The Access Board's Medical Diagnostic Equipment Accessibility Standards Advisory Committee has issued its final report on “Advancing Equal Access to Diagnostic Services: Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities.” The report includes detailed recommendations on standards for access to equipment such as examination tables and chairs, weight scales, and diagnostic equipment. Among other things, the report address transfer access, armrests, lift compatibility, and other features for accessibility. The standards, which are being developed as directed under the ACA, still must be approved by the full Access Board.
The Medicare Payment Advisory Commission (MedPAC) has released its 2013 Data Book on Health Care Spending and the Medicare Program. The publication provides information on national health care and Medicare spending and utilization, Medicare and dual-eligible beneficiary demographics, Medicare quality, Medicare beneficiary and other payer liability, and related issues.
As covered on Reed Smith’s Life Sciences Legal Update blog, Affinity Health Plan, Inc. (Affinity) recently reached a $1.2 million settlement with the HHS Office for Civil Rights related to potential violations of the Health Information Portability and Accountability Act of 1996 (HIPAA). Affinity self-reported a breach after learning from a CBS Evening News investigative report that electronic protected health information (PHI) was stored on the hard drives of photocopiers formerly leased to Affinity. Since almost every business uses photocopiers, Affinity serves as a reminder that all covered entities and business associates should implement policies and procedures to ensure that all hard drives are scrubbed of PHI before leaving their possession. For more information, please see the full post.
As reported on Reed Smith's Life Sciences Legal Update blog, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China recently announced that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. Noting that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits, the investigation is intended to strengthen hospitals’ management of the use of medical devices and to regulate the use of high value medical consumables. The Beijing MOH will also develop a database that will track the price and model of devices implanted in each patient, require hospitals to improve their purchasing management systems, and conduct periodic inspections of hospitals’ purchasing and management of medical consumables. For more information about this recent investigation and increased life sciences regulatory enforcement in China, see the full post.
The Medicare Payment Advisory Commission (MedPAC) has released its June 2013 Report to the Congress on Medicare and the Health Care Delivery System. The report examines a number of potential ways to reform Medicare, including the following:
- Redesigning the Medicare benefit. MedPAC continues to discuss the concept of competitively determined plan contributions (CPC), under which Medicare beneficiaries could receive care through either a private plan or traditional fee-for-service, but the premium paid by the beneficiary could vary depending on the coverage option chosen. The federal government’s payment for a beneficiary’s care would be determined through a competitive process comparing the costs of available options for coverage. The report identifies key issues to be addressed if the Congress wishes to pursue a policy option like CPC, such as how benefits could be standardized for comparability, how to calculate the Medicare contribution, and the structure of subsidies for low-income beneficiaries.
- Reducing Medicare payment differences across sites of care. MedPAC notes that Medicare payment rates often vary for similar services provided to similar patients, simply because they are provided in different sites of care (e.g., physician’s office vs. hospital outpatient department). The report identifies services that may be eligible for equalizing or narrowing payment differences across settings.
- Bundling post-acute care services. MedPAC explores the implications for quality and program spending for different design features of post-acute care payment bundles, such as the services included, the length of time covered by the bundle, and the method of payment.
- Reducing hospital readmissions. MedPAC suggests further refinements to improve incentives for hospitals and generate program savings through reduced readmissions, including proposals to address the effect of random variation on hospitals with small numbers of cases, the inability of the industry to reduce average penalties with improved performance, the correlation of patient income and readmission rates, and the inverse relationship between readmissions and mortality for cardiac patients.
- Payments for hospice services. MedPAC presents information on the prevalence of long-stay patients and the use of hospice services among nursing home patients to inform future hospice payment reforms. MedPAC also provides additional information supporting its March 2009 recommendations to revise the hospice payment system.
- Improving care for dual-eligible beneficiaries. MedPAC discusses the potential role that federally qualified health centers and community health centers can play in coordinating care for Medicare-Medicaid dual-eligible beneficiaries.
In addition to discussing these delivery reforms, the MedPAC report addresses Congressionally-mandated reviews of the following topics: Medicare ambulance add-on payments; geographic adjustment of fee schedule payments for the work effort of physicians and other health professionals; and Medicare payment for outpatient therapy services.
The Medicaid and CHIP Payment and Access Commission (MACPAC) has released its June 2013 Report to the Congress on Medicaid and CHIP, covering issues such as Medicaid and CHIP eligibility, coverage for maternity services, increased Medicaid payment for primary care physicians services, access to care for persons with disabilities, Medicaid and CHIP data for use in oversight and program monitoring, and program integrity efforts. This report also includes the latest MACStats data supplement.
Today, the Obama Administration released its proposed federal budget for fiscal year 2014. As widely reported, the budget incorporates an offer the President made to Congress in December 2012 to achieve nearly $1.8 trillion in additional deficit reduction over the next 10 years, including $401 billion in health savings (the Administration observes that this level of cuts would “provide more than enough deficit reduction to replace the damaging cuts required by the Joint Committee sequestration”).
Virtually all provider types – and drug manufacturers – would be impacted by the budget provisions, if adopted as proposed. The budget proposal is certainly subject to change during the legislative process, particularly as the House and Senate leadership pursue alternative budget frameworks, and indeed, gridlock could prevent significant action on entitlement reform this year. Nevertheless, the proposals bear careful monitoring because they could eventually be included in any long-elusive “grand bargain” to reform the Medicare program and reduce the federal debt.
Highlights of the Administration’s Medicare and Medicaid proposals include the following:Continue Reading...
MedPAC has released its annual report to Congress on Medicare Payment Policy, including payment update recommendations for all the major Medicare FFS payment systems and limited Medicare Advantage (MA) recommendations. The report also includes data on the status of the MA and Medicare Part D programs, including information about enrollment, plan options, and beneficiary cost-sharing. Note that while MedPAC’s recommendations are not binding, Congress and CMS often take into account MedPAC’s assessments when updating Medicare payment policies. Major recommendations include the following (many of which were included in previous reports):Continue Reading...
The Medicaid and CHIP Payment and Access Commission (MACPAC) has released its “March 2013 Report to the Congress on Medicaid and CHIP,” including both policy recommendations and data updates. The policy recommendations address implementation of ACA provisions designed to expand health insurance coverage. First, MACPAC recommends that Congress create a statutory option for states to implement 12-month continuous eligibility for children enrolled in CHIP and adults enrolled in Medicaid, in conformance with policies in effect for children in Medicaid (the report notes that the option will otherwise be removed under new income-counting eligibility standards). Second, MACPAC recommends that Congress permanently fund Transitional Medical Assistance (TMA), while allowing states to opt out of the program if they expand to the new adult group added by the ACA. The report also includes a discussion of various policy issues involving the dually eligible Medicare and Medicaid population, and it provides an update to its MACStats data supplement.
In case you missed them, Reed Smith attorneys have recently prepared the following Client Alerts on major regulatory issues:
The HHS Office for Civil Rights recently announced its first settlement and corrective action plan following a HIPAA breach affecting fewer than 500 individuals. Additional information about the settlement is available on Reed Smith’s Life Sciences Legal Update blog.
On November 21, 2012, the Massachusetts Public Health Council finalized amendments to the State’s Marketing Code of Conduct, which restricts certain payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners and imposes other disclosure requirements regarding such payments. The rules, which are effective December 7, 2012, are summarized on the Reed Smith’s Life Sciences Legal Update blog.
On the Reed Smith Life Sciences Legal Update blog, Health Care team members Thomas Greeson and Paul Pitts have written about post-election implications for the radiology industry. The report describes their assessments of the short and mid-term time horizon for a number of health policy developments such as integration (e.g., accountable care organizations), government enforcement, antitrust, and self-referrals. For additional details, see our full post.
Massachusetts Approves Emergency Amendments on State "Sunshine Act" Drug/Device Manufacturer Reporting Requirements
On the Reed Smith Life Sciences Legal Update blog, there is a recent post regarding the Massachusetts Public Health Council’s approval of emergency amendments to the State’s Marketing Code of Conduct regulations. The underlying regulations restrict certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners (HCPs) and require disclosure of payments and transfers of value to HCPs. The emergency amendments, which follow state legislative amendments, now allow manufacturers to provide modest meals and refreshments to HCPs at non-CME educational presentations and modify applicable reporting requirements. The amendments also address the interaction of state requirements and federal law, including the ACA’s Physician Payment Sunshine Act provisions. For additional details, see our full post.
Vermont Offers Limited Amnesty to Device and Biologic Manufacturers who Failed to Report Payments to Health Care Providers
This post was written by Katie C. Pawlitz.
Today the Office of the Vermont Attorney General announced that the Vermont Attorney General is offering limited amnesty to medical device and biologic manufacturers who have failed to report pursuant to Vermont’s Prescribed Products Gift Ban and Disclosure Law. The offer will remain open until October 1, 2012. In order to take advantage of the offer, manufacturers must email firstname.lastname@example.org with the following information: (1) manufacturer name; (2) reporting periods not reported; and (3) name, address, email, and phone number of the representative with whom Vermont should communicate.
The reporting obligation under the Vermont Law became effective July 1, 2009 and, to date, manufacturers have been required to report to Vermont with respect to three reporting periods. The amnesty offer is limited to financial penalties authorized under the Law and does not apply to back-payment of registration fees or penalties for violations of other aspects of the Law, such as gift ban violations. The Office of the Attorney General has indicated that it does not anticipate seeking full disclosure for unreported activity, but that it does anticipate requiring at a later date, disclosure of aggregate information regarding the activity.
The Senate Health, Education, Labor and Pensions Committee held a field hearing in Connecticut on “Lyme Disease: A Comprehensive Approach to an Evolving Threat.” On September 11, 2012, the House Ways and Means Oversight Subcommittee is holding a hearing on the Internal Revenue Service’s implementation of various ACA tax provisions. Also on September 11, the House Small Business Healthcare Subcommittee is holding a hearing on "Medicare's Durable Medical Equipment Competitive Bidding Program: How Are Small Suppliers Faring?"
Reed Smith’s Life Sciences Legal Update blog discusses a recent decision by the United States District Court for the Southern District of Ohio that may make it much harder for qui tam relators to rely upon stolen medical records or patient information in False Claims Act ("FCA") whistleblower actions. In the decision, Cabotage v. Ohio Hospital for Psychiatry, No. 11-cv-50 (S.D. Ohio July 27, 2012), the district court held that a registered nurse was not permitted to support her allegations of FCA violations by relying on confidential protected health information that she surreptitiously removed from the hospital where she was employed.
Fifth Circuit Upholds Ability of Government Employee Fraud Investigators to Bring Qui Tam False Claims Actions
Reed Smith's Global Regulatory Enforcement Law Blog recently featured a post on the Fifth Circuit’s ruling in United States ex rel. Little v. Shell Exploration & Production Co., in which the Court held that government employees are entitled to bring qui tam actions under the False Claims Act (FCA) – even if their federal job function is to investigate fraud on behalf of the government.
The Patient-Centered Outcomes Research Institute (PCORI) is seeking comments on its draft Methodology Report, proposing standards for the conduct of patient-centered outcomes research. The report covers, among other things, the rationale for standards for patient-centeredness, prioritizing topics for research; choosing a study design; and for designing, conducting, and reporting research (including standards for adaptive and Bayesian trial designs, registries, and diagnostic tests). The report also highlights what PCORI characterizes as gaps in evidence that should be addressed by PCORI’s program of methodological research. Comments will be accepted until September 14, 2012.
On July 26, 2012, the Justice Department announced that U.S. Attorney’s offices across the nation are teaming with the Civil Rights Division to target enforcement efforts on ensuring that people with disabilities, especially those who are deaf or hard of hearing, have access to medical information provided to them in a manner that is understandable to them. The “Barrier-free Health Care Initiative” also will target physical access to medical buildings for individuals with disabilities.