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State legislative approaches to regulating coverage for experimental procedures.

As addressed in past issues of the Newsletter, the Employment Retirement Income Security Act ("ERISA"), 29 U.S.C. sections 1001 et seq., limits the ability of states to regulate the terms and conditions of group health plans. See Newsletters, Vol. 8, No. 6, June 1993, at 6 and 23; Vol. 8, No. 1, January 1993, at 7; Vol. 7, No. 2, February 1992, at 13; Vol. 6, No. 11, November 1991, at 3. Under ERISA, states cannot mandate that self-insured group health plans or employers provide specific types of coverage. Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 105 S.Ct. 2380 (1985). Such mandates are enforceable only as to insurance companies and HMOs, and only to the extent that they are deemed to "regulate insurance." Id. As a result, state legislative attempts to regulate experimental treatment insurance coverage have largely been limited to health plans that are not self insured. Given the inconsistent handling of experimental treatment insurance coverage by both insurance companies and courts across the nation, state legislatures have demonstrated that they are ready to address this matter themselves. However, unless ERISA is amended to afford employees with self-insured plans the same protections as those with insured plans, such state efforts will not be able to resolve the problem for all citizens.

Bone Marrow Transplantation↗

Medicare and Medicaid programs; quarterly listing of program issuances and coverage decisions--second quarter 1994--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations and other Federal Register notices, and statements of policy that were published during April, May, and June of 1994 that relate to the Medicare and Medicaid programs. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe. We are also providing the content of revisions to the Medicare Coverage Issues Manual published between April 1 and June 30, 1994. On August 21, 1989, we published the content of the Manual (54 FR 34555) and indicated that we will publish quarterly any updates. Adding to this listing the complete text of the changes to the Medicare Coverage Issues Manual allows us to fulfill this requirement in a manner that facilitates identification of coverage and other changes in our manuals.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare program; Medicare coverage of prescription drugs used in immunosuppressive therapy--HCFA. Final rule.

This final rule amends the regulations to provide Medicare coverage for prescription drugs used in immunosuppressive therapy furnished to an individual who receives an organ transplant for which Medicare payment is made. This rule reflects the enactment of section 1861(s)(2)(J) of the Social Security Act that provides Medicare coverage for prescription drugs used in immunosuppressive therapy for a period of up to 1 year from the date of discharge from an inpatient hospital stay during which the Medicare-covered organ or tissue transplant was performed. This final rule also implements section 13565 of the Omnibus Budget Reconciliation Act of 1993 (Public Law 103-66) and section 160 of the Social Security Act Amendments of 1994 (Public Law 103-432) that, beginning January 1, 1995, expand Medicare coverage for prescription drugs used in immunosuppressive therapy from 1 year to a phased-in period of 3 years from the date of discharge from a hospital stay during which the Medicare-covered organ or tissue transplant was performed.

Centers for Medicare and Medicaid Services, U.S.↗

Medicaid program; eligibility and coverage requirements--HCFA. Final rule with comment period.

These regulations amend the requirements for coverage of certain groups of individuals under Medicaid and the requirements for determining Medicaid eligibility. The regulations relate to coverage of individuals in optional categorically needy groups; aged, blind and disabled individuals in States that use more restrictive requirements for Medicaid than those under the Supplemental Security Income (SSI) program; individuals receiving optional State supplementary payments; individuals under age 21 who are not receiving AFDC; individuals who are ineligible for cash assistance under the Social Security Act because of requirements that do not apply under Medicaid; and medically needy groups. In addition, the regulations revise the methodologies for determining income and resource eligibility under Medicaid, including financial responsibility of relatives, and for determining financial eligibility of medically needy groups, including determining medically needy income levels. These regulations interpret provisions of the Tax Equity and Fiscal Responsibility Act of 1982, as amended by several acts, including, most recently, the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Family Support Act of 1988, the Omnibus Budget Reconciliation Act of 1989, and the Omnibus Budget Reconciliation Act of 1990. We are also making some administrative changes to achieve more efficient operation of the Medicaid Program.

Adolescent↗

Medicare program; Medicare coverage of hepatitis B vaccine for high and intermediate risk individuals, hemophilla clotting factors and certain X-ray services--HCFA. Final rule.

This final rule implements section 2323 of Public Law 98-369, the Deficit Reduction Act of 1984, which provides Medicare coverage for hepatitis B vaccine for those individuals who are eligible for Medicare and at high or intermediate risk of contracting hepatitis B. This final rule defines those individuals who are at high or intermediate risk of contracting hepatitis B. It also implements section 2324 of Public Law 98-369, which provides coverage for the self-administration of hemophilia clotting factors and the items necessary for their administration to Medicare eligibles. In addition, this final rule clarifies regulations governing Medicare coverage of certain x-ray services.

Centers for Medicare and Medicaid Services, U.S.↗

Childhood immunization coverage in zone 3 of Dhaka City: the challenge of reaching impoverished households in urban Bangladesh.

A household survey of 651 children aged 12-23 months in Zone 3 of Dhaka City carried out in 1995 revealed that 51% of them had fully completed the series of childhood immunizations. Immunization coverage in slum households was only half that in non-slum households. Apart from residence in a slum household, other characteristics strongly associated with the completion of the entire series of childhood immunizations included the following: educational level of the mother, number of children in the family household, mother's employment status, distance from the nearest immunization site, and number of home visits from family-planning field workers. The findings point to the need to improve childhood immunization promotion and service delivery among slum populations. Two promising strategies for improving coverage are to reduce the number of missed opportunities for immunization promotion during encounters between health workers and clients, and to identify through visits to households those children who need additional immunizations. In the long run, increasing the educational level of women will provide a strong stimulus for improving childhood immunization coverage in the population.

Age Factors↗

Federal Old-Age, Survivors, and Disability Insurance; coverage of employees of private nonprofit organizations--SSA. Proposed rules.

These proposed rules implement sections 102, 321, 322 and 323 of Pub. L. 98-21 (the Social Security Amendments of 1983). Generally, these provisions: (1) Mandatorily cover for Social Security purposes employees of private nonprofit organizations; (2) Provide additional Social Security coverage for certain work performed outside the United States (U.S.); (3) Provide coverage under the Social Security program for certain foreign earned income; (4) Provide special Social Security insured status requirements for certain nonprofit organization employees covered as a result of these amendments; and (5) Provide Social Security coverage for employment and self-employment that is identified as "covered" for purposes of title II of the Social Security Act (the Act) by the provisions of a totalization agreement between the U.S. and another country.

Organizations, Nonprofit↗

Malpractice insurance options: claims-made vs. occurrence coverage.

Professional liability insurance is not the trivial matter it was once. Premium costs are significant, the threat of malpractice litigation is tangible, sources of coverage are diverse, and there has been a proliferation of insurance carriers of different genres. Such changes have elevated the choice of malpractice insurance policy to the status of a major decision about which practitioners must be well informed. Differences between claims-made and occurrence coverage are clarified, and the advantages and disadvantages of each type of coverage are canvassed. The benefits of insuring with a commercial carrier versus a physician-owned company are also discussed in the light of trends in the structure of the liability insurance industry.

Insurance, Liability↗

Medicare program; exclusion from Medicare coverage of certain food allergy tests and treatments--HCFA. Proposed notice.

This notice proposes to exclude certain food allergy testing and treatment techniques from Medicare coverage. The procedures that would be excluded from coverage are the cytotoxic leukocyte test, sublingual, intracutaneous and subcutaneous provocative and neutralization testing, and neutralization therapy for food allergies. The Medicare statute and regulations preclude reimbursement for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Available evidence does not show that these tests and therapies for food allergies are safe and effective. Therefore, we are proposing to exclude these techniques from Medicare coverage and provide a uniform Medicare policy concerning these exclusions.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare program; coverage of home intravenous drug therapy services--HCFA. Proposed rule.

These proposed regulations would expand coverage under Medicare part B to include coverage of home intravenous (IV) drug therapy services as authorized by section 203 of the Medicare Catastrophic Coverage Act of 1988. They include requirements for certification and for review and approval of the need for the covered services by a peer review organization, and they place limits on acceptance of and payments for certain patient referrals for covered home IV drug therapy services as specified in the statute. Home IV drug therapy services are covered by Medicare beginning January 1, 1990.

Catastrophic Illness↗

[A study on the coverage, strategy and cost of hepatitis B vaccination in China, 1996].

To understand the coverage, strategy and cost of hepatitis B (HB) vaccination of China in recent years, a randomized two-stage household sampling survey was carried out at 112 Disease Surveillance Points(DSPs) from 25 provinces, autonomous regions and municipalities of China in 1996. Results showed that the rates of HB vaccination coverage among neonates were 96.9% in the urban DSPs and 50.8% in the rural DSPs in 1993-1994, while in 7-9 year-old students both rates were 85.8% and 31.5% in 1994, respectively. Up to 1994, 97.5% of the urban DSPs and 73.9% of the rural DSPs had a neonates vaccination against HB program integrated with routine EPI. Some of the DSPs had a lower neonates coverage due to insufficient amountad unreasonable distribution of the vaccine (used for adults) and high cost. It seems necessary to evaluate the maternal prescreening program regarding the quality of serological testing to HBVMs. Remarkable achievements have been made in terms of strategy development and planning on HB immunization in China.

Child↗

Root coverage and papilla reconstruction in Class IV recession: a case report.

While root coverage is predictable for Miller Class I and II recessions, the surgical regeneration or reconstruction of a lost interdental papilla is more difficult to obtain. To date only a few successful case reports have been reported, and there are no studies that report a predictable technique to obtain papilla reconstruction or root coverage on Class IV recessions. This case report, which is part of a preliminary study, outlines a surgical technique to obtain simultaneous root coverage and papilla reconstruction.

Connective Tissue↗

[Survey of measles vaccine coverage in Brazzaville].

Measles is an infectious disease that continues to be a significant cause of morbidity and mortality among children in Brazzaville. A measles vaccination coverage survey was conducted for children aged 9 to 23 months. A standard EPI cluster sample was applied in two areas: urban and peri-urban. Measles coverage of children after the vaccination campaign according to history ranged from 36.6% in urban to 38.6% in peri-urban areas, compared with 34.5 and 42.8% for routine vaccination in the same areas. The overall rate of measles coverage was 75.4%. The mean age of children was 46 weeks.

Congo↗

Hepatitis B vaccination coverage among Asian and Pacific Islander children--United States, 1998.

Asian and Pacific Islander (API) children in the United States have high rates of hepatitis B virus (HBV) infection (1-3). To prevent these infections, hepatitis B vaccination has been recommended for these children since the vaccine was first licensed by the Food and Drug Administration in 1981 (4). Recommendations have included universal hepatitis B vaccination of API infants beginning in 1990 and catch-up vaccination for API children aged <7 years (5). These recommendations were reinforced in 1991 when hepatitis B vaccination was recommended for all infants, particularly in populations such as API children with high rates of early childhood HBV infection (6). In 1995, vaccination was recommended for unvaccinated API children aged <11 years and catch-up vaccination for children aged 11-12 years who had not received hepatitis B vaccine (HepB) (7). Series completion among API children aged 19-35 months increased from 39% in 1994 to 88% in 1997 (8). However, among older API children, hepatitis B vaccination coverage was 10% in 1995 (7). In 1998, to examine trends in hepatitis B vaccination catch-up coverage among API children born before 1994, surveys were conducted in six U.S. cities. This report summarizes the results of the surveys, which indicate varying coverage among API children and suggest a need for continued focused vaccination programs for this population.

Asian↗

American Academy of Pediatrics. Committee on Medical Liability. Professional liability coverage for residents and fellows.

The American Academy of Pediatrics first developed a policy on professional liability coverage for pediatricians-in-training in 1989 and subsequently reaffirmed its basic position with slight modification in 1993. In this latest iteration of the statement, the original positions have been strengthened to address changes in the professional liability insurance industry, the structure and settings of residency training, and mandated reporting to health provider data banks. The new policy emphasizes the need to provide pediatricians in training with adequate professional liability insurance coverage and to educate residents and fellows on the importance of adequate and uninterrupted professional liability coverage-both during and after residency.

Humans↗

How to talk to the media: televised coverage of public health issues in a disaster.

Public health officials often are critical of the way television news covers disasters, while broadcast journalists complain of a lack of cooperation from the public health sector during disaster coverage. This article summarizes the issues discussed in a session on Televised Coverage of Disasters, presented in April 1999 at the UCLA Conference on Public Health and Disasters in Los Angeles. Public health officials were asked to "talk back to their television sets" in a dialog with television journalists. Concerns included: 1) the lack of balance in television coverage that is dominated by sensational images that may frighten rather than inform the public; 2) the potential for psychological damage to viewers when frightening images are shown repeatedly in the days and weeks of the disaster; and 3) the perception that TV reporters place too much emphasis on crime, property damage, and loss of life, giving relatively low priority to disaster preparedness and to public health issues in the aftermath of a disaster. Options for improving communication between television journalists and public health professionals also are discussed.

California↗

Low-cost on-the-job peer training of nurses improved immunization coverage in Indonesia.

In Indonesia responsibility for immunizations is placed on local government health centres and on the nurses who provide the immunizations at each centre. An on-the-job peer training programme for these nurses, which was designed to improve the immunization performance of poorly performing health centres in terms of coverage and practice in Maluku province, was evaluated. Experienced immunization nurses were sent to health centres where nurses were inexperienced or performing poorly; the experienced nurses spent 1-2 weeks providing on-the-job training for the less experienced ones. An evaluation of the 13 centres that participated in the programme and the 95 that did not found that the programme increased both immunization coverage and the quality of practice. Coverage of diphtheria/pertussis/tetanus (DPT), polio, and measles vaccinations rose by about 39% in all 13 participating centres when compared with non-participating centres, and by about 54% in the 11 centres that had a functioning transportation system during the year after training. These results reflect increases in the actual number of doses given and improvements in the accuracy of reports. Potential threats to the study's validity were examined and found not to be significant. The out-of-pocket cost of the training programme was about US$ 53 per trainee or about US$ 0.05 per additional vaccine reported to have been given. The marginal cost per additional fully immunized child was estimated to be US$ 0.50.

Cost-Benefit Analysis↗

Study of impact of nutrition & health day strategy on the coverage rates of supplementary nutrition and health interventions among the ICDS beneficiaries in a rural block of Madhya Pradesh.

To study the trends of beneficiary coverage (pregnant and lactating women and children less than two years of age) for utilization of supplementary nutrition and health services in a rural block before and after the launch of a strategy to converge Health & Integrated Child Development Services (ICDS) on a single day christened "Nutrition and Health Day" (NHD). It is a before and after intervention design in rural ICDS block Amarwada in district Chhindwada. As a part of intervention, NHD were organised on which convergent services of Health & ICDS were made available to the beneficiaries. On the weekly NHDs, uncooked supplementary nutrition for the week was distributed to pregnant and lactating mothers and children under two. The Health worker visited the Anganwadi Centre (AWC) and immunized children and pregnant women, distributed IFA, Vitamin A and provided health and nutrition education. The study assessed the impact of these interventions on the coverage rates of the services. Study was conducted between May 97 and March 98. The routine monitoring reports of the ICDS and Health System of the state government were used as study tools. The study sample comprised of AWC beneficiaries in the project area. The total population of the block was 89,476. Participation in the supplementary nutrition program (SNP) increased two to three folds in all categories of the target population. Immunization and Vitamin A coverage levels for children also showed an increase of about 3 and 5-8 times from baseline status respectively in a year's time. Among pregnant women, Tetanus Toxoid (TT) and Iron and Folic Acid (IFA) utilization rates have also shown two and five fold increase respectively.

Adolescent↗