H.R. 2256 — what changed

“7330B. Annual report on Veterans Health Administration and furnishing of hospital care, medical services, and nursing home care

changed “(a) Report required—Not later than March 1 of during each year, of years 2016 through 2020, the Secretary shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on the furnishing of hospital care, medical services, and nursing home care under the laws administered by the Secretary Secretary, and on the administration of the provision of such care and services by the Veterans Health Administration during the calendar year preceding the calendar year during which the report is submitted.

“(b) Contents of report—Each report required by subsection (a) shall include each of the following for the year covered by the report:

“(1) An evaluation of the effectiveness of the Veterans Health Administration program in increasing the access of veterans eligible for hospital care, medical services, and nursing home care furnished by the Secretary to such care.

“(2) An evaluation of the effectiveness of the Veterans Health Administration in improving the quality of health care provided to such veterans, without increasing the costs incurred by the Government or such veterans, which includes the relevant information for each medical center and Veterans Integrated Service Network of the Department set forth separately.

“(3) An assessment of—

“(A) the workload of physicians and other employees of the Veterans Health Administration;

“(B) patient demographics and utilization rates;

“(C) physician compensation;

“(D) the productivity of physicians and other employees of the Veterans Health Administration;

“(E) the percentage of hospital care, medical services, and nursing home care provided to such veterans in Department facilities and in non-Department facilities and any changes in such percentages compared to the year preceding the year covered by the report;

“(F) pharmaceutical prices; and

changed “(G) third party third-party health billings owed to the Department, including the total amount of such billings and the total amounts collected, set forth separately for claims greater than $1000 $1,000 and for claims equal to or less than $1000.$1,000.

“(c) Definitions—In this section, the terms “hospital care”, “medical services”, “nursing home care”, and “non-Department facilities” have the meanings given such terms in section 1701 of this title.”

“8129. Procurement of biological implants

“(a) In general

“(1) The Secretary may procure biological implants of human origin only from vendors that meet the following conditions:

“(A) The vendor uses the standard identification system adopted or implemented by the Secretary under section 7330C(a) of this title and has safeguards to ensure that a distinct identity code has been in place at each step of distribution of each biological implant from its donor.

“(B) The vendor is registered as required by the Food and Drug Administration under subpart B of part 1271 of title 21, Code of Federal Regulations, or any successor regulation, and in the case of a vendor that uses a tissue distribution intermediary or a tissue processor, the vendor provides assurances that the tissue distribution intermediary or tissue processor is registered as required by the Food and Drug Administration.

“(C) The vendor ensures that donor eligibility determinations and such other records as the Secretary may require accompany each biological implant at all times, regardless of the country of origin of the donor of the biological material.

“(D) The vendor agrees to cooperate with all biological implant recalls conducted on the vendor’s own initiative, on the initiative of the original product manufacturer used by the vendor, by the request of the Food and Drug Administration, or by a statutory order of the Food and Drug Administration.

“(E) The vendor agrees to notify the Secretary of any adverse event or reaction report it provides to the Food and Drug Administration, as required by section 1271.350 of title 21, Code of Federal Regulations, or any successor regulation, or any successor regulation, or of any warning letter from the Food and Drug Administration issued to the vendor or a tissue processor or tissue distribution intermediary it uses by not later than 60 days after the vendor receives such report or warning letter.

“(F) The vendor agrees to retain all records associated with the procurement of a biological implant by the Department for at least 10 years after the date of the procurement of the biological implant.

“(G) The vendor provides assurances that the biological implants provided by the vendor are acquired only from tissue processors that maintain active accreditation with the American Association of Tissue Banks or a similar national accreditation specific to biological implants.

“(2) The Secretary may procure biological implants of non-human origin only from vendors that meet the following conditions:

“(A) The vendor uses the standard identification system adopted or implemented by the Secretary under section 7330C(a) of this title.

“(B) The vendor is a registered establishment as required by the Food and Drug Administration under sections 807.20 and 807.40 of title 21, Code of Federal Regulations, or any successor regulation, (or is not required to register pursuant to section 807.65(a) of such title) and in the case of a vendor that is not the original product manufacturer of such implants the vendor provides assurances that the original product manufacturer is registered as required by the Food and Drug Administration.

“(C) The vendor agrees to cooperate with all biological implant recalls conducted on the vendor's own initiative, on the initiative of the original product manufacturer used by the vendor, by the request of the Food and Drug Administration, or by a statutory order of the Food and Drug Administration.

“(D) The vendor agrees to notify the Secretary of any adverse event report it provides to the Food and Drug Administration as required in part 803 of title 21, Code of Federal Regulations, or any warning letter from the Food and Drug Administration issued to the vendor or the original product manufacturer it uses by not later than 60 days after the vendor receives such report or warning letter.

“(E) The vendor agrees to retain all records associated with the procurement of a biological implant by the Department for at least 10 years after the date of the procurement of the biological implant.

“(3)

“(A) The Secretary shall procure biological implants under the Federal Supply Schedules of the General Services Administration unless such implants are not available under such Schedules.

“(B) With respect to biological implants listed on the Federal Supply Schedules, the Secretary shall accommodate reasonable vendor requests to undertake outreach efforts to educate medical professionals of the Department about the use and efficacy of such biological implants.

“(C) In the case of biological implants that are unavailable for procurement under the Federal Supply Schedules, the Secretary shall procure such implants using competitive procedures in accordance with applicable law and the Federal Acquisition Regulation.

“(4) Section 8123 of this title shall not apply to the procurement of biological implants.

“(b) Penalties—In addition to any applicable penalty under any other provision of law, any procurement employee of the Department who is found responsible for a biological implant procurement transaction with intent to avoid or with reckless disregard of the requirements of this section shall be ineligible to hold a certificate of appointment as a contracting officer or to serve as the representative of an ordering officer, contracting officer, or purchase card holder.

“(c) Definitions—In this section:

“(1) The term biological implant shall have the meaning given such term in section 7330C(d) of this title.

“(2) The term distinct identity code means a code that—

“(A) relates a biological implant to the human donor of the implant and to all records pertaining to the implant;

“(B) includes information designed to facilitate effective tracking, using such code, from the donor to the recipient and from the recipient to the donor; and

“(C) satisfies the requirements of section 1271.290 of title 21, Code of Federal Regulations, or any successor regulation.

“(3) The term “tissue distribution intermediary” means an agency that acquires and stores human tissue for further distribution and performs no other tissue banking functions.

“(4) The term “tissue processor” means an entity processing human tissue for use in biological implants including activities performed on tissue other than donor screening, donor testing, tissue recovery and collection functions, storage, or distribution.”