Preliminary discussions surrounding drug supply chain safety legislation show several differences between House and Senate proposals, with a lower chamber draft leaving out provisions such as those providing FDA with authority to share confidential information with foreign regulators and to request records.

Care coordination is not something that can be achieved by simply plugging new technology or professionals into the health care system, some members of Congress' Medicare advisory board said Friday (April 6), and the failure of most coordinated care demonstrations to return significant savings and quality improvements could be a result of the health care delivery system, not the demonstrations themselves.

Medicare would include catastrophic coverage, seniors would pay a surcharge for Medigap supplemental insurance plans, and CMS could change cost sharing depending on the value of services, even after passing catastrophic thresholds, were Congress to accept draft recommendations that Medicare Payment Advisory Commission approved Thursday (April 5).

FDA's top drug official recommended against statutory specificity limiting the agency's use of a special population limited medical use designation initially floated for antibiotics but also discussed for obesity drugs, as debate emerges about whether the agency should be given extensive authority to use the designation broadly or if that power should be narrowly defined in specific drug areas.

A safety advocate said FDA approval of an obesity drug recently recommended by an advisory committee would be a mistake because the product's clinical trials only included obese people, therefore making it difficult to know the risks for patients that are not obese, but seek weight loss.

A recent FDA advisory committee decision to evaluate all obesity drugs for cardiovascular risks was supported by an industry analyst for establishing standards for obesity drug development and a safety advocate for setting strong safety standards.

Some members of Congress' Medicare advisory board worried Thursday (April 5) that the size of CMS demonstrations aimed at aligning Medicare and Medicaid financing for people who are in both programs pushes the plan from a demonstration towards a waiver program.

There is growing concern over what the implications would be for money that has already been spent under the health reform law if the Supreme Court decides that the entire law is unconstitutional, sources tell Inside Health Policy, and answers are far from clear.

FDA cannot regulate drug company rebuttals of comparative effectiveness research or the risk information that companies circulate about off-label uses, drug companies say, because free-speech rights protect the exchange of scientific information and the communications do not fall under the agency's explicit powers over labeling and advertising.

CEOs from each of Select Medical's 111 long-term care hospitals (LTCHs) were on the Hill last week to lobby House and Senate leadership and committees of jurisdiction on a bill that would set criteria for admitting patients to LTCHs, Select Medical President David Chernow told Inside Health Policy.

When patients are sent home from hospitals to recover with the help of home health-care services, Medicare saves a significant amount of money on average compared to other post-acute settings, according to a industry funded study released Thursday (April 5).

Draft drug reform legislation released by the Senate health committee Wednesday (April 4) instructs FDA to release long-awaited social media guidance, with the bill also including previously introduced measures codifying the accelerated approval process, creating a new breakthrough drug designation to speed up development of promising medications and expanding the agency's use of experts for advice on rare diseases.

Supporters of the health law are pointing to a couple of key statements by Chief Justice John Roberts and Justice Anthony Kennedy made during last week's oral arguments that they say indicate the two conservative justices may accept the government's argument that the requirement for most Americans to have minimum coverage is constitutional.

Safety advocates continue to push for stronger conflict-of-interest requirements as part of legislation reauthorizing user fees as draft bills in the House and Senate remove caps on the number of waivers FDA can grant and they are also working to pass a law reforming federal advisory committees that could also apply to FDA panels if repeal efforts succeed.

FDA's top drug officials touted the advancement of a combination clinical trial program for tuberculosis backed by a public-private partnership, saying drug companies should join other firms in similarly structured coalitions to conduct pivotal trials.

House Energy and Commerce Republicans are pushing FDA to justify several policy changes they say the agency is proposing in a draft guidance on in vitro diagnostics for research and investigational use, largely echoing concerns raised by industry over the agency's definition of intended use, regulation of clinical laboratories and a requirement that manufacturers must ensure end users are compliant with regulations.

Hospital stakeholders say CMS' unprompted decision to increase the number of additional documents that Recovery Audit Contractors (RACs) can request during investigations could lead to additional administrative burdens and worry that increased document requests could be the wave of the future.

A coalition of hospitals working to reverse a health reform provision affecting the Medicare wage index that it says benefits Massachusetts to the detriment of other states has asked CMS Acting Administrator Marilyn Tavenner to use administrative authority to address the issue in the forthcoming proposed inpatient prospective payment regulation.

As part of a sizeable stakeholder effort to improve health care quality and reduce patient harm and waste, nine physician specialty societies -- including the American Academy of Family Physicians, the American College of Radiology and the American Society of Clinical Oncology -- have identified 45 commonly-used tests that they say are often unnecessary and whose use physicians and patients should question.

FDA's tentative plan to move some prescription drugs to over-the-counter, but with conditions for safe use that other OTC drugs do not contain, could undermine some of the administration's health-care reform efforts to improve the quality of care, including Accountable Care Organizations, according to a physician representing the American Medical Association.