The Centers for Medicare & Medicaid Services (CMS) has released several important decisions recently, affecting various areas of the health care industry.

A National Coverage Determination has been issued this month, which expands Medicare coverage of artificial hearts that have been implanted as part of Food and Drug Administration studies, and that meet the CMS' Coverage with Evidence Development (CED) research requirements regarding safety, patient protections, and monitoring. The decision changes previous policy in place since 1986, and now gives opportunities for beneficiaries to gain advantages of new technology. According to CMS Acting Administrator Kerry Weems, the decision also "encourages the completion of FDA post-approval studies." Artificial hearts assist patients who are waiting for donor hearts or those who aren't able to receive transplants. Clinical trials on artificial heart devices have been conducted since 1986, which has indicated to CMS that enough evidence of safety and health outcomes exist for the devices in FDA-approved studies to be covered through Medicare.

CMS has also published the final regulation establishing rate year (RY) 2009 Federal payment rates and policies for long-term care hospitals (LTCHs). LTCHs are considered hospitals with an average Medicare inpatient stay longer than 25 days. There are nearly 400 LTCHs in the U.S., offering acute care treating severely ill patients, or those with complicated medical conditions. The new rate enables quality treatment for those who need long-term care. If a patient is admitted to an LTCH within 60 days after being discharged from another inpatient facility, no second deductable need be paid. Administrator Weems commented that the new rule will encourage LTCHs to "provide compassionate, efficient care to some of Medicare's most severely ill patients." The standard Federal rate for LTCHs is raised by 2.7 percent from the 2008 rate established by Congress in the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA). While the LTCH payments will not include payments for physicians and nonphysician providers who bill Medicare separately, if the cost of the LTCH treating a beneficiary is higher than estimated, Medicare will cover a certain percentage of the excess costs.

CMS recently initiated a pilot project to encourage Medicare beneficiaries to utilize internet resources to track health care, and facilitate communication with health care providers. The project involves and on-line tool, a Personal Health Record (PHR). The PHR enables beneficiaries collection and access to their health information and their health care services. The CMS has stressed that privacy and security safeguards are instituted for data protection. The pilot test will begin in South Carolina and will run for 12 months. Information from health care providers will be entered in the PHR upon a beneficiary's registration. Prescription drug information will not be automatically entered, but a user may enter his or her own medication information to the PHR.

A PHR is under the control of the patient and is different than an electronic health record (EHR), which is under the control of the physician. The beneficiary controls control who may access the information in the PHR.

Finally, the CMS has proposed stronger protections for beneficiaries enrolled in Medicare Advantage health plans and Medicare prescription drug plans, and beneficiaries enrolled in special needs plans.

The proposed regulation is continuing compliance and oversight of the Medicare Advantage program, and prohibits unsolicited door-to-door marketing and cold-calling of beneficiaries, as well as sales activities in areas where beneficiaries receive health care education or services. Another proposal is a requirement for Medicare Advantage organizations to have state-licensed agents for MA and Part D marketing, and to establish level commission structures for sales agents and brokers for all years and all MA plan product types. Under the proposal, CMS would be able to determine flexible penalty amounts and authority to impose a penalty of up to $25,000 for each enrollee affected by a violation.

The rule also proposes new protections for beneficiaries enrolled in special needs plans in institutions such as nursing homes, and those eligible for both Medicare and Medicaid programs and/or have certain severe or disabling chronic conditions. The protections include a requirement that 90 percent of new enrollees in special needs plans be special needs individuals, and protection of beneficiaries from being billed for cost-sharing that is not their responsibility.

More information is available at: http://www.cms.hhs.gov/apps/media/press_releases.asp