Life Science Compliance Update

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29 posts from December 2011

December 30, 2011

FDA the Headache of Developing a Biosimilar Pathway

Biosimilar Pathway
A recent article from MedPage Today explored a provision in the healthcare reform bill that called on the Food and Drug Administration (FDA) to create an expedited pathway for approving biosimilars -- the nonidentical "generic" versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis.  

As we noted back in September, FDA is expected to issue guidance on the subject shortly.  (Well, maybe not) 

The primary concern for the FDA is how to ensure that a biosimilar is the same as its original biologic.  Writing for MedPage Today, Bruce S. Rubin, MD, explained the “crucial differences that separate "generics" from biosimilars.”

He noted that, “Most traditional drugs, like Tylenol, are chemically synthesized, which means they have structures that are consistent and known.  Biologics, on the other hand, are fashioned out of living cells, meaning they have much more complex structures, which are not as easily understood as the makeups of chemically created drugs.”

Dr. Rubin explained that, “Because a chemically created drug can be reproduced easily, the generic versions are no different than their name-brand counterparts and can be verified through testing and analysis.”

However, he noted that, “With biosimilars this is not always the case. That's because biologics are more complex structures that are much more difficult to replicate. An error in reproduction could cause unanticipated or harmful side effects.  This fact illustrates why the FDA needs to exercise added caution when setting out the process and priorities for approving biosimilar products.”

Dr. Rubin explained that, “Right now, no biosimilar exists on the U.S. market; because of their complexity, they weren't included in the Hatch-Waxman legislation that set the regulatory framework for other generic drugs.”  The Affordable Care Act however changed that, which led to FDA beginning to hold meetings last November to develop a biosimilar approval process.

In order to ensure the safety of biosimilar drugs for patients, Dr. Rubin recommended that the FDA:

  • Require clinical trials or other appropriate clinical testing before the approval of biosimilars
  • Ensure robust pharmacovigilance, the surveillance of a drug's performance, including adverse reactions, after it's been released for marketing. Of primary importance is the creation of a traceability system that includes distinctive labeling, product tracking codes, and a way to report adverse reactions
  • Require different names for all biologic medicines in order to prevent confusion for physicians and patients
  • Require transparent and clear product labels that educate patients about the trials conducted on that specific product, not just the reference product
  • Guarantee that patients and their doctors have the ability to decide treatment by ensuring a treatment plan is not altered by a pharmacist without the consent of the physician and patient

Dr. Rubin asserted that, “Including these requirements would assure patients and their families that the FDA is set on striking the right balance between cost effectiveness and patient safety.”

He emphasized that, “biologics and biosimilars could revolutionize the way the U.S. treats some of the most painful, most deadly diseases. But like the advances that came before them, these new treatments must undergo a thorough evaluation process before their approval.  Patient safety must be considered first if we are to uphold America's system for pharmaceutical review and approval.”

December 29, 2011

CMS Final Rule on Hospital Meaningful Use and Quality Reporting

Hospital Computing
The Centers for Medicare & Medicaid Services' final rule updating the hospital outpatient prospective payment system (OPPS) and payment rates contains a specific provision designed to make meeting Meaningful Use easier.  The rule finalizes the launch of a pilot program that would allow for the electronic reporting of clinical quality measures (CQMs) under the electronic health record incentive program.

The final rule with comment period, released Nov. 1, will allow eligible and critical access hospitals to report CQMs electronically to meet that core objective for Meaningful Use of their EHR systems, instead of having to calculate the CQM results and attesting to them.  If a hospital reported the CQMs electronically, CMS would calculate the results for them.  If, based on CMS' calculations, a hospital doesn't meet the CQMs, it still would have the opportunity to measure them itself and attest to the results.

Comments on the final rule will be accepted through January 3, 2012.

If the hospital successfully reports the CQMs electronically, it would meet that core objective, but still would need to meet and attest to the other core and menu set objectives required under the EHR program.

The pilot program would help hospitals test the interoperability and functionality of their certified EHR systems and help advance EHR reporting, according to the rule.  Participation in the pilot would be voluntary.

CMS reported in the final rule that it had received a lot of industry support for the pilot, which it had suggested in its proposed OPPS rule released July 18.  The agency acknowledged that it anticipated only those hospitals that are the most ready to transmit this information electronically would participate in the pilot, but encouraged hospitals to participate for the "valuable learning process."  CMS also indicated that it would provide education, outreach and testing of the reporting pilot.

According to a summary by CMS, the final rule also updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from their continuing experience with this system. These changes are applicable to services furnished on or after January 1, 2012.

CMS is also revising the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, adding new requirements for ASC Quality Reporting System, and making additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program.

Finally, CMS announced changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.

December 28, 2011

Institute of Medicine Report on Essential Benefits

Esential Benefits
The Patient Protection and Affordable Care Act of 2010 (ACA) was enacted to help uninsured Americans obtain health insurance.  As part of this effort, private health insurance plans will be offered to low- and moderate-income individuals and small employers through state-based “purchasing exchanges,” often with financial help. 

To ensure a more consistent level of benefits, the ACA requires that certain insurance plans—including those par­ticipating in the state purchasing exchanges—cover a package of diagnostic, preventive, and therapeutic services and products that have been defined as “essential” by the Department of Health and Human Services (HHS). 

This package—commonly referred to as a set of essential health benefits (EHB)—constitutes a minimum set of benefits that the plans must cover, but insurers may offer additional benefits. The EHB are intended to cover health care needs, to promote services that are medically effective, and to be afford­able to purchasers. 

The ACA stipulated that HHS will define what the EHB package should include, while states will oversee day-to-day running of the exchanges.  To assist with this, HHS asked the Institute of Medicine (IOM) to recommend a process that would help HHS do two things: 1) define the benefits that should be in the EHB, and 2) update the benefits to take into account advances in sci­ence, gaps in access, and the impact of any benefit changes on cost. 

The IOM appointed a committee to meet this task. The charge of the committee specifi­cally was not to decide what is covered in the EHB but rather to propose a set of criteria and methods that should be used in deciding what benefits are most important for coverage. 

The IOM completed its task and published a nearly 300-page report, outlining its recommendations about the process the HHS secretary should use to define and update essential health benefits.  One article noted that, “America's Health Insurance Plans commended the IOM for its recommendations, particularly the one on a premium target.”

“With this thoughtful report, the IOM is urging policymakers to strike a balance between the affordability of coverage and the comprehensiveness of coverage,” AHIP President and CEO Karen Ignagni said in a news release. “We agree that this balance is critical to ensuring that individuals, working families and small employers can afford health insurance. The recommendation that the initial EHB package reflect the scope of benefits and design provided under a typical small employer plan is an important step toward maintaining affordability.” 

In an e-mailed statement, HHS Secretary Kathleen Sebelius said she appreciated the IOM's work and looks forward to reviewing the recommendations.  “But before we forward a proposal, it is critical that we hear from the American people,” Sebelius said in the statement. “To accomplish this goal, HHS will initiate a series of listening sessions where Americans from across the country will have the chance to share their thoughts on these issues.”


IOM Committee 

Committee members who worked on the report combined perspectives from four areas—economics, ethics, evidence-based practice and population health—to create what the IOM called an “overarching framework” for HHS.  

In considering its task, the committee recognized two competing goals: to provide health insurance coverage for a wide range of health needs and to make it affordable. If it was not affordable, then many people would not be able to obtain it, even with government help, and this would conflict with the purpose of the ACA. Thus, the commit­tee saw its primary task as finding the right bal­ance between making coverage available for indi­viduals to get the care they need at a cost they could afford. This balance will help ensure that an estimated 68 million people have access to care covered by the EHB. 

The committee recommended that HHS develop the EHB package by keeping in mind what small employ­ers and their employees can afford. Employers who offer insurance packages make such choices now. Keeping the EHB affordable is necessary for consumers, employers, and taxpayers. To maxi­mize the number of people with insurance, the committee proposed that HHS embrace a frame­work for the entire EHB package that would: 

  • consider the population’s health needs as a whole;
  • encourage better care by ensuring good sci­ence is used to inform coverage decisions;
  • emphasize the judicious use of resources; and
  • carefully use economic tools to improve value and performance.  

The ACA requires that the EHB include at least 10 general categories of health services and have benefits similar to those currently provided by a typical employer. The 10 categories include: 

  • Ambulatory patient services
  • Emergency services
  • Hospitalization
  • Maternity and newborn care
  • Mental health and substance use disorder ser­vices, including behavioral health treatment
  • Prescription drugs
  • Rehabilitative and habilitative services and devices
  • Laboratory services
  • Preventive and wellness services and chronic disease management
  • Pediatric services, including oral and vision care  

The committee also identified a set of crite­ria for considering the content of the whole EHB package and specific components within it, as well as methods for defining and updating the EHB (see Criteria).  Current state insurance man­dates—requirements that had previously been established by state law—should not automatically be included in the EHB package but reviewed in the same way as other potential benefits. 

In both defining and updating the EHB package, IOM recommended that the methods used by HHS should be highly visible and allow for current and future enrollees to help define priorities for coverage. As envisioned by the committee, the public deliberation process would enable individuals— working in small group meet­ings around the country—to participate in a pri­oritization process, where different elements of coverage–specific services, types of cost-sharing, degree of provider choice, approval requirements, etc.–are discussed and debated. Learning from these groups will help HHS understand potential enrollees’ priorities when tradeoffs are necessary. A small number of these meetings would comple­ment the process HHS would normally use for receiving public comment. 

IOM stated that, “Consumers, employers, insurers, care provid­ers, and government have a shared responsibility for improving health and using resources wisely. Only medically necessary services should be covered, and decisions by insurers about what is “medically necessary” should depend on the cir­cumstances of an individual case. Under the ACA, when patients are denied care by their insurer, they have the right to appeal to an external review by experts.” 

IOM also noted that, “Some flexibility in defining the contents in the EHB will help encourage innovation at the state level. Proposed state-specific variations should be consistent with the ACA statute, abide by the selection criteria in this report, produce a benefits package that is equivalent in value to the EHB, and utilize meaningful public input.” 

The report also states that, “HHS should update the EHB package annually, beginning in 2016, to promote better health out­comes for both individuals and the broader pop­ulation. The benefit package needs to be based on credible evidence of effectiveness.  A National Benefits Advisory Council, appointed through a nonpartisan process, should be established to offer external advice on updates, data require­ments, and the research plan.” 

The IOM commit­tee recommended that HHS immediately begin developing a plan for identifying data needs and a research agenda that will support the EHB updat­ing process. The ability of the states to provide consistent and usable information to HHS will be enhanced if data needs are outlined at the start. 

In updating the benefits, IOM noted that “HHS should con­sider the projected cost of the current package, taking into account medical inflation, utilization of health services, and other factors. Any adjust­ments to the content of the EHB package should be made within that projected cost.

IOM noted that, “without serious attention to rising health care costs across all sectors, the EHB will become unaf­fordable over time. Thus, HHS, working with oth­ers, including the private sector, should develop a strategy to reduce the rate of growth in health care spending, bringing it in line with the rate of growth in the economy. This will help preserve what benefits are covered by the EHB package.” 

Ultimately, the IOM committee recognized the need to balance cost with the breadth of benefits covered in the EHB, otherwise, “we may never achieve the health care coverage envisioned in the ACA.”  IOM noted that, “If accessing benefits is too difficult, people will not get the care that they need. And if health care spending continues to rise so rapidly, the benefits covered under the EHB will begin to erode, eventually resulting in minimal coverage for the people who need it most.”

 

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