hearing

According to Politico the draft rule for the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) has been sent to the Office of Management and Budget (OMB) at the White House for review.   Which means the draft rule should be released sometime in April.

The Subcommittee on Health of the Committee on Energy and Commerce recently held a hearing, focused on MACRA and how to implement Medicare payment reforms. Dr. Patrick Conway, the Deputy Administrator for Innovation and Quality and Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS) was present as a witness, offering testimony on the progress CMS has made as well as future changes CMS would like to see made.


The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is the product of years of bipartisan work to repeal the Sustainable Growth Rate (SGR). MACRA permanently repealed the SGR formula and somewhat provides stability in Medicare base payments through 2019. MACRA alters how the Medicare program pays for services, as well as how providers interact with Medicare.

Not only did MACRA attempt to respond to criticism about how providers are reimbursed, how they interact with the program, the development of new quality measures and means of evaluating and integrating new practice models into the system, but it was also meant to add a layer of transparency into the development and operation of how Medicare reimburses providers.

MACRA provides for updates to the fee schedule of .5% from July 2015 through 2019, at which point services on the physician fee schedule will remain at the 2019 level and be adjusted based on a provider's participation in MIPS or a qualifying APM. After 2026, providers participating in a qualified APM will receive a .75% update and all others will receive a .25% update.

Instead of applying the typical "one size fits all approach," MACRA allows eligible professionals and eligible organizations to identify quality measures and then tailor the quality measures that best fit their individual practice and specialty. Eligible professionals are assessed only on the categories that apply to them, and the categories may be reweighted to compensate, as needed. Each year, the Secretary will establish a performance threshold based on the performance of all participating eligible professionals, who will be informed of how they performed in the prior period and what performance threshold they must meet to be eligible for incentive payments and to avoid penalties. Additionally, eligible professionals who scores fall into a high performance category will receive an additional bonus payment, and providers who make notable gains in performance will be rewarded.

Hearing Discussion

Reporting Period Length

One of the important topics discussed during the hearing was what the best time period is for physicians to submit their quality reports to Medicare. According to Dr. Conway, historically, CMS has "had a performance period that is twelve months, and often providers wanted three to four months to finish reporting on quality measures." Dr. Conway explained that currently, "providers are reporting quality measures now through middle of April" and that "payments end up being made about twelve months after the end of the performance period, or eight months after they finish reporting quality measures."

Dr. Conway testified that several years back, CMS asked physician and clinician groups if they wanted to have similar reporting periods to hospitals, who submit quarterly reports, which allows for more rapid feedback. Many of the physician and clinician groups were not interested in a quarterly reporting cycle, they like the annual reporting cycle.

Today, groups like the American Academy of Family Physicians are actually calling for CMS to announce a 90-day reporting period as soon as possible. AAFP is concerned that requiring physicians to report performance measurements for an entire year "would hinder efforts to prepare for the transition to new payment models" outlined by MACRA. AAFP claims that a shorter reporting period would allow physicians to update their technology and improve interoperability with other institutions.

MIPS Flexibility is Key

Dr. Conway and Rep. Kathy Castor went back and forth a bit on how MIPS makes things easier for providers. Dr. Conway stated that it's truly the flexibility of MIPS, which allows CMS to lower the burden on physicians, makes data collection more meaningful, and part of the normal workflow.

March 25, 2016

House Oversight Committee: America’s Heroin and Opioid Abuse Epidemic

On the same day that the FDA issued black box warning to all immediate release opioids, the House Committee on Oversight and Government Reform held a hearing entitled "America's Heroin and Opioid Abuse Epidemic." The hearing focused on the alarming increase in abuse of illegal opioids, i.e., heroin and fentanyl, as well as controlled prescription opioids like hydrocodone and oxycodone.

According to the Centers for Disease Control and Prevention (CDC), the rate of overdose deaths involving opioids increased by 200% from 2000 to 2014. Additionally, in 2014, sixty-one percent of drug overdose deaths involved some form of opioid, and on average, seventy-eight Americans die daily from overdoses of heroin or painkillers. Congress has held several hearings over the past few months on the topic, and adding to their concern, researchers have found that prescription opioid abuse serves as a gateway of sorts to heroin use and the National Institute on Drug Abuse shows an increasing number of high school students and young adults using OxyContin.

Congressional members in attendance at the hearing heard from five witnesses from various organizations and government agencies: The Honorable Michael Botticelli, the Director of the Office of National Drug Control Policy; Mr. Lou Milione, the Deputy Assistant Administrator for Diversion Control at the Drug Enforcement Administration; Ms. Kana Enomoto, the Acting Administrator for Substance Abuse and Mental Health Services Administration; Leana S. Wen, MD, MSC., FAAEM, the Health Commissioner at the Baltimore city Health Department; and The Honorable Teresa Jacobs, the Mayor of Orange County, Florida.


Rehab Can't Be the Only Solution

Republican John Mica, got quite vocal at the hearing, when he stated that rehabilitation is not enough when it comes to dealing with heroin and opioid addiction. As he stated, "treatment is at the end of the process. They've already been addicted." Mica called for immediate action, "we haven't killed this many people in multiple-year wars as we're killing in one year. We are going to lose half a million people in a decade at this rate. Every family has been affected by it, and now it's just a slaughter out of control."

Emergency Fund

Representative Carolyn Maloney was one of several Congressional members present who were perturbed that a $600 million emergency fund has been passed in the Senate as part of the Comprehensive Addiction and Recovery Act, but the House has not picked up a companion bill. In her mind, and in the mind of others, what good is the emergency fund if it has not been funded? Representative Maloney urged colleagues on both sides of the aisle to work on passing a companion bill funding the $600 million before going home for recess.

Safe Prescribing

Dr. Wen was asked several times what she felt caused the epidemic and what can be done in the future to stop the epidemic from spreading any further. Dr. Wen believes that part of the problem is the cultural idea that there is a pill to resolve every pain and that there is one pill or combination of pills that will patients to be completely pain free. She believes that before we can truly evaluate and halt the epidemic, it is important to get away from that idea, and instead, move toward an idea that appropriate treatment should be the goal.

Dr. Wen also stated that she believes that the CDC guidelines released recently are helpful, but that more concrete guidelines would be helpful, including specifics on: monitoring and regulating the price of naloxone, require co-prescriptions for naloxone to every individual receiving opioid medications, require a "black box warning" on opioids and benzodiazepines, and remove barriers that currently exist to prescribing Buprenorphine.

Other Topics

Another topic touched upon was brought up by Mayor Jacobs, who reminded Congressional members that the country galvanized around the tobacco industry years ago, which had a huge impact and helped to reduce tobacco use and deaths related to tobacco. She suggested that something similar be done with opioids, and perhaps if Americans came together and work on a campaign to create and increase awareness for painkiller, heroin, and opioid addictions, there could be a huge impact.

Congressman Ken Buck mentioned the idea that many young people, including teenagers, are actually getting the drugs from their parent's drug cabinets. He encouraged the FDA and other governmental agencies to look into doing something similar to opioid bottles as is done to aspirin bottles, and creating tamper resistant bottles. The DEA also agreed that would be something to look into.


Currently, primary and secondary prevention programs are in place to decrease the use of potential gateway drugs in youth and others who are vulnerable to heroin use. In 2015, $400 million was appropriated to address the opioid epidemic – an increase of $100 million; however, to date, none of the money has been spent.

On Tuesday afternoon, following the hearing, the Food and Drug Administration (FDA) announced new guidelines, which call for prescription labels to warn that opioids can cause a dangerous central nervous system reaction if they interact with antidepressants and migraine medications, along with other warnings.

March 23, 2016

Senate HELP Committee Continues Work on 21st Century Cures Corollary

Earlier this week, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on a package of legislative measures that are targeted at facilitating medical innovation. This hearing, the second in a set of three, is the Senate's response to the House-passed 21st Century Cures Act (H.R. 6). We wrote about the first hearing, and a recap can be found here.

While the second meeting featured much partisan debate and fanfare, the Committee advanced all seven medical innovation measures before them, with six passing by voice and one measure passing by roll call vote of 20-2.

In opening statements, Senator Lamar Alexander, Committee Chairman, acknowledged the anticipated contention on the panel over what he referred to as a "surge" of additional mandatory funding requested by Democrats for the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Even expecting contention, the Chairman expressed optimism about the Committee's capacity for compromise, stating that if the Committee successfully creates an innovation agenda, it may be the "most important legislation passed this year."

As may be expected, Ranking Member Senator Patty Murray and Senator Elizabeth Warren both showed strong support for increasing mandatory funding for the FDA and the NIH, each introducing an amendment to S. 1878: one to create a medical device evaluation system and the other to create a biomedical innovation fund. Senator Murray also expressed concern that some of these bills may increase FDA responsibilities and not compensate the FDA for that. While both senators started out firmly believing that any agreement needed to include increased funding, they both withdrew their amendments, including any requests for additional funding, in order to find other consensus points and come to an agreement.

The measures approved in the Committee are as follows:

The Advancing Hope Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act (FDCA) to expand the priority review voucher program for rare pediatric diseases to including treatments for both sickle cell disease and pediatric cancers. The voucher program will be extended by removing the provision that terminates the program one year after the FDA's issuance of three rare pediatric disease vouchers. However, a voucher may not be issued for a rare pediatric disease product, if a voucher was ever issued for the product as a tropical disease product. Additionally, a drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of their intent to do so upon submission of their new drug application.

The bill's sponsor, Senator Robert Casey explained that this program is integral to fostering innovation and incentivizing private companies to invest in rare children's diseases. Such an incentive is necessary because private companies tend to not see a return on research investment in this area.

This is the one measure passed via a roll call, following adoption of the following amendments: (1) specify the criteria for "rare pediatric disease," (2) insert a section related to rare pediatric disease product applications, (3) require the comptroller to conduct a study on the GAO report on the effectiveness of awarding priority review vouchers for the sponsorship of rare pediatric disease product application, and (4) require the results of the study to be reported to congress.

The Advancing Breakthrough Medical Devices for Patients Act of 2015

This bill amends the FDCA to expand the FDA's priority review of breakthrough medical devise to include all classes of devices. Currently, only new or highest risk (Class III) devices are eligible. However, this bill would make it so that upon a sponsor's request, the FDA would be forced to determine whether a device meets the criteria for priority review as a breakthrough device.

To expedite the development and review of designated medical devices, the FDA must: "assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive and timely communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, [and] assign staff to address questions by institutional review committees concerning investigational use of the device."

Senator Richard Burr emphasized the idea that this measure would not change the standards that devices are required to meet in order to reach the market, but instead simply changes the approach by which device approvals can be accelerated.

The Medical Countermeasures Innovation Act of 2015

This bill encourages the development of medical countermeasures in case of biological attacks and naturally occurring outbreaks. This bill is intended to build upon the Pandemic and All-Hazards Preparedness Act, by leveraging the innovation of the private sector through priority review vouchers. The urgency of this problem has been exemplified with the Ebola and Zika outbreaks over the past year.

The Medical Electronic Data Technology Enhancement for Consumers Health Act

This bill amends the FCPA to exclude several classes of devices from FDA-regulation as a medical device. Some of the included classes are: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals.

The bill also states that the FDA must classify a medical device accessory according to its intended function, not the classification of the medical device with which it is used.

This measure was adopted without any discussion.

The Combination Product Regulatory Fairness Act of 2015

This bill attempts to address regulations on combination drug and device products. There was little discussion accompanying this bill, but Senator Casey did briefly speak out in favor of the measure, noting that it will allow for improved communication with the FDA and manufacturers.

The Patient-Focused Impact Assessment Act of 2015

This bill amends the FDCA to require the package of information published by the FDA upon approval of a new drug to include documentation of efforts to assess patient engagement. The required documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including any patient preferences and patient-reported or caregiver-reported outcomes. The FDA is also required to annually summarize, and publish, the data that is collected in this documentation.

Senator Susan Collins, a cosponsor of the bill, believes that patient input is a valuable resource and should play a larger role in FDA decision-making.

The Adding Zika Virus to the FDA Priority Review Voucher Program Act

This bill also amends the FDCA, to add the Zika virus to the list of tropical diseases under the priority review voucher program. The priority review voucher program awards a voucher to the sponsor of a new drug or a new biological product that is approved to prevent or treat a tropical disease, which allows the holder of the voucher to have a future new drug or biological product application acted upon by the FDA within six months.

Chairman Alexander mentioned at the outset of this meeting that the Zika virus is a top concern and priority for the HELP panel.

The final HELP Committee on medical innovation is slated for April 6, 2016, at which time Chairman Alexander hopes to have a final package ready for floor consideration.


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