Life Science Compliance Update

October 13, 2016

HHS Issues Open Government Plan


On October 6, 2016, the U.S. Department of Health and Human Services announced its fourth Open Government Plan, which details initiatives that build on its goals of increasing transparency and boosting collaboration with stakeholders, particularly through data sharing.

Through its issuance of the newest plan, HHS is seeking new approaches to connect with underserved communities to share ways HHS can help them have the necessary building blocks to lead healthy and productive lives – many of which come in the form of making data and information products available to the public.

The plan outlines efforts toward new legislation that would increase transparency around financial data for information technology programs, as well as HHS’ efforts to better respond to the public through Freedom of Information Act (FOIA) requests. The plan also discusses “substantial progress” that has been achieved by HHS on the initiatives of the first three versions of the HHS Open Government Plan and stresses the role of the public in achieving progress via collaboration.

Over the past eight years, HHS has made available to the public nearly 3,000 datasets that enable the public and private development of technology applications and services that improve HHS’ ability to deliver on its mission. The resources provided are becoming important factors in improving the quality of America’s health care delivery system, enhancing the safety of America’s food supply, increasing program effectiveness in support of early child development and families in need, and developing new approaches to preventing disease.

Flagship Plan Initiatives

The Fourth plan highlights several flagship initiatives that attempt to underscore the key strategies HHS will focus on, including:

  • Promoting the Open Payments initiative, which publishes data on the financial relationships between the health care industry and health care providers;
  • Enhancing the Blue Button service to provide a developer-friendly, standards-based data Application Programming Interface (API) that enables beneficiaries to connect their Medicare claims data to the applications, services, and research programs they trust.
  • Undertaking strategic new projects to improve block grant programs that support children and families under the Title V Block Grant Program; and
  • Creating a public comment database for the Physical Activity Guidelines update process. The database, which will be open for comment over the next two years, will play a role in the development of the Physical Activity Guidelines for Americans.

Another flagship initiative focuses on the PMI Cohort Program, which operates under the Precision Medicine Institute. HHS hopes to recruit at least one million participants to improve HHS’ ability to prevent and treat disease based on individual differences in lifestyle, environment, and genetics.

Precision medicine is expected to revolutionize healthcare, which an eventual market worth over $87 billion. The PMI Cohort Program aims to be revolutionary not just in terms of its data collection, but also in its effort to empower study participants along with healthcare professionals and researchers to create a “new model of research in which people become true partners in the process, not research subjects.” Participants in the program will be able to choose what data to share, have input into study design and implementation, and have access to a “wide range” of their individual data and aggregate study results.

For more information or details on this new Open Government Plan, you can access the plan here. HHS encourages stakeholders to participate and share their opinions at

September 30, 2016

Webinar: Open Payments Retrospect and Looking Forward


On October 13, 2016, qordata will be hosting a webinar, “Retrospect and Looking Forward: A Review of Two Full Years of Open Payments Data and Media Coverage, The Indications for the Future.”

With three years of published public data available through CMS submissions in Open Payments, the media is working hard at mining transparency data to bring health care fraud cases to the enforcement authorities’ attention. As time passes by, the government is also enhancing the ways in which it prosecutes, arrests and penalizes those engaged in fraud. With the media working hard to bring these cases to light, pharma companies need to work more efficiently in terms of documenting their spend data.

Presenting the webinar will be our very own Thomas Sullivan, along with Zafar Ahmed of qordata. The webinar will go through the 2014-2015 Open Payments data, discuss the media on Open Payments during the week of the 2015 release, evaluate prosecutions using Open Payments, deliberate the CMS questions on Open Payments, assess Congressional actions on Open Payments, and review global ag spend and media.

In this webinar, Thomas Sullivan will give a detailed review of the 2014-2015 Open Payments Data, evaluate persecutions and provide an in-depth assessment of the congressional actions on Open Payments.  He will further provide information about the ways in which Open Payments data and other tied in spend reports are being evaluated by the media in hopes of finding data anomalies.

Chief Compliance Officers, Directors of Compliance, Managers of Compliance, and any other interested parties are encouraged to attend and register here.

August 25, 2016

Deep Dive Analysis of 2017 Proposed Physician Fee Schedule


As we previously covered, in July CMS released its annual proposed updates to the Physician Fee Schedule. There are a number of potentially important areas of this proposal to our readers, including a section on Open Payments. The proposed rule can be found here, along with its page on the Federal Register website. The “Proposed Physician Fee Schedule 2017 - Open Payments Section” can be downloaded here. Comments are due to CMS by 5 p.m. on September 6, 2016. When commenting, refer to file code CMS-1654-P. Comments may be submitted electronically at Follow the instructions for "submitting a comment." Below, we provide additional information on the proposal’s impact on Open Payments, the Stark law, ACOs, physician reimbursement codes, and more.

Open Payments Program

Since the publication and implementation of the Open Payments Final Rule, stakeholders have provided feedback to CMS regarding aspects of the Open Payment program. CMS writes that it has identified areas in the rule that might benefit from revision. In order to consider the views of all stakeholders, CMS is soliciting comments to inform future rulemaking. CMS specifically says it does not intend to finalize any requirements related to Open Payments directly as a result of this proposed rule; rather, it expect to conduct future rulemaking.

While the proposed rule solicits input concerning a host of issues, a number of key areas of note including request for information on: (1) allowing physicians to review manufacturer reports prior to submission to CMS; (2) whether the categories used by the CMS to identify the nature of the payments is adequate; and (3) recommendations on how to streamline and improve accuracy of the program. The failure of CMS to streamline the review process has prevented the overwhelming majority of physicians from reviewing the reports and seeking correction. The data currently lacks validation and cannot be reasonably relied upon to provide information about physician and industry financial interactions. 

Stark Law

In June 2015, the D.C. Circuit Court of Appeals concluded in Council for Urological Interests v. Burwell that CMS’ previous attempts to administratively codify a prohibition on “per click” leases for offices and equipment was based on an unreasonable interpretation of the Stark law. In the proposed rule, CMS is “re-proposing” the physician self-referral per-click restrictions related to arrangements involving the rental of office space or equipment.

Specifically, CMS proposes adding a requirement that rental charges for office space or equipment may not be determined using a formula based on per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the lessee. CMS believes that most parties already comply with these regulatory provisions since they originally became effective in October 2009, before the D.C. Circuit struck down the ban on per-click rental charges in 2015. Thus, per-unit payments for the rental of office space or equipment will be permissible under the proposal, but only where the referral for the service to be provided in the rented office space or using the rented equipment does not come from the lessor. 


The proposal includes changes applicable to specific programs and payors, including Medicare Shared Savings, Medicare Advantage, and Accountable Care Organizations. For the Medicare Shared Savings Program, potential changes include quality reporting, including changes to measures, revisions that would permit eligible professionals in ACOs to report quality apart from the ACO, and updates to align with the Physician Quality Reporting System and the proposed Quality Payment Program. The proposed rule also includes modifications to align beneficiaries to an ACO when a beneficiary has designated an ACO professional as responsible for their overall care.

Proposed changes related to the Medicare Advantage (MA) Program include requiring MA providers or suppliers that furnish health care items or services to Medicare enrollees who receive Medicare benefits through a MA organization to be enrolled in Medicare and be in an approved status, effective two years from the publication date of the final rule.

New Service Payments 

In this rule, CMS proposes numerous policy updates for primary care services. The proposed policy updates in this rule include recognizing two new CPT codes for separate payment for non-face-to-face prolonged E/M services, which are currently considered to be bundled under the fee schedule. CMS is also proposing to make separate payments for a broader application of care management for beneficiaries with diagnosed behavioral conditions in a primary care setting. 

CMS is also aiming to increase payment for chronic care management (CCM) services. CMS will recognize payment for existing CPT codes and adding a G-code that improves payment for visits that qualify as initiating visits for CCM services. CMS is also proposing a G-code that would provide separate payment to a physician for assessing and creating a care plan for beneficiaries with cognitive impairment.  The CPT code will be available for this service in 2018.

Medicare Telehealth Services

After receiving requests from various stakeholders to add telehealth services as Medicare-covered services effective for CY 2017, CMS responded by proposing to expand the list of telehealth services eligible for Medicare reimbursement. Additionally, CMS proposed modifications to current policies on Place of Service (POS) coding.

As telehealth has grown in popularity as a means of delivering healthcare to patients, CMS has recognized its value by continuing to add related services to the list of services eligible for Medicare reimbursement.

CMS proposes to add the following services to the list of telehealth services eligible for Medicare reimbursement beginning CY2017: (1) End-stage Renal Disease (ESRD) Related Services; (2) Advance Care Planning Services; and (3) Critical Care Consultations. CMS also received requests to add services to the telehealth list that it determined did not meet CMS’s criteria for reimbursable telehealth services. CMS considered, but rejected, adding the following procedures for Medicare reimbursement: observation codes; emergency department services; psychological testing; physical therapy, occupational therapy and speech-language pathology services.

Conversion Factor

Under the proposed rule, the 2017 MPFS conversion factor (CF)would be $35.7751, down slightly compared to the 2016 CF of $35.8043. This update reflects a 0.5% update factor specified under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which is offset by a -0.51% relative value unit (RVU) budget neutrality adjustment and a -0.07% adjustment resulting from implementation of a multiple procedure payment reduction policy.

Global period

In the proposed rule, CMS is hoping to implement a controversial data collection related to the Medicare Access and Chip Reauthorization Act of 2015 (MACRA) that requires CMS to collect data on global packages. CMS believes that it may have misvalued these global packages because CMS lacks accurate data on the services provided to Medicare beneficiaries during the 10 day and 90 day post-surgery period.

CMS pays for global packages by grouping the procedure and services in periods both before and after the procedure. Currently, CMS does not have data to indicate the number, or value, of services provided as part of the global package, particularly the pre and post-operative services. Prior to MACRA, CMS had proposed to require physicians to bill all 10 and 90 day global surgery packages as 0 day global surgeries and then bill separately the post-operative care, which would normally be included in the 10 and 90 day episode. The reason for this 0 day requirement was to allow CMS to collect the data necessary to increase the accuracy of Medicare’s payments for the 10 and 90 day surgery packages in the future. One provision in MACRA prohibited CMS from implementing its 0 day strategy and also requires CMS to collect claims-level data to more accurately value, and pay for, services that are paid as part of a global package.

CMS proposes that all practitioners who bill 10 day and 90 day global surgery packages use specific G-codes for documenting in 10-minute intervals their time providing patient care during the global package period. The PFS lists activities included in a typical visit for the proposed G-codes, including taking interim patient history; managing medications; writing progress notes, post-operative orders, prescriptions, and discharge summaries; coordinating care with clinical staff; and, in general, completing forms. Reporting of these activities in 10-minute intervals is required. MACRA provides CMS the authority to impose a 5% payment withhold for practitioners who do not comply with the required claims-based information. CMS, however, is proposing that it would not immediately implement its authority for payment withholds but might do so depending on whether there is an acceptable level of participation.

Appropriate Use Criteria

CMS proposes to continue implementation of a Protecting Access to Medicare Act of 2014 (PAMA) requirement that physicians who order advance diagnostic imaging services consult with appropriate use criteria (AUC) via a clinical decision support mechanism (CDSM). The proposed rule proposes eight priority clinical areas for AUC, sets forth CDSM requirements and the CDSM application process, and proposes exceptions for ordering professionals for whom consultation with AUC would pose a significant hardship. While PAMA mandates that CMS fully implement the AUC program by January 1, 2017, CMS confirmed that it will not meet this deadline. The requirement that ordering professionals begin consulting CDSMs and furnishing professionals append AUC related information to the Medicare claim will not begin earlier than January 1, 2018.

CMS Diabetes Prevention Program

In the program, CMS proposes to allow beneficiaries to participate by “self-referral, community-referral, and healthcare practitioner-referral.” CMS further proposes using a 12-month CDC-approved Diabetes Prevention Program (DPP) curriculum, with 16 core sessions over 16-26 weeks, with the option for monthly core maintenance sessions after 6 months. CMS furthermore proposes that those who successfully complete the yearlong program and maintain the minimum weight loss, be eligible for additional monthly maintenance sessions. CMS also proposes a reimbursement table using a pay-for-performance model, linking payment with number of sessions attended and achievement of weight loss goals, as attested and documented by DPP providers. Documentation should be detailed and kept for 7 years, including status, sessions attended, coaches, date and place, and weight, and comply with HIPAA and all privacy laws. CMS requests feedback on the payment structure and guidance on the technical infrastructure to meet these requirements and other regulatory obligations. Finally, CMS recognizes the importance of patient choice to select the DPP provider that best meets each individual’s unique needs and preferences. CMS requests guidance on quality metrics for public reporting that benchmark DPP performance to support member choice.


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