On April 20, 2015, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) released educational guidance designed to assist governing boards of health care organizations (“Boards”) in their compliance oversight functions. This guidance, entitled “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”), was developed in a collaborative effort among the OIG, the Association of Healthcare Internal Auditors (“AHIA”), the American Health Lawyers Association (“AHLA”), and the Health Care Compliance Association (“HCCA”). The Guidance updates previous guidance issued by OIG and AHLA, and incorporates insight from the AHIA and HCCA to help assist the internal auditors, compliance officers, and lawyers that report to the Boards. The document addresses four key issues relating to a Board’s oversight and review of compliance program functions: (1) the roles and relationships among an organization’s audit, compliance, and legal departments; (2) the mechanisms and processes for reporting to the Board; (3) identifying and auditing regulatory risk; and (4) methods to encourage organization-wide accountability for achieving compliance goals and objectives.
Continue Reading OIG Partners with Industry Associations by Issuing Practical Guidance for Health Care Governing Boards on Compliance Oversight
CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas
On November 6, 2014, CMS published a final rule that makes significant and highly technical changes to Medicare payment policies for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS). Notably, the rule finalizes a new methodology for adjusting Medicare DMEPOS fee schedule payment amounts across the country using information from the Medicare DMEPOS Competitive Bidding Program (CBP). CMS estimates that this methodology will cut Medicare DMEPOS reimbursement by more than $4.4 billion over fiscal years 2016 through 2020. The rule also finalizes a mechanism to test the use of bundled monthly payment amounts for certain DME under competitive bidding; modifies CBP change of ownership (CHOW) and termination of contract rules; and codifies Medicare hearing aid coverage policy. Note that CMS did not adopt its proposal to clarify practitioner qualifications for providing custom fitting services for orthotics. The following is a summary of the final rule, with particular emphasis on revisions to CMS’s July 11, 2014 proposed rule.
Continue Reading CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas
HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
On September 19, 2014, the Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) in which it identified several potential regulatory risks to federal health care programs as the result of coupon programs used by drug manufacturers to reduce or eliminate patient copayments for brand-name drugs. In the SAB, the OIG explains that coupon program sponsors and pharmacies will risk the receipt of penalties if they do not take steps to actively prevent federal health care program beneficiaries from using the coupons. According to the OIG, these coupon programs qualify as examples of remuneration offered to consumers to encourage the purchase and use of specific items, and therefore implicate the federal Anti-Kickback Statute. In addition, a claim that includes items or services resulting from such a kickback violation would constitute a false or fraudulent claim under the False Claims Act.
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Is anybody home? Medicare contractors on the prowl for DMEPOS supplier violations of posted business hours and other physical facility standards.
Medicare suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) should be on the alert for enhanced Medicare supplier standard compliance monitoring by CMS, the National Supplier Clearinghouse (NSC), and their agents. Recently, these entities have taken draconian actions to revoke the enrollment of a number of suppliers who failed to be present during indicated hours of operation. Recent Administrative Law Judge (ALJ) decisions have upheld such revocations for technical violation of the Medicare supplier standard, even in the face of extenuating circumstances, reinforcing the need for suppliers to review their practices and policies to ensure full compliance.
Continue Reading Is anybody home? Medicare contractors on the prowl for DMEPOS supplier violations of posted business hours and other physical facility standards.
Supreme Court Upholds ACA Insurance Mandate, Limits Withholding of Medicaid Funds to States
This post was also written by Tillman J. Breckenridge. As has been widely reported, today the U.S. Supreme Court ruled that the Affordable Care Act’s (ACA) individual health insurance mandate does not violate the Constitution because it may be viewed as a permissible tax on individuals who do not obtain health insurance. The only provision of the law that the Court invalidated is a Medicaid provision that threatened states with the loss of existing Medicaid funding if they decline to comply with the ACA’s Medicaid coverage extension. By preserving the vast majority of the landmark health reform law, the Court avoided the policy chaos that would have resulted from striking down the ACA in its entirety. There is now legal certainty for state and federal governments, health care providers and suppliers, drug and device manufacturers, employers and individuals. As discussed below, the focus in Washington will return to continuing implementation of the law. Nevertheless, although the legal battle is over, the political fight will continue and likely reverberate through the coming Presidential and Congressional election campaigns.
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Summary and Analysis of Medicare’s Shared Savings Program for Accountable Care Organizations
The Patient Protection and Affordable Care Act (“PPACA”), enacted in March 2010, requires that the Secretary (“Secretary”) of the Department of Health & Human Services (“HHS”) establish a Medicare “Shared Savings Program” by January 1, 2012. The Shared Savings Program is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to
Court Permits Legal Challenge to Health Reform Law to Proceed
As widely reported in the media, on October 14, 2010, a federal judge in Florida ruled that he will allow a lawsuit challenging the constitutionality of the Affordable Care Act to proceed. The lawsuit argues that the ACA’s individual mandate that people buy health insurance or else pay a penalty exceeds Congress’s authority under the
CMS Proposes Broad Expansion of Medicare/Medicaid/CHIP Provider and Supplier Screening Requirements Under Affordable Care Act Authority
On September 23, 2010, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement provisions of the Affordable Care Act (ACA) designed to strengthen provider and supplier screening requirements under the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP). According to CMS, the Proposed Rule is intended to ensure “that
Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers
In April 2010, Reed Smith provided an extensive analysis 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). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.
In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.
Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.
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Caution Lights Ahead for Pharmaceutical Settlements? Impact of Medicaid Exclusion Provisions of PPACA
We want to alert our manufacturer clients to the potential importance of a specific provision included in our analysis of the recent health care reform legislation. As we note at page 108 of our memorandum:
Medicaid Exclusion from Participation Relating to Certain Ownership, Control, and Management Affiliations (Sec. 6502)
[T]his provision requires Medicaid agencies to exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that: (1) has failed to repay overpayments during the period as determined by the Secretary; (2) is suspended, excluded, or terminated from participation in any Medicaid program; or (3) is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.
Continue Reading Caution Lights Ahead for Pharmaceutical Settlements? Impact of Medicaid Exclusion Provisions of PPACA
Reed Smith Issues Major Analysis of the Patient Protection and Affordable Care Act, Focusing on Health Care Provider and Medical Product Manufacturer Impact
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA), a sweeping measure designed to expand access to health insurance, reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. The President also signed a second bill into law on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which includes a series of “fixes” to the PPACA, including substantive changes to the PPACA’s provisions regarding Medicare prescription drug coverage, Medicare Advantage and fee-for-service payments, Stark law self-referral policy, and Medicaid matching payments, among many others. Within the thousands of pages of the new laws are numerous provisions that will have a direct and material impact on nearly every component of the health care delivery and financing systems in the United States, including health insurers, health care providers, and manufacturers of pharmaceuticals and medical devices, as well as employers, taxpayers, and patients. Moreover, the impact of some of these provisions will be felt immediately, as certain provisions are effective upon enactment, and some have January 1, 2010 effective dates. Reed Smith has prepared a major Alert concentrating on those provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers.
Continue Reading Reed Smith Issues Major Analysis of the Patient Protection and Affordable Care Act, Focusing on Health Care Provider and Medical Product Manufacturer Impact
Identity Theft Red Flag Rule Further Postponed
On April 30, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC’s jurisdiction an additional 3 months to develop and implement their identity theft prevention programs as required under the FTC’s so-called Identify Theft Red Flag Rule. The FTC also stated that that some entities,
American Recovery and Reinvestment Act — Health Information Privacy/Incentives, Medicaid Funding & Other Health Provisions
On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith’s Health Care Memorandum summarizes the major health policy provisions of the Act.
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