Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act” (so referenced herein, or as the “Act”). The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.

The Proposed Rule comes more than two months after CMS’s statutory deadline of October 1, 2011. CMS proposes an expansive reading of its statutory authority, arguably extending reporting requirements to manufacturers and payments not contemplated by Congress. Moreover, while offering some much-needed clarification regarding certain tracking and reporting obligations under the Act, it leaves many questions unanswered. Indeed, CMS solicits comments on almost every aspect of the Proposed Rule – 60 topic areas in all. Accordingly, significant ambiguity still remains in terms of compliance with certain aspects of the Act. Comments to the Proposed Rule are due no later than 5 p.m. ET February 17, 2012.

This Client Alert outlines the guidance and proposals included in the Proposed Rule. As further discussed in this Alert, CMS has delayed implementation of tracking requirements under the Physician Payment Sunshine Act, but applicable manufacturers and GPOs still are advised to continue to prepare for implementation of the Act, potentially occurring during this calendar year 2012. Applicable manufacturers and applicable GPOs may do so by taking steps to ensure that tracking and reporting systems conform to the requirements of the Act and the Proposed Rule, to the extent clarity is currently available, and by closely monitoring future CMS guidance in this area.

To read the full Alert, click here.

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HHS has issued its final “Strategic Framework on Multiple Chronic Conditions.” The initiative is designed to represent a “paradigm shift” from a focus on individual chronic diseases to one that uses a multiple chronic conditions approach. HHS highlights the health care resource implications associated with MCCs, since 66% of the country’s total health care spending goes toward care for the roughly quarter of Americans with MCCs (e.g., arthritis, chronic respiratory conditions, diabetes, heart disease, hypertension, and mental health conditions). The framework provides options for HHS to strengthen coordination of its efforts internally and collaboration with stakeholders externally. The framework has four overarching goals: to provide better tools to caregivers; to maximize the use of proven self-care management and other services by individuals with MCCs; to foster health care and public health system changes to improve the health of individuals with MCCs; and to facilitate research in this area. Each of these goals includes several key objectives and strategies to guide HHS’s efforts.

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The Department of Justice’s Civil Rights Division and the HHS OCR have issued technical assistance guidance for medical providers on requirements for providing accessible medical services to people with mobility disabilities. Specifically, “Access to Medical Care for Persons with Mobility Disabilities” describes how the Americans with Disabilities Act and Section 504 of the Rehabilitation Act of 1973 apply to providers, including an overview of requirements, answers to, commonly asked questions, and illustrated examples of accessible facilities, exam rooms, and medical equipment. 

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Suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) will be impacted, directly and indirectly, by numerous provisions of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), collectively known as the “Affordable Care Act” or ACA.

Among other things, the Affordable Care Act:  expands the Medicare DMEPOS competitive bidding program; revises the Medicare DMEPOS fee schedule payments (including applying a “productivity adjustment” to the fee schedule update); exempts pharmacies from certain DMEPOS accreditation requirements; revises Medicare power wheelchair payment policy; mandates disclosure of certain payments between manufacturers and physicians; institutes a variety of new program integrity provisions; and imposes a new tax on medical devices.  These provisions are discussed in greater detail below. 

This memorandum supplements our extensive Affordable Care Act analysis released in April 2010, which explains how the law expands access to health insurance (including through subsidies, mandates, and market reforms); reduces health care spending (particularly in the Medicare program); expands federal fraud and abuse authorities; and institutes a variety of other health policy reforms.  We also have posted additional Reed Smith Health Care Reform Review articles focusing on specific aspects of the legislation on our health policy blog, Health Industry Washington Watch, where we also are reporting on implementation efforts associated with the ACA.

To read the full alert, click here.

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