Life Science Compliance Update

September 30, 2016

Webinar: Open Payments Retrospect and Looking Forward

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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

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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 regulations.gov. 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. 

ACOs

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.

August 19, 2016

New Jersey Interactive “Transparency” Map

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NJ Spotlight, a website that highlights “news issues and insight for New Jersey” recently created an interactive map of New Jersey doctors who received transfers of value from industry in 2015. The map, which can be found here, allows interested readers to see payments by zip code and details on those doctors who received the most money on the map, in addition to individual payments to doctors by searching the databases that are arranged by last names.

According to the United States Centers for Medicare and Medicaid Services (CMS), New Jersey doctors and hospitals received nearly $59 million last year from drug companies and device makers in gifts, travel, royalties, and consulting/other fees. Of that money, doctors received more than $56 million, while forty-seven hospitals received roughly $2.8 million.

In addition to the interactive map, NJ Spotlight also dissected the payments made to physicians and arranged them in lists, by physician last name. Letters A-L and hospital payments can be found here, while letters M-Z can be found here.

Hospital Receipts

Hackensack University Medical Center was the hospital that received the most in payments - $791,980 – with almost $600,000 of that in payments from Intuitive Surgical, Inc., maker of the da Vinci robotic surgery system. That roughly $600,000 in payments were paid primarily as rental or facility fees.

Morristown Medical Center received $550,000, more than half in the form of grants, with the largest amount (almost $262,000) coming from Novartis Pharmaceuticals, a New Jersey based company.

St. Joseph Hospital and Medical Center in Paterson received $284,000, with the largest payment a $176,000 grant from Gilead Sciences, Inc.

Doctor Receipts

In addition to those hospitals, thirty-one individual doctors received more than $200,000 each. More than 23,000 New Jersey doctors, dentists, optometrists, podiatrists, chiropractors, and others received payments ranging from a few pennies to $4.4 million. That large $4.4 million payout was categorized as a dividend or return on investment, paid by Par Pharmaceutical of New York to Sharad Sunder Mansukani, a Moorestown ophthalmologist. In part because of that large payout, Mansukani received the most payments of any doctor in New Jersey ($5.1 million), mostly in dividends from Par. He also received an additional $45,000 from Par and $40,000 from Immucor, Inc., of Georgia as faculty or speaking fees.

There was only one other doctor who received over $1 million in payments – Randal Betz, an orthopedic surgeon from Lawrenceville. He received payments from a total of nine companies, including $1.4 million in royalty or licensing fees from DePuy Synthes Products, LLC. Roughly $300,000 in other payments led to a total of almost $1.7 million in total payments received.

Other Payments Made

A dozen companies made over $1 million in payments, with the biggest categories for faculty or speaking fees ($16.6 million) and consulting fees ($11.3 million). Companies also spent around $10 million on food and beverages, $4.5 million on physicians’ travel and lodging, $1.3 million in grants, $1.2 million in education, and $1 million for speaking or teaching as part of a continuing medical education program. There were also more than $5 million in investment returns and nearly $5 million in royalty or licensing fees received by doctors.

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