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31 posts from March 2016

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 MACRA permanently repealed the SGR formula and somewhat provides stability in Medicare base payments through 2019.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 30, 2016

New HIPAA Audits Announced

After many years of anticipation, the Office of Civil Rights (OCR) launched a new round of audits to gauge compliance with patient privacy provisions under the Health Insurance Portability and Accountability Act (HIPAA). These audits are intended to determine whether or not healthcare organizations and their contractors are in compliance with HIPAA. If organizations and contractors are not in compliance OCR is hoping that the audits will trigger a reaction and allow them to get in front of potential problems and better direct guidance to address issues that affect the confidentiality and security of protected health information (PHI).

The launch came with little fanfare, starting with emails to "covered entities" (i.e., healthcare providers, insurance plans, and clearinghouses) and to business associates that may handle patient information on behalf of those entities. The emails ask them to verify contact information, which, once verified, will lead to receipt of a "pre-audit questionnaire," seeking details on their business size, business type, and operations. If an entity or associate does not respond to the "pre-audit questionnaire," OCR will use publicly available information about the entity in creating the audit pool. An entity who fails to respond to OCR may still be selected for an audit or subject to a compliance review.

Once OCR receives the audit questionnaires back, it will create a pool of audit targets that represents a range of covered entities and business associates. According to OCR, the wider the range of audit candidates, the better idea OCR will have of HIPAA compliance across the industry.

The audits will take place in several rounds: desk audits (focused on document review) make up the majority of the audits and will take place in two rounds. The first round will focus on covered entities and the second round will focus on their business associates. The desk audits are expected to be completed by December 2016. The third round of audits is reserved for on-site audits, which will begin later in the year. Additionally, just because an entity undergoes a desk audit does not release them from a potential on-site audit. HHS will cover the cost of the on-site auditor; neither covered entities nor their business associates are responsible for the costs of the audit program.

Desk Audits

Entities who are selected for a desk audit will be informed via email and will be asked to provide documents and other data. The desk audit will focus on compliance with particular provisions of the HIPAA Privacy, Security, and Breach Notification Rules, such as risk analyses, notices of privacy requests, and response to requests for PHI access. Those subjected to an audit will be given ten days to submit the requested information to OCR through a portal. Once OCR receives the documents, it will review them and develop draft findings, which will then be shared with the audited entity, allowing ten business days for an entity response. The written entity response will be included in the final audit report, which will also be shared with the entity.

On-Site Audits

An on-site audit is also preceded by an email, and will take place over three to five days, depending on the size of the entity. On-site audits will be more comprehensive and have a broader focus on HIPAA requirements. Entities subject to an on-site audit will also have ten business days to review the draft findings and provide written responsive comments to the auditor. A final report will then be shared with the audited entity.

What Comes After the Audit

Following an audit, if any serious issues were uncovered, an OCR compliance review may be done. Even though OCR will not post a list of audited entities, nor will they post the findings of an individual audit that clearly identifies the audited entry, audit notification letters and other audit information may be discoverable under the Freedom of Information Act (FOIA).

Generally, OCR will use the audit reports to determine what types of technical assistance should be developed and what types of corrective action would be the most helpful. OCR will also use information gleaned from the audits to develop tools and guidance to assist the industry in compliance self-evaluation, preventing further breaches.


March 29, 2016

FDA Announces Labeling Changes for Immediate Release Opioid Medications

The United States Food and Drug Administration has announced new required class-wide safety labeling changes for immediate-release (IR) opioid pain medication. Included in the changes is a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death.

The updated indication clarifies that because of those risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options, such as non-opioid analgesics or opioid combination products, are inadequate or not tolerated. Additionally, the dosing information provides clarity to previous instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient.

The FDA will also require a precaution that chronic maternal use of opioids during pregnancy can result in NOWS, neonatal opioid withdrawal syndrome, which can be life-threatening to the child if not recognized and treated immediately.

The FDA is also requiring an update of labeling for all opioids (ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition, known as serotonin syndrome.

These changes come with a Safety Announcement by the FDA, where the FDA reminded prescribers and patients alike that opioids can lead to a rare, but serious, condition, where the adrenal glands do not produce adequate amounts of cortisol, which helps the body respond to stress. Additionally, included in the Safety Announcement is a statement that long-term use of opioids can be associated with decreased sex hormone levels and symptoms, such as reduced interest in sex, impotence, or even infertility. The Safety Announcement provides tips for patients and healthcare professionals for how to notice, evaluate, and possibly prevent the serious conditions warned of from happening.

These changes also follow changes the FDA made in 2013, where class-wide labeling changes were made for ER/LA opioid analgesics, including modifications to the products' indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the risks associated with patients taking those drugs.

The FDA is continuing to review available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once the FDA has completed a review of all available scientific information, it will work to take "necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications."

FDA Commissioner Robert Califf, M.D., believes that these actions "are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic."


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